(73 days)
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.
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
The provided document is a 510(k) summary for the Tyber Medical Trauma Screw. It describes the device's characteristics, intended use, and substantial equivalence to a predicate device, but it does not contain information about the acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML medical device.
The document pertains to a physical medical device (trauma screw) and primarily focuses on demonstrating substantial equivalence through non-clinical testing of mechanical properties, specifically static torsion. There is no mention of an algorithm, AI, or machine learning model.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving an AI/ML device meets them based on the provided text. The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are highly specific to AI/ML device evaluations and are not applicable to the content of this 510(k) summary for a trauma screw.
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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
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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
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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 Nameand Number | Smooth or threaded metallic bone fixation fastener21 CFR 888.3040 |
| Classification Panel: | Orthopedic |
| Product Code | HWC |
| Predicate Devices | Tyber Medical Trauma Screw – K133842 |
| Reference Device forsurface 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 aswell as an optional washer to the previously cleared headlesstrauma screw with and without previously cleared modifiedsurface treatment. The screws will be provided sterile andnon-sterile in both solid and cannulated form, made of fromtitanium (with and without Modified Surface treatment) and |
| Intended Use | A trauma screw designed to apply compression and fixationbetween two adjacent segments of cortical and/or calcaneusbone. |
| Indications for Use | The Tyber Medical Trauma Screw is indicated for use in bonereconstruction, osteotomy, arthrodesis, joint fusion, fracturerepair, and fracture fixation of bones appropriate for the size ofthe device. Screws are intended for single use only. |
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| Statement ofTechnologicalComparison andFundamental ScientificTechnology | Tyber Medical Trauma Screw and its predicate device havethe same indications for use, similar design, same materials,technology principles of operation and test results. |
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| ----------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Nonclinical Testing Summary | The following tests were performed to demonstrate that the TyberMedical Trauma Screw is substantially equivalent to the predicatedevice (K133842).Static Torsion Test per ASTM F543 The results of these studies showed that the Tyber Medical TraumaScrew met the acceptance criteria.Additional engineering analysis of the new device and the predicatewas 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. |
§ 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.