(103 days)
The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are indicated for fixation of bone fracture, for bone reconstruction or arthrodesis in presence of appropriate immobilization. The size of the implant should be adapted to the specific indication.
MEMOMETAL implants are single-use bone fixation appliances intended to be permanently implanted. MEMOMETAL implants are available in 2 different designs: - Snap-off pin, smooth with a stop and a sharp self drilling tip - Notched with a T-shaped head.
The provided 510(k) Premarket Notification for MEMOMETAL Technologies Osteosynthesis implants (K102072) describes performance data related to the mechanical properties of the implants. This submission focuses on demonstrating substantial equivalence to predicate devices through engineering rationale and mechanical testing, rather than clinical outcome studies involving human or animal subjects that would typically involve acceptance criteria for a study with a test set, ground truth, and expert evaluation as you've outlined.
Therefore, many of the requested categories (2-9) are not applicable to the type of information presented in this regulatory submission. The performance data provided is primarily engineering-based.
Here's a breakdown of the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flexure Loading | Not explicitly defined as numerical acceptance criteria in the summary. Implied to be comparable to predicate devices. | Comparison of mechanical properties of Ti-Fuse® and K-Snap® implants to predicate (K100736 Schilling Metalltechnik GMBH Kirschner and Guide wire) under flexure loading. Result: Data performed, indicating comparability. |
| K-Snap® Insertion Testing | Not explicitly defined as numerical acceptance criteria (e.g., maximum force, depth). Implied to demonstrate no premature breakage. | Testing in cortical bone. Result: Premature breakage doesn't occur. |
Study Description (based on available information):
This submission relies on engineering rationale and mechanical testing to demonstrate the substantial equivalence of the MEMOMETAL implants (K-Snap® & Ti-Fuse®) to their predicate devices. The study is a comparative mechanical performance study rather than a clinical trial.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the summary (typical for mechanical testing, where the number of test samples for each mechanical property is usually defined by a standard).
- Data Provenance: The study was conducted by MEMOMETAL Technologies (a French company). The testing is likely prospective in nature (i.e., designed and performed for this submission).
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. Ground truth as typically understood for clinical or image-based studies (e.g., expert consensus on diagnoses) is not relevant for this type of mechanical testing. The "ground truth" here is physics and engineering principles, with measurements taken from the devices and comparator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a human-reader-based 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 a human reader or AI-assisted study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "stand-alone" performance is the mechanical performance of the devices themselves, as tested. There is no algorithm involved in the clinical sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is based on objective mechanical measurements (e.g., force, displacement, material properties) as defined by established engineering and materials science standards for such implants. There is no expert consensus, pathology, or outcomes data used as ground truth for this mechanical study.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of mechanical performance testing for medical devices.
9. How the ground truth for the training set was established
Not applicable.
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510k Premarket Notification Osteosynthesis implants MEMOMETAL TECHNOLOGIES
Revision 3, 10/11/2010
SECTION 5: 510(K) SUMMARY
NOV - 3 2010
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 50 66Fax :+ 33 (0)2 99 05 95 62 |
|---|---|
| Contacts | Gilles AUDIC Quality ManagerBernard PRANDI General Managere-mail: gilles.audic@memometal.combernard.prandi@memometal.com |
| Preparation date | 07/19/2010 |
| Trade Name | MEMOMETAL Implants (K-Snap® & Ti-Fuse®) |
| Common Name | MEMOMETAL implants |
| Classification Name | Smooth or threaded metallic bone fastener |
| Product code | HTY |
| Legally marketed predicate devices | K100736 SMT Schilling Metalltechnik GMBH Kirschner andGuide wireK022599 Newdeal K-Wire |
| Description | MEMOMETAL implants are single-use bone fixationappliances intended to be permanently implanted.MEMOMETAL implants are available in 2 different designs:- Snap-off pin, smooth with a stop and a sharp self drilling tip- Notched with a T-shaped head. |
| Intended Use | The MEMOMETAL implants (K-Snap® & Ti-Fuse®) areindicated for fixation of bone fracture, for bone reconstructionor arthrodesis in presence of appropriate immobilization. Thesize of the implant should be adapted to the specificindication. |
| Performance data | Engeneering rationale containing a comparison of mechanical |
| properties of Ti-Fuse® and K-Snap® implants K100736 SMT | |
| Schilling Metalltechnik GMBH Kirschner and Guide wire under | |
| flexure loading (typical mechanical solicitation of the implants | |
| during the osteosynthesis period) has been performed. | |
| K-Snap® insertion testing in cortical bone has been | |
| performed to demonstrate that premature breakage doesn't | |
| occur. | |
| Substantial equivalence | The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are |
| substantially equivalent to their predicate (K100736) SMT | |
| Schilling Metalltechnik GMBH Kirschner and Guide wire and to | |
| Newdeal K-Wire (K022599) in terms of intended use, design | |
| and function. Any minor differences between these devices do | |
| not raise new questions of safety and effectiveness. |
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510k Premarket Notification Revision 3, 10/11/2010 + Osteosynthesis implants MEMOMETAL TECHNOLOGIES
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MEMOMETAL TECHNOLOGIES % Mr. Gilles Audic Quality Manager Campus de Ker Lann - Rue Blaise Pascal 35170 BRUZ - France
NOV - 3 2010
Re: K102072
Trade/Device Name: MEMOMETAL osteosynthesis implants (K-Snap® & Ti-Fuse®) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fasteners Regulatory Class: Class II Product Code: HTY Dated: September 3, 2010 Received: September 7, 2010
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. 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 device-related adverse events) (21 CFR 803); 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.
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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510k Premarket Notification Osteosynthesis implants MEMOMETAL TECHNOLOGIES
Revision 3, 10/11/2010
INDICATIONS FOR USE
NOV - 3 2010
02072 510(k) Number (if known):
Device Name: MEMOMETAL osteosynthesis implants (K-Snap® & Ti-Fuse®) Indications for Use:
The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are indicated for fixation of bone fracture, for bone reconstruction or arthrodesis in presence of appropriate immobilization. The size of the implant should be adapted to the specific indication.
Prescription Use > (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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Souters for mxn
(Division Sign)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K102072
left
Page 10
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.