(53 days)
The Activ Ankle range is intended for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.
The Activ Ankle range consists of plates with screws designed for fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults. Washers are also available for use with screws. The implants of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial A) contain implants and instruments, or instruments only. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136 and ISO 5832-3).
This document is a 510(k) summary for the Activ Ankle range, which are metallic bone fixation appliances. It explicitly states that no clinical studies were performed to demonstrate that the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, the detailed information requested regarding acceptance criteria based on human performance, sample sizes for test sets, expert ground truth adjudication, MRMC studies, and standalone algorithm performance cannot be provided from this document.
Here's what can be extracted regarding the non-clinical testing and the basis for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical studies were performed, there are no acceptance criteria related to human performance or device efficacy in a clinical setting. The "acceptance criteria" here relate to the non-clinical mechanical performance.
| Criterion | Reported Device Performance/Comparison (Based on Substantial Equivalence Claim) |
|---|---|
| Static bend test (ASTM F382) | Comparative testing performed, implying performance is equivalent to predicates. |
| Fatigue bend test (ASTM F382) | Comparative testing performed, implying performance is equivalent to predicates. |
| Endotoxins testing (LAL quantitative kinetic chromogenic method) | Performed, implying compliance with sterility/safety standards. |
| Intended Use | Equivalent to predicate devices. |
| Design | Equivalent to predicate devices. |
| Materials | Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136 and ISO 5832-3), equivalent to predicate devices. |
| Mechanical Safety and Performance | Equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable for clinical performance. For mechanical tests, the specific number of devices tested is not detailed in this summary.
- Data provenance: Not applicable for clinical performance. The mechanical testing would have been conducted in a laboratory setting by Newclip Technics or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set requiring expert ground truth was established.
4. Adjudication method for the test set:
Not applicable.
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 is a medical device for bone fixation, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable.
7. The type of ground truth used:
Not applicable for clinical performance. For the mechanical tests, the "ground truth" would be the measured physical properties and performance metrics against established standards (ASTM F382) and comparison to predicate devices.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of Device Substantiation:
The Activ Ankle range demonstrates its safety and effectiveness through substantial equivalence to existing legally marketed devices (predicates). This equivalence is based on similarities in:
- Intended use (fixation of fractures, osteotomies, pseudarthroses of specific ankle bones and syndesmotic repair).
- Design (plates with screws and washers).
- Materials (Titanium alloy Ti-6Al-4V ELI).
- Mechanical safety and performance, as confirmed by comparative static and fatigue bend tests (ASTM F382) and endotoxins testing.
The document explicitly states: "No clinical studies were performed." The conclusion of substantial equivalence is based on non-clinical comparative data against the identified predicate devices.
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January 16, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Newclip Technics % J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K173641
Trade/Device Name: Activ Ankle Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 17, 2017 Received: November 24, 2017
Dear Mr. Webb:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -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
Activ Ankle
Indications for Use (Describe)
The Activ Ankle range is intended for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.
| 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) |
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510 (k) Summary for the ACTIV ANKLE range 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Activ Ankle range.
Summary preparation date: October 25, 2017
| 1. Submitter: | Contact Person: |
|---|---|
| NEWCLIP TECHNICSP.A. de la Lande Saint Martin45 rue des GarottièresF-44115 Haute-Goulaine - FranceTelephone: (33) 2 28 21 37 12 | J.D. WebbThe OrthoMedix Group, Inc.1001 Oakwood BlvdRound Rock, TX 78681Telephone: 512-388-0199 |
| 2. Trade name: | Activ Ankle |
| Common Name: | Plate, Fixation, Bone / Screw, Fixation, bone |
| Product code: | HRS - Plate, Fixation, BoneHWC - Screw, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bonefixation appliances and accessories.(21 CFR part. 888.3030)Smooth or threaded metallic bonefixation fastener (21 CFR part. 888.3040) |
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3. Primary predicate or legally marketed devices which are substantially equivalent:
- Activ Ankle Locking Plating System of Newclip Technics (K143061) .
Secondary predicate or legally marketed devices which are substantially equivalent:
- Ortholoc® 3Di Ankle Fracture System of Wright Medical Technology . (K131093)
- Small Fragment Set 3.5 of AAP Implantate AG (K113652) .
- . Alians Elbow Locking Plating System (K152289)
- Large Screws of Newclip Technics (K172596) .
| 4. Description of the device: | The Activ Ankle range consists of plates with screws designed for fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults. Washers are also available for use with screws. The implants of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Activ Ankle range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial A) contain implants and instruments, or instruments only |
|---|---|
| ------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136 and ISO 5832-3).
provided sterile by gamma sterilization.
- Function: The implants of Activ Ankle range are intended for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.
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5. Substantial equivalence claimed to predicate devices:
The Activ Ankle range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.
6. Intended use:
The Activ Ankle range is indicated for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative static bend test. (ASTM F382) ●
- . Comparative fatigue bend test. (ASTM F382)
- Endotoxins testing is performed using LAL quantitative kinetic . chromogenic method.
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
Newclip Technics considers the Activ Ankle range to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.