The I.B.S.® Snap-off screws are indicated for bone reconstruction, osteotomy and fracture fixation of bones appropriate for the size of the device. Examples include: Mono-cortical fixation of small bone fragments Weil osteotomy Osteotomies and fractures fixation in the foot and hand.

Device Description

The I.B.S.® Snap-off screw is a one-piece device made of Titanium Alloy intended to be used as a screw for bone reconstruction, osteotomy and fracture fixation of bones appropriate for the size of the device. The implant is a self-drilling and self-tapping snap-off screw. It is machined on the end of a drill shank which inserts into a driver. After insertion of the screw into the bone, the drill shank twists off and breaks cleanly from the screw head. The implant is supplied sterile and is available in various sizes diameters and lengths. The I.B.S.® Snap-off screws are manufactured from titanium alloy TA6V as per ISO 5832-3 and ASTM F136. They do not have any coating. The I.B.S.® Snap-off screws are designed for single use only. The I.B.S.® Snap-off screws are supplied sterile, using gamma irradiation.

AI/ML Overview

The provided document is a 510(k) summary for a medical device, the In2Bones I.B.S.® Snap-off screw. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence, which is the basis for FDA clearance for similar devices.

Here's an analysis based on the information provided:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (What was tested)	Reported Device Performance
Mechanical performance according to ASTM F543-07 (Torque to failure, insertion torque, axial pullout strength, and self-tapping performance of screws). This standard also covers requirements for materials, finish, marking, care and handling, and acceptable dimensions and tolerances.	The I.B.S.® Snap-off screw performed as expected for each test.
Engineering / dimensional comparison to predicate devices.	Performed to ascertain substantial equivalence.
Material: Made from Titanium Alloy TA6V (ISO 5832-3 and ASTM F136).	Manufactured from Titanium Alloy TA6V as per ISO 5832-3 and ASTM F136.
Design Features: Solid/non-cannulated, self-tapping, self-drilling, snap-off design.	Same as predicate devices.
Indications for Use: Bone reconstruction, osteotomy, and fracture fixation of bones appropriate for the size of the device. (Specifically: Mono-cortical fixation of small bone fragments, Weil osteotomy, Osteotomies and fractures fixation in the foot and hand).	Substantially equivalent to predicate devices.
Intended for surgical implantation longer than 30 days.	Same as predicate devices.
Equivalent size range (diameters and lengths).	Covered by the predicate devices.

Sample size used for the test set and the data provenance:
The document does not specify the sample size used for the mechanical testing or the engineering/dimensional comparison.
The provenance of the data is a "test lab" (stated under "Summary Performance Data"), but further details such as country of origin, retrospective or prospective nature of the data collection (if applicable) are not provided. Given these are mechanical and dimensional tests, they are inherently prospective during the device development and validation phase.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of regulatory submission. The device is a bone fixation screw; its performance is assessed through objective mechanical testing and engineering comparisons, not through human interpretation of images or symptoms that would require expert consensus for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the reasons stated above. Adjudication methods are typically used in clinical studies or studies involving expert review of ambiguous cases, which is not the nature of the testing described here.
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:
This information is not applicable. This submission is for a physical orthopedic implant, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable for the same reasons as #5.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical testing, the "ground truth" is defined by the standards set forth in ASTM F543-07 (e.g., minimum torque to failure, pullout strength, etc.) and by the specifications and dimensions of the predicate devices for comparison. It's objective, quantitative data derived from engineering principles and standardized tests, not biological outcomes or expert opinions.
The sample size for the training set:
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
How the ground truth for the training set was established:
This information is not applicable for the same reasons as #8.

Summary

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

Image /page/0/Picture/1 description: The image shows a logo for "In2Bones". The logo is an oval shape that is split into two parts by a white line. The text "In2Bones" is written in black letters on the right side of the oval. The logo is simple and modern.

ﺔ

23, charren du Va: " 20120 Eculiv "

21 + 7210 - 72 20

outar solar hots

K132911 page 1 of 4

004_Revised 510(k) Summary for I.B.S. Snap-off Screw (K132911) Response to September 17, 2013 RTA Checklist, Section A4a.pdf

510(k) SUMMARY

In2Bones I.B.S." Snap-off screw

Sponsor identification	In2Bones SAS28 chemin du Petit Bois69130 Ecully - FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29
Establishment registration number	New company. Will register following FDA clearance
Date of preparation	August 1st, 2013
Contact person	Norman EstrinEstrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Fax: (301) 294-0126Email: estrin@yourFDAconsultant.com
Authorized Agent in theUnited States	Norman EstrinEstrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Fax: (301) 294-0126Email: estrin@yourFDAconsultant.com
Proprietary Name	I.B.S.® Snap-off screw
Common name	Bone fixation screw
Device classification regulation	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastenerClass II
Device ProductCode and Panel	HWC: screw, fixation, bone87 orthopedics
Device Description	The I.B.S.® Snap-off screw is a one-piece device made of TitaniumAlloy intended to be used as a screw for bone reconstruction,osteotomy and fracture fixation of bones appropriate for the size of thedevice.
	The implant is a self-drilling and self-tapping snap-off screw. It ismachined on the end of a drill shank which inserts into a driver. Afterinsertion of the screw into the bone, the drill shank twists off andbreaks cleanly from the screw head.
	The implant is supplied sterile and is available in various sizesdiameters and lengths.
	Sizes:The I.B.S.® Snap-off screws are available in various diameters andlengths.
	Material:The I.B.S.® Snap-off screws are manufactured from titanium alloyTA6V as per ISO 5832-3 and ASTM F136. They do not have anycoating.
	Single use:The I.B.S.® Snap-off screws are designed for single use only.Sterilization:
	The I.B.S.® Snap-off screws are supplied sterile, using gammairradiation.
	Place of use:The I.B.S.® Snap-off screws are indicated for use in a hospital, oroutpatient surgery center where sterile field may be created andmaintained.
Predicate Devices	Integra / Newdeal Spin screw (K991477)Arthrex Low Profile Screws (K103705)Nexa Orthopedics / Nexa Bone screw (K053394)
Indications for use	The I.B.S.® Snap-off screws are indicated for bone reconstruction,osteotomy and fracture fixation of bones appropriate for the size of thedevice.
	Examples include:Mono-cortical fixation of small bone fragmentsWeil osteotomyOsteotomies and fractures fixation in the foot and hand.

