(74 days)
No
The device description and intended use focus on mechanical fixation principles and components, with no mention of AI or ML technologies.
Yes
The device is described as an "external fixation screw" and part of a system intended to obtain "non-rigid fixation" and "stimulate bone re-growth" for treating "severe articular fractures, pseudo-arthrosis and limb lengthening." These are all therapeutic actions.
No
The device is described as an external fixation screw and system used for non-rigid fixation of bone to stimulate bone re-growth, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes physical components (Schanz screws, round bars, threads, square tangs) used for external fixation of bone, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "external fixation of bone" and "to obtain a safe, nonrigid fixation, to stimulate bone re-growth." This describes a surgical device used directly on the patient's body to treat a physical condition.
- Device Description: The description details a physical screw designed to be inserted into bone as part of an external fixation system.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside or on the body) for a structural and therapeutic purpose.
N/A
Intended Use / Indications for Use
The Intended Use of the Sintea Biotech Traumafix (TFX) System is to obtain a safe, nonrigid fixation, to stimulate bone re-growth. The function of the Schanz Screw is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct.
The Sintea Biotech Schanz Screw is indicated for use in the external fixation of bone.
Product codes (comma separated list FDA assigned to the subject device)
JDW
Device Description
Schanz's screws are components of the Sintea Traumafix (TFX) system and were developed for external fixation according to Ilizarov's principle to treat severe articular fractures, pseudo-arthrosis and limb lengthening. The purpose of the TFX system is to obtain a safe, non-rigid fixation, to stimulate bone re-growth. The function of the Schanz's screws is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct. The Schanz's screws are available in three different diameters (4.0, 5.0, 6.0 mm) and three different lengths (120, 150, 180 mm). They consist of round bars having a thread at one end and a square tang at the other end to allow for easy screwing. Furthermore, the threaded length may be interrupted to allow bi-cortical fixation. The special shape of the threaded extremity makes the screws self-tapping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 tests of the Sintea Biotech Traumafix System with Schanz Screw demonstrate that the device is safe and effective for its intended use.
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.
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
031154
page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS Sintea Biotech Traumafix System with Schanz Screw
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k) premarket notification is in accordance with 21 CFR 807.87 and the SMDA.
-
- Submitter of 510(k)
JUN 2 4 2003
- Submitter of 510(k)
Marianne Grunwaldt Regulatory Affairs Specialist Sintea Biotech, Inc. 407 Lincoln Road Ste 10L Miami Beach, FL 33139
Telephone: (305) 673-6226 Facsimile: (305) 673-3312
-
- Name of Device
- 2.1 Trade / Proprietary Name
- Sintea Biotech Traumafix System with Schanz Screw
- 2.2 Common / Usual Name Fixation Pins
- 2.3 Classification Name Smooth or threaded bone fixation fastener (21 CFR 888.3040)
-
- Applicant / Manufacturer Sintea Biotech, Srl. Via Aquileia 33/H Baranzate Milano, Italy
Telephone: 011-39-02-38204222 Facsimile: 011-39-02-38204230
-
- Reason for Submitting the 510(k)
Sintea Biotech, Inc. intends to commercially distribute a modified version of its previously 510(k)-cleared Traumafix external fixation system. Sintea Biotech wishes to distribute the Traumafix system with an additional Schanz screw component.
- Reason for Submitting the 510(k)
-
- Device Description
Schanz's screws are components of the Sintea Traumafix (TFX) system and were developed for external fixation according to Ilizarov's principle to treat severe articular fractures, pseudo-arthrosis and limb lengthening. The purpose of the TFX system is to obtain a safe, non-rigid fixation, to stimulate bone re-growth. The function of the Schanz's screws is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct. The Schanz's screws
- Device Description
1
K031154
page 2 of 2
are available in three different diameters (4.0, 5.0, 6.0 mm) and three different lengths (120, 150, 180 mm). They consist of round bars having a thread at one end and a square tang at the other end to allow for easy screwing. Furthermore, the threaded length may be interrupted to allow bi-cortical fixation. The special shape of the threaded extremity makes the screws self-tapping.
Mechanical tests of the Sintea Biotech Traumafix System with Schanz Screw demonstrate that the device is safe and effective for its intended use.
-
- Predicate Device Identification and Statement of Technological Comparison
The Sintea Biotech Traumafix System (K022065, Decision Date 08/06/2002) was found to be substantially equivalent to referenced predicate device(s). This new 510(k) submission seeks to add a Schanz Screw component to the approved system. Other marketed external fixation systems that are similar to the Traumafix System incorporate screw components into their design. One such system, Howmedica Osteonics Corp.'s Apex Fixation Pins (K011136, Decision Date 05/04/2001, and K861766, Decision Date 07/08/1986) is the predicate device for this submission. The Sintea Biotech Traumafix System's Screw and Howmedica Osteonics Corp.'s Apex Fixation Pins are similar in that:
- Predicate Device Identification and Statement of Technological Comparison
-
the devices have the same intended use and indications for use ●
-
the screw components are made of the same materials ●
-
the external portion of the devices is made of the same material ●
-
the mode of fixation of the devices is identical ●
-
the devices have similar form, function, components, instruments, geometry, ● features and packaging
-
the devices have the same labeling and are both sold non-sterile with sterilization ● required prior to use.
In summary, the use of OSR-based process controls, testing standards, material standards and similarities to the predicate device establish that the Sintea Biotech Traumafix System's with Schanz Screw is equivalent to Howmedica Osteonics Corp.'s Apex Fixation Pins and that it is safe and effective for its intended use.
7. Intended Use
The Intended Use of the Sintea Biotech Traumafix (TFX) System is to obtain a safe, nonrigid fixation, to stimulate bone re-growth. The function of the Schanz Screw is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct.
8. Indications for Use
The Sintea Biotech Schanz Screw is indicated for use in the external fixation of bone.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines representing the feathers. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2003
Ms. Marianne Grunwaldt Regulatory Affairs Specialist Sintea Biotech, Inc. 407 Lincoln Road, Suite 10L Miami Beach, FL 33139
Re: K031154
Trade/Device Name: Sintea Biotech Schanz Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: April 10, 2003 Received: May 28, 2003
Dear Ms. Grunwaldt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Sincerely yours,
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
JUN 2 4 2003
of l Page
510(k) Number (if known): K0.31154
Sintea Biotech Schanz Screw
Device Name:
Indications For Use:
.
The Sintea Biotech external fixation screw is indicated for use in the external fixation of bone.
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Mark A. Melkus
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Number K031154