(249 days)
The Navis® radius Plate is indicated for the fixation of fractures and osteotomies involving the distal radius.
MEMOMETAL Navis® Bone Plating System is single use bone fixation appliances intended to be permanently implanted. They are designed with anatomical shape plates made of biocompatible titanium alloy. The Bone Plating System use 2.5 mm locking, unlocking screws and 1.8 mm smooth locking pegs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different lengths, widths, number of plate holes, left and right shapes.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
Key Takeaways:
- This document describes a 510(k) premarket notification for the Memometal Navis® Bone Plating System.
- The primary method for demonstrating substantial equivalence was mechanical testing comparing the new device to legally marketed predicate devices.
- No clinical tests were used or presented, meaning there's no information on human reader performance, AI assistance, or related clinical metrics.
- The focus is on mechanical properties of the implants themselves, not diagnostic or AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must achieve relative to predicates) | Reported Device Performance (How the device measured up) |
|---|---|
| Equivalence in mechanical characteristics for plates: | Demonstrated equivalence in 3-point bending test for plates with Aptus® Medartis bone plate system (K051567) per ASTM F382-99. |
| - Bending strength | Demonstrated equivalence in bending resistance under bending loading conditions for plates with Aptus® Medartis bone plate system (K051567). |
| Equivalence in mechanical characteristics for pegs: | Demonstrated comparative mechanical properties (bending strength) of pegs with TRIMED Bone plates (K060041). |
| - Bending strength | Demonstrated equivalence in back-out resistance of pegs on plates with STRYKER variax® distal radius system (K050512 & K060514). |
| - Back-out resistance | |
| Substantial equivalence in: | Determined to be substantially equivalent in: |
| - Intended use and indications for use | - Intended use and indications for use |
| - Material (titanium alloy) | - Material (titanium alloy) |
| - Design (thickness, length, number of holes for plates; diameter, length for pegs) | - Design (thickness, length, number of holes for plates; diameter, length for pegs) |
| - Function | - Function |
| No new questions of safety and effectiveness | Minor differences do not raise new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of plates/pegs tested. The document refers to "mechanical characterization of plates" and "mechanical characterization of pegs," implying a sample was used, but the exact number isn't stated.
- Data Provenance: The tests were "performed to demonstrate equivalence," indicating a controlled lab setting rather than clinical data. The ASTM F382-99 standard for the 3-point bending test suggests standardized laboratory conditions. No country of origin for the test data is explicitly mentioned, but the submitter is based in France. The data is entirely retrospective in the sense that it evaluates the manufactured device; there's no prospective patient follow-up mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This study did not involve human experts establishing ground truth for a test set, as it was a mechanical performance study of an implantable device, not a diagnostic or AI-driven imaging study. The "ground truth" was established by the physical properties and performance metrics of the predicate devices as measured under standardized test conditions.
4. Adjudication Method for the Test Set
- Not applicable. There was no subject interpretation or clinical assessment requiring adjudication. The study involved objective mechanical measurements.
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
- No, an MRMC study was NOT done. This document pertains to a bone plating system, which is an implantable device, not a diagnostic imaging AI tool. Therefore, there's no concept of human readers or AI assistance in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI algorithm. It is a physical bone plating system.
7. The Type of Ground Truth Used
- The "ground truth" for this study was the established mechanical performance and design characteristics of legally marketed predicate devices (Medartis Aptus®, TRIMED Bone plates, and STRYKER variax®). The new device's mechanical properties were measured and compared against these established benchmarks to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This study did not involve a training set as it was not an AI/machine learning study.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As stated above, there was no training set.
