Physician Instructions for Use Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Canary Medical, Inc.
TABLE OF CONTENTS 1. OVERVIEW OF THE CANARY TIBIAL EXTENSION WITH CHIRP SYSTEM.................... 5 2. ADDITIONAL REFERENCED DOCUMENTS................................................................. 6 3. TERMS AND ACRONYMS .......................................................................................... 7 4. DEVICE SYSTEM DESCRIPTION ................................................................................. 9 4.1. The Canary Tibial Extension (CTE)...................................
6. LIMITATIONS .......................................................................................................... 26 7. CONTRAINDICATIONS ............................................................................................ 26 8. MRI Compatibility .................................................................................................. 27 9. GENERAL WARNINGS AND PRECAUTIONS............................................................. 27 9.1. CTE ..............................
11.4.4. Intraoperative: Connection of Canary CTE to Zimmer Biomet Tibial Baseplate and Implantation ......................................................................................... 37 11.4.5. Postoperative: Link the CTE implant and Knee Prosthesis Components to the Patient 39 11.5. 11.5.1. HCP.................................................................................................................. 39 Patient ..................................................................................
19.3. Base Station Units and Accessories ................................................................ 51 20. WARRANTY............................................................................................................. 51 21. PATENTS AND TRADEMARKS ................................................................................. 51 APPENDIX 1 – SYMBOLS GLOSSARY .............................................................................. 53 APPENDIX 2 – DEFINITIONS ...........................
1. OVERVIEW OF THE CANARY TIBIAL EXTENSION WITH CHIRP SYSTEM Before using this device, carefully read all instructions for use. The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) is a tibial extension implant containing electronics and software. Using internal motion sensors (3D accelerometers and 3-D gyroscopes), the CTE collects kinematic data pertaining to a patient’s gait and activity level following total knee arthroplasty (TKA).
Figure 1: Canary Medical CTE with CHIRP System 2. ADDITIONAL REFERENCED DOCUMENTS Table 1 lists additional documents relevant to the CTE with CHIRP System which are referenced in this Instructions for Use (IFU). Table 1 Document Title Document Number Canary Medical Surgical Technique K01-CTE-300005 Location Printed/electronically available www.canarymedical.com Patient Manual K01-HBS-300003 Printed Document Shipped with Home Base Station www.canarymedical.
Document Title Document Number K01-HBS-300005 Patient Quick Start Guide –Setting Up Your Patient Account Location Printed. Provided to patient at surgeon’s office. www.canarymedical.com OR Quick Start Guide – OR Base Station Setup K01-ORBS300003 Printed Document Shipped with OR Base Station www.canarymedical.com 97-5026-001-00 Zimmer Biomet Persona Knee Surgical Technique Zimmer Biomet Instructions for Use 87-6204-042-99 3. TERMS AND ACRONYMS Table 2 lists terms and acronyms used in this document.
Term Meaning IFU Instructions for Use IM Intramedullary IMU Inertial Measurement Unit MCU Microcontroller Unit OR Operating Room PC Personal Computer PMMA Cement Polymethylmethacrylate Bone Cement PPE Personal Protective Equipment RF Radio Frequency RoHS Restriction of Hazardous Substances ROM Range of Motion RTU Ready to Use TKA Total Knee Arthroplasty USB Universal Serial Bus Physician Instructions for Use DRAFT Page | 8
4. DEVICE SYSTEM DESCRIPTION The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) is a system that combines physical components, electronics, software, and user interfaces to collect, store, analyze, transmit, and display patient data for use by both physicians and patients. Table 3 lists the components and interfaces of the CTE with CHIRP System.
Component or Interface Home Base Station System Description Model Number or Catalogue Number Canary OR Application TBD Barcode Scanner AC-900001 USB Power and Data Cables TBD Home Base Station Unit 43-5570-001-14 USB Data and Power Cables AC-900002 Power Adapter AC-900003 Base Station Setup Tool (software application) TBD Canary Cloud Data Management Platform (Cloud) Manages and processes patient data that can be accessed through the patient or physician portal Canary Medical Gait Parame
prosthesis. Like a traditional tibial extension, the CTE provides additional stability to the replacement knee joint. In addition, the software and electronics embedded within the CTE collect the patient’s functional movement and gait parameter information post-surgery. The CTE is an implantable device that is provided sterile to the customer. It is sterilized via Ethylene Oxide (EtO) and is packed in sterile packaging inside a sealed, tamper-proof outer box.
