(205 days)
The INVISION® 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 INVISION® Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, 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 stems, talar domes, talar plates, and tibial trays.
The provided text describes the INVISION® Total Ankle Revision System, a medical device, and its FDA 510(k) summary of safety and effectiveness. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/algorithm-based diagnostic or prognostic device.
The document is a traditional 510(k) submission for a physical medical implant (an ankle prosthesis). The "acceptance criteria" and "study" mentioned in your request, along with details like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set sample size," are all relevant to the evaluation of AI/Machine Learning-based medical devices, particularly those that generate diagnostic or prognostic outputs.
The information provided in the document focuses on:
- Device Description: What the total ankle revision system is.
- Intended Use and Indications for Use: The conditions for which the device is intended.
- Technological Characteristics Comparison with Predicate Devices: Comparing the new system to previously approved ankle prostheses, noting similarities in indications, instrumentation, materials, and sterilization, and a minor difference in talar plate fixation.
- Non-Clinical Evidence for Substantial Equivalence: This includes mechanical testing (fatigue, shear, wear, torsional, torque-off, pull-off testing) to show the new device performs at least as well as or better than predicate systems.
- Clinical Evidence: Stated as "N/A," indicating no new human clinical trials were conducted for this 510(k) submission to demonstrate substantial equivalence, likely relying on the established performance of the predicate devices.
- Conclusion: The device is substantially equivalent to predicate devices based on the submitted non-clinical evidence.
Therefore, I cannot provide the requested table or detailed answers for an AI/algorithm study as the document describes a physical medical implant approval.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2016
Wright Medical Technology, Incorporated Ms. Tara Conrad Regulatory Affairs Specialist II 1023 Cherry Road Memphis, Tennessee 38117
Re: K153008
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: April 11, 2016 Received: April 12, 2016
Dear Ms. Conrad:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/ResourcesforYou/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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, post-traumatic, or degenerative arthritis.
The INVISION® Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, 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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K153008 Page 1 of 2
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 use of the INVISION® Total Ankle Revision System.
| 1. | Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 |
|---|---|---|
| Date: | April 11, 2016 | |
| Contact Person: | Tara ConradRegulatory Affairs Specialist IIOffice (901) 867-4367Fax (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 SystemK103374 INBONE® II Total Ankle SystemK051023 INBONE® II Total Ankle System |
| 4. | Device DescriptionThe subject INVISION® Total Ankle Revision System is a fixed-bearing system that isspecifically designed considering revision procedures. Based on the INBONE® Total AnkleSystem platform, INVISION® Total Ankle Revision System includes tibial stems, talar domes,talar plates, and tibial trays. | |
| 5. | Intended Use and Indications for Use |
The INVISION® 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.
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The INVISION® Total Ankle Revision System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
Technological Characteristics Comparison 6.
The INVISION® Total Ankle Revision System has identical indications, utilizes similar instrumentation, is made from identical materials, and has identical sterilization methods when compared to the legally marketed predicate devices.
The INVISION® Total Ankle Revision System features a talar plate with three talar pegs for fixation while the predicate systems utilize either two talar pegs or two talar pegs and one talar stem for fixation.
7. Substantial Equivalence- Non-Clinical Evidence
Mechanical testing (including Fatigue Testing and Shear testing), analysis of wear testing. torsional testing, torque-off testing and pull-off testing have shown that the performance of the subject system is substantially equivalent or greater than the predicate systems.
Substantial Equivalence- Clinical Evidence 8.
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.