(309 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of the screws, with no mention of AI or ML.
Yes
The device aids in bone fixation and stabilization, which is a therapeutic intervention for fractures, osteotomies, and arthrodeses.
No
The device description indicates that the I.B.S.™ osteosynthesis screws are used for the fixation of bones (arthrodeses, osteotomies, fractures) and osteosyntheses, which are surgical procedures for internal fixation of bone fragments. This is a therapeutic function, not a diagnostic one. A diagnostic device would typically identify or detect a disease or condition.
No
The device description clearly states that the device is a physical osteosynthesis screw made of titanium alloy, which is a hardware component.
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 long or short bones of the upper and lower limbs" and "Osteosyntheses requiring a mono or bicortical compression." This describes a surgical implant used in vivo (within the body) to stabilize bone.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / 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 indication.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Not Found
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.
K050346, K052576, K962011, K071639, K944330, K962011
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.
0
510(k) SUMMARY In2Bones I.B.S.™ osteosynthesis screws
| Sponsor identification: | Eric Fourcault
Chief Executive Officer
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: | New Company. Will register following FDA clearance. |
| Date of preparation: | April 29, 2014 |
| Contact person | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Fax: (301) 294-0126
Email: estrin@yourFDAconsultant.com |
| Authorized U.S. Agent
in the United States | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Fax: (301) 294-0126
Email: estrin@yourFDAconsultant.com |
| Proprietary Name | I.B.S.™ osteosynthesis screws |
| 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: 87 orthopedics |
1
1
·
| 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 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. | |
| Predicate | |
| Devices: | 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 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 | |
| indication. |
2
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 of
Technological
characteristics | The technological characteristics of the I.B.S.™ osteosynthesis screws
are the same as the characteristics of predicates devices in terms of
indications for use and design. All the screws have the following
features:
- Cannulated - the I.B.S.™ osteosynthesis screws and all the
predicate devices are cannulated. - Made from Titanium alloys, with no new materials being
introduced in the product - the IBS.™ osteosynthesis screws
and all predicate devices are manufactured in Titanium alloy
TA6V, except the SBI® AutoFix, which is manufactured in
Stainless Steel 316L. - Compression design: non-threaded part allowing compression
between two bone fragments - The I.B.S.™ Compression screw
and all predicate devices have a non-threaded part allowing
compression between two bone fragments - Neutralization design: fully threaded - The I.B.S.™
Neutralization screw and all predicate devices are fully
threaded - Equivalent size range: The diameters and lengths covered by
the predicate devices enable to cover all diameters and lengths
of 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. An
engineering / dimensional comparison to the predicates was performed to
demonstrate substantial equivalence. Based on these similarities, the
I.B.S.™ osteosynthesis screws are substantially equivalent to the predicates
identified in the 510(k) Summary. |
3
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
5
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