(128 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data collection and processing, not AI/ML analysis.
No
The device provides objective kinematic data as an adjunct to patient monitoring, but explicitly states that the data are "not intended to support clinical decisionmaking and have not been shown to provide any clinical benefit," thus it does not treat or cure.
No
The device description explicitly states that the kinematic data generated by the system "are not intended to support clinical decisionmaking and have not been shown to provide any clinical benefit," which contradicts the purpose of a diagnostic device. It also states the data are an "adjunct to other physiological parameter measurement tools."
No
The device description explicitly lists hardware components like the "Canary Tibial Extension (CTE) implant," "Operating Room (OR) Base Station System (BS1)," and "Home Base Station System (BS2)," in addition to software components.
Based on the provided information, the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The CTE with CHIRP System is an implanted device that collects objective kinematic data (movement data) directly from the implanted medical device (the tibial extension) within the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to provide kinematic data as an adjunct to other physiological parameter measurement tools used by the physician during post-surgical care. This data is collected in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
Therefore, the device's function and intended use clearly fall outside the scope 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) 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 decision-making and have not been shown to provide any clinical benefit.
The CTE with CHIRP System is compatible with Zimmer Personalized Knee System.
Product codes (comma separated list FDA assigned to the subject device)
QPP
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
total knee arthroplasty (TKA)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were performed to support the modifications to the subject device: Shock Survival Electrical Life Test Battery Longevity Electronic Functionality Software Verification
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
June 22, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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
1
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
2
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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3
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 LLC
2710 Loker Ave. West, Suite 350
Carlsbad, CA 92010 |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3015802419 |
| Contact Person: | Nora C.R. York
Vice President, Regulatory Affairs and Quality Affairs
Mobile: 760-497-6115
Email: nyork@canarymedical.com |
| Date of Summary
Preparation: | March 23, 2022 |
| Subject Device: | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting
Processor (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 Reporting
Processor (CHIRP) System (DEN200064) |
| Purpose of Submission: | The purpose of this submission is to add a dedicated low-power
accelerometer for activity monitoring (step counting) and detection of
significant motion to trigger kinematic data collection. The design
enhancements are intended to increase the kinematic data sampling day
collection capability using the same battery. The design enhancement
does not change the intended use / indications for use or fundamental
scientific technology of the device. The addition of the accelerometer
necessitates other accommodations to the printed circuit board assembly
(PCBA) and associated embedded software. |
| Device Description: | 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). |
| Indications for Use: | 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 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. |
| Summary of
Technological
Characteristics and
Comparison: | The rationale for substantial equivalence is based on comparative
assessment 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 the
predicate device. |
| | Sterility: Same as the predicate device. Packaging: Same as the predicate device. |
| Summary of
Performance Data: | The following non-clinical tests were performed to support the
modifications to the subject device: Shock Survival Electrical Life Test Battery Longevity Electronic Functionality Software Verification |
| Substantial Equivalence
Conclusion: | The subject device has the same intended use and indications for use as
the predicate device. The subject device has the same technological
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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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.
5
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.