4.2. CTE Template The CTE Template is a surgical instrument used to assist the surgeon during preoperative planning. The CTE Template will be used to assess the patient anatomy for the Zimmer Biomet Persona Tibia Baseplate with Canary Tibial Extension construct sizing. 4.3. CTE with CHIRP System Surgical Instrumentation All CTE with CHIRP System Surgical Instrumentation is supplied non-sterile in an instrument tray.
4.3.2. Canary Tibia Cut Guide (5 Degree – L/R) The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona Primary Knee with a Canary Tibial Extension (CTE) Implant. Figure 5 shows the Canary Medical Tibia Resection Cutting Guides. Left Cutting Guide Right Cutting Guide Figure 5: Canary Tibia Resection Cutting Guides 4.3.3.
4.3.4. CTE Provisional The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation. Figure 7 shows the CTE Provisional. Figure 7: CTE Provisional 4.4.
Analysis and conversion to Canary Medical Gait Parameters for viewing on the Physician and Patient Dashboards. The following information describes the Base Station systems. 4.4.1. OR Base Station System The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Cloud. The action of associating the CTE with the patient also enables the home base station to recognize the CTE when the patient returns home after surgery, thus enabling upload of kinematic data from the CTE to the Canary Cloud without patient intervention. The OR Base Station System consists of an OR Base Station unit, dedicated laptop PC loaded with the Canary software application, barcode scanner, and USB cables. Figure 8 shows a schematic of the OR Base Station System.
Knee Implant Collects Data Base Station Transfers Data Cloud Processes Data Figure 9: Base Station Communication Dashboards Display Data to Doctor and Patient 4.4.3. The Canary Medical Cloud Data Management Platform (Cloud) The Canary Cloud Data Management Platform (“Cloud”) allows users to access it through a browser-based web application.
The CHIRP system is not intended to provide real time data like a smart watch or smart phone. Rather, it collects data over the course of a day, analyzes it while the patient is asleep, and presents the previous day’s data for HCP and patient review the following day. The CTE implant has the ability to store 30 day of data.
Figure 10: Screenshot of Patient Chart on Physician Dashboard Physician Instructions for Use DRAFT Page | 19
4.6. Patient Dashboard The Patient Dashboard is located on the Canary Medical website and is accessible by the patient via his/her Internet browser. Patients can view selected CMGPs generated by their CTE implant, including gait information and activity level. Information available to patients includes: Walking Speed (feet/second) Step Count Range of Motion (degrees) Stride length (feet) Distance (miles) Cadence (steps/minute) Figure 11 shows a screenshot of the Patient Dashboard.
Figure 11: Screenshot of Patient Dashboard Physician Instructions for Use DRAFT Page | 21
5. INTENDED USE 5.1. Intended Use The CTE with CHIRP System is intended to provide objective kinematic data while providing additional stability afforded by a traditional tibial extension. The implanted medical device is used to assist the patient and the physician during a patient’s TKA post-surgical care.
The implanted CTE collects data from internal motion sensors, and when queried by a Home Base Station, transmits the CTE motion sensor data to the associated Home Base Station System. The Home Base Station System then uploads the data to the Canary Cloud Data Management Platform via the patient’s Internet connection. Users of the System are the Patient with the CTE with CHIRP System and their designated Health Care Professional (HCP) with access to the Patient’s CTE data.
Page | 24 OR Base Station System Base Station Unit Dedicated Laptop PC Software Application Bar Code Scanner Power and Data Cables Canary Tibial Extension (CTE) Implant Canary specialized assembly and insertion components o Impaction Sleeve o 5 deg Left Tibial Resection Cutting Guide o 5 deg Right Tibial Resection Cutting Guide o Tibial Drill Bit o CTE Provisional Canary Tibial Extension (CTE) Implant Component/User Interface Physician Instructions for Use DRAFT Perform self-test and sensor check on C
Page | 25 Cloud Data Management Platform Interactions OR Base Station, Home Base Station, Physician and Patient Information Maintenance and security, Canary Medical Gait Parameter Software Review patient’s gait information and activity level Review patient’s gait analytics and activity level Set up Base Station components in Patient’s home Connect to personal computing device and home wireless Internet Download Base Station Setup Tool application to set up communication between the CTE, Base Station U
6. LIMITATIONS The patient needs to have sufficient intramedullary space to accommodate the increased length of the CTE implant in order to avoid cortical perforation. Before choosing the CTE implant for a patient, assess if the patient’s anatomy is appropriate by using the Canary CTE implant X-Ray Templates. The patient must have access to a computer with USB connection and home wireless Internet access in order for their data to be collected, stored, and transmitted by the CTE with CHIRP System. 7.
