(253 days)
The I.B.S.TM 2.0 Osteosynthesis screws are intended for:
- The fixation of arthrodeses, osteotomies or fractures of the upper and lower limbs
- Osteosynthesis requiring mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
The I.B.S.TM 2.0 Osteosynthesis screw is a line extension of the existing compression screw line cleared in K131920 I.B.S.TM Osteosynthesis screw.
The I.B.S.TM 2.0 Osteosynthesis screws are cannulated screws available in a compression 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 I.B.S.TM 2.0 Osteosynthesis screws 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 2.0 Osteosynthesis screws are available in 2.0mm diameter, in length ranging from 10mm to 30mm.
Material: The I.B.S.TM 2.0 Osteosynthesis screws are manufactured from titanium alloy Ti6Al4V as per ISO 5832-3 and ASTM F136. They do not have any coatings.
Single use: The I.B.S.TM 2.0 Osteosynthesis screws are designed for single use only.
Sterilization: The I.B.S.TM 2.0 Osteosynthesis screws are supplied sterile, using gamma irradiation.
Place of use: The I.B.S.TM 2.0 Osteosynthesis screws are indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
This document describes the I.B.S.™ 2.0 Osteosynthesis screw, a bone fixation fastener. The acceptance criteria and supporting studies are based on mechanical performance tests, demonstrating substantial equivalence to predicate devices rather than direct clinical outcomes or AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Test Name) | Reported Device Performance (I.B.S.™ 2.0) |
|---|---|
| Torsional Properties (Engineering/Dimensional Comparison) | Demonstrated substantial equivalence to the predicate device SBI AUTOFIX screw diameter 2.0 (K052567). The specific numerical values for torque resistance are not provided but are implied to be within acceptable ranges compared to the predicate. |
| Torque to Failure (ASTM F543-13) | Met all acceptance criteria and/or showed similar results as the predicate device Vilex Cannulated Bone Screw Double Thread (K014154). Specific numerical performance not provided. |
| Insertion Torque (ASTM F543-13) | Met all acceptance criteria and/or showed similar results as the predicate device Vilex Cannulated Bone Screw Double Thread (K014154). Specific numerical performance not provided. |
| Axial Pullout Strength (ASTM F543-13) | Met all acceptance criteria and/or showed similar results as the predicate device Vilex Cannulated Bone Screw Double Thread (K014154). Specific numerical performance not provided. |
| Self-Tapping Performance (ASTM F543-13) | Met all acceptance criteria and/or showed similar results as the predicate device Vilex Cannulated Bone Screw Double Thread (K014154). Specific numerical performance not provided. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mechanical performance test set (e.g., number of screws tested for each mechanical property). The data provenance is from mechanical bench testing conducted by a test laboratory. The country of origin for the data is not specified, but the sponsor is In2Bones SAS, located in France. The study is a retrospective comparison against known predicate device performance and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a mechanical bone fixation screw, and its performance is evaluated against engineering standards and comparison with predicate devices, not through expert-labeled data for an AI algorithm.
4. Adjudication Method for the Test Set
Not applicable. Performance is determined by mechanical testing results against predetermined criteria in ASTM F543-13 and comparison to predicate devices, not by expert adjudication of clinical outcomes or image interpretations.
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 a medical device for bone fixation, not an AI software/algorithm requiring an MRMC comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering standards (ASTM F543-13) and direct mechanical comparison to legally marketed predicate devices. The objective is to demonstrate substantial equivalence in terms of mechanical properties.
8. The Sample Size for the Training Set
Not applicable. No training set is mentioned as this is a physical medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
In2Bones SAS % Norman Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K160174
Trade/Device Name: I.B.S.TM 2.0 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: August 30, 2016 Received: August 31, 2016
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160174
Device Name
I.B.S.TM 2.0 Osteosynthesis screw
Indications for Use (Describe)
The I.B.S.TM 2.0 Osteosynthesis screws are intended for:
-
The fixation of arthrodeses, osteotomies or fractures of the upper and lower limbs
-
Osteosynthesis requiring mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
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 gray and white, with the "2" in IN2BONES being orange. The logo is in an oval shape, with a white line running through the middle.
