(160 days)
The Tyber Medical BioTy® Nanotopography 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. The screw is intended for single use only.
A trauma screw with BioTy® Nanotopography Surface Treatment is designed to apply compression and fixation between two adjacent segments of cortical and/or cancellous bone.
This FDA document is for a medical device called the "Tyber Medical BioTy® Nanotopography Trauma Screw." It's a 510(k) premarket notification, meaning it's seeking to demonstrate substantial equivalence to previously marketed devices, rather than proving novel effectiveness. Therefore, the information provided focuses on non-clinical testing and comparison to predicates, not on clinical trials or AI performance.
Based on the provided text, I cannot answer the questions regarding acceptance criteria and study design for AI devices because:
- This is not an AI/ML device. The document describes a trauma screw with a specific surface treatment (BioTy® Nanotopography), which is a physical medical device, not a software algorithm or an AI system.
- No clinical study to prove AI performance is mentioned. The "Clinical Test Summary" explicitly states "n/a" (not applicable), indicating that no clinical trials were conducted or reported for this submission to evaluate the device's performance in humans. The testing performed was non-clinical (mechanical, invitro, pyrogenicity) to evaluate the physical characteristics and safety of the screw itself and its surface treatment.
- Acceptance criteria for AI performance are not relevant here. The acceptance criteria discussed in the document relate to the physical properties, safety, and substantial equivalence of the trauma screw to predicate devices, not to metrics like sensitivity, specificity, F1-score, or human reader improvement with AI assistance.
Therefore, since the input document does not pertain to an AI device or a clinical study for an AI device, I cannot provide the requested information.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2016
Tyber Medical LLC Mark Schenk Vice President Of Regulatory And Quality 89 Headquarters Plaza North, #1464 Morristown. New Jersey 07960
Re: K161597
Trade/Device Name: Tyber Medical BioTy® Nanotopography 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: October 26, 2016 Received: October 31, 2016
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 Part 801); medical device reporting (reporting of medical devicerelated 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.
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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" (21 CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161597
Device Name
Tyber Medical BioTy® Nanotopography Trauma Screw
Indications for Use (Describe)
The Tyber Medical BioTy® Nanotopography Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screw is intended for single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Summary
as required by section 807.92(c).
Tyber Medical
BioTy® Nanotopography Trauma Screw
K161597
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| Intended Use | A trauma screw with BioTy® Nanotopography Surface Treatment isdesigned to apply compression and fixation between two adjacentsegments of cortical and/or cancellous bone. |
|---|---|
| Indications for Use | The Tyber Medical BioTy® Nanotopography Trauma Screw isindicated for use in bone reconstruction, osteotomy, arthrodesis,joint fusion, fracture repair, and fracture fixation of bonesappropriate for the size of the device. The screw is intended forsingle use only. |
| Statement of | Tyber Medical BioTy® Nanotopography Trauma Screw and its |
|---|---|
| Technological | predicate device have the same as or similar indications for use, |
| Comparison and | design, materials, technology and principles of operation and test |
| Fundamental Scientific | results. |
| Technology |
| Nonclinical TestingSummary | No new mechanical testing in regards to the strength of the implantwas performed for this submission because the devices are identicalto previously cleared devices.The purpose of this submission is to add detail to the description ofthe modified surface treatment. Additional invitro testing andengineering analysis of the surface treatment was performed.Pyrogenicity testing was performed per ST72:2011. |
|---|---|
| Clinical Test Summary | n/a |
| Conclusion | The Tyber Medical BioTy® Nanotopography Trauma Screw and its predicate device have the same indications for use, and the same design, and test results. Both devices are manufactured using materials with a long history of use in orthopedic implants. |
|---|---|
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.