The MEMOMETAL MEMORY STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Device Description

MEMOMETAL MEMORY STAPLES are single-use bone fixation appliances intended to be permanently implanted. Memory staples are bipodal or quadripodal compression staples made of shape memory nickel titanium alloy.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (MEMOMETAL MEMORY STAPLES) and includes performance data based on adherence to industry standards, rather than a study against a specific set of acceptance criteria with reported device performance metrics in the format requested.

Here's an attempt to structure the information based on the request, extracting what is available and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance and Compliance
Material Properties	Conformance to ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.	The MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) "conform to ASTM F2063-05".
Mechanical/Functional	Conformance to ASTM F564-02 (2006) Standard Specification and Test Methods for Metallic Bone Staples. This standard outlines requirements and test methods for metallic bone staples, likely covering aspects like mechanical strength, corrosion resistance, and other relevant performance characteristics for surgical staples.	The MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) "conform to ASTM F564-02 (2006)".
Substantial Equivalence	Demonstrated substantial equivalence to legally marketed predicate devices (K964226 MEMORY STAPLE (LANDOS - DEPUY Inc) and K993714 MEMOGRAPH STAPLE (BIOMEDICAL ENT. INC)) in terms of intended use, indications for use, material, design, and function, with no new questions of safety and effectiveness raised by minor differences.	The MEMOMETAL STAPLES are "substantially equivalent to their predicate devices... 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."

No information is available for the following points as the document pertains to a 510(k) submission for a physical medical device, not an AI/software device requiring a clinical study with image data and expert review.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this type of device and submission. Performance is based on compliance with material and mechanical standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 device is a physical bone staple, not an AI/software for interpretation.

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 (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" here is compliance with established engineering and material standards.

8. The sample size for the training set

Not applicable.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the word "CONFIDENTIAL" in bold, uppercase letters. Above the word, there is a handwritten code "K070031/" in black ink. The word "CONFIDENTIAL" is partially obscured by a rectangular border.

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 TECHNOLOGIESCampus de Ker Lann - Rue Blaise Pascal35170 BRUZ - FrancePhone: + 33 (0)2 99 05 59 69Fax :+ 33 (0)2 99 05 95 62
Contacts	Gilles AUDIC Quality ManagerBernard PRANDI General Managere-mail: gilles.audic@memometal.com bernard.prandi@memometal.com
Preparation date	December 20, 2006
Trade Name	MEMOMETAL MEMORY STAPLES (MEMOCLIP - EASYCLIP - FOR FUSION)
Common Name	MEMORY STAPLE
Classification Name	Staple, Fixation, Bone
Legally marketed predicate devices	K964226 MEMORY STAPLE (LANDOS - DEPUY Inc)K993714 MEMOGRAPH STAPLE (BIOMEDICAL ENT. INC)
Description	MEMOMETAL MEMORY STAPLES are single-use bonefixation appliances intended to be permanently implanted.Memory staples are bipodal or quadripodal compressionstaples made of shape memory nickel titanium alloy.
Indication for use	The MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP andFOR FUSION) are indicated for hand and foot bonefragments osteotomy fixation and joint arthrodesis
Performance data	THE MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP andFOR FUSION) conform to ASTM F564-02 (2006) StandardSpecification and Test Methods for Metallic Bone Staples andto ASTM F2063-05 Standard Specification for WroughtNickel-Titanium Shape Memory Alloys for Medical Devicesand Surgical Implants.
Substantial equivalence	THE MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP andFOR FUSION) are substantially equivalent to their predicate
devices MEMORY STAPLE K964226 and MEMOGRAPH
STAPLE K993714 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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510k Premarket Notification Memory staples MEMOMETAL TECHNOLOGIES

CONFIDENTIAL

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Public Health Service

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: K070031

Trade/Device Name: Memometal Memory 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 28, 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.

Sincerely yours,

Harbauerfneems

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 MEMORY STAPLES Indications for Use:

The MEMOMETAL MEMORY STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

and and the first of the first the first of the first of the first of the many of the many of the many of the many of the many of the many of the many of the many of the manyPrescription Use	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(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)

llara Buelum for MLM

(Division Sign-Off) (Division Signeral, Restorative, and Neurological Devices

510(k) Number K070037

Regulation Number and Section

§ 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.