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MAR 1 5 2011
510k Premarket Notification Navis® Bone Plating System MEMOMETAL TECHNOLOGIES
SECTION 5: 510(K) SUMMARY
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 59 69 | |
| Fax :+ 33 (0)2 99 05 95 62 | |
| Contacts | Gilles AUDIC Quality Manager |
| Bernard PRANDI General Manager | |
| e-mail: gilles.audic@memometal.com | |
| bernard.prandi@memometal.com | |
| Preparation date | 06/15/2010 |
| Trade Name | Memometal Navis® Bone Plating System |
| Common Name | Memometal Navis® Bone Plating System |
| Class | II |
| Product Code | HRS |
| HWC | |
| CFR section | 888.3030 |
| Classification Name | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Legally marketed | K051567 MEDARTIS, INC. APTUS® Titanium Fixation System |
| predicate devices | K060041 TRIMED Bone plates |
| K050512 & K060514 STRYKER variax® distal radius system | |
| Description | MEMOMETAL Navis® Bone Plating System is single use bone |
| fixation appliances intended to be permanently implanted. | |
| They are designed with anatomical shape plates made of | |
| biocompatible titanium alloy. The Bone Plating System use 2.5 | |
| mm locking, unlocking screws and 1.8 mm smooth locking | |
| pegs. The drill holes of the plates are aligned to assure the | |
| screws do not touch. The plates vary essentially through |
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| 510k Premarket Notification | |
|---|---|
| Navis® Bone Plating System | |
| MEMOMETAL TECHNOLOGIES |
| different lengths, widths, number of plate holes, left and | |
|---|---|
| right shapes. | |
| Intended Use &Indication for use | The Navis® radius Plate is indicated for the fixation offractures and osteotomies involving the distal radius. |
| Performance data | No clinical tests were used in the claim of substantialequivalence. |
| Mechanical characterization of plates including 3 pointsbending test have been performed to demonstrateequivalence between Memometal Navis® bone plate system(K101930) and Aptus® Medartis bone plate system(K051567). The test was processed in accordance with theASTM F382-99 standard. | |
| Additionally a characterization of the bending resistance ofMemometal Navis® plates (K101930) and Medartis Aptus®plates (K051567) in bending loading conditions has beenperformed. | |
| An engeneering rationale containing a comparison ofmechanical properties bending strength between MemometalNavis® Pegs (K101930) and Trimed pegs (K060041) hasbeen performed. | |
| Mechanical characterization of pegs back out resistance onplates has been performed to demonstrate equivalencebetween Memometal Navis® bone plate system (K101930)and STRYKER variax® distal radius system (K050512 &K060514) | |
| All these tests demonstrate substantial equivalence betweenthe Navis® bone plating system and their predicate devices.For this reason we didn't consider pre clinical data necessary. | |
| Substantial equivalence | The MEMOMETAL Navis® Bone Plating Systems aresubstantially equivalent to their predicate MEDARTIS, INC.APTUS® Titanium Fixation System (K051567) for the platesand screws in terms of intended use and indications for use,material, design (thickness, length, number of holes) and |
| function, and to TRIMED Bone plates (K060041) & STRYKER | |
| variax® distal radius system (K050512 & K060514) for Pegs | |
| in terms material, design (diameter, length), mechanical | |
| characteristics (back out and bending strength) and function. | |
| Any minor differences between these devices do not raise | |
| new questions of safety and effectiveness. |
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K 101930
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510k Premarket Notification Navis® Bone Plating System MEMOMETAL TECHNOLOGIES
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is made up of three curved lines, and the words are in a simple sans-serif font. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Memometal Technologies % Mr. Gilles Audic Campus de Ker Lann Rue Blaise Pascal 35170 BRUZ FRANCE
MAR 1 5 201
Re: K101930
Trade/Device Name: Memometal Navis Bone Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: March 1, 2011 Received: March 7, 2011
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
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Page 2 - Mr. Gilles Audic
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 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/ReportalProblem/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 yours.
AS.B.mh
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 | |
|---|---|
| Navis® Bone Plating System | |
| MEMOMETAL TECHNOLOGIES |
INDICATIONS FOR USE
510(k) Number (if known): _ K101930 Device Name: MEMOMETAL Navis® Bone Plating System Indications for Use:
- The Navis® radius Plate is indicated for the fixation of fractures and osteotomies involving the distal radius.
| Prescription Use(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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign Off)
(Division Sign-Off)Y Division of Surgical, Orthopedic, and Restorative Devices
K101930
510(k) Number
§ 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.