(309 days)
The I.B.S.™ osteosynthesis screws are intended for:
- The fixation of arthrodeses, osteotomies or fractures of long or short bones of the upper and lower limbs
- Osteosyntheses requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
The I.B.S.TM osteosynthesis screws are cannulated screws, available in a compression and a neutralization design. The cannulation of the screws provides a helpful feature during surgery, as a wire is used to guide insertion of the screw. The compression design has a non-threaded shaft, allowing optimal compression between the two bone fragments, which may enhance bone osteosynthesis. The neutralization design is fully threaded and may be preferred when stabilization of the bone fragments without strong compression is required, as for example in some fractures in multiple fragments, or osteoporotic bone. Both designs are self-drilling and self-tapping screws, which enables introduction of the screw without any preparation of the hole (using a drill and /or a tap) in most cases.
Sizes: The I.B.S.TM osteosynthesis screws are available in 2.5mm, 3.0mm, 3.5mm, 4.5mm, 6.0mm, 6.5mm, and 8.0mm diameters, in length ranging from 20mm to 160mm.
Material: The I.B.S.TM osteosynthesis screws are manufactured from titanium alloy Ti6A14Vas per ISO 5832-3 and ASTM F136. They do not have any coatings.
Single use: The I.B.S.TM osteosynthesis screws are designed for single use only.
Sterilization: The I.B.S.TM osteosynthesis screws are supplied sterile, using gamma irradiation.
Place of use: The I.B.S.TM osteosynthesis screws are indicated for use in a hospital, or outpatient surgery center where sterile fields may be created and maintained. They are prescription devices.
Here's an analysis of the provided 510(k) summary regarding the In2Bones I.B.S.™ osteosynthesis screws, focusing on acceptance criteria and supporting studies:
This submission is for a medical device (osteosynthesis screws), not an AI/ML powered device. Therefore, many of the typical acceptance criteria and study components related to AI devices (such as sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable.
The approval for this device is based on substantial equivalence to existing predicate devices, meaning it has similar intended use, materials, dimensions, and designs, and does not raise new questions of safety or effectiveness. The study demonstrating this is primarily a comparative engineering and dimensional analysis rather than a clinical trial or AI performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (as demonstrated by comparison to predicates) |
|---|---|
| Intended Use: Fixation of arthrodeses, osteotomies or fractures of long or short bones of upper and lower limbs; osteosyntheses requiring mono or bicortical compression. | Identical. The I.B.S.™ osteosynthesis screws have the same indications for use as the predicate devices. This is stated as: "The I.B.S.™ osteosynthesis screws are intended for: - The fixation of arthrodeses, osteotomies or fractures of long or short bones of the upper and lower limbs - Osteosyntheses requiring a mono or bicortical compression." |
| Technological Characteristics: | Similar/Equivalent. The device's technological characteristics are deemed the same as the predicate devices. Specifically: - Cannulation: The I.B.S.™ screws and all predicates are cannulated. - Material: The I.B.S.™ screws are made from Titanium alloy Ti6A14V (ISO 5832-3 and ASTM F136), similar to most predicates (except SBI® AutoFix which uses Stainless Steel 316L). No new materials are introduced. - Compression Design: The I.B.S.™ Compression screw has a non-threaded part for compression, similar to all compression predicates. - Neutralization Design: The I.B.S.™ Neutralization screw is fully threaded, similar to all neutralization predicates. - Size Range: The I.B.S.™ screws (2.5mm to 8.0mm diameters, 20mm to 160mm lengths) are covered by the size ranges of the predicate devices. |
| Material/Biocompatibility: Titanium alloy Ti6A14V (ISO 5833-3, ASTM F136). | Compliant/Equivalent. Manufactured from titanium alloy Ti6A14Vas per ISO 5832-3 and ASTM F136, which are established medical device standards and consistent with predicate devices. |
| Sterilization Method: Gamma irradiation. | Compliant/Equivalent. Supplied sterile via gamma irradiation, a standard sterilization method for medical devices. |
| Safety and Effectiveness: Demonstrate no new questions of safety or efficacy. | Demonstrated by Substantial Equivalence. Based on the identical intended use and similar technological characteristics (materials, design features, size range), the device is deemed as safe and effective as the predicate devices. An "engineering / dimensional comparison to the predicates was performed to demonstrate substantial equivalence." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a hardware medical device seeking substantial equivalence, not an AI/ML device requiring a test set of data. The "test" here refers to the comparison of the physical device to its predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth in the context of expert labeling or adjudication is required for this type of device submission. The "ground truth" for substantial equivalence is the established safety and efficacy of the predicate devices, which has been previously reviewed and cleared by the FDA based on their respective data.
4. Adjudication method for the test set
- Not Applicable. No test set or expert adjudication process as would be used for an AI/ML device.
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 is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the regulatory clearance of the predicate devices by the FDA, which implicitly confirms their safety and effectiveness for their stated indications. The I.B.S.™ screws are compared against these already-cleared devices. No new clinical "ground truth" (e.g., pathology or outcome data specific to this device) was required for this 510(k) submission.
8. The sample size for the training set
- Not Applicable. This is a hardware medical device, not an AI/ML device. The "training" for such a device involves engineering design, material selection, and manufacturing processes, not data training.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set in the context of AI/ML. The design and manufacturing of the device would have followed established engineering principles and medical device standards (e.g., ISO, ASTM), and in-house testing to ensure it meets its specifications, but this is not referred to as a "training set" with "ground truth" in the AI sense.
