(82 days)
No
The device description and performance studies focus on the mechanical properties and comparison to predicate devices, with no mention of AI or ML.
No
The device is an osteosynthesis staple used for mechanical stabilization of osteotomies, not for treating or preventing diseases or restoring body functions by biological, chemical, or pharmacological means.
No
Explanation: The device is described as an "osteosynthesis staple" used for Akin type osteotomies, which indicates it is an implant used for surgical fixation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical osteosynthesis staple made from PEEK, a material, and is supplied sterile for surgical use. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical fixation (osteosynthesis) during a specific type of foot surgery (Akin type osteotomies). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (a staple) made of PEEK, designed to be surgically inserted into bone.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to help diagnose or monitor medical conditions. This device is a surgical implant used for structural support during a procedure.
N/A
Intended Use / Indications for Use
The OS2®-VP Varisation Staples are indicated for Akin type osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, or outpatient surgery center where sterile field may be created and maintained.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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510(k) SUMMARY For In2Bones ÒS2®-VP Varisation Staple
| Sponsor identification | In2Bones SAS
28 chemin du Petit Bois
69130 Ecully - France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
registration number | 3010470577 |
| Date of preparation | March 9th, 2016 |
| Contact person | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Cell: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Authorized Agent in
the United States | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Fax: (301) 294-0126
Cell: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Proprietary Name | OS2®-VP Varisation Staple |
| Common name | Bone staple |
| Device classification
regulation | 21 CFR 888.3030: Single/multiple component metallic bone
fixation appliances and accessories
Class II |
| Device Product
Code and Panel | JDR: staple, fixation, bone
87 orthopedics |
4
Device Description
| 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. | |
|---|---|
| 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 type |
| osteotomies. | |
| Comparison of the | |
| indications for use | |
| with the predicate | |
| devices: | OS2®-VP Varisation Staple has indications for use identical |
| to those of OS2®-V Varisation Staple (K143323) primary | |
| predicate device. As with the other predicate devices, the | |
| OS2®-VP Varisation Staple is indicated for surgical | |
| implantation longer than 30 days and for the fixation of bone | |
| in foot. | |
| Comparison of | |
| Technological | |
| characteristics and | |
| Substantial | |
| Equivalence Summary | The 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. |
5
| Summary
Performance Data | 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. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONCLUSION | Based on the comparison of indications for use and
technological characteristics and the results of the testing
performed, the OS2®-VP Varisation Staples are substantially
equivalent to the predicate devices identified in the 510(k)
submission. |