8. MRI Compatibility The CTE implant is expected to be MRI conditional. (Pending completion of MRI safety testing). WARNING: Pending completion of MRI safety testing. 9. GENERAL WARNINGS AND PRECAUTIONS 9.1. CTE WARNING: Do not use the CTE implant or other sterile packaged components if the package is opened or damaged. This could mean the device is no longer sterile. Use of non-sterile implants or components might result in patient infection, injury, or death.
10. PRINCIPLES OF OPERATION This section provides information describing how the Canary CTE with CHIRP System collects, stores, transmits, and processes the kinematic data generated by the CTE implant.
The CTE has the capability to store up to 30 days of data in memory. If the data contained in the CTE’s memory cannot be transmitted to the Cloud due to connectivity issues with a Base Station and the implant has reached its memory limit, new data will overwrite the oldest data first. In this scenario, data will be lost. The Home Base Station can store up to 45 days of transmitted data if it is not able to connect to the Cloud but is still able to communicate with the implant locally. 10.2.
Parameter Distance Description Units Distance traveled. Calculated from step count and stride length meters Cadence, Stride, Tibia ROM, and Knee ROM are statistical values calculated on the collected sampling day data. The range of motion measurements are schematically illustrated in Figure 12 he angle calculated based on a combination of tabular hip and femur reference data and the Tibia ROM data. – 11.
This information is provided from a user perspective. It is intended to provide directions for HCPs (including surgeons, surgeon’s staff, physicians, and nurses) in the use of the CTE with CHIRP System. It is also intended to inform HCPs about their patients’ role in the use of the system to support patients’ understanding of their health care needs. 11.1. Surgeon’s Office Patient Account Setup 11.1.1.
2. Figure 14 shows a screenshot of the Patient List screen. Click on “Create.” Figure 14: Patient List Screen 3. Use the “Create Patient” screen (Figure 15) to enter the patient’s information (name, DOB, email, etc.). Click “Submit.
4. Instruct the patient to watch for an email with a link and directions on how to register and set up a patient account. 5. Provide the patient with a copy of the Quick Start Guide, Setting Up Your Patient Account, document # K01-HBS-300005 11.2. Patient Registration and Account Setup 11.2.1. Patient The patient receives the email and uses the Quick Start Guide, Setting Up Your Patient Account, document # K01-HBS-300005, to register and set up a patient account.
2. Opens the package, inspects the equipment, and identifies the enclosed Quick Start Guide and Patient Manual. 3. Turns on the patient’s personal computer with USB connection, opens a web browser, navigates to the Canary website, and logs into the patient’s account, which was created previously. 4. Follows the instructions in the Quick Start Guide and Patient Manual to set up the Base Station. 11.4. Day of Surgery The following provides instructions on how to set up, test, and activate the CTE implant.
Base Station Screw Stand Figure 16: Base Station in Stand – Rear View b. Connect the USB cable to the OR Base Station on one end and the Laptop PC on the other, as shown in Figures 17 and 18. Figure 17 Figure 18 c. Connect the Barcode Scanner to the Laptop. d. Plug the Laptop into a power outlet (if needed). e. Turn on the Laptop. The Canary Operating Room Application (OR App) will launch automatically.
f. Ensure the OR Base Station and Laptop are connected. This is indicated by the green “Base Station” icon at the top right of the Laptop screen. g. Ensure an Internet connection has been established and the OR App is connected to the Internet. This is indicated by the green “Internet” icon at the top right of the screen. If the OR App is not connected to the Internet, check the time of last sync. If it has been some time since this has been done, move to a location and attempt to connect to the Internet.
CAUTION: Perform the tibia resection using the Canary Medical Tibia Resection Cutting Guide. The Zimmer Biomet Persona Tibia Resection Cutting Guides have not been tested for use with the Canary Tibial Extension (CTE). 1. Use the Persona instrumentation to properly align and size the tibia plate 2. Create a pilot hole using the Zimmer Biomet Drill Guide and Persona Tibial Drill Bit.
