(138 days)
Wright's PROPHECY™ Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The PROPHECY™ Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE™, INFINITY™, and INVISION™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only. The PROPHECY® Preoperative Reports are intended for use with Wright's INBONE® INFINITY® and INVISION® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Wright Medical's PROPHECY INVISION Preoperative Navigation Alignment System (K162795) is being expanded to include patient-specific guides for the INVISION Total Ankle System. Like the predicates PROPHECY INFINITY and PROPHECY INBONE guides, the subject patient-specific guides are created to fit the anatomy of the patient's distal tibia and proximal talus, and when used in combination with the reusable instruments, facilitate positioning of INVISION Total Ankle Implants.
I apologize, but the provided text from the FDA 510(k) K170968 does not contain the detailed study information required to answer your request about acceptance criteria and device performance.
The document is a 510(k) summary for a pre-operative navigation system. While it mentions that evaluations were conducted to support safety and efficacy, it only lists the types of evaluations (e.g., "Pre-operative vs Post-operative Analysis of Implant Placement," "Guide Placement Repeatability Inter-surgeon Variability"). It explicitly states "N/A" for clinical evidence ("SUBSTANTIAL EUIVALENCE – CLINICAL EVIDENCE N/A").
To provide the information you've requested regarding acceptance criteria, reported performance, sample sizes, expert qualifications, ground truth establishment, etc., I would need access to the full submission or specific study reports that detail the results of these evaluations. This 510(k) summary only provides a high-level overview and states that the device is substantially equivalent based on non-clinical evidence.
Therefore, I cannot populate the table or answer the specific questions about the study design and results from the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. Alayne Melancon Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117
August 16, 2017
Re: K170968
Trade/Device Name: PROPHECY INVISION Pre-operative Navigation System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN, OYK Dated: March 24, 2017 Received: March 31, 2017
Dear Alayne Melancon:
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
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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,
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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Indications for Use
510(k) Number (if known)
K170968
Device Name
PROPHECY™ INVISION™ Preoperative Navigation System
Indications for Use (Describe)
Wright's PROPHECY™ Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The PROPHECY™ Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE™, INFINITY™, and INVISION™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only. The PROPHECY® Preoperative Reports are intended for use with Wright's INBONE®, INFINITY® and INVISION® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
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)
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)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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K170968 Page 1 of 3
Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 vmt.com
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510(K) SUMMARY
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 PROPHECY INVISION Pre-operative Navigation System.
(a)(1) MANUFACTURER IDENTIFICATION
Submitted By:
Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
Date:
March 24, 2017
Contact Person:
Alayne Melancon Regulatory Affairs Specialist Office: (901)290-5986 Fax: (901)867-4190
(a)(2) SUBJECT DEVICE INFORMATION
| Proprietary Name: | PROPHECY INVISION Pre-operative Navigation System |
|---|---|
| Common Name: | Alignment Guide |
| Classification Name & Reference: | 21 CFR 888.3110 - Class II |
| Device Product Code & Panel: | HSN, OYK – Orthopedic |
(a)(3) PREDICATE DEVICE INFORMATION
| PROPHECY INVISION Pre-operative Navigation Alignment System: | K162795 |
|---|---|
| PROPHECY INFINITY Pre-operative Navigation Alignment System: | K131283 |
| PROPHECY INBONE Pre-operative Navigation Alignment System: | K110360 |
| INVISION Total Ankle System: | K142117, K153008 |
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(a)(4) DEVICE DESCRIPTON
Wright Medical's PROPHECY INVISION Preoperative Navigation Alignment System (K162795) is being expanded to include patient-specific guides for the INVISION Total Ankle System. Like the predicates PROPHECY INFINITY and PROPHECY INBONE guides, the subject patient-specific guides are created to fit the anatomy of the patient's distal tibia and proximal talus, and when used in combination with the reusable instruments, facilitate positioning of INVISION Total Ankle Implants.
(a)(5) INTENDED USE
Wright's PROPHECY™ Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The PROPHECY™ Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE™, INFINITY™, and INVISION™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only. The PROPHECY® Preoperative Reports are intended for use with Wright's INBONE® INFINITY® and INVISION® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject PROPHECY INVISION Pre-operative Navigation System has identical indications and software components. The materials and design are substantially equivalent to the predicate devices and are summarized in the table below.
| SUBJECT | PREDICATES | ||
|---|---|---|---|
| PROPHECY INVISION | PROPHECY INFINITY(K131283) | PROPHECY INBONE(K110360) | |
| Patient-SpecificGuides | -Tibia Alignment -Guide-Tibia Spacer Guide-Talus Spacer Guide-Tibia Stem Guide | -Tibia Alignment Guide-Talus Alignment Guide | -Tibia Alignment Guide-Talus Alignment Guide-Tibia Stem Guide |
| Materials | Patient-specific guides:Duraform PolyamideAccessory instrument:stainless steel, Radel | Patient-specific guides:Duraform PolyamideAccessory instrument:stainless steel | Patient-specific guides:Duraform PolyamideAccessory instrument:stainless steel |
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
The following evaluations were conducted to support the safety and efficacy of the PROPHECY INVISION Pre-operative Navigation System:
- Guide Design Process Validation Designer Repeatability
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- -Pre-operative vs Post-operative Analysis of Implant Placement
- Guide Placement Repeatability Inter-surgeon Variability -
(b)(2) SUBSTANTIAL EQUIVALENCE – CLINICAL EVIDENCE N/A
(b)(3) SUBSTANTIAL EUIVALENCE - CONCLUSIONS
The design characteristics of the subject device 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.