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

に

K132911 page 2 of 4

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

K132911 page 3 of 4

COMPARISON OF THE INDICATIONS FOR USE WITH THE PREDICATE DEVICES:

As with the predicate devices, the I.B.S.® Snap-off screws are indicated for surgical implantation longer than 30 days in the fixation of bone fractures or for bone reconstruction.

510k number	K132911	K991477	K103705	K053394
manufacturer	In2Bones	Newdeal -- anIntegra Lifesciencescompany	Arthrex	Nexa Orthopedics/ Tornier
Name ofdevice	I.B.S.® Snap-offscrew	SPIN® screw	Low Profile Screw- QuickFix	Nexa Bone screwsystem / NexFix
Use	Single use	Single use	Single use	Single use
Fixation	Bone	Bone	Bone	Bone
Indicationsfor use	The I.B.S.® Snap-off screws areindicated for bonereconstruction,osteotomy andfracture fixation ofbones appropriatefor the size of thedevice.Examples include:Mono-corticalfixation of smallbone fragmentsWeil osteotomyOsteotomies andfractures fixation inthe foot and hand.	The SPIN® Snap-offscrew is indicatedfor fixing theelective osteotomiesof the mid-footbones and themetatarsal andphalanges of thefoot only.Examples include:Weil osteotomyUnicortical smallbone fixation	The Arthrex LowProfile Screws(2.0-3.0mm solid)are intended to beused as stand-alone bone screws,or in a plate-screwsystem for internalbone fixation forbone fractures,fusions,osteotomies andnon-unions in theankle, foot, hand,and wrist.	The Nexa bonescrew systemprovides fixationof fractures,fusions, orosteotomies of thehand and foot.

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

K132911 page 4 of 4

Comparison ofTechnologicalcharacteristics	The technological characteristics of the I.B.S.® Snap-off screw are thesame as the characteristics of predicates devices in terms of intendeduse and design. All the screws have the following features:- Solid / non-cannulated – the I.B.S.® Snap-off screws and allpredicate devices are solid / non-cannulated screws- Self-tapping and self-drilling, with a snap-off design - theI.B.S® Snap-off screws and all predicate devices are self-tapping and self-drilling screws with a snap-off mechanism- Material: made from Titanium alloys, with no new materialsbeing introduced in the product - the I.B.S.® Snap-off screwsand all predicate devices are manufactured from TitaniumAlloy TA6V- Equivalent size range: the diameters and lengths covered by thepredicate devices enable to cover diameters and lengths of theI.B.S.® Snap-off screws- Indicated for surgical implantation longer than 30 days - theI.B.S.® Snap-off screws and all predicate devices are indicatedfor surgical implantation longer than 30 days
Substantial EquivalenceSummary	The I.B.S.® Snap-off screw has similar technological characteristicswhen compared to the predicate devices.
Summary PerformanceData	Mechanical testing was performed according to ASTM F543-07. Thisstandard describes methods to assess the torque to failure, insertiontorque, axial pullout strength, and self-tapping performance of screws.The specification standard provides requirements for materials, finish,marking, care and handling, and the acceptable dimensions andtolerances for metallic bone screws implanted into bone tissue. As thespecification standard states, the dimensions and tolerances areapplicable only to metallic bone screws described in the specificationitself. Additional information must be provided to document that thedesign of the product will provide adequate mechanical properties forthe particular application.In addition, an engineering / dimensional comparison to the predicateswas performed to ascertain substantial equivalence.The results of the testing performed by the test lab indicated that theI.B.S.® Snap-off screw performed as expected for each test.
CONCLUSION	Based on the evaluations performed, the design and indications ofthe I.B.S.® Snap-off screw are substantially equivalent to thepredicates identified in the 510(k) submission. No new materials orprocesses are used in the development of this implant.In addition, the results of the testing performed by the test labindicated that the screws performed as expected for each test.The I.B.S.® Snap-off screws are acceptable for the application.

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

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

April 4, 2014

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

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

Re: K132911

Trade/Device Name: I.B.S.® Snap-off screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 8, 2014 Received: March 11. 2014

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

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

Page 2 -Norman Estrin, Ph.D.

(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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance 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.

Sincerely yours,

Mark N. Mellerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

K132911 page 1 of 1

Indications for Use

510(k) Number (if known): K132911

Device Name: I.B.S snap-off screw

Indications For Use:

The I.B.S snap-off screws are intended for bone reconstruction, osteotomy and fracture fixalinn of bones appropriate for the size of the device. Examples include : Mono-cortical fixation of small bone fragments Weil ostcolomy Osteotomies and fractures fixation in the foot and hand.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabet顾迹:rank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 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.