CTE Impaction Sleeve CAUTION: Do not attempt to connect the Canary CTE to the Zimmer Biomet Persona® Knee tibial plate without the Canary Medical instrumentation. Use of different instrumentation may result in incorrect connection or damage to the implant components. After preparation of the patient and confirmation of the trial devices, perform the following steps: 1. Remove and discard the plastic cap on the Zimmer tibial plate. 2. Remove and retain the set screw on the Zimmer tibia plate. 3.
11.4.5. Postoperative: Link the CTE implant and Knee Prosthesis Components to the Patient After the surgery is complete, use the OR PC Application and Bar Code Scanner to link the patient’s implant components with the patient in the patient’s account using the steps below: 1. Go to the Main Menu screen. 2. Under “Postoperative,” click on “Link Implant – Patient.” 3. Choose the patient’s name from the list or click “Manually Enter Patient” to enter the patient’s information.
The CTE with CHIRP System is designed to operate autonomously. Using its proprietary data collection and power management algorithms, the CTE implant will collect, store, and transmit encrypted raw kinematic data from the implant’s triaxial accelerometers and triaxial gyroscopes via the patient’s home Base Station unit to the Cloud. The data will then be processed, analyzed, and converted to quantifiable Canary Medical Gait Parameter metrics.
The CHIRP System is compatible with a range of computing devices and systems. Table 6 lists the compatible device types and operating systems, and minimum specifications that will be required in order for data from the CTE to be accessible from the Canary Medical website to health care providers and patients. Table 6.
Category Current Consumption Specification Long Term Storage: Up to 36 months at 22 +/- 6 degrees C, stored in supplier’s ambient environment. Normal Operating Conditions: The battery shall meet all performance requirements over a temperature range of 35 to 41°C inclusive. Lowest Usage Current Consumption: < 200 nA Communication Standby Current Consumption: < 500 nA Low Resolution Mode Current Consumption: < 15µA.
Category Specification Protection from Ingress of Liquids Standard IEC-60601, clause 6.3. [Also identified in ISO-14708-1 and IEC60529.] CTE Impaction Sleeve OAL: 63.5 mm Max OD: 22 mm ID: 13.08 mm Material: 17-4 PH SS Table 6: OR Base Station System Specifications OR Base Station Unit Specification Weight 1 lb. Dimensions 18 cm wide by 18 cm long by 5 cm high. Power Source AC/DC; external mains; USB AC/DC power adapter or from an external PC. Battery Battery CR1220, coin cell.
OR Base Station Unit Specification Mode of Operation Operational Modes: Power on (w/self-test) Normal operating Fault (self-test failure) Mode of Operation: The surgical team uses the OR Base Station System before and during the TKA surgery to register the patient and initiate the CTE implant so that it will begin collecting data after the patient’s surgery.
OR Base Station Unit Specification Personal Computer Specification Manufacturer Dell Operating System Windows 10 Canary Software Specification Version TBD Bar Code Scanner and Cable Specification Manufacturer Aibecy Handheld 2.4G Wireless 1D/2D/QR Barcode Scanner Bar Code Reader with USB Receiver 4000 Code Storage Capacity for POS PC Android IOS. USB Power and Data Cables Specification Manufacturer Qualtek 3021084-03 (OR 3ft USB Data cable) Dimensions USB 2.
Home Base Station Unit Specification Power Source AC/DC Battery Battery CR1220, coin cell. LED Light Output Red, Green - 78 mW Blue - 80 mW Red, Green, Blue (RGB) 625nm Red, 525nm Green, 470nm Blue LED Indication - Discrete 1.9V Red, 3.3V Green, 3.
Home Base Station Unit Specification Recommended Operating Conditions Temperature: +5°C to +40°C; Relative Humidity: 15% to 93% (non-condensing). Safe Storage and Transport Temperature Range Storage: 15° C to 25° C Transportation Environment: Per ISTA 3A, method ASTM D4332. Safe Storage and Transport Relative Humidity Storage: 10% to 90% (noncondensing). Transportation Environment: (noncondensing). 10% Protection from Electric Shock Per IEC 60601-1-11, clause 10.1.
15. DATA SECURITY AND PATIENT PRIVACY All communication between the CTE implant and the Base Station units employs a unique communication protocol, with each CTE having a unique radio that is assigned to it in manufacturing. Base stations can communicate with only one CTE at a time using this radio ID. NOTE: A patient could potentially have two CTE implants (one in each knee) but would only need one Base Station in that scenario.
