(124 days)
The canturio® se (Canturio Smart Extension) 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 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 30mm sized tibial stem extension.
The objective kinematic data generated by the canturio® se with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.
The canturio® se with CHIRP System is compatible with Zimmer Personalized Knee System.
The canturio® se is a tibial extension implant or stem that is attached by the orthopedic surgeon to the Zimmer Biomet Persona® tibial baseplate to form the patient's tibial knee prosthesis. The software and electronics embedded within the canturio® se prosthesis collect the patient's functional movement and gait parameter data post-surgery. Like a traditional tibial extension, the canturio® se provides additional stability in the same manner as a traditional knee extension.
The canturio® se (Canturio Smart Extension or CSE) is used with the Canary Health Implanted Reporting Processor (CHIRP) System which is comprised of the following subsystems:
- Operating Room Base Station Subsystem ("OR BS"),
- Home Base Station Subsystem (“HBS”),
- Canary Cloud Data Management Platform ("Cloud" or "CMDP") subsystem and
- Canary Medical Gait Parameters (CMGP) software module.
Each CHIRP subsystem combines physical components, electronics, software, and user interfaces to collect, store, analyze, transmit, and display patient data for use by both physicians and patients.
The provided text describes a 510(k) premarket notification for a medical device called "canturio® se (Canturio Smart Extension)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a study proving the device meets specific acceptance criteria for AI performance.
Therefore, many of the requested details, such as the specific acceptance criteria for AI/algorithm performance, ground truth establishment methods, expert qualifications, and MRMC study results, are not explicitly available in the provided text, as this is a traditional medical device submission, not specifically one for an AI/ML medical device where those details would be paramount.
However, based on the information available, here's what can be extracted and inferred:
Device Purpose and General Performance Testing:
The canturio® se 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. It's crucial to note the statement: "The objective kinematic data generated by the canturio® se 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 primary function is data collection and not an AI-driven diagnostic or treatment recommendation system that would typically require extensive performance criteria and studies as outlined in your request.
The performance data summarized focuses on non-clinical tests to support modifications to the device itself, ensuring its safety and functionality as an implantable device that collects data. These tests are not "AI performance" related in the sense of accuracy, sensitivity, specificity, etc., for a machine learning model.
Acceptance Criteria and Reported Device Performance (Inferred from device type and summary):
Since the device is stated to provide "objective kinematic data" and is a "product line extension" of a predicate device, the acceptance criteria would likely revolve around the accuracy, reliability, and reproducibility of these kinematic measurements themselves. The "reported device performance" would be the successful demonstration of these factors through non-clinical testing.
| Acceptance Criteria (Inferred) | Reported Device Performance (From "Summary of Performance Data") |
|---|---|
| Mechanical Integrity/Durability: Device withstands expected mechanical stresses and fatigue over its intended lifespan. | Mechanical Fatigue: Tested to ensure durability. (Passed/Met - inferred by clearance) |
| Electrical Integrity/Longevity: Electronic components function reliably for the device's lifespan; battery performance meets specifications. | Shock Survival: Tested. (Passed/Met - inferred by clearance) Electrical Life Test: Performed. (Passed/Met - inferred by clearance) Battery Longevity: Tested. (Passed/Met - inferred by clearance) Electronic Functionality: Tested. (Passed/Met - inferred by clearance) |
| Accuracy, Reliability, and Reproducibility of Kinematic Measurements: The data collected by the device is consistent and accurate. | Accuracy, reliability, and reproducibility of kinematic measurements: Tested. (Passed/Met - inferred by clearance) |
| Electromagnetic Compatibility (EMC) and Interference (EMI): Device operates without problematic interference and is not susceptible to external EMI. | Electromagnetic compatibility (EMC) and electromagnetic interference (EMI): Tested. (Passed/Met - inferred by clearance) |
| Biocompatibility: Materials are safe for implantation. | Biological Evaluation: Performed. (Passed/Met - inferred by clearance) |
| Hermeticity: Electronic enclosures protect components from bodily fluids. | Hermeticity of any electronic component enclosures: Tested. (Passed/Met - inferred by clearance) |
| Magnetic Resonance Compatibility: Device is safe for use with MRI. | Magnetic Resonance Compatibility: Tested. (Passed/Met - inferred by clearance) |
| Software Functionality: Software components (OR BS, HBS, Cloud, CMGP) perform as intended. | Software Verification: Performed. (Passed/Met - inferred by clearance) |
Since this is a 510(k) for a hardware device that collects data, and explicitly states the data is not for clinical decision-making or benefit, the traditional AI/ML performance study criteria listed in your request are not applicable or detailed in this document. The focus for this review is substantial equivalence to the predicate device based on material, design, and general device performance.
