(76 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 device. Screws are intended for single use only.
General trauma screw for compression and fixation of bone. The purpose of this submission is to add MR Conditional information to the device labeling for K133842. The intended use and technological characteristics of the device remain unchanged.
The provided text describes a 510(k) premarket notification for the "Tyber Medical Trauma Screw." This document focuses on demonstrating substantial equivalence to a predicate device, specifically to add MR Conditional information to the device labeling.
Based on the information provided, this submission does not involve an AI/ML medical device, and therefore, it does not contain the information requested regarding acceptance criteria and studies for device performance in the context of AI/ML.
The "Acceptance Criteria" and "Study that proves the device meets the acceptance criteria" sections, along with all the detailed points you requested (sample sizes, ground truth establishment, expert adjudication, MRMC studies, etc.), are relevant to AI/ML device submissions, particularly those involving diagnostic or prognostic algorithms that analyze medical images or data.
The provided document is for a traditional medical device (a trauma screw) and outlines non-clinical testing for MR safety and mechanical properties.
Here's why the requested information isn't present in this document:
- Type of Device: The device is a "Tyber Medical Trauma Screw," a physical bone fixation fastener. It's not an AI/ML algorithm.
- Purpose of Submission: The primary purpose of this 510(k) is to add "MR Conditional" information to the device labeling and to compare its mechanical performance (driving torque) to a predicate device.
- Testing Described: The document details non-clinical testing such as:
- MR Safety Testing (in accordance with ASTM 2503-13): Magnetically induced displacement force, magnetically induced torque, MR image artifact, and RF-induced heating.
- Mechanical Testing: Driving Torque per ASTM F543-17 Annex A2.
- Clinical Test Summary: Explicitly states "n/a" (not applicable), confirming no clinical studies were performed or required for this submission.
Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance, ground truth, expert opinions, or MRMC studies from the provided text.
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January 8, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
Tyber Medical LLC Jessica Stigliano Regulatory Affairs Specialist 83 South Commerce Way, Suite 310 Bethlehem, Pennsylvania 18017
Re: K192974
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: November 8, 2019 Received: November 12, 2019
Dear Jessica Stigliano:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6A: Division Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192974
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.
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 Trauma Screw
K192974
| Submitted | 10/23/2019 |
|---|---|
| Submitter: | Tyber Medical LLC |
| 83 South Commerce Way, Suite 310 | |
| Bethlehem, PA 18017 | |
| Contact Person | Primary Contact: |
| Jessica Stigliano | |
| Regulatory Affairs Specialist | |
| Phone: 866-761-0933 (ext. 424) Fax: (866) 889-9914 | |
| Email: jstigliano@tybermed.com | |
| Secondary Contact: | |
| Mark Schenk | |
| V.P. Regulatory | |
| Phone: 610-849-0645 | |
| Email: mschenk@tybermed.com | |
| Trade Name | Tyber Medical Trauma Screw |
| Common Name | Bone Compression Screw |
| Device Class | Class II |
| Classification 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 |
| Device Description | General trauma screw for compression and fixation of bone.The purpose of this submission is to add MR Conditionalinformation to the device labeling for K133842. The intendeduse and technological characteristics of the device remainunchanged. |
| Intended Use | A trauma screw designed to apply compression and fixationbetween two adjacent segments of cortical and/or cancellousbone. |
| Indications for Use | The Tyber Medical Trauma Screws are 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 of | The purpose of this submission is to add MR Conditional |
|---|---|
| Technological | information to the device labeling. Tyber Medical Trauma |
| Comparison and | Screw and its predicate devices have the same indications |
| Fundamental Scientific | for use, similar design, same materials, and technology |
| Technology | principles of operation. |
| Nonclinical TestingSummary | MR Safety Testing |
|---|---|
| Non-clinical testing is provided to support the conditional safetyof Tyber Medical Trauma Screw in the MR environment. Thefollowing MRI safety evaluations that were performed (inaccordance with ASTM 2503-13) are listed below along with theassociated ASTM standard test methods. Magnetically induced displacement force: ASTM F2052-15 Magnetically induced torque: ASTM F2213-17 MR image artifact: ASTM F2119-07 RF-induced heating: ASTM F2182-11a The non-clinical performance data demonstrate that whenexposed to the MR environment under specific MR conditionsof use, the Tyber Medical Trauma Screw raises no newquestions of safety or effectiveness. | |
| Mechanical TestingThe following mechanical testing has been conducted for thesubject device and predicate device: Driving Torque per ASTM F543-17 Annex A2 The driving torque performance of the subject device has beendetermined to be greater than or equivalent to the predicatedevice, and do does not raise any new issues of safety andeffectiveness. | |
| Clinical Test Summary | n/a |
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| Conclusion | The purpose of this submission is to add MR Conditional information to the device labeling. Tyber Medical Trauma Screw and its predicate device have the same indications for use, similar design, and technology principles of operation. |
|---|---|
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
K192974 Page 3 of 3
§ 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.