16.2. Base Station Units and Accessories Maintain the Base Station Units and Accessories by keeping them clean, dry, and free of surrounding clutter. Home Base Station: Dust with a clean, dry, soft cloth. OR Base Station: The following solutions have been tested for safe cleaning of the OR Base Station unit, part # 43-5570-002-14 only. Wipe the OR Base Station Unit with a soft cloth dampened with one of these solutions. 1. 2. 3. 4. 5. 6. 7.
18. SERVICING 18.1. CTE The CTE is an implant, thus, it is unable to undergo service from a mechanical perspective, however, the CTE can receive software updates initiated from the Canary Cloud. 18.2. Base Station Units and Accessories If a Base Station Unit or accessory is not working properly, please see Appendix 3, Troubleshooting, for a potential solution to the problem.
19. DISPOSAL 19.1. CTE The CTE is a single-use device. If explantation is necessary, do not reuse, reprocess, or resterilize the CTE. Dispose of the explanted CTE according to your facility policy as biohazard medical electronics waste. Do not incinerate the explanted CTE. In the event of the death of a patient who has received the CTE implant, inform end-of-life staff that the patient has an implant containing a battery.
CHIRP CHARM DIGITAL REFORMULATION The Zimmer Biomet Persona® Personalized Knee System is a registered trademark of Zimmer Biomet.
Symbol Open Here Do Not Re-sterilize ISO 7000 — 3079 Graphical symbols for use on equipment -- Registered symbols ISO 7000-2608 Graphical symbols for use on equipment -- Registered symbols ISO 15223-1 clause 5.2.
Symbol ISO 15223-1 clause 5.4.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied IEC 60601-1 clause 7.
Symbol Designation Number and Title of the Standard Title of the Symbol in the Standard Page | 55 Physician Instructions for Use DRAFT ISO 7000-0626 Graphical symbols for use on equipment -- Registered symbols ISO 15223-1 clause 5.3.
Symbol Designation Number and Title of the Standard Page | 56 Physician Instructions for Use DRAFT Directs the user not to use ISO 15223-1 clause 5.2.8 ISO 11607-1 clause 10 the device if the package has been opened or damaged defibrillation-proof type IEC 60601-1 clause 8.5.5.1 CF applied part and IEC 60417-5336 symbol transport and storage ISO 14708-1 clause 9.11 humidity limit ISO 70002620 transport and storage ISO 14708-1 clause 9.
Symbol Page | 57 NRTL certification symbol FCC Declaration of Conformity electrical classification: Class II and IEC 604175172 symbol MRI Conditional with ASTM F2502 7.3.1.1 symbol: Meaning Physician Instructions for Use DRAFT ISO/TR 10974 2018-04 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device IEC 60601-1 clause 7.2.
APPENDIX 2 – DEFINITIONS Table 12 Term Definition Base Station Subsystem The Base Station subsystem serves as a conduit between the CTE implant and the Cloud subsystem. The Base Station subsystem consists of a Base Station unit and additional components (i.e. networkconnected PC, PC Application, etc.) to establish an appropriate transmission center in the use environment. The Base Station unit is an intermediary receiver / transmitter that is able to wirelessly communicate with a CTE implant.
Term Definition Gait Cycle or Stride Sequence of movements during locomotion in which one foot contacts the ground to when that same foot contacts the ground again Persons who have education in health care and are directly related to the provision of health care services (i.e. surgeons, physicians, physician’s assistants, nurses, nursing assistants, therapists, technicians) The geometric mechanics of motion Analyzed data from the CTE implant, derived from Raw Data. The full movement of a joint (i.e.
APPENDIX 3 – TROUBLESHOOTING Table lists some issues you might encounter with the CTE and CHIRP System, as well as some suggested actions which may resolve the issues. If you have a problem with the system that is not listed here or that cannot be resolved with the information provided, call Canary Medical. Table 13 Problem Action I can’t reach the Canary Medical website Check your Internet connection and make sure you are connected to the Internet.
Manufactured for: Canary Medical, LLC. 2710 Loker Ave. West Suite 350 Carlsbad, CA 92010 https://canarymedical.com/ Customer Service: 1-760-448-5066 LOMBARD GRAPHICS Tel: (562) 692-7070 Fax: (562) 699-2123 PLEASE READ THIS PROOF COMPLETELY AND CAREFULLY. WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS WHICH SHOW ON THIS PROOF AND ARE NOT CORRECTED. PLEASE SIGN AND RETURN AS SOON AS POSSIBLE. PROOFS HELD OVER 24 HOURS WILL DELAY PRODUCTION.
