(312 days)
No
The summary describes the collection of raw kinematic data and its processing into "Canary Medical Gait Parameter (CMGP) data" for monitoring. There is no mention of AI, ML, or any learning algorithms used in this processing or analysis. The focus is on data collection, transmission, and presentation of calculated parameters.
No.
The device collects objective kinematic data as an adjunct to other tools for patient monitoring, but it explicitly states that the data are "not intended to support clinical decision-making and have not been shown to provide any clinical benefit," thus disclaiming therapeutic intent or effect.
No
The "Intended Use / Indications for Use" section explicitly states: "The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit." This indicates that the device's output is not used for diagnosis.
No
The device description explicitly states that the Canary Tibial Extension is a "physical implant component" and includes hardware elements like an antenna, printed circuit assembly, sensors, and a battery embedded within the implant. It also includes external base station units with embedded firmware. While software is a crucial part of the system (OR App, Cloud subsystem, embedded firmware), the device is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to provide objective kinematic data from an implanted medical device during post-surgical care for total knee arthroplasty. This data is an adjunct to other physiological parameter measurement tools and is not intended to support clinical decision-making. IVDs are typically used to diagnose, monitor, or determine treatment based on analysis of biological samples in vitro (outside the body).
- Device Description: The device is a physical implant component (tibial extension) with embedded electronics to collect functional movement and gait parameter information. It also includes external base stations and a cloud-based system for data transmission and storage. This describes a system for collecting in vivo (within the body) data related to physical movement, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or performing tests in vitro. The data collected is kinematic data related to movement.
In summary, the Canary Tibial Extension with CHIRP System is a medical device that collects in vivo kinematic data to monitor patient function after knee surgery. It does not perform tests on biological samples outside the body, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment postsurgery.
The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension.
The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.
The CTE with CHIRP System is compatible with Zimmer Persona® Personalized Knee System.
Product codes (comma separated list FDA assigned to the subject device)
QPP
Device Description
For a complete description of the device system components and subsystems, please refer to the accompanying labeling for additional details.
Implant Description:
The Canary Tibial Extension is a physical implant component that is attached to the Zimmer Biomet Persona® tibial baseplate (K113369) to form the patient's tibial knee 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 provided sterile via Ethylene Oxide (EtO).
The CHIRP system collects unprocessed 3D accelerometer and 3D gyroscopic sensor data over the course of a day. The following table displays the gait and activity metrics generated:
The electronic and other unique elements incorporated within the CTE implant include an antenna, X-ray ID, printed circuit assembly, three-axis gyroscope, three-axis accelerometer, and a Lithium Carbon Mono-Fluoride (CFx) battery. To allow for wireless transmission of kinematic data, the nose cone is manufactured from polyether ether ketone (PEEK). All active electronics and the battery are encapsulated within a hermetically sealed titanium enclosure. The antenna is encapsulated by the PEEK nose cone and epoxy backfill, both of which are electrically nonconductive. The antenna is the only electrically active component of the CTE outside the hermetic assembly and, under normal operating conditions, is insulated by the epoxy backfill and PEEK nose cone from interacting electrically with surrounding tissue.
The CTE implant can store up to 30 days of data. If the CTE implant is unable to connect to the Home Base Station for an extended period, the full amount of data will be uploaded to the Canary Cloud once the patient's CTE connects to its Home Base Station. If there is no connection for periods greater than 30 days, new data will overwrite the oldest data until a connection to the patient's Home Base Station and the Canary Cloud is made. The CTE implant has been programmed to collect data using the schedule provided in the table below. This sampling schedule is controlled by firmware on the CTE which is loaded during the manufacturing process. When the CTE is not sampling, it is in a low power mode to conserve battery power.
When the CTE is not sampling after it has been implanted and activated, the CTE remains in a state of ultra-low power deep sleep prior to implantation to preserve battery power. Prior to implantation, the CTE remains constantly in a state of deep until "woken up" by the OR Base Station the day of implantation.
Base Station Description:
The CTE with CHIRP system is composed of external base station units with embedded firmware that facilitate communication with the CTE implant. The main function of the base station units is to act as a conduit to receive and transmit encrypted raw kinematic data from the CTE to the Cloud Based software system.
All communication between the Base Station units and the CTE implant employs a unique communication protocol, with each CTE implant having a unique radio ID that is assigned to it in manufacturing. Base stations can communicate with only one CTE at a time using the unique radio ID. The communication between base stations and CTE implant is also encrypted (both the data payload and messaging) with the unique encryption key assignment during the manufacture of the CTE. Communication integrity and data integrity checks are applied on the data received at both ends.
