(233 days)
The INVISION™ Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.
The INVISION™ Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
The subject INVISION™ Total Ankle Revision System is a fixed-bearing system that is specifically designed considering revision procedures. Based on the INBONE® Total Ankle System platform, INVISION™ Total Ankle Revision System includes tibial trays that are compatible with the INBONE® Total Ankle System talar stems and INBONE® Sulcus Poly Inserts. To accommodate various patients' boney defects, the INVISION™ tibial trays are available in two heights: +4 mm and +8 mm, which are an additional 4 mm or 8 mm above the current INBONE® height.
This document is a 510(k) premarket notification for the INVISION™ Total Ankle Revision System. It describes the device, its intended use, and its equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to the requested information:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would typically be associated with AI/software medical devices. This document concerns a physical orthopedic implant.
The document states "Dimensional comparisons were used to demonstrated that the tibial trays of the INVISION™ Total Ankle Revision System does not present a new worst-case compared to the tibial trays of the INBONE® Total Ankle System." This can be interpreted as the performance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not present a new worst-case compared to predicate device's tibial trays in terms of dimensions. | Demonstrated that the tibial trays of the INVISION™ Total Ankle Revision System do not present a new worst-case compared to the tibial trays of the INBONE® Total Ankle System through dimensional comparisons. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document refers to an orthopedic implant, and the primary evidence for substantial equivalence is based on dimensional comparisons to predicate devices, not on data from a "test set" in the context of diagnostic or AI performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth, in this context, would be the design specifications and established safety/performance of the predicate devices. Expert consensus for performance metrics is not mentioned as part of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this device's submission.
5. 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
Not applicable. This device is an ankle prosthesis, not an AI-powered diagnostic tool. Hence, no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly used for establishing substantial equivalence for a physical device like this is primarily engineering specifications and established performance characteristics of the predicate devices. Dimensional comparisons are used to show the new device is within the safe and effective range established by the predicate.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is mentioned or relevant to this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Wright Medical Technology, Incorporated Ms.Val Mvles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K142117
Trade/Device Name: INVISION™ Total Ankle Revision System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN Dated: February 23, 2015 Received: February 24, 2015
Dear Ms. Myles:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Val Myles
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
INVISION Total Ankle Revision System
Indications for Use (Describe)
The INVISION Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.
The INVISION Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 wmt.com
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the INVISION™ Total Ankle Revision System.
| 1. | Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 |
|---|---|---|
| Date: | February 23, 2015 | |
| Contact Person: | Val MylesRegulatory Affairs SpecialistOffice (901) 290-5162Fax (901) 867-4190 | |
| 2. | Proprietary Name: | INVISION™ Total Ankle Revision System |
| Common Name: | Ankle Prosthesis | |
| Classification Name and Reference: 21 CFR 888.3110- Class II | ||
| Device Product Code, Device Panel: HSN - Orthopedic | ||
| 3. | Predicate Device: | K140749 INFINITY® Total Ankle SystemK123954 INFINITY® Total Ankle SystemK133585 INBONE® II Total Ankle SystemK100886 INBONE® II Total Ankle System |
| 4. | Device Description | The subject INVISION™ Total Ankle Revision System is a fixed-bearing system thatis specifically designed considering revision procedures. Based on the INBONE®Total Ankle System platform, INVISION™ Total Ankle Revision System includestibial trays that are compatible with the INBONE® Total Ankle System talar stems |
and INBONE® Sulcus Poly Inserts. To accommodate various patients' boney defects, the INVISION™ tibial trays are available in two heights: +4 mm and +8 mm, which are an additional 4 mm or 8 mm above the current INBONE® height.
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5. Intended Use and Indications for Use
The INVISIONTM Total Ankle Revision System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
The INVISION™ Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INVISIONTM Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
6. Technological Characteristics Comparison
The INVISION Total Ankle Revision System has identical indications, utilizes similar instrumentation, is made identical materials, and has identical sterilization methods when compared with the legally marketed predicate devices.
Substantial Equivalence- Non-Clinical Evidence 7.
Dimensional comparisons were used to demonstrated that the tibial trays of the INVISION™ Total Ankle Revision System does not present a new worst-case compared to the tibial trays of the INBONE® Total Ankle System.
8. Substantial Equivalence- Clinical Evidence
N/A
9. Substantial Equivalence- Conclusions
The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.