(75 days)
The MEMOMETAL varisation staple is intended to be implanted for fixation of small bone fractures or for small bone reconstruction. The MEMOMETAL varisation staple is indicated for Akin type osteotomy.
MEMOMETAL varisation staple is a staple with two self drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface
This submission is for a medical device (MEMOMETAL varisation staples), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable. The documentation focuses on demonstrating substantial equivalence to a predicate device, as required for traditional 510(k) submissions for non-AI medical devices.
However, I can extract the relevant performance data and the study type conducted for this medical device:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Conformance | Conforms to ISO 5832-1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:1997). |
| Functional & Mechanical Performance | Conforms to ASTM F564-02 Standard Specification and Test Methods for Metallic Bone staples. |
2. Sample Size and Data Provenance
Not applicable. The submission is for a non-AI medical device and relies on material and mechanical standard conformance rather than clinical or algorithmic data.
3. Number and Qualifications of Experts for Ground Truth
Not applicable for a non-AI device.
4. Adjudication Method
Not applicable for a non-AI device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant to AI-assisted diagnostic devices to assess the impact of AI on human reader performance, which is not the subject of this 510(k) submission.
6. Standalone Algorithm Performance
Not applicable as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
For this physical device, the "ground truth" is defined by established engineering standards for metallic implants and bone staples. This includes:
- Material composition and properties: Defined by ISO 5832-1.
- Mechanical performance (e.g., strength, fatigue): Defined by ASTM F564-02.
8. Sample Size for Training Set
Not applicable as there is no algorithm or training set for a physical medical device.
9. How Ground Truth for Training Set Was Established
Not applicable.
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SECTION 5: 510(K) SUMMARY
MAR 1 9 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c)
| Submitter | MEMOMETAL TECHNOLOGIES |
|---|---|
| Campus de Ker Lann - Rue Blaise Pascal | |
| 35170 BRUZ - France | |
| Phone : + 33 (0)2 99 05 50 66 | |
| Fax :+ 33 (0)2 99 05 95 62 | |
| Contacts | Gilles AUDIC Quality Manager |
| Bernard PRANDI General Manager | |
| e-mail: info@memometal.com | |
| Preparation date | December 15, 2006 |
| Trade Name | MEMOMETAL varisation staples (AV XX-YY) |
| Common Name | Varisation staples |
| Classification Name | Staples, Fixation, Bone |
| Legally marketedpredicate devices | (DEPUY Inc) varisation staple |
| Description | MEMOMETAL varisation staple is a staple with two selfdrilling tips. The treatment with a varisation staple allows, afterpossible treatment of the second ray, to correct the valgusdeformation of the first ray and to recreate a square or Greekfoot. Two types of staples are available depending on thebone surface |
| Intended Use | The MEMOMETAL varisation staple is intended to beimplanted for fixation of small bone fractures or for small bonereconstruction. |
| Indication for use | The MEMOMETAL varisation staple is indicated for Akintype osteotomy. |
| Performance data | The MEMOMETAL varisation staple is conform to ASTMF564-02 Standard Specification and Test Methods for MetallicBone staples and to ISO 5832-1 Implants for surgery -Metallic materials - Part 1: Wrought stainless steel (ISO 5832- |
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| 510k Premarket Notification | |
|---|---|
| Varisation staples MEMOMETAL | |
| TECHNOLOGIES |
| 1:1997). | |
|---|---|
| Substantial equivalence | THE MEMOMETAL varisation staples are substantially equivalent to their predicate devices Depuy .inc varisation staples in terms of intended use and indications for use, material, design and function. Any minor differences between these two devices do not raise new questions of safety and effectiveness. |
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Public Health Service
Image /page/2/Picture/2 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 an abstract symbol that resembles an eagle or a stylized human figure, with three flowing lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Memometal Technologies % Gilles Audic Quality Manager Rue Blaise Pascal Campus De Kerr Lann Bruz, France F35170
MAR 1 9 2007
Re: K070033
Trade/Device Name: Memometal Varization Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: December 19, 2006 Received: January 03, 2007
Dear Mr. Audic:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Mr. Gilles Audic
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Barbere Buchup
Mark N. Melkerson Director Division of General, Restorative and Neurological 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: MEMOMETAL VARISATION Indications for Use:
- The MEMOMETAL varisation staples (AV XX-YY) are indicated for Akin type osteotomies
Prescription Use >| AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Buehlm
(Division Sign-Off, Division of General Restorative, and Neurological Devices
510(k) Number K070033
§ 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.