The Operating Room (OR) Base Station (BS1) subsystem consists of a laptop computer with the customized OR Application (OR App) software to initialize the CTE implant and record implant and procedural information, an OR base station unit, a bar code reader to incorporate TKA component and CTE serial number information, and USB cables to attach the OR base station unit and bar code reader to the computer. The surgical team uses the BS1 during the TKA surgery to register the patient and activate the CTE implant so that it will begin collecting data after the patient's surgery. The hardware functions are limited to assisting the following software functions: electronic transfer, storage, or display of medical device data.
After the TKA is implanted, the OR application is used to scan the barcodes on the labels of the CTE and other implanted TKA components; these data can also be manually entered. This information can then be submitted by the OR App to the Canary Cloud. This action associates the particular CTE with the previously registered patient in the Canary 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, thus enabling upload of kinematic data from the CTE to the Cloud without patient intervention.
The Home Base Station (BS2) subsystem is located in the patient's home, is set up by the patient prior to the date of surgery, and is used to transmit patient's gait and activity information collected by the CTE. BS2 consists of a Home Base Station unit, a USB power and data cable, and a power adapter. These items are used in concert with a USB-enabled personal computer and the patient's home wireless Internet connection. The Home Base Station can store up to 45 days of CTE-transmitted data if it is not able to connect to the Cloud but is able to communicate with the implant locally.
The OR Base Station variant does not have wireless capability as no connectivity is needed in the operating room for functionality. The Home Base Station unit includes Wi-Fi capability to transfer data from the CTE to the Canary Cloud.
Canary Medical Cloud Data Management Platform (CDMP or "Cloud"):
The Cloud subsystem is intended to receive and store all healthcare professional (HCP) and patient data for pre-operative, day of operation, and post-operation activities, including unprocessed, patient kinematic data from the CTE implant. The post-operation processed, patient Canary Medical Gait Parameter (CMGP) data will be used by HCPs to monitor the patient's post-TKA procedure function as an adjunct to other physiological parameter measurement tools. The Cloud is accessible through a browser-based web application.
Manual Instruments and Accessories:
All CTE with CHIRP System Surgical Instrumentation is supplied non-sterile in an instrument tray:
- . Impaction Sleeve: A reusable instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Plate. The Impaction Sleeve protects the implant's electronic components from impaction forces that occur during assembly.
- . Canary Tibia Cut Guide (5 DEGREE - L/R): Used for tibia preparation when implanting a Persona Primary Knee with a Canary Tibial Extension (CTE) Implant.
- . Canary Drill Bit: Used to create the cavity in the patient's tibial intramedullary (IM) canal to fit the CTE implant and cement mantle.
- . CTE Provisional: The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Tibial Extension adds 28 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to test the depth of the drilled intramedullary hole to ensure the fit of the CTE implant within the patient's anatomy prior to CTE implantation.
- CTE Template: The CTE 14mm x 58mm X-Ray 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. It is composed of acetate and is used as an overlay to the patient's X-ray image; therefore, it has no contact with the patient.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tibial knee prosthesis
Indicated Patient Age Range
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Intended User / Care Setting
Physician, Patient, Home, Hospital operating room
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The test objective was to validate the performance of the CTE with CHIRP System by measuring the Canary Medical Gait Parameters (CMGP) mean percent error (MPE) in comparison to an established and accepted gold standard kinematic gait measurement system. The primary endpoint was to demonstrate the walking speed reported by the CTE with CHIRP System is equivalent to the walking speed measured by a gold standard system. Secondary endpoints were to report accuracy of the remaining CMGP - Cadence, Stride Length, Functional Knee Range of Motion (ROM), and Tibia Range of Motion compared to the gold standard system.
A total of (b) (4) test subjects were recruited. Test subjects wore an (b) (4)
Simultaneously, kinematic data were collected by the CTE implant and the motion capture system for comparison. The range of test speeds covered both acute (2-weeks post-surgery) and long term (12-months post-surgery) recovery phases.
Based on literature findings, the reported minimal clinically important improvement in walking speed was 0.32 m/s: therefore, this value was utilized as the pre-specified threshold indicative of the minimal clinically important change in walking speed for patients who have undergone TKA. Instead of pre-defining a statistical hypothesis for test comparison of these parameters to the motion capture system, the mean percentage error (MPE) was calculated across all steps and all subjects at each walking speed and Bland-Altman analyses comparing these measures to the camera-based motion capture system was performed and reported.
Step count was measured directly by the CTE's internal IMU using the standard Android 4.4 step counting function and was not evaluated in this protocol. The Distance CMGP parameter was derived by multiplying Step Count by Stride Length and was also not evaluated as a part of this protocol.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
System Integration Validation Testing: System integration testing was performed to validate the intended end-to-end behavior of the CTE with CHIRP system, including access, account creation, and subsystem interaction designed for use in both the home and hospital operating room environments. This testing demonstrated that the system can successfully perform the following functions as intended by the end-user: Canary admin setup of hospital and hospital admin, Hospital administrator set up of Doctor, Doctor registration and set up of patient, Patient registers and sets up base station, OR application used for day of surgery to test and activate implant, and link the implant to the patient, Patient ability to view CMGP parameters on Canary Cloud Patient Dashboard user interface, Doctor's ability to view patient's CMGP parameters on Canary Cloud Physician Dashboard user interface.
