(88 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 compressive screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis compressive screws are canulated compressive screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis compressive screws are compressive canulated bone screws which allow a permanent compression, thus supporting a secure osseous restoration.
The provided text describes the 510(k) premarket notification for the Nexis® osteosynthesis compressive screws. This is a medical device application for bone fixation, and the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and testing for a new or novel device's performance against specific metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for a software algorithm/AI device is not applicable to this document.
Here's why and what information is provided:
- Device Type: The Nexis® osteosynthesis compressive screws are physical implants (canulated compressive screws made of Titanium). They are not an AI/software device.
- Regulatory Pathway: The 510(k) pathway demonstrates that the new device is "substantially equivalent" to predicate devices already on the market. This involves comparing characteristics like material, mechanical properties, and intended use. It does not typically require the establishment of new, performance-based acceptance criteria in the way an AI/software device would, nor does it conduct studies to prove the device meets such criteria in terms of diagnostic accuracy or output performance.
- "Performance data" in this context refers to engineering and biocompatibility testing, not diagnostic performance. The document states:
- "The biocompatibility evaluation for new devices Nexis® osteosynthesis compressive screws was conducted in accordance with Blue Book Memorandum #G95-1... and International Standard ISO 10993-1..."
- "The new devices Nexis® osteosynthesis compressive screws have similar technological characteristics in terms of design and mechanical characteristics (Driving and removal torque, pull-out strength, torsional resistance) and thus are believed to be substantially equivalent to the predicate Memometal Fixos screws (device references: S-Fix/C-Fix/P-Fix) (K070039) and SBI Autofix™ System (K052576)."
- Clinical and Animal Studies: The document explicitly states: "Clinical studies were not required for this submission. Animal studies were not required for this submission."
In summary, none of the requested information regarding acceptance criteria, study design for performance metrics, sample sizes for test/training sets, expert ground truth establishment, or AI-specific study types (MRMC, standalone algorithm performance) can be extracted from the provided text because it pertains to a different type of medical device and regulatory submission.
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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 QA/RA Director Espace Performance Alphasis - Batiment C1-C2 35769 Saint Gregoire France
Re: K143229
Trade/Device Name: Nexis® osteosynthesis compressive screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 20, 2014 Received: November 24, 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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section
4: Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (if known) | K143229 |
|---|---|
| Device Name | Nexis ® osteosynthesis compressive screws |
| Indications for Use (Describe) |
|---|
| -------------------------------- |
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.
Type of Use (Select one or both, as applicable)
2 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.
FOR FDA USE ONLY
Concurrence 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 the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EBF
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en®
"510(k) Summary" as required by section 807.92(c)
| 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 | January 27th, 2015 |
| Trade name | Nexis® osteosynthesis compressive screws |
|---|---|
| Common Name | Screw, Fixation, Bone |
| Classification Name | Smooth or threaded metallic fixation fastener (21CFR 888.3040, productcode 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.510(k) number: K052576Device name: SBI Autofix™ System |
|---|---|
| Original applicant: Small Bone Innovations International S.A. | |
| This predicate has not been subject to a design-related recall. | |
| Description | Nexis® osteosynthesis compressive screws are single-use bone fixationdevices intended to be permanently implanted. Nexis® osteosynthesiscompressive screws are canulated compressive screws made of Titanium(Alloy Ti-6Al-4V ELI).Nexis® osteosynthesis compressive screws are compressive canulatedbone screws which allow a permanent compression, thus supporting asecure osseous restoration. |
| Intended use | The Nexis® osteosynthesis compressive screws are intended for fixing andstabilizing the elective osteotomies of the mid-foot bones and metatarsaland phalanges of the foot only. |
| Comparison of thetechnologicalcharacteristics with thepredicate device | The new devices Nexis® osteosynthesis compressive 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 references: S-Fix/C-Fix/P-Fix) (K070039)and SBI Autofix™ System (K052576). |
| Performance data | The biocompatibility evaluation for new devices Nexis® osteosynthesiscompressive 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 compressive 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 references: S-Fix/C-Fix/P-Fix)(K070039) and SBI Autofix™ System (K052576). | |
| Indication for use | The Nexis® osteosynthesis compressive screws are indicated for fixingand stabilizing the elective osteotomies of the mid-foot bones andmetatarsal and phalanges of the foot only.The indication for use statement for the Nexis® osteosynthesiscompressive screws is not strictly identical to the predicate devices; |
| device nor do they affect the safety and effectiveness of the devicerelative to the predicate. Both the subject and the predicate device havethe same intended use for fixation, correction and stabilization of smallbones in the foot. | |
| Clinical studies | Clinical studies were not required for this submission. |
| Animal studies | Animal studies were not required for this submission. |
| Conclusion | Nexis® osteosynthesis compressive are substantially equivalent to theirpredicate devices Memometal Fixos screws (device references: S-Fix/C-Fix/P-Fix) (K070039) and SBI AutofixTM System (K052576), in terms ofintended use and indications for use, material, design and function. Anyminor differences between these devices do not raise new questions ofsafety and effectiveness. |
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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1 n o v astep - Siège Social / Service Client
Espace Performane - Alphasis - Batiment C1-C2 - 35769 SANT-GREGONE Cedex - FFANCE
Tél. +33 (0)2 99 23 60 77 - Fax : +33 (0
Code A.P.E.: 3250ANSIRET 752 292 797 00012 N° TVA Intracommunautaire FR 64 752 292 797
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1 no vastep - Siège Social / Service Client
Espace Performance - Alphasis - Batiment C1-C2 - 35769 SANT-GREGONE Cedex - FFANCE
Tél. +33 (0)2 99 23 60 77 - Fax : +33 (0)3
§ 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.