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510(k) SUMMARY In2Bones I.B.S.™ osteosynthesis screws
| Sponsor identification: | Eric FourcaultChief Executive OfficerIn2Bones™ SAS28 chemin du Petit Bois69130 ECULLY, FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29 |
|---|---|
| Establishmentregistration number: | New Company. Will register following FDA clearance. |
| Date of preparation: | April 29, 2014 |
| Contact person | Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Fax: (301) 294-0126Email: estrin@yourFDAconsultant.com |
| Authorized U.S. Agentin the United States | Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Fax: (301) 294-0126Email: estrin@yourFDAconsultant.com |
| Proprietary Name | I.B.S.™ osteosynthesis screws |
| Common name | Bone fixation screw |
| Device classificationregulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixationscrew or fastener, Class II |
| Device ProductCode and Panel | HWC: 87 orthopedics |
1
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·
| Device Description | Design and features: |
|---|---|
| The I.B.S.TM osteosynthesis screws are cannulated screws,available in a compression and a neutralization design. | |
| The cannulation of the screws provides a helpful feature during | |
| surgery, as a wire is used to guide insertion of the screw. The | |
| compression design has a non-threaded shaft, allowing optimal | |
| compression between the two bone fragments, which may | |
| enhance bone osteosynthesis. | |
| The neutralization design is fully threaded and may be preferredwhen stabilization of the bone fragments without strong | |
| compression is required, as for example in some fractures in | |
| multiple fragments, or osteoporotic bone. Both designs are self- | |
| drilling and self-tapping screws, which enables introduction of | |
| the screw without any preparation of the hole (using a drill and | |
| /or a tap) in most cases. | |
| Sizes: | |
| The I.B.S.TM osteosynthesis screws are available in 2.5mm, | |
| 3.0mm, 3.5mm, 4.5mm, 6.0mm, 6.5mm, and 8.0mm diameters, | |
| in length ranging from 20mm to 160mm. | |
| Material: | |
| The I.B.S.TM osteosynthesis screws are manufactured from | |
| titanium alloy Ti6A14Vas per ISO 5832-3 and ASTM F136. | |
| They do not have any coatings.Single use: | |
| The I.B.S.TM osteosynthesis screws are designed for single use | |
| only. | |
| Sterilization: | |
| The I.B.S.TM osteosynthesis screws are supplied sterile, using | |
| gamma irradiation. | |
| Place of use: | |
| The I.B.S.TM osteosynthesis screws are indicated for use in a | |
| hospital, or outpatient surgery center where sterile fields may be | |
| created and maintained. They are prescription devices. | |
| PredicateDevices: | Compression design:Newdeal Stabilization screw (K050346) |
| SBI Autofix (K052576) | |
| Synthes 7.0/7.3 cannulated screw (K962011) | |
| Neutralization design:Newdeal QWIX positioning screw (K071639) | |
| Acumed Acutrak screws (K944330) | |
| Synthes 7.0/7.3 cannulated screw (K962011) | |
| Indications for use: | The I.B.S.™ osteosynthesis screws are intended for: |
| - The fixation of arthrodeses, osteotomies or fractures of long or shortbones of the upper and lower limbs | |
| - Osteosyntheses requiring a mono or bicortical compression | |
| The size of the chosen screw should be adapted to the specificindication. |
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Comparison of the indications for use with the predicate devices:
As with the predicate devices, the I.B.S™ osteosynthesis screws are indicated for surgical
implantation longer than 30 days in the fixation of bone fractures or for bone reco
| Comparison ofTechnologicalcharacteristics | The technological characteristics of the I.B.S.™ osteosynthesis screwsare the same as the characteristics of predicates devices in terms ofindications for use and design. All the screws have the followingfeatures:- Cannulated - the I.B.S.™ osteosynthesis screws and all thepredicate devices are cannulated.- Made from Titanium alloys, with no new materials beingintroduced in the product - the IBS.™ osteosynthesis screwsand all predicate devices are manufactured in Titanium alloyTA6V, except the SBI® AutoFix, which is manufactured inStainless Steel 316L.- Compression design: non-threaded part allowing compressionbetween two bone fragments - The I.B.S.™ Compression screwand all predicate devices have a non-threaded part allowingcompression between two bone fragments- Neutralization design: fully threaded - The I.B.S.™Neutralization screw and all predicate devices are fullythreaded- Equivalent size range: The diameters and lengths covered bythe predicate devices enable to cover all diameters and lengthsof the I.B.S.™ osteosynthesis range. |
|---|---|
| Conclusions | The I.B.S.™ osteosynthesis screw has a similar intended use, materials,dimensions, and designs when compared to the predicate devices. Anengineering / dimensional comparison to the predicates was performed todemonstrate substantial equivalence. Based on these similarities, theI.B.S.™ osteosynthesis screws are substantially equivalent to the predicatesidentified in the 510(k) Summary. |
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Pablic Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
May 1, 2014
In2Bone SAS % Norman F. Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac. Maryland 20854
Re: K131920
Trade/Device Name: In2Bone I.B.STM Osteosynthesis 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 18. 2014 Received: March 19, 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 docs 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 Part 801); medical device reporting (reporting of medical
{4}------------------------------------------------
Page 2 - Dr. Norman F. Estrin
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/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,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K131920 Device Name: I.B.S.™ osteosynthesis screw
Indications For Use:
The I.B.S.™ osteosynthesis screws are intended for:
-
The fixation of arthrodeses, osteotomies or fractures of long or short bones of the upper and lower limbs
-
Osteosyntheses requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
Prescription Use _ _ x _ x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Limin Sun -S 2014.04.30 18:16:00 -04'00'
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131920
§ 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.