Mechanical Bench Testing - CTE Shock Survival: Bench testing was performed to demonstrate that the CTE was designed and constructed to withstand the mechanical shocks caused by mishandling during implant procedure and mechanical forces that may occur during normal conditions of use, including the time prior to implantation. CTEs were exposed to a range of controlled shock and vibration conditions to verify survival of the CTE when exposed to anticipated worst-case conditions. A sample size of (b) (4) production-equivalent CTEs were used. All CTE samples passed all pass/fail criteria, demonstrating normal operation of the CTEs after cumulative exposure to shocks and random vibration.
Mechanical Bench Testing - CTE Transverse Fatigue Testing: Bench testing was performed to provide objective evidence that the CTE has enough fatigue strength to survive worst-case loading conditions without compromising the hermetic integrity of the interior electronics package. All samples tested at an applied moment of (b) (4) Nm ran out to (b) (4) cycles. Visual inspection under (b) (4) magnification of the samples tested at an applied moment of (b) (4) Nm showed no evidence of a breach in the hermetic enclosure. All CTE implants passed all pass/fail criteria, demonstrating that the CTE has enough fatigue strength to survive worst-case loading conditions without compromising the hermetic integrity of the interior electronics package.
Wear Debris Characterization Testing: Simulated bench testing was conducted to assess the amount of generated wear debris during the service life of the CTE implant. All specimens reached 10,000,000 cycles of fatigue loading at (b) (4) Nm. Optical inspection of the constructs under (b) (4) x magnification showed no evidence of fracture, cracking, or deformation. The conclusion of this report is that the CTE implant and a previously cleared comparator Zimmer Biomet stem extension generate similar amounts of particulate matter when cemented and assembled to the Zimmer Biomet Persona tibia tray and loaded per ASTM F1800.
CTE Static Pull Force Test: Bench testing was performed to evaluate the static axial strength of the proximal taper interface of the subject CTE implant and Zimmer Persona Tibial Baseplate in comparison to the Zimmer NexGen knee system. The subject device axial and torsional pull force were higher than the previously cleared Zimmer knee systems and, thus, satisfied the proposed acceptance criteria.
CTE Implant Characterization and Verification Testing - CTE Inertial Motion Unit (IMU) Performance Testing: Bench testing was performed to verify that the subject device meets IMU performance requirements for intended use. For IMU accelerated life stability testing, test results show that the accelerometer and gyroscope offset were within specified limits of the IMU accuracy and reliability, as stated in the manufacturer datasheet. For IMU shock and vibration stability testing, worst-case shock testing was performed on CTE samples, including shocks of both (b) (4) g and (b) (4) g applied load. Test results show all IMU calibration coefficient shifts were well within the ranges determined from accelerated life testing, demonstrating no significant IMU drift that would impact longitudinal activity and gait interpretation. For CMGP sensitivity to IMU draft, the worst-case effects were evaluated using "simulated aged" calibration coefficients. Only one (1) of the "aged" devices resulted in a reported walking speed shift outside the clinically significant range of +/- (b) (4) m/s, indicating the probability of a clinically significant erroneous walking speed value after 9.1 years is approximately (b) (4) under the assumptions used for this simulation study.
CTE Internal Moisture: Bench testing was performed to verify that the design and assembly procedures of the CTE meet the electronics hermeticity requirement that the CTE internal electronics and battery modules be housed in a hermetically sealed enclosure. Internal moisture concentrations on the five test samples ranged from (b) (4) to (b) (4) ppm, which meets the proposed acceptance criterion.
CTE Physical Properties: Characterization testing was performed to verify the CTE implant meets mass, surface finish, corrosion resistance, and particulate requirements.
CTE Electronic Function: Verification testing was performed to evaluate that the following electronic component requirements were met: Radio, Non-Volatile Memory, Inertial Measurement Unit, Real Time Clock, Processor, Memory Size, IMU Resolution. All acceptance criteria were met to demonstrate that design outputs met design inouts.
Bone Loss Cadaver Study: A cadaver study using osteoporotic tibias was performed to demonstrate the amount of bone loss and revision requirements upon removal of a well-cemented subject CTE implant compared to the extraction and revision of a control group using standard primary TKA. (b) (4) surgeons performed a total of (b) (4) implantations using the CTE with CHIRP System. While bone loss volume of the CTE with CHIRP System is greater than the Zimmer Biomet Persona with Stem System, the increase in bone loss volume was determined to be clinically acceptable by the surgeon evaluators.
