(95 days)
The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
Nexis® osteosynthesis snap-off screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis snap-off screws are non canulated snap-off screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis snap-off screws are non canulated snap-off bone screws which allow a permanent compression, thus supporting a secure osseous restoration.
The document describes a 510(k) premarket notification for the "Nexis® osteosynthesis snap-off screws" device, comparing it to a predicate device, the "Memometal Fixos screws." This type of submission relies on demonstrating substantial equivalence to a legally marketed device rather than conducting extensive new clinical trials. Therefore, the information provided does not align with the typical structure of acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.
However, I can extract and structure the available information regarding the "performance data" that NOVASTEP provided to demonstrate substantial equivalence, framing it in terms of "acceptance criteria" and "reported device performance" as much as possible for this specific type of device (an orthopedic screw).
Acceptance Criteria and Reported Device Performance for Nexis® osteosynthesis snap-off screws
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Based on comparison to predicate and recognized standards) | Reported Device Performance (Summary from 510(k) submission) |
|---|---|
| Material Composition | Similar material: Titanium (Alloy Ti-6Al-4V ELI), in accordance with ISO 5832-3 (Implants For Surgery -- Metallic Materials -- Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy). |
| Mechanical Characteristics | Similar mechanical characteristics to the predicate device (Memometal Fixos screws), specifically mentioning: - Driving and removal torque - Pull-out strength - Torsional resistance |
| Biocompatibility | Evaluation conducted in accordance with Blue Book Memorandum #G95-1 (Use of International Standard ISO-10993) and International Standard ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process) as recognized by FDA. |
| Design Characteristics | Similar design characteristics to the predicate device. Nexis® screws are described as non-cannulated snap-off screws designed for permanent compression and secure osseous restoration. |
| Intended Use & Indications for Use | Identical intended use: fixing and stabilizing elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The performance data for mechanical testing and biocompatibility study typically involves a certain number of samples for each test, but the specific quantities are not detailed in this summary.
- Data Provenance: Not explicitly stated. These tests are usually conducted in specialized labs.
- Retrospective or Prospective: Not applicable in the context of comparing a new device's material and mechanical properties to a predicate and recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study involving expert assessment of data like in AI/ML performance evaluation. The "ground truth" here related to engineering standards and material properties.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context refers to established engineering standards (e.g., ISO 5832-3 for material, ASTM F543-13 for mechanical tests, ISO 10993 for biocompatibility) and the known characteristics of the legally marketed predicate device (Memometal Fixos screws). The testing confirms the new device's properties align with these standards and the predicate.
8. The sample size for the training set
- Not applicable. No training set is used for this type of device submission.
9. How the ground truth for the training set was established
- Not applicable. No training set is used for this type of device submission.
Summary Explanation:
The "study" demonstrating the device meets the acceptance criteria is detailed under "Performance data" in the 510(k) summary. It states that NOVASTEP's Nexis® osteosynthesis snap-off screws have been evaluated for biocompatibility according to FDA-recognized ISO 10993 standards and for mechanical characteristics (driving and removal torque, pull-out strength, torsional resistance) to demonstrate similarity with the predicate device, Memometal Fixos screws. The material (Titanium Alloy Ti-6Al-4V ELI) is also stated to be in accordance with ISO 5832-3 and similar to the predicate.
