(124 days)
Not Found
No
The summary describes the collection, storage, analysis, transmission, and display of kinematic data, but there is no mention of AI or ML being used for analysis or interpretation. The analysis appears to be based on objective kinematic data and gait parameters.
No
The device is described as providing "objective kinematic data" as an "adjunct to other physiological parameter measurement tools." The "Intended Use / Indications for Use" section explicitly states that the data "are not intended to support clinical decision-making and have not been shown to provide any clinical benefit." This indicates its purpose is informational rather than therapeutic.
No
The device collects kinematic data and explicitly states that the data generated are "not intended to support clinical decision-making and have not been shown to provide any clinical benefit." This indicates it's not used for diagnosis.
No
The device description explicitly states that the system is comprised of physical components, electronics, and software, and the canturio® se itself is a tibial extension implant with embedded software and electronics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The canturio® se with CHIRP System is an implanted medical device that collects kinematic data (data related to movement) from a patient's knee after total knee replacement surgery. It measures functional movement and gait parameters.
- Intended Use: The intended use is to provide objective kinematic data as an adjunct to other physiological parameter measurement tools used by a physician during post-surgical monitoring and treatment. It explicitly states the data are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly measures physical movement.
In summary, the device is a biomechanical sensor and data collection system implanted within the body, not a test performed on a biological sample outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
QPP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, patient monitoring
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: Mechanical Fatigue Shock Survival Electrical Life Test Accuracy, reliability, and reproducibility of kinematic measurements Electromagnetic compatibility (EMC) and electromagnetic interference (EMI) Hermeticity of any electronic component enclosures Biological Evaluation Battery Longevity Electronic Functionality Software Verification Magnetic Resonance Compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains 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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
2
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 LLC
2710 Loker Ave. West, Suite 350
Carlsbad, CA 92010 |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3015802419 |
| Contact Person: | Kevin Leung
Associate Director, Regulatory Affairs
Mobile: (562 )547-4067
Email: 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 Reporting
Processor (CHIRP) System (DEN200064) |
| Purpose of Submission: | The purpose of this submission is to seek 510(k) clearance for the
canturio® se (Canturio Smart Extension or CSE) implant designed to
replicate the canturio® te (Canturio Tibial Extension or CTE) (predicate
device; reference DEN200064) as a product line extension offering of
smaller size for patients whose physician believe would benefit from a
30mm-sized tibial stem and adjunctive kinematic gait data, remote
monitoring, post-total knee arthroplasty (TKA) surgery. |
| Device Description: | 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. |
| Indications for Use: | 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 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 30 mm
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
Biomet Persona® The Personalized Knee® System. |
| Summary of
Technological
Characteristics and
Comparison: | The rationale for substantial equivalence is based on comparative
assessment of the following characteristics:
• Intended use: Same as the predicate.
• Indications for use: Substantially equivalent to the predicate
with the only difference in shorter length variant.
• Materials: Same as the predicate device.
• Geometry/Configuration/Size (of Tibial Extension): Same
geometry/configuration as the predicate device but shorter
length |
| | Performance: Same as 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: Mechanical Fatigue Shock Survival Electrical Life Test Accuracy, reliability, and reproducibility of kinematic
measurements Electromagnetic compatibility (EMC) and electromagnetic
interference (EMI) Hermeticity of any electronic component enclosures Biological Evaluation Battery Longevity Electronic Functionality Software Verification Magnetic Resonance Compatibility |
| Substantial Equivalence
Conclusion: | The subject device has the same intended use and substantially equivalent
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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