Cadaveric Design Validation Testing: The primary objective of this cadaveric study is to evaluate the CTE with CHIRP System to ensure that the System conforms to the defined intended use and user needs within the surgical environment. For evaluation of the CTE with CHIRP System, each related question in the questionnaire was answered "Yes." For evaluation of drill bit feedback and risk of tibia cortical perforation, all surgeons felt contact with cortical bone. For surgeon evaluation of the CMGP dashboard, all surgeons answered "Yes" for each related question in the questionnaire. For evaluation of wireless quality of service, distance of (b) (4), and meters were used with relative position of the base station to the cadaver knee with CTE implant. 100% of (b) (4) attempts succeeded in connecting to the implant. Only (b) (4) attempts took over a minute to connect to the implant (97.98% of attempts were under seconds). Moreover, (b) (4) connection attempts at (b) (4) meters were successful while the subject device product requirement is only 2 meters. The test results demonstrated successful data collection, wireless data transmission, and data processing from the CMGP algorithm. The testing also demonstrated that surgeons are able to follow directions of the surgical technique and comprehend displayed data on the CMGP Dashboard.
Gait Parameters Design Validation: The test objective was to validate the performance of the CTE with CHIRP System by measuring the Canary Medical Gait Parameters (CMGP) mean percent error (MPE) in comparison to an established and accepted gold standard kinematic gait measurement system. Test results show that walking speed were within pre-specified equivalence bounds of 0.32 m/s. Since the CTE measure of walking speed is considered equivalent to camera-based motion capture, the primary endpoint was met. The 95% confidence limits for the mean were all below zero, indicating that the CTE consistently underestimated walking speed. but results for each speed were also within the equivalence bounds for the primary analysis, indicating any difference has minimal clinical importance. Of the secondary endpoints, the most accurate CTE measurement across all walking speeds was cadence while stride length was the least accurate. The 95% confidence limits for stride length and tibia range of motion do not include zero, indicating that the CTE with CHIRP consistently underestimated these values. In comparison to the use of plastic goniometers, the knee range of motion measurements of the CTE implant are more accurate. Due to the limitations of the test setup (e.g., soft tissue movement, the implant not being rigidly attached to the tibia with bone cement, unwanted CTE micro motion, misalignment), the test environment represents a worst-case test scenario.
Usability Testing: Human factor usability (HF/U) validation testing was performed for the use of the CTE with CHIRP System with (b) (4) groups of study participants identified as circulating nurses in the operating room (OR) environment, patients in the home environment, and surgeons. The home usability testing did not reveal any significant end-user problems with device. All results and design recommendations were reviewed, and design modifications were implemented in response to key findings during usability activities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3600 Implantable post-surgical kinematic measurement knee device.
(a)
Identification. An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post surgery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be conducted:
(i) Mechanical testing must evaluate the mechanical function (mechanical fatigue, static mechanical strength) and durability of the implant.
(ii) Simulated use testing must evaluate the ability of the device to be sized, inserted, and sufficiently secured to any compatible components.
(iii) Testing must demonstrate the accuracy, reliability, and reproducibility of kinematic measurements.
(iv) Testing must demonstrate diagnostic and therapeutic ultrasound conditions for safe use.
(v) Testing must demonstrate that the device performs as intended under anticipated conditions of use demonstrating the following performance characteristics, if applicable:
(A) Magnetic pulse output testing;
(B) Magnetic and electrical field testing; and
(C) Testing of the safety features built into the device.
(vi) Testing must demonstrate hermeticity of any electronic component enclosures.
(2) Performance testing must evaluate the compatibility of the device in a magnetic resonance (MR) environment.
(3) Human factors testing must demonstrate that the intended user(s) can correctly use the device for its intended use, including for implantation and post-procedure data access.
(4) Performance data must demonstrate the sterility of the device implant and patient-contacting components.
(5) Performance data must validate the reprocessing instructions for the reusable components of the device.
(6) The patient-contacting components of the device must be demonstrated to be biocompatible.
(7) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(8) Performance testing must demonstrate the electromagnetic compatibility/interference, (EMC/EMI), electrical safety, thermal safety, battery safety, and wireless performance of the device.
(9) Software verification, validation, and hazard analysis must be performed.
(10) The labeling must include the following:
(i) A shelf life;
(ii) Physician and patient instructions for use, including images that demonstrate how to interact with the device;
(iii) Detailed instruction of the surgical technique;
(iv) Hardware and software requirements for interacting with the device;
(v) A clear description of the technological features of the device including identification of the device materials, compatible components, and the principles of operation;
(vi) Identification of magnetic resonance (MR) compatibility status;
(vii) Validated methods and instructions for reprocessing of any reusable components; and
(viii) A statement regarding the limitations of the clinical significance of the kinematic data.
0
DE NOVO CLASSIFICATION REQUEST FOR
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) Svstem
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Implantable post-surgical kinematic measurement knee device. An implantable postsurgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post-surgery.
