(86 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and material of a physical implant (compression staple) and do not mention any software, algorithms, or data processing capabilities that would involve AI/ML.
No
The device is an osteosynthesis staple used for fixation of arthrodesis, osteotomies, and fractures, which are structural repairs rather than treatments for a disease or condition in a therapeutic sense.
No
Explanation: The device is an osteosynthesis staple used for fixation, not for identifying or determining the nature of a disease or condition.
No
The device description clearly states it is an "osteosynthesis staple" manufactured from PEEK, which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The OS2®-C Compression Staple is an implantable device used for the physical fixation of bones (arthrodesis, osteotomies, and fractures) in the hand or foot. It is a surgical tool, not a diagnostic test performed on bodily fluids or tissues.
The description clearly indicates it's a physical implant for structural support, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
The OS2®-C Compression Staples are indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery.
The number and size of the OS2®-C Compression Staples must be adapted to the indication.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The OS2®-C Compression Staple is an osteosynthesis staple, enabling a constant and reproducible compression.
The OS2®-C Compression Staple is available in multiple lengths and interaxis. It is delivered sterile, ready to use, pre-assembled on its inserter.
The implant is manufactured from PEEK-OPTIMA®, polymer from Invibio®, and is designed for single use only.
Sizes:
The OS2®-C Compression Staple is available in various interaxis from 11mm to 15mm.
Material:
The OS2®-C Compression Staple is manufactured from PEEK according to standard ASTM F2026.
It does not have any coating.
Single use:
The OS2®-C Compression Staple is designed for single use only.
Sterilization:
The OS2®-C Compression Staple is supplied sterile, using gamma irradiation.
Place of use:
The OS2®-C Compression 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
hand or foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, or outpatient surgery center
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 assessment for the OS2®-C Compression Staple was made through mechanical comparison with predicate devices, animal and clinical testing being considered not applicable.
Mechanical testing for both OS2®-C Compression Staple and predicate device was performed according to ASTM F564-06.
The OS2®-C Compression Staple is substantially equivalent to the predicate devices identified in the 510(k) submission.
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.
K112794, K011716, K070031, K071586
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.
Not Found
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.
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Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2016
In2Bones SAS % Dr. Norman Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K153395
Trade/Device Name: OS2® -C Compression 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: November 22, 2015 Received: November 24, 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/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
2
Indications for Use
510(k) Number (if known) K153395
Device Name
OS2®-C Compression Staple
Indications for Use (Describe)
The OS2®-C Compression Staples are indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery.
The number and size of the OS2®-C Compression Staples must be adapted to the indication.
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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Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is in a gray oval shape with a white line that curves around the left side of the oval. The text "IN2BONES" is in white, with the "2" in orange.
For In2Bones OS2®-C ComMARY
For In2Bones OS2®-C Compression 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 | November 20, 2015 |
| Contact person | Norman F. Estrin. Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
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
Email: estrin@yourFDAconsultant.com |
| Proprietary Name | OS2®-C Compression Staple |
| Common name | Bone Compression 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®-C Compression Staple is an osteosynthesis staple, enabling a
constant and reproducible compression.
The OS2®-C Compression Staple is available in multiple lengths and
interaxis. It is delivered sterile, ready to use, pre-assembled on its
inserter.
The implant is manufactured from PEEK-OPTIMA®, polymer from
Invibio®, and is designed for single use only.
Sizes:
The OS2®-C Compression Staple is available in various interaxis from
11mm to 15mm.
Material:
The OS2®-C Compression Staple is manufactured from PEEK
according to standard ASTM F2026.
It does not have any coating.
Single use:
The OS2®-C Compression Staple is designed for single use only.
Sterilization:
The OS2®-C Compression Staple is supplied sterile, using gamma
irradiation.
Place of use:
The OS2®-C Compression Staple is indicated for use in a hospital, or
outpatient surgery center where sterile field may be created and
maintained. |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Devices | Biotech International / EOS Eleos Memory Staple (K112794)
Integra / Newdeal UNI-CLIP (K011716)
Memometal Easyclip (K070031)
Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586) - PEEK |
| Indications for use: | The OS2®-C Compression Staples are indicated for fixation of
arthrodesis, osteotomies and fractures in hand or foot surgery.
The number and size of the OS2®-C Compression Staples must be
adapted to the indication. |
| Comparison of the
indications for use with
the predicate devices: | As with the predicate devices, the OS2®-C Compression Staple is
indicated for surgical implantation longer than 30 days in the fixation
of bone fractures or for bone reconstruction in hand and foot. |
| Comparison of
Technological
characteristics | The technological characteristics of the OS2®-C Compression Staple
are the same as the characteristics of predicate devices in terms of
intended use and design. All these implants have the following features:
- Insertion into bone: The OS2®-C Compression Staple and all
predicate devices are intended for surgical implantation into
bone for longer than 30 days. - Design: The OS2®-C Compression Staple has partially similar
design, when compared to the Integra / Newdeal UNI-CLIP |
| | (K011716), Memometal Easyclip (K070031), Biotech
International / EOS Eleos Memory Staple (K112794) and
Memometal Easyclip (K070031); all are compression staples
with various interaxis and leg lengths in the range. Any
differences of design from staple to staple do not affect the
Safety and Effectiveness of the OS2®-C Compression Staple.
Material: The OS2®-C Compression Staple are manufactured
from the same raw material when compared to the Smith and
Nephew Bioraptor 2.3 PK suture anchor (K071586) and meet
appropriate ASTM standard.
Equivalent size range: The OS2®-C Compression Staple has
similar range size when compared to the Biotech International
Eleos Memory Staple (K112794), Integra / Newdeal UNI-CLIP
(K011716) and Memometal Easyclip (K070031). |
| Substantial Equivalence
Summary | The OS2®-C Compression Staple intended use, design, material,
technological characteristics and principles of operation are
substantially equivalent to those of predicate devices, if applicable.
The OS2®-C Compression Staple has similar mechanical properties
when compared to the Biotech International Eleos Memory Staple
(K112794). |
| Summary Performance
Data | Performance assessment for the OS2®-C Compression Staple was made
through mechanical comparison with predicate devices, animal and
clinical testing being considered not applicable.
Mechanical testing for both OS2®-C Compression Staple and predicate
device was performed according to ASTM F564-06.
The OS2®-C Compression Staple is substantially equivalent to the
predicate devices identified in the 510(k) submission. |
| CONCLUSION | Based on the evaluations performed, the design and indications of
the OS2®-C Compression Staple are substantially equivalent to the
predicate devices identified in the 510(k) submission. No new
materials or processes are used in the development of this implant.
In addition, the results of the testing performed by the test
laboratory indicated that the implants performed as expected for
each test.
The OS2®-C Compression Staples are acceptable for the
application. |
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