(23 days)
The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture nonunions. Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
The VALOR® Ankle Fusion Nail System - Extended Screw Lengths are a line extension to the existing VALOR® Ankle Fusion Nail System and will be offered in multiple lengths. The implants will be manufactured from titanium alloy.
This 510(k) summary describes a device (VALOR® Ankle Fusion Nail System - Extended Screw Lengths) that is a line extension of an existing product, and therefore does not include a study proving device performance against acceptance criteria in the same way a novel device might. Instead, it relies on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Fatigue resistance comparable to predicate device | "The results of the test show that the subject VALOR® Ankle Fusion Nail System - Extended Screw Lengths can be expected to perform at least as well as legally marketed predicate devices." | This is a general statement. Specific numerical criteria (e.g., cycles to failure, load limits) are not provided in this summary. |
| Material Compatibility | Same materials as predicate device | "The subject VALOR® Ankle Fusion Nail System - Extended Screw Lengths and the legally marketed predicate VALOR® Ankle Fusion Nail System have the same... materials." (Titanium alloy) | No specific material property tests or acceptance criteria are detailed. |
| Design Characteristics | Substantially equivalent design features to predicate device | "The design features of the VALOR® Ankle Fusion Nail System - Extended Screw Lengths are substantially equivalent to the design features of other devices previously cleared for market." | The only stated difference is overall length. |
| Intended Use | Same indications for use as predicate device | "The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection." (Full list provided in the "Indications for Use" section). | The subject and predicate devices share the same clinical indications. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The study involved "fatigue testing" but the number of samples tested is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data for this 510(k) submission, as no clinical evidence was presented or required. The equivalence was shown through non-clinical (bench) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was a non-clinical (bench) study.
4. Adjudication method for the test set
- Not applicable. This was a non-clinical (bench) study.
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 not an AI-powered device, and no clinical or MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical fatigue testing, the "ground truth" would be the engineering specifications and performance benchmarks established for the predicate device, or industry standards for intramedullary fixation rods. The summary indicates performance "at least as well as legally marketed predicate devices," implying the predicate's performance serves as the benchmark.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of the Study:
The study proving the device meets acceptance criteria was a non-clinical bench test, specifically fatigue testing. The purpose of this testing was to demonstrate substantial equivalence to the predicate VALOR® Ankle Fusion Nail System (K090857).
- Methodology: Fatigue testing was conducted on the subject device (VALOR® Ankle Fusion Nail System - Extended Screw Lengths).
- Acceptance Standard: The acceptance criteria for the fatigue test were implicitly tied to the performance of the legally marketed predicate device. The new device needed to perform "at least as well as" the predicate.
- Results: The fatigue testing results indicated that the subject device "can be expected to perform at least as well as legally marketed predicate devices."
- Conclusion: Based on this non-clinical evidence, along with material and design comparisons, the device was deemed substantially equivalent, meaning it meets the necessary safety and effectiveness standards without requiring clinical studies. The only stated difference between the new device and the predicate was its overall length.
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MAR 2 3 2011
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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 VALOR® Ankle Fusion Nail System - Extended Screw Lengths.
Wright Medical Technology, Inc.
A.1. Submitted By:
5677 Airline Rd
Arlington, TN 38002
| Date: | February 25, 2010 |
|---|---|
| Contact Person: | Ryan Bormann |
| Regulatory Affairs Specialist | |
| (901) 867 - 4409 | |
| A.2. Proprietary Name: | VALOR® Ankle Fusion Nail System - Extended Screw Lengths |
| Common Name: | Ankle Fusion Nail |
| Device Classification Regulation: | 21 CFR 888.3020--Class II |
| Device Product Code & Panel: | HSB Rod, Fixation, Intramedullary and Accessories |
| 87 Orthopedics | |
| A.3. Predicate Device: | VALOR® Ankle Fusion Nail System (K090857) |
A.4. Device Description
The VALOR® Ankle Fusion Nail System - Extended Screw Lengths are a line extension to the existing VALOR® Ankle Fusion Nail System and will be offered in multiple lengths. The implants will be manufactured from titanium alloy.
The design features of the VALOR® Ankle Fusion Nail System - Extended Screw Lengths are substantially equivalent to the design features of other devices previously cleared for market.
A.5. Intended Use
The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture nonunions. Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
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A.6. Technological Characteristics Comparison
The subject VALOR® Ankle Fusion Nail System - Extended Screw Lengths and the legally marketed predicate VALOR® Ankle Fusion Nail System have the same indications, materials and design.
The VALOR® Ankle Fusion Nail System - Extended Screw Lengths differ from the legally marketed predicate VALOR® Ankle Fusion Nail System in overall length.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence was shown through fatigue testing. The results of the test show that the subject VALOR® Ankle Fusion Nail System - Extended Screw Lengths can be expected to perform at least as well as legally marketed predicate devices.
The safety and effectiveness of the VALOR® Ankle Fusion Nail System - Extended Screw Lengths is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.
B.2. Substantial Equivalence - Clinical Evidence
N/A
B.3. Substantial Equivalence - Conclusions
Substantial equivalence is shown through bench testing and design characteristics. The materials and indications are similar and no new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is oriented to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Mr. Ryan Bormann 5677 Airline Road Arlington, TN 38002
MAR 2 3 2011
Re: K110552
Trade/Device Name: VALOR Ankle Fusion Nail System – Extended Screw Lengths Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 25, 2011 Received: February 28, 2011
Dear Mr. Bormann:
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
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Page 2 - Mr. Ryan Bormann
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Image /page/3/Picture/4 description: This image contains a letter from Mark N. Melkerson, Director, with a URL at the top: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. The letter is signed, and the signature includes the title "CLINICAL DIRECTOR". The letter is likely a formal communication from the FDA.
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_ K110552
Device Name: _VALOR® Ankle Fusion Nail System - Extended Screw Lengths
Indications For Use:
The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign-Off) (Division Sign-on-on), Orthopedic, and Restorative Devices
510(k) Number K110552
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.