(115 days)
Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
Airlock® osteosynthesis plate systems are bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.
This document is a 510(k) premarket notification for the "Airlock® osteosynthesis plate system." It's a review by the FDA to determine substantial equivalence to a legally marketed predicate device, not a study proving device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving it cannot be extracted from this document, as it outlines regulatory approval based on equivalence rather than detailed performance study results.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. This document is a 510(k) summary for regulatory clearance, not a performance study report with acceptance criteria and measured performance. It states that the device has "similar technological characteristics" and "mechanical characteristics" to the predicate device, implying equivalence rather than direct performance measurement against specific acceptance criteria.
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. This document does not detail a test set sample size or data provenance from a performance study.
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. This document does not describe a process for establishing ground truth using experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not describe an adjudication method for a test set.
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 document is for a mechanical medical device (osteosynthesis plate system), not an AI-assisted diagnostic device. Therefore, an MRMC study with human readers and AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document is for a mechanical medical device (osteosynthesis plate system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This document does not describe the establishment of a ground truth for a performance study. The approval is based on substantial equivalence to a predicate device, supported by material and mechanical properties comparisons.
8. The sample size for the training set
Not applicable. This document does not describe a training set as it pertains to a mechanical medical device and regulatory clearance based on equivalence.
9. How the ground truth for the training set was established
Not applicable. This document does not describe a training set or its ground truth establishment.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures in profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2015
NOVASTEP Mr. Gilles Audic QA/RA Director Espace Performance Alphasis Batiment C1-C2 Saint Gregoire, France 35769
Re: K143523
Trade/Device Name: Airlock® osteosynthesis plate system Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: February 10, 2015 Received: February 13, 2015
Dear Mr. Gilles 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
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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 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 | |
|---|---|
| Indications for Use | |
| 510(k) Number (if known) | K143523 |
| Device Name | Airlock® osteosynthesis plate systems |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017See PRA Statement below. | |
| Indications for Use ( Describe ) | Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients. |
| Type of Use ( Select one or both, as applicable ) | |
| 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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@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 |
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Image /page/3/Picture/0 description: The image shows the logo for "novastep". The logo is in a pink color. The word "novastep" is written in lowercase letters. There is a registered trademark symbol to the right of the word.
"510(k) Summary" as required by section 807.92(c)
| Submitter | NOVASTEPEspace performance AlphasisBâtiment C1-C235769 SAINT GREGOIREFrancePhone : + 33 (0)2 99 33 86 50Fax : + 33 (0)9 70 29 18 95 |
|---|---|
| Contact person | Mister Gilles AUDICQA / RA DirectorCell phone: +33 (0)6 30 93 96 08e-mail: gilles.audic@novastep-ortho.com |
| Preparation date | February 10th 2015 |
| Trade name | Airlock® osteosynthesis plate system |
|---|---|
| Common Name | Plate, Fixation, Bone |
| Classification Name | Single / Multiple component metallic bone fixation appliances andaccessories (21CFR 888.3030, product code HRS) |
| Regulatory class | II |
| Legally marketedpredicate devices | 510(k) number: K083447Device name: Anchorage® Bone Plate SystemOriginal applicant: MEMOMETAL TECHNOLOGIES. |
|---|---|
| Description | Airlock® osteosynthesis plate systems are bone fixation devices intendedto be permanently implanted. Plates are designed with different shapesand are made of Titanium (Alloy Ti-6Al-4V ELI).The system uses either 3mm or 3,5mm locking and non-locking screws. |
| The drill hole are aligned to make sure there is no risk of conflict betweenthe screws. | |
| The plates vary essentially through different curvatures, lengths, numberof holes and shape. | |
| Intended use | Airlock® osteosynthesis plate systems are intended for fixation andstabilization of fresh fractures, revision procedures, joint fusion andreconstruction of small bones of the hand, feet, wrist, ankles, fingers andtoes. The system may be used in both adult and pediatric patients. |
| Comparison of thetechnologicalcharacteristics with thepredicate device | The new devices Airlock® osteosynthesis plate systems plates have similartechnological characteristics in terms of material (ISO5832-3 Implants forsurgery - Metallic material - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy) and mechanical characteristics (ASTM F382-99 StandardSpecification and Test Methods for Metallic Bone plates) and thus arebelieved to be substantially equivalent to the predicate MEMOMETALAnchorage® Bone Plate System plates (K083447). |
| The new devices Airlock® osteosynthesis plate systems screws havesimilar technological characteristics in terms of material (ISO5832-3Implants for surgery - Metallic material - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy) and mechanical characteristics (ASTM F543-13 Standard Specification and Test Methods for Metallic Bone screws PartA1 & A3) and thus are believed to be substantially equivalent to thepredicate MEMOMETAL Anchorage® Bone Plate System screws(K083447). | |
| Performance data | The biocompatibility evaluation for new devices Airlock® osteosynthesisplate systems 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 Airlock® osteosynthesis plate systems have similartechnological characteristics in terms of design and mechanicalcharacteristics and thus are believed to be substantially equivalent to thepredicate MEMOMETAL Anchorage® Bone Plate System (K083447). | |
| Indication for use | The Airlock® osteosynthesis plate systems are indicated for fixation andstabilization of fresh fractures, revision procedures, joint fusion andreconstruction of small bones of the hand, feet, wrist, ankles, fingers andtoes. The system may be used in both adult and pediatric patients. |
| Clinical studies | Clinical studies was not required for this submission |
| Animal Study | Animal Study was not required for this submission |
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Image /page/4/Picture/1 description: The image shows the word "novastep" in a stylized font. The word is in a pink color. To the left of the word is a pink design element that looks like a stylized "N". To the right of the word is a circled R symbol.
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K143523 page 3 of 3
Image /page/5/Picture/1 description: The image shows the logo for Novastep. The logo consists of a stylized, abstract shape on the left, followed by the word "novastep" in a sans-serif font. A registered trademark symbol is located to the upper right of the word "novastep". The color of the logo is a muted pink.
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
§ 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.