NEW REGULATION NUMBER: 21 CFR 888.3600
CLASSIFICATION: Class II
PRODUCT CODE: QPP
BACKGROUND
DEVICE NAME: Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
SUBMISSION NUMBER: DEN200064
DATE DE NOVO RECEIVED: October 19, 2020
SPONSOR INFORMATION:
Canary Medical, Inc. 2150 Western Parkway, Suite 202 Vancouver, BC V6T 1V6 Canada
INDICATIONS FOR USE
The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment postsurgery.
1
The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension.
The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.
The CTE with CHIRP System is compatible with Zimmer Persona® Personalized Knee Svstem.
LIMITATIONS
The sale, distribution, and use of the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System are restricted to prescription use in accordance with 21 CFR 801.109.
The outputted data from the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System are not intended to be utilized for clinical decision-making and has not been evaluated for such a purpose.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
For a complete description of the device system components and subsystems, please refer to the accompanying labeling for additional details.
Implant Description:
The Canary Tibial Extension is a physical implant component that is attached to the Zimmer Biomet Persona® tibial baseplate (K113369) to form the patient's tibial knee 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 provided sterile via Ethylene Oxide (EtO).
The CHIRP system collects unprocessed 3D accelerometer and 3D gyroscopic sensor data over the course of a day. The following table displays the gait and activity metrics generated:
| PARAMETER | DESCRIPTION | UNITS | AVAILABLE
TO WHOM? |
|---------------|----------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------|
| Walking Speed | Mean sagittal plane distance walked per unit time. Directly calculated from cadence and stride length for each gait cycle. | meters per second/s | Physician
Patient |
Table 1: Gait Parameters Collected by the CTE with CHIRP System
2
| Cadence | Mean steps per minute. Derived from two
consecutive peak angular velocities. | steps per minute | Patient |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------|
| Stride length | Mean distance traveled during one gait
cycle. | meters | Physician
Patient |
| Knee ROM | Mean sagittal plane functional knee joint
range of motion. Difference between
maximum and minimum knee joint flexion. | degrees | Physician
Patient |
| Tibia ROM | Mean sagittal plane range of motion of the
tibia with respect to the floor. Difference
between the minimum and maximum tibia
to floor angle. | degrees | Physician |
| Step Count | Number of steps taken during a Sampling
Day. | steps | Physician
Patient |
| Distance | Distance traveled. Calculated from step
count and stride length | meters | Physician
Patient |
Image /page/2/Figure/1 description: This image shows a diagram of a tibial plate and chirp TKA assembly. The diagram shows the anterior orientation of the tibial plate. The chirp TKA assembly has a set-screw recess with a ramp and an alignment reference mark. The diagram also shows that the diameter of the assembly is 14 mm, and the height is 73 mm.
Figure 1 (from left to right): a) CTE implant attached to tibial baseplate; b) alternate view of CTE assembly and tibial base plate; and c) CTE implant with dimensional attributes
The electronic and other unique elements incorporated within the CTE implant include an antenna, X-ray ID, printed circuit assembly, three-axis gyroscope, three-axis accelerometer, and a Lithium Carbon Mono-Fluoride (CFx) battery. To allow for wireless transmission of kinematic data, the nose cone is manufactured from polyether ether ketone (PEEK). All active electronics and the battery are encapsulated within a hermetically sealed titanium enclosure. The antenna is encapsulated by the PEEK nose cone and epoxy backfill, both of which are electrically nonconductive. The antenna is the only electrically active component of the CTE outside the hermetic assembly and, under normal operating conditions, is insulated by the epoxy backfill and PEEK nose cone from interacting electrically with surrounding tissue.
3
Image /page/3/Figure/0 description: The image shows a cross-sectional view of a device, possibly a medical device or sensor, with various components labeled. The components include an extension, battery, electronics, sleeve, bipolar FT, epoxy backfill, antenna, and PEEK nose cone. The device appears to be cylindrical in shape and is likely designed for insertion or implantation.
Figure 2: CTE assembly cross-sectional views
The CTE implant can store up to 30 days of data. If the CTE implant is unable to connect to the Home Base Station for an extended period, the full amount of data will be uploaded to the Canary Cloud once the patient's CTE connects to its Home Base Station. If there is no connection for periods greater than 30 days, new data will overwrite the oldest data until a connection to the patient's Home Base Station and the Canary Cloud is made. The CTE implant has been programmed to collect data using the schedule provided in the table below. This sampling schedule is controlled by firmware on the CTE which is loaded during the manufacturing process. When the CTE is not sampling, it is in a low power mode to conserve battery power.
Time Period | Sampling |
---|---|
Day 0 (day of surgery) to Day 1 | No sampling |
Day 2 to Day 365 | Daily |
Year 2 | 36 consecutive Days/Quarter |
Years 3 and beyond | 36 consecutive days commencing on the |
anniversary of the patient's surgery date |
Table 2: Sampling rate of CTE with CHIRP System
When the CTE is not sampling after it has been implanted and activated, the CTE remains in a state of ultra-low power deep sleep prior to implantation to preserve battery power. Prior to implantation, the CTE remains constantly in a state of deep until "woken up" by the OR Base Station the day of implantation.
