(95 days)
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 post-surgery.
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 Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is comprised of the following subsystems: Canary Tibial Extension (CTE) implant, Operating Room (OR) Base Station System ("BS1"), Home Base Station System ("BS2"), Canary Cloud Data Management Platform ("Cloud") and Canary Medical Gait Parameters (CMGP software module). The CTE and CHIRP System is intended to provide objective kinematic data on patient's total knee arthroplasty (TKA) function. The kinematic data produced by the CTE implant is intended as an adjunct to other physiological measurement tools post TKA surgical care while providing additional tibial stability afforded by traditional tibial extensions of similar length. The implanted CTE collects data from internal motion sensors, and when queried by a BS1 or BS2 over a communication interface, transmits the motion data to the Base Station System. The Base Station System, in turn, uploads the data to the Canary Cloud Data Management Platform. The User is defined as the Patient with the CTE and CHIRP System and their designated Health Care Professional (HCP) with access to the Patient's CTE data.
The CTE is designed for use with the Zimmer Biomet Persona Personalized Knee System tibial baseplate, to provide additional stability and collect kinematic data to assist the physician in monitoring patient activity following total knee arthroplasty (TKA) in between office visits.
The Canary Quantiles Recovery Curves software is an accessory and an optional software module for use with the CTE with CHIRP System. The software obtains kinematic data from the CTE with CHIRP System and provides aggregation and visualization of patient population data to HCPs to analyze patient recovery progress and direction of outcome.
The provided text is a 510(k) summary for the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System. It states that the device is substantially equivalent to a predicate device and details its description and indications for use. However, it does not contain information regarding specific acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device performance evaluation study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document only mentions "Software Verification & validation" and "System Integration Validation" as non-clinical activities performed to support modifications, indicating the assessment was likely focused on technical performance and safety/effectiveness equivalence, rather than a clinical performance study measuring diagnostic accuracy or similar metrics often associated with AI/ML systems.
This device appears to be an implanted sensor system providing kinematic data, where the "Canary Quantiles Recovery Curves software" is an accessory that aggregates and visualizes patient population data. The focus of the 510(k) is on the sensor system itself and its equivalence to a predicate, not on a specific AI/ML diagnostic or predictive algorithm being evaluated for performance against established ground truth in a clinical context.
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March 24, 2023
Canary Medical USA LLC Kevin Leung Associate Director, Regulatory Affairs 2710 Loker Ave. West, Suite 350 Carlsbad, California 92010
Re: K223803
Trade/Device Name: Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System Regulation Number: 21 CFR 888.3600 Regulation Name: Implantable Post-Surgical Kinematic Measurement Knee Device Regulatory Class: Class II Product Code: OPP Dated: February 24, 2023 Received: February 27, 2023
Dear Kevin Leung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song-S
Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223803/S001
Device Name
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Indications for Use (Describe)
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) postsurgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during patient monitoring and treatment post-surgery.
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 decisionmaking and have not been shown to provide any clinical benefit.
The CTE with CHIRP System is compatible with Zimmer Personalized Knee System.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K223803 Page 1 of 3
Image /page/3/Picture/1 description: The image shows the logo for Canary. The logo features a yellow canary bird with its wings spread, positioned above the word "canary" in black lowercase letters. The letters are in a simple, sans-serif font. The trademark symbol is located to the right of the word "canary".
510(K) SUMMARY
| Sponsor: | Canary Medical USA LLC2710 Loker Ave. West, Suite 350Carlsbad, CA 92010 |
|---|---|
| EstablishmentRegistration Number: | 3015802419 |
| Contact Person: | Kevin LeungAssociate Director, Regulatory AffairsMobile: 562-547-4067Email: kleung@canarymedical.com |
| Subject Device: | Canary Tibial Extension (CTE) with Canary Health ImplantedReporting Processor (CHIRP) System |
| Regulation Number: | 21 CFR 888.3600 |
| Product Code: | QPP |
| Device Class: | II |
| Predicate Device: | Canary Tibial Extension (CTE) with Canary Health Implanted ReportingProcessor (CHIRP) System (DEN200064) |
| Device Description: | The Canary Tibial Extension (CTE) with Canary Health ImplantedReporting Processor (CHIRP) System is comprised of the followingsubsystems: Canary Tibial Extension (CTE) implant, Operating Room (OR) Base Station System ("BS1"), Home Base Station System ("BS2"), Canary Cloud Data Management Platform ("Cloud") and Canary Medical Gait Parameters (CMGP software module). The CTE and CHIRP System is intended to provide objective kinematic data on patient's total knee arthroplasty (TKA) function. The kinematic data produced by the CTE implant is intended as an adjunct to other physiological measurement tools post TKA surgical care while providing additional tibial stability afforded by traditional tibial extensions of similar length. The implanted CTE collects data from internal motion sensors, and when queried by a BS1 or BS2 over a communication interface, transmits the motion data to the Base Station System. The Base Station System, in turn, uploads the data to the Canary Cloud Data Management Platform. The User is defined as the Patient with the CTE and CHIRP System and their designated Health Care Professional (HCP) with access to the Patient's CTE data. |
| The CTE is designed for use with the Zimmer Biomet PersonaPersonalized Knee System tibial baseplate, to provide additional stabilityand collect kinematic data to assist the physician in monitoring patientactivity following total knee arthroplasty (TKA) in between office visits. | |
| The Canary Quantiles Recovery Curves software is an accessory and anoptional software module for use with the CTE with CHIRP System. Thesoftware obtains kinematic data from the CTE with CHIRP System andprovides aggregation and visualization of patient population data to HCPsto analyze patient recovery progress and direction of outcome. | |
| Indications for Use | The Canary Tibial Extension (CTE) with Canary Health ImplantedReporting Processor (CHIRP) System is intended to provide objectivekinematic data from the implanted medical device during a patient'stotal knee arthroplasty (TKA) post-surgical care. The kinematic data arean adjunct to other physiological parameter measurement tools appliedor utilized by the physician during the course of patient monitoring andtreatment post-surgery. |
| The device is indicated for use in patients undergoing a cemented TKAprocedure that are normally indicated for at least a 58mm sized tibialstem extension. | |
| The objective kinematic data generated by the CTE with CHIRP Systemare not intended to support clinical decision-making and have not beenshown to provide any clinical benefit. | |
| The CTE with CHIRP System is compatible with Zimmer Persona®Personalized Knee System. | |
| Summary ofTechnologicalCharacteristics andComparison: | The rationale for substantial equivalence is based on comparativeassessment of the following characteristics:• Indications for use: Same as the predicate device.• Intended Use: Same as the predicate device.• Materials: Same as the predicate device.• Design Specifications (hardware) Same as the predicate device.• Performance: Same as predicate device.• Sterility: Same as the predicate device.• Packaging: Same as the predicate device. |
| Summary ofPerformance Data: | The following non-clinical activities were performed to support themodifications to the subject device:• Software Verification & validation• System Integration Validation |
| Substantial Equivalence | The subject device has the same intended use and technological |
| Conclusion: | characteristics to the predicate, and the performance data and analyses demonstrate that:any differences do not raise new questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate device. |
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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.