(187 days)
The 611 Ankle Fusion Nail is intended to immobilize tibiotalar and subtalar joints of the ankle in order to obtain the fusion of these joints and to decrease pain as compared to the preoperative condition.
The immobilization of the ankle with the 611 Ankle Fusion Nail is indicated in the following cases:
- Severe defects of the ankle and subtalar joints and/or deformations with/without instability,
- Avascular necrosis of the talus,
- Traumatic or post-traumatic involvement of the ankle and subtalar joints,
- Degenerative pathologies: primary or post-trauma osteoarthritis, rheumatoid polyarthritis.
- Revision of the arthrodesis or revision of the total ankle prosthesis,
- Neuroarthropathy or neuropathic deformation of the ankle/Charcot Foot.
The 611 Ankle Fusion Nail consists of an Ankle nail associated with locking screws as well as a plug. The Ankle nails are available in variety of diameters and angulations. The plug screwed into the threaded end of the nail is to prevent bone ingrowth. The locking screws are self-tapping screws.
All components of the 611 Ankle Fusion Nail are single use devices. The Ankle nail and plug are delivered sterile. The locking screws are delivered non sterile with the instrumentation.
The provided text describes a medical device, the "611 Ankle Fusion Nail," and its substantial equivalence to predicate devices, but it does not contain information related to software or AI performance.
Therefore, I cannot provide an answer based on the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment that would typically apply to an AI device. The document focuses on regulatory approval for a physical orthopedic implant.
Here's why the AI-specific questions cannot be answered from this document:
- No AI Device: The "611 Ankle Fusion Nail" is a physical intramedullary fixation rod made of titanium alloy for ankle arthrodesis. It is not an AI or software-based device.
- No Performance Metrics for AI: The "acceptance criteria" discussed in the document relate to the physical and mechanical properties of the nail (e.g., fatigue testing), material equivalence, and intended use equivalence with predicate devices. There are no sensitivity, specificity, AUC, or other AI performance metrics.
- No Study for AI Performance: The "study" mentioned is "Fatigue testing" (page 3), which is a non-clinical test for a physical implant, not a study evaluating AI diagnostic or decision-making accuracy.
- No Test/Training Sets or Ground Truth for AI: Since there's no AI component, there are no test sets, training sets, data provenance, expert ground truth establishment, or adjudication methods relevant to AI performance.
- No MRMC Study: There's no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study as the device is not an AI-assisted diagnostic tool.
In summary, the provided text describes the regulatory clearance process for a physical medical device and does not contain any information about its performance as an AI device.
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K130051 (1/4)
SIC(R) Summary
JUL 1 5 2013
Summary of Safety and Effectiveness information 510(k) Premarket Notification – 611 Ankle Fusion Nail
Date prepared: January 2nd, 2012
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
| Trade name: | 611 Ankle Fusion Nail |
|---|---|
| Common name: | Ankle Arthrodesis Nail |
| Classification name: | 888.3020 Fixation, Intramedullary and Accessories |
2) Submitter
Tornier SAS 161 Rue Lavoisier 38330 Montbonnot Saint Martin - France
3) Applicant
Tornier SAS 161 Rue Lavoisier 38330 Montbonnot Saint Martin - France
4) Company contact
Tornier SAS Mr Damien Guillaud Regulatory Affairs Specialist 161, rue Lavoisier 38334 Montbonnot Cedex - FRANCE Fax: 00 33 4 76 61 35 59 Tel: 00 33 4 76 61 35 00 E-mail: damien.guillaud@tornier.fr
5) Classification
Device class: Class II Classification panel: Orthopedic Product code: нав
6) Equivalent Predicate devices
T2 Ankle Arthrodesis Nail, HOWMEDICA OSTEONICS CORP (now STRYKER), K051590. Synthes Hindfoot Arthrodesis Nail System, SYNTHES (USA), K051678.
Section 5 - Page 1/ page 4
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7) Device description
The 611 Ankle Fusion Nail consists of an Ankle nail associated with locking screws as well as a plug. The Ankle nails are available in variety of diameters and angulations. The plug screwed into the threaded end of the nail is to prevent bone ingrowth. The locking screws are self-tapping screws.
All components of the 611 Ankle Fusion Nail are single use devices. The Ankle nail and plug are delivered sterile. The locking screws are delivered non sterile with the instrumentation.
8) Materials
The nail, the locking screws and the plug are made out of titanium alloy (Ti6Al4V) according to ISO 5832-3.
9) Intended Use
The 611 Ankle Fusion Nail is intended to immobilize tibiotalar and subtalar joints of the ankle in order to obtain the fusion of these joints and to decrease pain as compared to the preoperative condition.
10) Indications For Use
The immobilization of the ankle with the 611 Ankle Fusion Nail is indicated in the following cases:
- Severe defects of the ankle and subtalar joints and/or deformations with/without ﻴ instability,
- Avascular necrosis of the talus, -
- Traumatic or post-traumatic involvement of the ankle and subtalar joints, -
- -Degenerative pathologies: primary or post-trauma osteoarthritis, rheumatoid polyarthritis.