Therefore, for the remainder of your points, the answer is:
- Sample sizes used for the test set and the data provenance: Not specified for "kinematic measurements" in terms of subject count, nor is data provenance (country of origin, retrospective/prospective) for such measurement described. The testing described appears to be primarily bench/laboratory non-clinical testing of the device hardware and software.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. The "ground truth" for this device would be objective physical measurements, not expert interpretations.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not specified.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No. This device is not an AI interpretation tool for human readers; it's a data collection device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "kinematic measurements" functionality is "standalone" in that it captures data without human input beyond the system setup. However, this isn't an AI algorithm in the sense of a diagnostic or predictive model.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For kinematic measurements, the ground truth would typically be established by highly accurate motion capture systems or physical measurement standards, not expert consensus or pathology.
- The sample size for the training set: Not applicable. This device is not described as having an AI/ML model that requires a "training set" in the conventional sense for a diagnostic or prognostic application. The "software verification" refers to traditional software validation processes.
- How the ground truth for the training set was established: Not applicable, as there's no described AI/ML training set.
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April 24, 2024
Canary Medical USA, LLC Kevin Leung Associate Director, Regulatory Affairs 2710 Loker Avenue West. Suite 350 Carlsbad, California 92010
Re: K234056
Trade/Device Name: canturio® se (Canturio Smart Extension) Regulation Number: 21 CFR 888.3600 Regulation Name: Implantable Post-Surgical Kinematic Measurement Knee Device Regulatory Class: Class II Product Code: QPP Dated: March 25, 2024 Received: March 25, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
| Peter G. | Digitally signed by Peter G. Allen -S |
|---|---|
| Allen -S | Date: 2024.04.24 01:21:50 -04'00' |
For Lixin Liu. Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
l
Submission Number (if known)
Device Name
canturio® se (Canturio Smart Extension)
ndications for Use (Describe)
The canturio® se (Canturio Smart Extension) 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 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 30mm sized tibial stem extension.
The objective kinematic data generated by the canturio® se with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.
The canturio® se 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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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: | canturio® se (Canturio Smart Extension) (K234056) |
| 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 seek 510(k) clearance for thecanturio® se (Canturio Smart Extension or CSE) implant designed toreplicate the canturio® te (Canturio Tibial Extension or CTE) (predicatedevice; reference DEN200064) as a product line extension offering ofsmaller size for patients whose physician believe would benefit from a30mm-sized tibial stem and adjunctive kinematic gait data, remotemonitoring, post-total knee arthroplasty (TKA) surgery. |
| Device Description: | The canturio® se is a tibial extension implant or stem that is attachedby the orthopedic surgeon to the Zimmer Biomet Persona® tibialbaseplate to form the patient's tibial knee prosthesis. The softwareand electronics embedded within the canturio® se prosthesis collectthe patient's functional movement and gait parameter data post-surgery. Like a traditional tibial extension, the canturio® se providesadditional stability in the same manner as a traditional knee extension.The canturio® se (Canturio Smart Extension or CSE) is used with theCanary Health Implanted Reporting Processor (CHIRP) System which iscomprised of the following subsystems:- Operating Room Base Station Subsystem ("OR BS"), |
| • Home Base Station Subsystem (“HBS”),• Canary Cloud Data Management Platform ("Cloud" or "CMDP") subsystem and• Canary Medical Gait Parameters (CMGP) software module.Each CHIRP subsystem combines physical components, electronics, software, and user interfaces to collect, store, analyze, transmit, and display patient data for use by both physicians and patients. | |
| Indications for Use: | The canturio® se (Canturio Smart Extension) with Canary HealthImplanted Reporting Processor (CHIRP) System is intended toprovide objective kinematic data from the implanted medicaldevice during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to otherphysiological parameter measurement tools applied or utilized bythe physician during the course of patient monitoring andtreatment post-surgery.The device is indicated for use in patients undergoing a cementedTKA procedure that are normally indicated for at least a 30 mmsized tibial stem extension.The objective kinematic data generated by the canturio® se withCHIRP System are not intended to support clinical decision-makingand have not been shown to provide any clinical benefit.The canturio® se with CHIRP System is compatible with ZimmerBiomet Persona® The Personalized Knee® System. |
| Summary ofTechnologicalCharacteristics andComparison: | The rationale for substantial equivalence is based on comparativeassessment of the following characteristics:• Intended use: Same as the predicate.• Indications for use: Substantially equivalent to the predicatewith the only difference in shorter length variant.• Materials: Same as the predicate device.• Geometry/Configuration/Size (of Tibial Extension): Samegeometry/configuration as the predicate device but shorterlength |
| Performance: Same as predicate 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: Mechanical Fatigue Shock Survival Electrical Life Test Accuracy, reliability, and reproducibility of kinematicmeasurements Electromagnetic compatibility (EMC) and electromagneticinterference (EMI) Hermeticity of any electronic component enclosures Biological Evaluation Battery Longevity Electronic Functionality Software Verification Magnetic Resonance Compatibility |
| Substantial EquivalenceConclusion: | The subject device has the same intended use and substantially equivalentindications for use as the predicate device. The subject device has thesame technological characteristics to the predicate, and the performancedata and analyses demonstrate 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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§ 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.