510(k) SUMMARY For In2Bones I.B.S.TM 2.0 Osteosynthesis screw
| 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 |
| 510(k) number | K160174 |
| Date of preparation | October 5, 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 StatesI.B.S.TM 2.0Osteosynthesis Screw | 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 | I.B.S.TM 2.0 Osteosynthesis screw |
| Common name | Bone fixation screw |
| Device classificationregulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixationscrew or fastenerClass II |
| Device ProductCode and Panel | HWC: screw, fixation, bone87 orthopedics |
| Device Description | The I.B.S.TM 2.0 Osteosynthesis screw is a line extension ofthe existing compression screw line cleared in K131920I.B.S.TM Osteosynthesis screw. |
| The I.B.S.TM 2.0 Osteosynthesis screws are cannulatedscrews available in a compression design.The cannulation of the screws provides a helpful featureduring surgery, as a wire is used to guide insertion of thescrew.The compression design has a non-threaded shaft, allowingoptimal compression between the two bone fragments,which may enhance bone osteosynthesis. | |
| The I.B.S.TM 2.0 Osteosynthesis screws are self-drilling andself-tapping screws, which enables introduction of the screwwithout any preparation of the hole (using a drill and /or atap) in most cases. | |
| Sizes: The I.B.S.TM 2.0 Osteosynthesis screws are availablein 2.0mm diameter, in length ranging from 10mm to 30mm. | |
| Material: The I.B.S.TM 2.0 Osteosynthesis screws aremanufactured from titanium alloy Ti6Al4V as per ISO5832-3 and ASTM F136. They do not have any coatings. | |
| Single use: The I.B.S.TM 2.0 Osteosynthesis screws aredesigned for single use only. | |
| Sterilization: The I.B.S.TM 2.0 Osteosynthesis screws aresupplied sterile, using gamma irradiation. | |
| Place of use: The I.B.S.TM 2.0 Osteosynthesis screws areindicated for use in a hospital, or outpatient surgery centerwhere sterile field may be created and maintained. | |
| Predicate Devices | Vilex Cannulated Bone Screw Double Thread (K014154)I.B.S.TM osteosynthesis screw (K131920)SBI AUTOFIX screw (K052576) |
| Indications for use: | The I.B.S.TM 2.0 Osteosynthesis screws are intended for:- The fixation of arthrodeses, osteotomies or fractures ofsmall bones of the upper and lower limbs- Osteosynthesis requiring mono or bicortical compressionThe size of the chosen screw should be adapted to thespecific indications. |
| Comparison ofTechnological | The technological characteristics of the I.B.S.TM 2.0 Osteosynthesisscrews are equivalent to the characteristics of predicate devices in |
| characteristics | terms of design, size range, raw material. All these implants have the following features: |
| - Insertion into bone: The I.B.S.TM 2.0 Osteosynthesis screws and all predicate devices are intended for surgical implantation into bone for longer than 30 days. | |
| - Compression design: This design corresponds to a non-threaded part allowing compression between two bone fragments. The I.B.S.TM 2.0 Osteosynthesis screws and all predicate devices have a non-threaded part allowing compression between two bone fragments. | |
| - Design: The Vilex Cannulated Bone Screw Double Thread (K014154), the I.B.S.TM osteosynthesis screw (K131920) and the SBI AUTOFIX screw (K052576) predicates have similar design as the I.B.S.TM 2.0 Osteosynthesis screw. They all are cannulated, self-tapping and self-drilling screws with a compression design. | |
| - Indications for use: The Vilex Cannulated Bone Screw Double Thread (K014154), the SBI AUTOFIX screw (K052576) and the I.B.S.TM osteosynthesis screw (K131920) predicates have equivalent indications for use as the I.B.S.TM 2.0 Osteosynthesis screw. | |
| - Equivalent size range: The Vilex Cannulated Bone Screw Double Thread predicate (K014154) has similar size range of 2.0mm diameter and length from 10mm to 24mm as the I.B.S.TM 2.0 Osteosynthesis screw. | |
| The I.B.S.TM osteosynthesis screw predicate (K131920) has similar lengths from 12mm to 28mm as the I.B.S.TM 2.0 Osteosynthesis screw. The I.B.S.TM osteosynthesis screw predicate (K131920) has a comparable diameter of 2.5mm instead of 2.0mm for the I.B.S.TM 2.0 Osteosynthesis screw. The SBI AUTOFIX predicate (K050681) has identical size range of 2.0mm diameter and length from 10mm to 30mm as the I.B.S.TM 2.0 Osteosynthesis screw. | |
| - Material: The I.B.S.TM 2.0 Osteosynthesis screw has identical raw material, when compared to the Vilex Cannulated Bone Screw Double Thread (K014154), the I.B.S.TM osteosynthesis screw (K131920) and the SBI AUTOFIX screw (K052576): all are manufactured from Titanium alloy Ti6Al4V, according to ISO 5832-3 and ASTM E136 standards. | |
| SubstantialEquivalenceSummary | As described above, the I.B.S.TM 2.0 Osteosynthesis screws havesimilar technological characteristics when compared to the predicatedevices. |
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| Summary | Performance testing has been evaluated for I.B.S.TM 2.0 |
|---|---|
| Performance | Osteosynthesis screws through mechanical comparison with |
| Data | predicate devices, animal and clinical testing being considered |
| not applicable. | |
| First, an engineering / dimensional comparison to the predicateSBI AUTOFIX screw diameter 2.0 (K052576) was performedto ascertain substantial equivalence. This dimensionalcomparison enabled to demonstrate substantial equivalence ofthe I.B.S.TM 2.0 Osteosynthesis screw and the predicate deviceSBI AUTOFIX screw diameter 2.0 (K052576) as far as theTorsional properties are concerned. | |
| In addition, mechanical testing for I.B.S.TM 2.0 Osteosynthesisscrews and Vilex Cannulated Bone Screw Double Thread(K014154) predicate device was performed according to ASTMF543-13. This standard describes methods to assess the torqueto failure, insertion torque, axial pullout strength, and self-tapping performance of screws. Bench tests were performed toassess the torsional properties, driving torque and axial pulloutof the I.B.S.TM 2.0 Osteosynthesis screws. | |
| The results of the testing performed by the test laboratoryindicate that the I.B.S.TM 2.0 Osteosynthesis screw met allacceptance criteria and/or showed similar results as thepredicate device Vilex Cannulated Bone Screw Double Thread(K014154).Therefore, the subject device was demonstrated to be as safeand effective as the above predicates | |
| CONCLUSION | Based on the evaluations and the results of the testingperformed, the design and indications of the I.B.S.TM 2.0Osteosynthesis screws are substantially equivalent to thepredicate devices identified in the 510(k) submission. Nonew materials or processes are used in the development ofthis implant. |
§ 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.