- Revision of the arthrodesis or revision of the total ankle prosthesis, -
- Neuroarthropathy or neuropathic deformation of the ankle/Charcot Foot. -
Section 5 - Page 2/ page 4
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·
11) Summary of technological characteristics
| Main features or systemcharacteristics | 611 Ankle Fusion Nail | T2 Ankle ArthrodesisNail | Synthes HindfootArthrodesis NailSystem | |
|---|---|---|---|---|
| Manufacturer | Tornier | Howmedica OsteonicsCorp | Synthes (USA) | |
| K-number | pending | K051590 | K051678 | |
| Materials | nail | Titanium alloy | Titanium alloy | Titanium alloy |
| screws | Titanium alloy | Titanium alloy | Titanium alloy | |
| plug | Titanium alloy | Titanium alloy | Titanium alloy | |
| Sizes | nail | Length (mm): 180Curvature : 6° / 11°valgusLeft & rightProximal diameters :Ø10, Ø12Distal diameters : Ø12,Ø13 | Lengths (mm): 150 /200 / 300Curvature : 5° valgusLeft & rightProximal diameters :Ø10, Ø11, Ø12Distal diameters : Ø12 | Lengths (mm): 150 /180 / 240Curvature : 12° valgusLeft & rightProximal diameters :Ø10, Ø12, Ø13Distal diameters : Ø10,Ø12,5, Ø13 |
| Screws:dia.(mm) /Lengths | 5 / 20 to 100 | 5 / 25 to 120 | 5, 6 / 26 to 125 | |
| Plug -Thickness(mm): | 4 sizes (0, 2.5, 5, 7.5) | 4 sizes (0, 5, 10, 15) | 1 size (0) | |
| Screw positioning | - 2 tibial- 2 talo-calca | - 2 tibial- 2 calca- 1 talar | - 2 tibial- 2 calca- 1 talar | |
| Intended use | tibiotalocalcanealarthrodesis | tibiotalocalcanealarthrodesis | tibiotalocalcanealarthrodesis | |
| Method of fixation | cementless | cementless | cementless | |
| Terminal sterilization | Gamma | Gamma | Gamma |
The indications for use, the technical characteristics (manufacturing principle and method of fixation), the packaging and the sterilization process of the 611 Ankle Fusion Nail are identical or equivalent to the predicate devices.
Section 5 - Page 3/ page 4
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12) Non-clinical testing
Non-clinical testing were performed on the 611 Ankle Fusion Nail to assess that no new safety and efficiency issues were raised with this device.
The following test was performed:
- Fatigue testing. -
The results of those evaluations allow us to conclude that the proposed 611 Ankle Fusion Nail described in this submission does not induce any new or higher risk compared to the predicate devices and therefore both devices (proposed and predicate) are substantially equivalent.
13) Substantial equivalence conclusion
Substantial equivalence of the new 611 Ankle Fusion Nail to the cleared predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:
- The 611 Ankle Fusion Nail is compared to the predicate devices.
- The 611 Ankle Fusion Nail has the same intended use as the cleared predicates and has very similar indications for use.
- Major technological characteristics are equivalent between the 611 Ankle Fusion Nail and the ı predicate devices:
- Equivalence of general features, -
- Equivalent technological features: materials, -
- Equivalent biomechanical features: mechanical characteristics, -
- Equivalent means of fixation, -
- Equivalent prosthetic dimensions, -
- Equivalent surgical technique. -
Therefore, in light of the above information, the company believes that the 611 Ankle Fusion Nail' may be cleared via the 510(k) notification process for use as an ankle arthrodesis nail.
Section 5 - Page 4/ page 4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2013
Tornier SAS % Mr. Damien Guillaud Regulatory Affairs Specialist 161 Rue Lavoisier 38334 Montbonnot Cedex France
Re: K130051
Trade/Device Name: 611 Ankle Fusion Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 10, 2013 Received: April 18, 2013
Dear Mr. Guillaud:
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. Damien Guillaud
device-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 clectronic 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 http://www.fda.gov/MedicalDcviccs/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin I. Keith
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: 611 Ankle Fusion Nail
Intended use:
The 611 Ankle Fusion Nail is intended to immobilize tibiotalar and subtalar joints of the ankle in order to obtain the fusion of these joints and to decrease pain as compared to the preoperative condition.
Indications For Use:
The immobilization of the ankle with the 611 Ankle Fusion Nail is indicated in the following cases:
- Severe defects of the ankle and subtalar joints and/or deformations with/without instability,
- Avascular necrosis of the talus,
- Traumatic or post-traumatic involvement of the ankle and subtalar joints,
- Degenerative pathologies: primary or post-trauma osteoarthritis, rheumatoid polyarthritis.
- Revision of the arthrodesis or revision of the total ankle prosthesis,
- Neuroarthropathy or neuropathic deformation of the ankle/Charcot Foot.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Page 1 of 1
Division of Orthopedic Devices
§ 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.