Base Station Description:
The CTE with CHIRP system is composed of external base station units with embedded firmware that facilitate communication with the CTE implant. The main function of the base station units is to act as a conduit to receive and transmit encrypted raw kinematic data from the CTE to the Cloud Based software system.
All communication between the Base Station units and the CTE implant employs a unique communication protocol, with each CTE implant having a unique radio ID that is assigned to it
4
in manufacturing. Base stations can communicate with only one CTE at a time using the unique radio ID. The communication between base stations and CTE implant is also encrypted (both the data payload and messaging) with the unique encryption key assignment during the manufacture of the CTE. Communication integrity and data integrity checks are applied on the data received at both ends.
The Operating Room (OR) Base Station (BS1) subsystem consists of a laptop computer with the customized OR Application (OR App) software to initialize the CTE implant and record implant and procedural information, an OR base station unit, a bar code reader to incorporate TKA component and CTE serial number information, and USB cables to attach the OR base station unit and bar code reader to the computer. The surgical team uses the BS1 during the TKA surgery to register the patient and activate the CTE implant so that it will begin collecting data after the patient's surgery. The hardware functions are limited to assisting the following software functions: electronic transfer, storage, or display of medical device data.
After the TKA is implanted, the OR application is used to scan the barcodes on the labels of the CTE and other implanted TKA components; these data can also be manually entered. This information can then be submitted by the OR App to the Canary Cloud. This action associates the particular CTE with the previously registered patient in the Canary 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, thus enabling upload of kinematic data from the CTE to the Cloud without patient intervention.
The Home Base Station (BS2) subsystem is located in the patient's home, is set up by the patient prior to the date of surgery, and is used to transmit patient's gait and activity information collected by the CTE. BS2 consists of a Home Base Station unit, a USB power and data cable, and a power adapter. These items are used in concert with a USB-enabled personal computer and the patient's home wireless Internet connection. The Home Base Station can store up to 45 days of CTE-transmitted data if it is not able to connect to the Cloud but is able to communicate with the implant locally.
The OR Base Station variant does not have wireless capability as no connectivity is needed in the operating room for functionality. The Home Base Station unit includes Wi-Fi capability to transfer data from the CTE to the Canary Cloud.
Canary Medical Cloud Data Management Platform (CDMP or "Cloud"):
The Cloud subsystem is intended to receive and store all healthcare professional (HCP) and patient data for pre-operative, day of operation, and post-operation activities, including unprocessed, patient kinematic data from the CTE implant. The post-operation processed, patient Canary Medical Gait Parameter (CMGP) data will be used by HCPs to monitor the patient's post-TKA procedure function as an adjunct to other physiological parameter measurement tools. The Cloud is accessible through a browser-based web application.
Manual Instruments and Accessories:
All CTE with CHIRP System Surgical Instrumentation is supplied non-sterile in an instrument tray:
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- . Impaction Sleeve: A reusable instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Plate. The Impaction Sleeve protects the implant's electronic components from impaction forces that occur during assembly.
- . Canary Tibia Cut Guide (5 DEGREE - L/R): Used for tibia preparation when implanting a Persona Primary Knee with a Canary Tibial Extension (CTE) Implant.
- . Canary Drill Bit: Used to create the cavity in the patient's tibial intramedullary (IM) canal to fit the CTE implant and cement mantle.
- . CTE Provisional: The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Tibial Extension adds 28 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to test the depth of the drilled intramedullary hole to ensure the fit of the CTE implant within the patient's anatomy prior to CTE implantation.
- CTE Template: The CTE 14mm x 58mm X-Ray 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. It is composed of acetate and is used as an overlay to the patient's X-ray image; therefore, it has no contact with the patient.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The CTE with CHIRP system is manufactured from the following patient-contacting materials:
| Description | Material | Direct Patient
Contact | Contact Duration |
|---------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------|-------------------|
| Implant | Victrex 450 G Natural PEEK per
ASTM F2026; Loctite M-31CL
Epoxy; Grade 23 Ti-6AI-4V per
ASTM F136 | Yes | Permanent (>30 d) |
| Patient-
contacting
Instruments | 17-4 PH or 455 Stainless Steel | Yes | Limited (≤24 h) |
Table 3: Manufactured Materials of Patient-Contacting Device Components
Biocompatibility evaluation has been completed according to 2020 FDA Guidance. Use. of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
For the permanent, implant, the following table shows the biocompatibility testing performed and the results, which were acceptable for a permanent implant in contact with bone/tissue:
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Test Description | Result |
---|---|
Cytotoxicity (MEM Elution per ISO | |
10993-5) | Non-cytotoxic |
Sensitization (Guinea Pig Maximization | |
test per ISO 10993-10) | Non-Sensitizer |
Irritation (Intracutaneous Injection per ISO | |
10993-10) | Non-Irritant |
Material Mediated Pyrogenicity in rabbits | |
(USP ) | Non-Pyrogenic |
Bacterial Endotoxin (BET, LAL testing | |
per USP ) | Non-Pyrogenic |
Acute/Subacute/Subchronic/Chronic | |
Systemic Toxicity, Genotoxicity and | |
Carcinogenicity (addressed through | |
chemical characterization and | |
toxicological risk assessment per ISO | |
10993-18/ISO 10993-17 | Non-systemically |
toxic/genotoxic/carcinogenic |
Table 4: Biocompatibility Testing Performed
All other components of the device system are either not patient-contacting or only have transitory contact with skin.
