The OS2®-VP Varisation Staple is an osteosynthesis staple manufactured from PEEK, a material recognized for its mechanical and radiolucent properties.
Sizes: The OS2®-VP Varisation Staple is available in various angles.
Material: The OS2®-VP Varisation Staple is manufactured from PEEK according to standard ASTM F2026.
Single use: The OS2®-VP Varisation Staple is designed for single use only.
Sterilization: The OS2®-VP Varisation Staple is supplied sterile, using gamma irradiation.
Place of use: The OS2®-VP Varisation Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.

AI/ML Overview

This document describes the regulatory clearance for the OS2®-VP Varisation Staple, a medical device for fixing foot bones. It is not an AI or software device. Therefore, the information requested about acceptance criteria, efficacy studies, and ground truth in the context of AI/software performance is not applicable to this document.

However, I can extract information related to the device's performance testing for its mechanical properties:

Description of Performance and Acceptance Criteria (Mechanical Testing):

The device's performance was evaluated through mechanical comparison with predicate devices. The claim of "substantial equivalence" is based on these mechanical tests.

The document states: "Performance testing has been evaluated for OS2®-VP Varisation Staple through mechanical comparison with predicate devices, animal and clinical testing being considered not applicable. Mechanical testing was performed according to dedicated protocols based on standard ASTM F564. The results of the testing performed by the test laboratories indicate that the OS2®-VP Varisation Staple performed as expected for each test."

Acceptance Criteria and Reported Device Performance Table:

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to dedicated protocols based on standard ASTM F564	Performed as expected for each test (mechanical testing)
Substantial equivalence to predicate mechanical characteristics	OS2®-VP Varisation Staple is similar to the primary predicate device OS2®-V Varisation Staple (K143323) in intended use, design, sizes and principles of operation, and is similar to the reference predicate device In2Bones DUAFIT® Interphalangeal Implant (K132912) in material.

Information not applicable to this document (as it is not an AI/software device):

Sample size used for the test set and data provenance (retrospective/prospective)
Number of experts used to establish ground truth and their qualifications
Adjudication method for the test set
Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
Standalone (algorithm only) performance
Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Sample size for the training set
How ground truth for the training set was established

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21, 2016

In2Bones SAS % Norman Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K153770 Trade/Device Name: OS2®-VP Varisation Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: December 30, 2015 Received: December 30, 2015

Dear Dr. Estrin:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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/ResourcesforYou/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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153770

Device Name OS2®-VP Varisation Staple

Indications for Use (Describe) The OS2®-VP Varisation Staples are indicated for Akin type osteotomies.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 Druq 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."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is set on a gray oval background. The text "IN2BONES" is in white, with the "2" in orange.

510(k) SUMMARY For In2Bones ÒS2®-VP Varisation Staple

Sponsor identification	In2Bones SAS28 chemin du Petit Bois69130 Ecully - FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29
Establishmentregistration number	3010470577
Date of preparation	March 9th, 2016
Contact person	Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Cell: 240-994-9999Email: estrin@yourFDAconsultant.com
Authorized Agent inthe United States	Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Fax: (301) 294-0126Cell: 240-994-9999Email: estrin@yourFDAconsultant.com
Proprietary Name	OS2®-VP Varisation Staple
Common name	Bone staple
Device classificationregulation	21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessoriesClass II
Device ProductCode and Panel	JDR: staple, fixation, bone87 orthopedics

{4}------------------------------------------------

Device Description

The OS2®-VP Varisation Staple is an osteosynthesis staplemanufactured from PEEK, a material recognized for itsmechanical and radiolucent properties.Sizes: The OS2®-VP Varisation Staple is available in variousangles.Material: The OS2®-VP Varisation Staple is manufacturedfrom PEEK according to standard ASTM F2026.Single use: The OS2®-VP Varisation Staple is designed forsingle use only.Sterilization: The OS2®-VP Varisation Staple is suppliedsterile, using gamma irradiation.Place of use: The OS2®-VP Varisation Staple is indicated foruse in a hospital, or outpatient surgery center where sterilefield may be created and maintained.
Predicate Devices	Primary predicate device:In2Bones OS2®-V Varisation Staple (K143323)
	Additional predicate device:Memometal Easyclip (K070031)Newdeal K Wire (K022599)
	Reference predicate devices:In2Bones DUAFIT® Interphalangeal Implant (K132912)
Indications for use:	The OS2®-VP Varisation Staples are indicated for Akin typeosteotomies.
Comparison of theindications for usewith the predicatedevices:	OS2®-VP Varisation Staple has indications for use identicalto those of OS2®-V Varisation Staple (K143323) primarypredicate device. As with the other predicate devices, theOS2®-VP Varisation Staple is indicated for surgicalimplantation longer than 30 days and for the fixation of bonein foot.
Comparison ofTechnologicalcharacteristics andSubstantialEquivalence Summary	The OS2®-VP Varisation Staple is similar to the primarypredicate device OS2®-V Varisation Staple (K143323) inintended use, design, sizes and principles of operation, and issimilar to the reference predicate device In2Bones DUAFIT®Interphalangeal Implant (K132912) in material.

{5}------------------------------------------------

SummaryPerformance Data	Performance testing has been evaluated for OS2®-VP VarisationStaple through mechanical comparison with predicate devices,animal and clinical testing being considered not applicable.Mechanical testing was performed according to dedicated protocolsbased on standard ASTM F564. The results of the testing performedby the test laboratories indicate that the OS2®-VP Varisation Stapleperformed as expected for each test.
CONCLUSION	Based on the comparison of indications for use andtechnological characteristics and the results of the testingperformed, the OS2®-VP Varisation Staples are substantiallyequivalent to the predicate devices identified in the 510(k)submission.

SummaryPerformance Data

Performance testing has been evaluated for OS2®-VP VarisationStaple through mechanical comparison with predicate devices,animal and clinical testing being considered not applicable.Mechanical testing was performed according to dedicated protocolsbased on standard ASTM F564. The results of the testing performedby the test laboratories indicate that the OS2®-VP Varisation Stapleperformed as expected for each test.

CONCLUSION

Based on the comparison of indications for use andtechnological characteristics and the results of the testingperformed, the OS2®-VP Varisation Staples are substantiallyequivalent to the predicate devices identified in the 510(k)submission.

Regulation Number and Section

§ 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.