(33 days)
The HV Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
- · Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- · Talar/navicular arthrodesis
The HV Screws are cannulated screws offered in 3.0mm diameter, various lengths, and have self-tapping features on both distal and proximal threads. All screws are manufactured from titanium alloy.
The provided document is a 510(k) Premarket Notification from the FDA regarding the HV Screw System by Wright Medical Technology, Inc. This document is a regulatory approval for a medical device (a bone fixation fastener), not a clinical study on an AI/machine learning diagnostic device.
Therefore, the input does not contain the information required to answer the questions about acceptance criteria, study design, ground truth establishment, or human reader performance for an AI/ML device.
Here's why the provided text does not contain the requested information:
- Type of Device: The HV Screw System is a physical medical implant (a screw for bone fixation), not an AI/machine learning software or diagnostic device. As such, the performance criteria and study methodologies described are for a mechanical implant, not an AI algorithm.
- Performance Metrics: The "Validation and/or Verification Method" in the document focuses on mechanical properties like torsional testing, axial pullout force, and bending strength, which are relevant to a screw's physical performance, not diagnostic accuracy (e.g., sensitivity, specificity, AUC).
- Clinical Evidence: The document explicitly states "8. Substantial Equivalence- Clinical Evidence: N/A". This indicates that no human clinical study was conducted for this submission, as is often the case for medical devices that demonstrate substantial equivalence to a predicate device through non-clinical (e.g., benchtop) testing.
- AI/ML Specifics: There is no mention of algorithms, machine learning, human readers, experts establishing ground truth for diagnostic images, test sets, training sets, or adjudication methods, as these concepts are not applicable to the HV Screw System.
Based on the provided text, I cannot fill in the requested table or answer the specific questions related to an AI/machine learning device.
The document describes the regulatory process for a physical medical device (HV Screw System) and its substantial equivalence to a predicate device based primarily on non-clinical (mechanical) testing. It does not provide any details about an AI/ML study.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2017
Wright Medical Technology, Inc. Ms. Tara Conrad Regulatory Affairs Specialist II 1023 Cherry Road Memphis. Tennessee 38117
Re: K170889
Trade/Device Name: HV Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 15, 2017 Received: March 24, 2017
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 Part 801); medical device reporting (reporting of medical device-
Image /page/0/Picture/11 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other, creating a sense of depth and unity.
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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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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 HV Screw System
Indications for Use (Describe)
The HV Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
- · Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- · Talar/navicular arthrodesis
| 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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K170889 Page 1 of 2
Headquarters Wright Medical Technology, Inc.
mohis TN 38117
901 867 997
wmt.com
Image /page/3/Picture/4 description: The image contains the logo for Wright. The logo consists of two overlapping trapezoids, one red and one orange, on the left side of the word "WRIGHT" in red, all caps. 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 HV Screw System.
| 1. | Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 | |
|---|---|---|---|
| 510(k) Number: | K170889 | ||
| Date: | April 25, 2017 | ||
| Contact Person: | Tara ConradRegulatory Affairs Specialist IIOffice(901) 867-4367(901) 867-4190Fax | ||
| 2. | Proprietary Name:Common Name:Classification Name and Reference: | HV Screw SystemCannulated Bone Screw21 CFR 888.3040- Class II- Smooth or threaded | |
| Device Product Code, Device Panel: | metallic bone fixation fastenerHWC - Orthopedic | ||
| 3. | Predicate Device: | K082320- Wright TM Compression Screw | |
| 4. | Device Description |
The HV Screws are cannulated screws offered in 3.0mm diameter, various lengths, and have self-tapping features on both distal and proximal threads. All screws are manufactured from titanium alloy.
ഹ Intended Use and Indications for Use
The HV Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- · Akin type osteotomy
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- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize
- metatarsus varus primus
- Talar/navicular arthrodesis
6. Technological Characteristics Comparison
The HV Screw System utilizes similar instrumentation, is made from identical materials, and has identical sterilization methods when compared to the legally marketed predicate device.
7. Substantial Equivalence- Non-Clinical Evidence
| Validation and/or | Acceptance Value/Criteria | Results | |
|---|---|---|---|
| Verification Method | |||
| Torsional TestingInsertion Torque।Removal Torque।Ultimate Torque। | Ultimate Torque mustexceed insertion torque andremoval torque by a safetyfactor | Acceptable | |
| Engineering AnalysisAxial Pullout ForceBending Strength-Torsional Strength | Comparable to the predicatedevice design | Acceptable | |
| Bacterial EndotoxinsTesting | < 20EU/device | Acceptable |
8. Substantial Equivalence- Clinical Evidence
- N/A
9. Substantial Equivalence- Conclusions
The design characteristics of the subject devices do not raise any different 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 system and are substantially equivalent.
N/A