Crucially, the document explicitly states: "Clinical studies were not required for this submission" and "Animal Studies were not required for this submission." This is typical for 510(k) submissions where substantial equivalence is primarily demonstrated through comparison to a predicate device's design, materials, and mechanical performance, and adherence to recognized standards, rather than new human clinical efficacy trials. The "acceptance criteria" are effectively the established standards and the characteristics of the predicate device that the new device must match or be equivalent to.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2015
NOVASTEP Mr. Gilles Audic OA/RA Director Espace Performance Alphasis - Batiment C1-C2 35769 Saint Gregoire France
Re: K143146
Trade/Device Name: Nexis® osteosynthesis snap-off screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 9, 2014 Received: December 12, 2014
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
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Page 2 - Mr. Gilles Audic
(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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section
(page 1/1)
4: Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug AdministrationIndications for Use | Expiration Date: January 31, 2017See PRA Statement below. |
| 510(k) Number (if known)K143146 | |
| Device NameNexis® osteosynthesis snap-off screws | |
| Indications for Use (Describe)The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the electiveosteotomies of the mid foot bones and the metatarsal and phalanges of the foot only. | |
| 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 A SEPARATE PAGE IF NEEDED. | |
| Type of Use (Select one or both, as applicable)FOR FDA USE ONLYConcurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995.DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov |
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Section
5: 510(k) Summary
| Submitter | NOVASTEP |
|---|---|
| Espace performance Alphasis | |
| Bâtiment C1-C2 | |
| 35769 SAINT GREGOIRE | |
| France | |
| Phone : + 33 (0)2 99 33 86 50 | |
| Fax :+ 33 (0)9 70 29 18 95 | |
| Contact person | Mister Gilles AUDIC |
| QA / RA Director | |
| Cell phone:+33 (0)6 30 93 96 08 | |
| e-mail: gilles.audic@novastep-ortho.com | |
| Preparation date | November 27th, 2014 |
"510(k) Summary" as required by section 807.92(c)
| Trade name | Nexis® osteosynthesis snap-off screws |
|---|---|
| Common Name | Screw, Fixation, Bone |
| Classification Name | Smooth or threaded metallic bone fixation fastener (21CFR 888.3040,product code HWC) |
| Regulatory class | II |
| Legally marketedpredicate devices | 510(k) number: K070039Device name: Memometal Fixos screwsOriginal applicant: MEMOMETAL TECHNOLOGIESThis predicate has not been subject to a design-related recall. |
|---|---|
| Description | Nexis® osteosynthesis snap-off screws are single-use bone fixationdevices intended to be permanently implanted. Nexis® osteosynthesissnap-off screws are non canulated snap-off screws made of Titanium(Alloy Ti-6Al-4V ELI). |
novastep - Siège Social / Service Client
Espace Performance - Alphasis - Bâtiment C1-C2 - 35769 SAINT-GREGOIRE Cedex - FRANCE
Tél. +33 (0)2 99 23 60 77 - Fax : +33 (0)9 70 29 18 95 Code A.P.E. : 3250A - NºSIRET : 752 292 797 00012 - Nº TVA Intracommunautaire FR 64 752 292 797
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| Nexis® osteosynthesis snap-off screws are non canulated snap-off bonescrews which allow a permanent compression, thus supporting a secureosseous restoration. | |
|---|---|
| Intended use | The Nexis® osteosynthesis compressive screws are single use devicesintended for the fixing and stabilizing the elective osteotomies of the midfoot bones and the metatarsal and phalanges of the foot only. |
| Comparison of thetechnologicalcharacteristics with thepredicate device | The new devices Nexis® osteosynthesis snap-off screws have similartechnological characteristics in terms of material (ISO 5832-3 Implants ForSurgery -- Metallic Materials -- Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy) and mechanical characteristics (ASTM F543-13 StandardSpecification and Test Methods for Metallic Medical Bone Screws) andthus are believed to be substantially equivalent to the predicateMemometal Fixos screws (device reference: W-Fix) (K070039). |
| Performance data | The biocompatibility evaluation for new devices Nexis® osteosynthesissnap-off screws was conducted in accordance with Blue BookMemorandum #G95-1 (Use of International Standard ISO-10993,'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing)"and International Standard ISO 10993-1 (Biological Evaluation of MedicalDevices - Part 1: Evaluation and Testing Within a Risk ManagementProcess) as recognized by FDA.The new devices Nexis® osteosynthesis snap-off screws have similartechnological characteristics in terms of design and mechanicalcharacteristics (Driving and removal torque, pull-out strength, torsionalresistance) and thus are believed to be substantially equivalent to thepredicate Memometal Fixos screws (device reference: W-Fix) (K070039). |
| Indication for use | The Nexis® osteosynthesis compressive screws are single use devicesindicated for the fixing and stabilizing the elective osteotomies of the midfoot bones and the metatarsal and phalanges of the foot only. |
| Clinical studies | Clinical studies were not required for this submission |
| Animal Studies | Animal Studies were not required for this submission |
| Conclusion | Nexis® osteosynthesis snap-off screws are substantially equivalent totheir predicate devices Memometal Fixos screws (device reference: W-Fix) (K070039), in terms of intended use and indications for use, material,design and function. Any minor differences between these two devicesdo not raise new questions of safety and effectiveness. |
1 nov astep - Siège Social / Service Client
Espace Performance - Alphasis - Batiment
§ 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.