(199 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and design of a physical screw for bone fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "screw for bone reconstruction, osteotomy and fracture fixation," which are therapeutic interventions for musculoskeletal conditions.
No
Explanation: The device is an implantable screw used for bone reconstruction, osteotomy, and fracture fixation. Its function is therapeutic/surgical, not diagnostic.
No
The device description explicitly states it is a one-piece device made of Titanium Alloy intended to be used as a screw for bone reconstruction, osteotomy and fracture fixation. This is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The I.B.S.® Snap-off screw is a surgical implant used for bone fixation and reconstruction within the body. It is a physical device inserted into bone tissue.
- Lack of Specimen Analysis: The device does not analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the I.B.S.® Snap-off screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 the device.
Examples include:
Mono-cortical fixation of small bone fragments
Weil osteotomy
Osteotomies and fractures fixation in the foot and hand.
Product codes (comma separated list FDA assigned to the subject device)
HWC
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.
Sizes:
The I.B.S.® Snap-off screws are available in various diameters and lengths.
Material:
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.
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 gamma irradiation.
Place of use:
The I.B.S.® Snap-off 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
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.
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)
Mechanical testing was performed according to ASTM F543-07. This standard describes methods to assess the torque to failure, insertion torque, 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 and tolerances for metallic bone screws implanted into bone tissue. As the specification standard states, the dimensions and tolerances are applicable only to metallic bone screws described in the specification itself. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application.
In addition, an engineering / dimensional comparison to the predicates was performed to ascertain substantial equivalence.
The results of the testing performed by the test lab indicated that the I.B.S.® Snap-off screw performed as expected for each test.
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.
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
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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 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 | August 1st, 2013 |
| Contact person | Norman Estrin
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Fax: (301) 294-0126
Email: estrin@yourFDAconsultant.com |
| Authorized Agent in the
United States | Norman Estrin
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.® Snap-off screw |
| Common name | Bone fixation screw |
| Device classification regulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Class II |
| Device Product
Code and Panel | HWC: screw, fixation, bone
87 orthopedics |
| 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. |
| | Sizes:
The I.B.S.® Snap-off screws are available in various diameters and
lengths. |
| | Material:
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. |
| | 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 gamma
irradiation. |
| | Place of use:
The I.B.S.® Snap-off screws are indicated for use in a hospital, or
outpatient surgery center where sterile field may be created and
maintained. |
| 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 the
device. |
| | Examples include:
Mono-cortical fixation of small bone fragments
Weil osteotomy
Osteotomies 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 -- an | ||
| Integra Lifesciences | ||||
| company | Arthrex | Nexa Orthopedics | ||
| / Tornier | ||||
| Name of | ||||
| device | I.B.S.® Snap-off | |||
| screw | SPIN® screw | Low Profile Screw |
- QuickFix | Nexa Bone screw
system / NexFix |
| Use | Single use | Single use | Single use | Single use |
| Fixation | Bone | Bone | Bone | Bone |
| 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 the
device.
Examples include:
Mono-cortical
fixation of small
bone fragments
Weil osteotomy
Osteotomies and
fractures fixation in
the foot and hand. | The SPIN® Snap-off
screw is indicated
for fixing the
elective osteotomies
of the mid-foot
bones and the
metatarsal and
phalanges of the
foot only.
Examples include:
Weil osteotomy
Unicortical small
bone fixation | The Arthrex Low
Profile Screws
(2.0-3.0mm solid)
are intended to be
used as stand-
alone bone screws,
or in a plate-screw
system for internal
bone fixation for
bone fractures,
fusions,
osteotomies and
non-unions in the
ankle, foot, hand,
and wrist. | The Nexa bone
screw system
provides fixation
of fractures,
fusions, or
osteotomies of the
hand and foot. |
3
K132911 page 4 of 4
| Comparison of
Technological
characteristics | The technological characteristics of the I.B.S.® Snap-off screw are the
same as the characteristics of predicates devices in terms of intended
use and design. All the screws have the following features:
- Solid / non-cannulated – the I.B.S.® Snap-off screws and all
predicate devices are solid / non-cannulated screws - Self-tapping and self-drilling, with a snap-off design - the
I.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 materials
being introduced in the product - the I.B.S.® Snap-off screws
and all predicate devices are manufactured from Titanium
Alloy TA6V - Equivalent size range: the diameters and lengths covered by the
predicate devices enable to cover diameters and lengths of the
I.B.S.® Snap-off screws - Indicated for surgical implantation longer than 30 days - the
I.B.S.® Snap-off screws and all predicate devices are indicated
for surgical implantation longer than 30 days |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence
Summary | The I.B.S.® Snap-off screw has similar technological characteristics
when compared to the predicate devices. |
| Summary Performance
Data | Mechanical testing was performed according to ASTM F543-07. This
standard describes methods to assess the torque to failure, insertion
torque, 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 and
tolerances for metallic bone screws implanted into bone tissue. As the
specification standard states, the dimensions and tolerances are
applicable only to metallic bone screws described in the specification
itself. Additional information must be provided to document that the
design of the product will provide adequate mechanical properties for
the particular application.
In addition, an engineering / dimensional comparison to the predicates
was performed to ascertain substantial equivalence.
The results of the testing performed by the test lab indicated that the
I.B.S.® Snap-off screw performed as expected for each test. |
| CONCLUSION | Based on the evaluations performed, the design and indications of
the I.B.S.® Snap-off screw are substantially equivalent to the
predicates identified in the 510(k) submission. No new materials or
processes are used in the development of this implant.
In addition, the results of the testing performed by the test lab
indicated 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