(128 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) postsurgical 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 decisionmaking and have not been shown to provide any clinical benefit.
The CTE with CHIRP System is compatible with Zimmer 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 provided text is a Traditional 510(k) Summary for the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System. This document focuses on demonstrating substantial equivalence to a predicate device and primarily describes the device's technological characteristics, indications for use, and summaries of performance data related to modifications.
The text does not include the type of detailed information requested in the prompt, such as:
- Specific acceptance criteria and reported device performance for kinematic data accuracy. The document states the device provides objective kinematic data but does not establish or report performance metrics for this data (e.g., accuracy, precision of angle measurement). The 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 suggests that the kinematic data itself is not the primary subject of a performance claim requiring detailed acceptance criteria in this submission.
- Sample sizes for test or training sets, data provenance, expert adjudication details. The submission describes non-clinical tests (Shock Survival, Electrical Life, Battery Longevity, Electronic Functionality, Software Verification) to support modifications to the subject device (addition of a low-power accelerometer), but it does not detail studies investigating the performance of the kinematic data collection itself in a clinical context.
- MRMC comparative effectiveness study results or standalone algorithm performance. Since the kinematic data is stated as "not intended to support clinical decision-making and have not been shown to provide any clinical benefit," a comparative effectiveness study with human readers or standalone performance metrics for an AI algorithm (beyond software verification) would not be expected or included.
- Type of ground truth and how it was established for kinematic data.
Based on the provided document, the only "acceptance criteria" and "reported performance" that can be inferred relates to the modifications made to the device, not the accuracy of the kinematic data itself. The performance data section lists generic non-clinical tests.
Therefore, I cannot populate the table or answer the specific questions as requested regarding acceptance criteria and a study proving the device meets those criteria for its primary function (kinematic data provision). The document focuses on demonstrating that the modified device remains as safe and effective as the predicate device, not on proving new performance claims.
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June 22, 2022
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Canary Medical USA LLC Nora York Vice President, Regulatory Affairs and Quality Affairs 2710 Loker Ave. West, Suite 350 Carlsbad, California 92010
Re: K220413
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: QPP Dated: Mav 26, 2022 Received: May 27, 2022
Dear Nora York:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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, 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) K220413
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 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 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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Traditional 510(k) Submission
Canary Tibial Extension (CTE) With Canary Health Implanted Reporting Processor (Chirp)
Image /page/3/Picture/3 description: The image shows the logo for Canary. The logo features a yellow bird above the word "canary" in black, lowercase letters. The bird is stylized with simple shapes, and the word "canary" is in a bold, sans-serif font. There is a trademark symbol to the right of the word.
510(K) SUMMARY
| Sponsor: | Canary Medical USA LLC2710 Loker Ave. West, Suite 350Carlsbad, CA 92010 |
|---|---|
| EstablishmentRegistration Number: | 3015802419 |
| Contact Person: | Nora C.R. YorkVice President, Regulatory Affairs and Quality AffairsMobile: 760-497-6115Email: nyork@canarymedical.com |
| Date of SummaryPreparation: | March 23, 2022 |
| Subject Device: | Canary Tibial Extension (CTE) with Canary Health Implanted ReportingProcessor (CHIRP) System (K220413) |
| 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) |
| Purpose of Submission: | The purpose of this submission is to add a dedicated low-poweraccelerometer for activity monitoring (step counting) and detection ofsignificant motion to trigger kinematic data collection. The designenhancements are intended to increase the kinematic data sampling daycollection capability using the same battery. The design enhancementdoes not change the intended use / indications for use or fundamentalscientific technology of the device. The addition of the accelerometernecessitates other accommodations to the printed circuit board assembly(PCBA) and associated embedded software. |
| 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). |
| Indications for Use: | The CTE and CHIRP System is intended to provide objective kinematicdata on patient's total knee arthroplasty (TKA) function. The kinematicdata produced by the CTE implant is intended as an adjunct to otherphysiological measurement tools post TKA surgical care while providingadditional tibial stability afforded by traditional tibial extensions ofsimilar length. The implanted CTE collects data from internal motionsensors, and when queried by a BS1 or BS2 over a communicationinterface, transmits the motion data to the Base Station System. TheBase Station System, in turn, uploads the data to the Canary Cloud DataManagement Platform. The User is defined as the Patient with the CTEand 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 PersonalizedKnee System tibial baseplate, to provide additional stability and collectkinematic data to assist the physician in monitoring patient activityfollowing total knee arthroplasty (TKA) in between office visits.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 predicate device.• Materials: Same as the predicate device.• Geometry/Configuration/Size (of Tibial Extension): Same as thepredicate device. |
| Sterility: Same as the predicate device. Packaging: Same as the predicate device. | |
| Summary ofPerformance Data: | The following non-clinical tests were performed to support themodifications to the subject device: Shock Survival Electrical Life Test Battery Longevity Electronic Functionality Software Verification |
| Substantial EquivalenceConclusion: | The subject device has the same intended use and indications for use asthe predicate device. The subject device has the same technologicalcharacteristics to the predicate, and the performance data and analysesdemonstrate that: any differences do not raise new questions of safety andeffectiveness; and the proposed device is at least as safe and effective as the legallymarketed predicate device. |
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K220413 Page 2 of 3
Traditional 510(k) Submission
Canary Tibial Extension (CTE) With Canary Health Implanted Reporting Processor (Chirp)
Image /page/4/Picture/3 description: The image shows the logo for Canary. The logo features a yellow bird perched above the word "canary" in a bold, black font. The bird is stylized with a simple, streamlined design, and the word "canary" is followed by the trademark symbol.
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K220413 Page 3 of 3
Traditional 510(k) Submission
Canary Tibial Extension (CTE) With
Canary Health Implanted Reporting Processor (Chirp)
Image /page/5/Picture/4 description: The image shows the logo for Canary. The logo features a yellow bird silhouette above the word "canary" in a bold, black sans-serif font. The bird is facing left with its wings slightly raised, and the word "canary" is positioned directly below it. There is a trademark symbol to the right of the word.
§ 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.