(253 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a bone screw, with no mention of AI or ML.
Yes
The device is used for the fixation of arthrodeses, osteotomies, or fractures, which are therapeutic interventions.
No
The device is an osteosynthesis screw used for the fixation of bones, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical screw made of titanium alloy, intended for surgical implantation. 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 clearly states the device is for the "fixation of arthrodeses, osteotomies or fractures of the upper and lower limbs" and "Osteosynthesis requiring mono or bicortical compression." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a physical screw made of titanium alloy, designed for surgical insertion into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is an implantable surgical device used inside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower limbs, small bones of the upper and lower limbs
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 testing has been evaluated for I.B.S.TM 2.0 Osteosynthesis screws through mechanical comparison with predicate devices, animal and clinical testing being considered not applicable.
First, an engineering / dimensional comparison to the predicate SBI AUTOFIX screw diameter 2.0 (K052576) was performed to ascertain substantial equivalence. This dimensional comparison enabled to demonstrate substantial equivalence of the I.B.S.TM 2.0 Osteosynthesis screw and the predicate device SBI AUTOFIX screw diameter 2.0 (K052576) as far as the Torsional properties are concerned.
In addition, mechanical testing for I.B.S.TM 2.0 Osteosynthesis screws and Vilex Cannulated Bone Screw Double Thread (K014154) predicate device was performed according to ASTM F543-13. This standard describes methods to assess the torque to failure, insertion torque, axial pullout strength, and self-tapping performance of screws. Bench tests were performed to assess the torsional properties, driving torque and axial pullout of the I.B.S.TM 2.0 Osteosynthesis screws.
The results of the testing performed by the test laboratory indicate that the I.B.S.TM 2.0 Osteosynthesis screw met all acceptance criteria and/or showed similar results as the predicate device Vilex Cannulated Bone Screw Double Thread (K014154).
Therefore, the subject device was demonstrated to be as safe and effective as the above predicates.
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.
Vilex Cannulated Bone Screw Double Thread (K014154), I.B.S.TM osteosynthesis screw (K131920), SBI AUTOFIX screw (K052576)
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
§ 888.3040 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.
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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
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,
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) 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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510(k) SUMMARY For In2Bones I.B.S.TM 2.0 Osteosynthesis screw
| 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 |
| 510(k) number | K160174 |
| Date of preparation | October 5, 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
I.B.S.TM 2.0
Osteosynthesis Screw | 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 | I.B.S.TM 2.0 Osteosynthesis screw |
| Common name | Bone fixation screw |
| Device classification
regulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixation
screw or fastener
Class II |
| Device Product
Code and Panel | HWC: screw, fixation, bone
87 orthopedics |
| Device Description | 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. |
| 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 of
small bones 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. |
| Comparison of
Technological | The technological characteristics of the I.B.S.TM 2.0 Osteosynthesis
screws 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. |
| Substantial
Equivalence
Summary | As described above, the I.B.S.TM 2.0 Osteosynthesis screws have
similar technological characteristics when compared to the predicate
devices. |
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5
6
| 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 predicate | |
| SBI AUTOFIX screw diameter 2.0 (K052576) was performed | |
| to ascertain substantial equivalence. This dimensional | |
| comparison enabled to demonstrate substantial equivalence of | |
| the I.B.S.TM 2.0 Osteosynthesis screw and the predicate device | |
| SBI AUTOFIX screw diameter 2.0 (K052576) as far as the | |
| Torsional properties are concerned. | |
| In addition, mechanical testing for I.B.S.TM 2.0 Osteosynthesis | |
| screws and Vilex Cannulated Bone Screw Double Thread | |
| (K014154) predicate device was performed according to ASTM | |
| F543-13. This standard describes methods to assess the torque | |
| to failure, insertion torque, axial pullout strength, and self- | |
| tapping performance of screws. Bench tests were performed to | |
| assess the torsional properties, driving torque and axial pullout | |
| of the I.B.S.TM 2.0 Osteosynthesis screws. | |
| The results of the testing performed by the test laboratory | |
| indicate that the I.B.S.TM 2.0 Osteosynthesis screw met all | |
| acceptance criteria and/or showed similar results as the | |
| predicate device Vilex Cannulated Bone Screw Double Thread | |
| (K014154). | |
| Therefore, the subject device was demonstrated to be as safe | |
| and effective as the above predicates | |
| CONCLUSION | Based on the evaluations and the results of the testing |
| performed, the design and indications of the I.B.S.TM 2.0 | |
| Osteosynthesis screws 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. |