(141 days)
No
The summary describes a system for creating patient-specific surgical guides based on imaging scans, but there is no mention of AI or ML being used in the process of generating these guides or reports. The focus is on "preoperative navigation alignment" and "patient specific surgical instrumentation" which are typically based on anatomical landmarks and traditional image processing/modeling techniques.
No.
The device is described as surgical instrumentation to assist in the positioning of total ankle replacement components and guiding the marking of bone, rather than directly treating a condition or disease.
No
Explanation: The device is described as patient-specific surgical instrumentation used to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. It provides a template of anatomy for alignment during surgery, rather than diagnosing a condition or disease.
No
The device description explicitly mentions "PROPHECY® Preoperative Navigation Alignment Guides" which are described as "patient specific surgical instrumentation" and "intended for single use only." This indicates a physical component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used to assist in the positioning of total ankle replacement components intraoperatively and in guiding bone marking. This is a surgical guidance and planning tool, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces that it provides a template of the patient's anatomy for surgical alignment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
The device falls under the category of surgical planning and guidance systems, which are distinct from IVDs.
N/A
Intended Use / Indications for 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® and INFINITY® 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.
Product codes
HSN, OYK
Device Description
PROPHECY® Preoperative Navigation Alignment System provides the surgeon a template of the patient's distal tibial and proximal talar anatomy. The PROPHECY® alignment report serves as a template for traditional alignmentation used with Wright's INBONE®, INFINITY , and INVISION® Total Ankle Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibial and proximal talar
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Design repeatability across design engineers -
-Software validation
These evaluations concluded the subject alignment guide is substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110306-PROPHECY® INBONE®, K131283-PROPHECY®INFINITY®, K142117-INVISION® Total Ankle System, K153008-INVISION® Total Ankle System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2017
Wright Medical Technology, Inc. Tara Conrad Regulatory Affairs Specialist II 1023 Cherry Road Memphis. Tennessee 37117
Re: K162795
Trade/Device Name: PROPHECY INVISION Preoperative Navigation Alignment 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: September 20, 2016 Received: October 4, 2016
Dear Tara 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 Part 801); medical device reporting (reporting of medical devicerelated 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.
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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
PROPHECY® INVISION® Preoperative Navigation Alignment 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® and INFINITY® 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)
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Headquarters Wright Medical Technology, Inc.
Memphis. TN 3811
901 867 9971
wtmt.com
Image /page/3/Picture/3 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side of the word "WRIGHT" in red, block letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.
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 PROPHECY® INVISION® Preoperative Navigation Alignment System.
| 1. | Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|----|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Date: | January 27, 2017 |
| | Contact Person: | Tara Conrad
Regulatory Affairs Specialist II
Office (901) 867-4367
Fax (901) 867-4190 |
| 2. | Proprietary Name: | PROPHECY® INVISION® Preoperative
Navigation Alignment System |
| | Common Name: | Alignment Guide |
| | Classification Name and Reference: | 21 CFR 888.3110 - Class II |
| | Device Product Code, Device Panel: | HSN, OYK |
| 3. | Predicate Device: | K110306-PROPHECY® INBONE®
K131283-PROPHECY®INFINITY®
K142117-INVISION® Total Ankle System
K153008-INVISION® Total Ankle System |
| 4. | Device Description | |
PROPHECY® Preoperative Navigation Alignment System provides the surgeon a template of the patient's distal tibial and proximal talar anatomy. The PROPHECY® alignment report serves as a template for traditional alignmentation used with Wright's INBONE®, INFINITY , and INVISION® Total Ankle Systems.
ട. Intended Use and Indications for 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
4
marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE® and INFINITY® 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.
6. Technological Characteristics Comparison
The PROPHECY® Preoperative Navigation Alignment system has identical indications, is made from identical materials and software when compared to the legally marketed predicate devices.
7. Substantial Equivalence- Non-Clinical Evidence
The main difference between the subject and predicate PROPHECY® systems is the addition of use with the INVISION® Total Ankle System. The following evaluations were conducted to support the safety and efficacy of the PROPHECY® INVISION® Alignment Report:
- Design repeatability across design engineers -
- -Software validation
These evaluations concluded the subject alignment guide is substantially equivalent to the predicates.
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.
b.