Regarding patient-contacting surgical instruments manufactured with stainless steel, passivation was conducted during the manufacturing process, and no chemicals were added after passivation. Therefore, no additional biocompatibility testing was needed for the patient-contacting surgical instrumentation.
PACKAGING, STERILIZATION, CLEANING, AND SHELF LIFE
CTE Implant
The CTE Implant is a single-use device provided clean and sterile to the end user.
Sterilization methods of the device have been validated in accordance with ISO 11135, "Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices", to ensure a sterility assurance level (SAL) of 106 before the device is marketed. Bacterial endotoxins testing (BET) was performed to determine that the subject device implant met pyrogen limit specifications. All tested lots passed with a reported value of 1 K. C. Foucher, "Identifying clinically meaningful benchmants for gait improvement after total hip arthroplasty," J. Orthop. Res., vol. 34, no. 1, pp. 88-96, Jan. 2016.
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Of the secondary endpoints, the most accurate CTE measurement across all walking speeds was cadence while stride length was the least accurate. The 95% confidence limits for stride length and tibia range of motion do not include zero, indicating that the CTE with CHIRP consistently underestimated these values. In comparison to the use of plastic goniometers, the knee range of motion measurements of the CTE implant are more accurate. Due to the limitations of the test setup (e.g., soft tissue movement, the implant not being rigidly attached to the tibia with bone cement. unwanted CTE micro motion, misalignment), the test environment represents a worst-case test scenario.
treadmill walking speed for all subjects | |||
---|---|---|---|
PARAMETER | UNITS | TREADMILL WALKING SPEED | |
Cadence | step/min | (b) (4) | |
Stride Length | m | ||
Functional |
Table 7: Secondary Endpoint CMGP Mean Values and Mean Error as a function of | |
---|---|
treadmill walking speed for all subjects |
Usability Testing
Knee ROM
Tibial ROM
deg
deg
Human factor usability (HF/U) validation testing was performed for the use of the CTE with CHIRP System with (0) (4) groups of study participants identified as circulating nurses in the operating room (OR) environment, patients in the home environment, and surgeons. Protocol designs for HF/U validation testing were consistent with the FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices."
A home environment formative usability test was performed to evaluate the home base station, the patient portal, and supporting user documentation. A total of " lay users from the general population was recruited to participate in a usability validation study of the CTE with CHIRP System with the patient user group in the home environment. Participants completed simulated-use tasks and answered critical knowledge questions in order to evaluate the usability of the CTE with CHIRP System for the home environment. The results of the home usability testing did not reveal any significant end-user problems with device.
An OR environment formative usability test was performed to evaluate the surgical technique and Physician Instructions for Use labeling and the use of CTE with CHIRP system components in an OR environment. Design strengths and opportunities for improvement were identified with the aim of improving the overall usability of the system through mitigating any observed use error.
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All results and design recommendations were reviewed, and design modifications were implemented in response to key findings during usability activities.
Human factors testing also included surgeon evaluation, which was described in the Cadaveric Design Validation Testing subsection above.
