(224 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical implantation of a joint prosthesis, with no mention of AI or ML technologies.
Yes
The Ensemble CMC is an implantable interpositional joint prosthesis intended to treat painful, unstable thumbs or thumbs with limited range of motion due to various forms of arthritis or post-fracture deformation. Its purpose is to restore function and alleviate symptoms, which aligns with the definition of a therapeutic device.
No
This device is an implant designed to replace anatomical structures (first metacarpal and trapezium) to restore function due to various arthritic conditions or post-fracture deformation. It is a therapeutic device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a physical implant (a joint prosthesis) made of pyrocarbon and graphite, and it is used with manual surgical instruments. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Ensemble CMC is a surgical implant designed to replace bones in the hand. It is a physical device implanted into the body.
- Intended Use: The intended use is to treat arthritis and bone loss by replacing damaged bones, not to analyze samples from the body.
The description clearly indicates this is a surgically implanted prosthesis, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Ensemble CMC is intended to replace the first metacarpal and the trapezium in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Product codes
KYI
Device Description
The Ensemble CMC implant is a single use, uncemented, one-piece interpositional joint prosthesis designed to fit in the space between the trapezium and first metacarpal for patients with early stage arthritis of the carpometacarpal joint (CMC). The Ensemble CMC is not intended to interact with other devices. It has upper and lower surfaces that are saddle (toroidal) shaped to match the anatomy of the base of the first metacarpal and the trapezium. The design of the Ensemble CMC allows for flexion-extension, abduction-adduction, and circumduction motions. The implant is manufactured with an On-X® PyroCarbon (pyrocarbon) layer encasing a graphite core and comes in three sizes. Each device is provided sterile in packaging containing a single implant, Instructions for Use, and patient chart labels.
A series of non-powered, hand-held manual surgical instruments can be used to prepare the joint space before implantation of the Ensemble CMC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metacarpal and the trapezium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-clinical mechanical testing was performed to demonstrate that the Ensemble CMC is substantially equivalent to the performance characteristics of the predicate devices currently marketed with respect to material characteristics, joint biomechanics, static and endurance testing. Cadaveric testing was performed to demonstrate the allowable range of motion and to confirm that the device does not cause impingement. Based on the results of the non-clinical testing, it can be concluded that the subject device is as safe and effective as legally marketed predicate devices.
No clinical performance data were needed to support substantial equivalence of this implant to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K042690, K061451, K092548, K111068, K033529
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.
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December 2, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ensemble Orthopedics, LLC Sandie Roth VP, Regulatory Affairs 107 Redbud Trail, Suite 11 Austin, Texas 78746
Re: K201072
Trade/Device Name: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist Joint Carpal Trapezium Polymer Prosthesis Regulatory Class: Class II Product Code: KYI Dated: October 30, 2020 Received: November 2, 2020
Dear Sandie Roth:
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 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
1
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 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.
Vesa Vuniqi Assistant Director DHT6A2: 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) K201072
Device Name ENSEMBLE CMC
Indications for Use (Describe)
The Ensemble CMC is intended to replace the first metacarpal and the trapezium in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Ensemble Orthopedics LLC. The word "ENSEMBLE" is written in a large, sans-serif font, with each letter outlined in black. Below the word "ENSEMBLE" is the text "ORTHOPEDICS LLC", written in a smaller, bold, sans-serif font.
510(k) Summary Ensemble CMC
July 24, 2020
Submitter:
Ensemble Orthopedics, LLC 107 Redbud Trail, Suite 11 Austin, TX 78746 Tel: (512) 364-3830 Contact: Sandie Roth, VP of Regulatory Email: sroth@ensembleortho.com
Establishment Registration Number: TBD
Name and Classification:
| Trade Name: | ENSEMBLE CMC |
|---|---|
| Common Name: | Carpometacarpal implant |
| Regulation Name: | Wrist joint carpal trapezium polymer prosthesis |
| Classification: | 21 CFR 888.3770 |
| Product Code: | KYI |
| Regulatory Class: | Class II |
Predicate Devices:
| K042690 | Ascension PyroSphere, Cleared December 13, 2004 |
|---|---|
| K061451 | Ascension CMC, Cleared August 11, 2006 |
| K092548 | Extremity Medical Trapezium, December 15, 2009 |
| K111068 | Stablyx CMC Arthroplasty, Cleared December 30, 2011 |
| K033529 | Tie-In Trapezium, Cleared December 3, 2003 |
Description of the Device:
The Ensemble CMC implant is a single use, uncemented, one-piece interpositional joint prosthesis designed to fit in the space between the trapezium and first metacarpal for patients with early stage arthritis of the carpometacarpal joint (CMC). The Ensemble CMC is not intended to interact with other devices. It has upper and lower surfaces that are saddle (toroidal) shaped to match the anatomy of the base of the first metacarpal and the trapezium. The design of the Ensemble CMC allows for flexion-extension, abduction-adduction, and circumduction motions. The implant is manufactured with an
4
On-X® PyroCarbon (pyrocarbon) layer encasing a graphite core and comes in three sizes. Each device is provided sterile in packaging containing a single implant, Instructions for Use, and patient chart labels.
A series of non-powered, hand-held manual surgical instruments can be used to prepare the joint space before implantation of the Ensemble CMC.
Intended Use:
The Ensemble CMC is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Technological Characteristics:
The substantial equivalence of the Ensemble CMC to the predicate device is demonstrated by similarities in indications for use, device design, materials, manufacturing process, anatomical site, principles of operation, and sterility status. A comparison of technological characteristics of the Ensemble CMC and the predicate devices do not raise any new questions of safety or effectiveness.
Non-Clinical Testing:
Non-clinical mechanical testing was performed to demonstrate that the Ensemble CMC is substantially equivalent to the performance characteristics of the predicate devices currently marketed with respect to material characteristics, joint biomechanics, static and endurance testing. Cadaveric testing was performed to demonstrate the allowable range of motion and to confirm that the device does not cause impingement. Based on the results of the non-clinical testing, it can be concluded that the subject device is as safe and effective as legally marketed predicate devices.
Clinical Performance:
No clinical performance data were needed to support substantial equivalence of this implant to the predicate device.
Conclusion:
The Ensemble CMC is substantially equivalent to the predicate device identified in this premarket submission.