(73 days)
No
The 510(k) summary describes a mechanical trauma screw and its intended uses. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical testing (static torsion) and engineering analysis, not algorithmic performance.
No.
The device is a trauma screw used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, which implies a structural and fixation role rather than a therapeutic one that would actively treat a condition. While it aids in the healing process, its primary function is mechanical support.
No.
The device is a surgical implant (trauma screw) used for bone reconstruction and fixation, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical screw made of titanium, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones." These are all surgical procedures performed directly on the patient's body.
- Device Description: The description details a "General trauma screw for compression and fixation of bone." This is a physical implant used in surgery.
- 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 samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
General trauma screw for compression and fixation of bone. This submission adds a headed screw and snap off option as well as an optional washer to the previously cleared headless trauma screw with and without previously cleared modified surface treatment. The screws will be provided sterile and non-sterile in both solid and cannulated form, made of from titanium (with and without Modified Surface treatment) and
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
Prescription Use
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)
The following tests were performed to demonstrate that the Tyber Medical Trauma Screw is substantially equivalent to the predicate device (K133842).
Static Torsion Test per ASTM F543 The results of these studies showed that the Tyber Medical Trauma Screw met the acceptance criteria. Additional engineering analysis of the new device and the predicate was also performed to demonstrate substantial equivalence.
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.
Tyber Medical Trauma Screw – K133842
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.
Tyber Medical MST Trauma Screw – K153180
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
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 stylized eagle with three heads facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
Tyber Medical LLC Mark Schenk Director of Quality Assurance and Regulatory Affairs 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960
Re: K153575
Trade/Device Name: Tyber Medical Trauma Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 22, 2015 Received: December 29, 2015
Dear Mr. Schenk:
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/Resourcesfor You/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 -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153575
Device Name Tyber Medical Trauma Screw
Indications for Use (Describe)
The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) Summary
as required by section 807.92(c).
Tyber Medical Trauma Screw
K 153575
| Submitted | 2/25/16 |
|---|---|
| Submitter: | Tyber Medical LLC |
| 89 Headquarters Plaza North, #1464 | |
| Morristown, New Jersey 07960 | |
| Contact Person | Mark F Schenk |
| Director of QA/RA | |
| Phone: (610) 507-8255 Fax: (866) 889-9914 | |
| Email: mschenk@tybermed.com | |
| Trade Name | Tyber Medical Trauma Screw |
| Common Name | Bone Compression Screw |
| Device Class | Class II |
| Regulation Name | |
| and Number | Smooth or threaded metallic bone fixation fastener |
| 21 CFR 888.3040 | |
| Classification Panel: | Orthopedic |
| Product Code | HWC |
| Predicate Devices | Tyber Medical Trauma Screw – K133842 |
| Reference Device for | |
| surface treatment | Tyber Medical MST Trauma Screw – K153180 |
| Device Description | General trauma screw for compression and fixation of bone. |
| This submission adds a headed screw and snap off option as | |
| well as an optional washer to the previously cleared headless | |
| trauma screw with and without previously cleared modified | |
| surface treatment. The screws will be provided sterile and | |
| non-sterile in both solid and cannulated form, made of from | |
| titanium (with and without Modified Surface treatment) and | |
| Intended Use | A trauma screw designed to apply compression and fixation |
| between two adjacent segments of cortical and/or calcaneus | |
| bone. | |
| Indications for Use | The Tyber Medical Trauma Screw is indicated for use in bone |
| reconstruction, osteotomy, arthrodesis, joint fusion, fracture | |
| repair, and fracture fixation of bones appropriate for the size of | |
| the device. Screws are intended for single use only. |
4
| Statement of
Technological
Comparison and
Fundamental Scientific
Technology | Tyber Medical Trauma Screw and its predicate device have
the same indications for use, similar design, same materials,
technology principles of operation and test results. |
| ----------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Nonclinical Testing Summary | The following tests were performed to demonstrate that the Tyber
Medical Trauma Screw is substantially equivalent to the predicate
device (K133842).
Static Torsion Test per ASTM F543 The results of these studies showed that the Tyber Medical Trauma
Screw met the acceptance criteria.
Additional engineering analysis of the new device and the predicate
was also performed to demonstrate substantial equivalence. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | n/a |
| Conclusion | Tyber Medical Trauma Screw and its predicate device have the same indications for use, similar design, and test results. Both devices are manufactured using materials with a long history of use in orthopedic implants. Therefore, the subject device was shown to be substantially equivalent to the predicate device. |