LABELING
The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System labeling consists of the following: device description, indications for use, instructions for use, contraindications, warnings, and precautions, MR compatibility, shelf life, potential adverse events, and disposal instructions. The labeling meets the requirements of 21 CFR 801.109 for prescription devices and specifically indicates that the device is not intended to be utilized for clinical decision-making and no data have been evaluated to support the demonstration of clinical benefit. Furthermore, the sterile packaging includes a shelf life for the device, and the labeling includes reprocessing instructions for the reusable instruments.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of an implantable post-surgical kinematic measurement knee device:
Identified Risks to Health | Mitigation Measures |
---|---|
Tissue injury, thermal injury, or | |
electric shock due to device | |
failure including: | |
Loss of hermeticity Battery failure | Thermal safety testing |
Electrical safety testing | |
Battery safety testing | |
Non-clinical performance testing | |
Loosening/migration due to | |
device failure at the | |
bone/implant interface | Non-clinical performance testing |
Labeling | |
Inaccurate, unreliable, and | |
irreproducible kinematic data | |
leading to improper post- | |
surgical patient management | Non-clinical performance testing |
Interference with imaging | |
modalities | Non-clinical performance testing |
Magnetic resonance compatibility testing | |
Data access failure and delayed | |
access to kinematic data due to: | |
Software failure Interference with other | |
devices Use error | Software verification, validation, and hazard analysis |
Electromagnetic compatibility (EMC) testing | |
Human factors testing | |
Labeling | |
Infection | Sterilization validation |
Reprocessing validation | |
Biocompatibility evaluation |
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Identified Risks to Health | Mitigation Measures |
---|---|
Labeling | |
Adverse tissue reaction | Biocompatibility evaluation |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the implantable post-surgical kinematic measurement knee device is subject to the following special controls:
-
- Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be conducted:
- a. Mechanical testing must evaluate the mechanical function (mechanical fatigue, static mechanical strength) and durability of the implant;
- b. Simulated use testing must evaluate the ability of the device to be sized, inserted and sufficiently secured to any compatible components;
- Testing must demonstrate the accuracy, reliability, and reproducibility of c. kinematic measurements; and
- d. Testing must demonstrate diagnostic and therapeutic ultrasound conditions for safe use.
- Testing must demonstrate that the device performs as intended under anticipated e. conditions of use demonstrating the following performance characteristics, if applicable:
- i. Magnetic pulse output testing
- ii. Magnetic and electrical field testing
- iii. Testing of the safety features built into the device.
- f. Testing must demonstrate hermeticity of any electronic component enclosures.
-
- Performance testing must evaluate the compatibility of the device in a magnetic resonance (MR) environment.
-
- Human factors testing must demonstrate that the intended user(s) can correctly use the device for its intended use, including for implantation and post-procedure data access.
-
- Performance data must demonstrate the sterility of the device implant and patientcontacting components.
-
- Performance data must validate the reprocessing instructions for the reusable components of the device.
-
- The patient-contacting components of the device must be demonstrated to be biocompatible.
-
- Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
-
- Performance testing must demonstrate the electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, battery safety, and wireless performance of the device.
-
- Software verification, validation, and hazard analysis must be performed.
-
- The labeling must include the following:
- a. A shelf life;
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- b. Physician and patient instructions for use, including images that demonstrate how to interact with the device;
- Detailed instruction of the surgical technique; C.
- d. Hardware and software requirements for interacting with the device;
- A clear description of the technological features of the device including e. identification of the device materials, compatible components, and the principles of operation;
- f. Identification of magnetic resonance (MR) compatibility status;
- Validated methods and instructions for reprocessing of any reusable components; g. and
- h. A statement regarding the limitations of the clinical significance of the kinematic data.
BENEFIT-RISK DETERMINATION
The probable benefits of the device are based on nonclinical laboratory studies as described above.
-The device reliably and reproducibly acquires and outputs kinematic gait measurement data.
-The device provides additional stabilization of the tibial tray component of a total knee arthroplasty construct by virtue of the extended tibial stem length that is provided by the device.
The risks of the device are also based on nonclinical laboratory studies described above.
The major risks associated with this device are:
-Infection
Because of the need for increased duration of surgery required in the operating room to register electronic communication between the stem transmitter and the base station a small increased risk of infection is acknowledged by the sponsor and felt to be acceptable.
-Bone loss and associated loosening of the implant
The incidence of bone loss/loosening in primary TKA is reported as 1-2%. These events usually occur in the longer time frame. These events are known to occur with longer stems and the use of cement. However, risks due to bone loss incurred in either the original surgical procedure, or in any necessary subsequent revision, should be no greater than those for a cemented and comparably sized (58mm) tibial stem extension device.
-Abnormal bony response to the novel construct of titanium. PEEK, and PMMA bone cement.
-If the intraosseous battery of this device has not been removed from a deceased patient prior to cremation, there is a risk of damage to crematory facilities and injuries to personnel from explosion of the battery when subjected to cremation temperatures.
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-Deleterious long-term effects due to the generation of wear debris, inflammatory responses, etc. emanating from the various titanium/PEEK/PMMA bone cement components and component interfaces. Wear testing and wear debris characterization were utilized by the sponsor to mitigate this risk.
PATIENT PERSPECTIVES
This submission did not include specific information on patient perspectives for this device.
BENEFIT/RISK CONCLUSION
In conclusion, given the available information above, for the following indication statement:
The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment postsurgery.
The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension.
The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.
The CTE with CHIRP System is compatible with Zimmer Persona® Personalized Knee System.
The probable benefits outweigh the probable risks for the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo for the Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System is granted, and the device is classified as follows:
Product Code: QPP
Device Type: Implantable post-surgical kinematic measurement knee device
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Regulation Number: 21 CFR 888.3600
Class: II