(77 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. The purpose of this submission is to add MR Conditional information to the device labeling for K153575. The intended use and technological characteristics of the device remain unchanged.
This document describes the 510(k) premarket notification for the Tyber Medical Trauma Screw (K192975). This submission's primary purpose is to add MR Conditional information to the device labeling for a previously cleared device (K153575). Therefore, the study described focuses on demonstrating the device's safety in an MRI environment, rather than its general clinical effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM Standards) | Reported Device Performance |
|---|---|
| Magnetic Resonance (MR) Safety (ASTM 2503-13 general requirement) | Demonstrated conditional safety of Tyber Medical Trauma Screw in the MR environment under specific MR conditions of use. |
| Magnetically induced displacement force (ASTM F2052-15) | Tests performed, results indicate conditional safety. (Specific performance values are not provided in this summary, only that testing was done and supports conditional safety.) |
| Magnetically induced torque (ASTM F2213-17) | Tests performed, results indicate conditional safety. |
| MR image artifact (ASTM F2119-07) | Tests performed, results indicate conditional safety. |
| RF-induced heating (ASTM F2182-11a) | Tests performed, results indicate conditional safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of devices tested for each non-clinical evaluation. It generally refers to "the Tyber Medical Trauma Screw" being exposed to the MR environment.
- Data Provenance: The data provenance is from non-clinical testing (bench testing) performed to evaluate the MRI safety of the device. There is no information about the country of origin, but it can be assumed to be conducted by or for Tyber Medical LLC, based in Bethlehem, Pennsylvania, USA. The study is prospective in nature, as it involves active testing to generate new safety data for the device in the MR environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable as the evaluations were non-clinical (bench testing) focusing on physical properties and interactions with an MRI scanner. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The ground truth was based on adherence to the specified ASTM testing standards and objective measurements.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluations were non-clinical (bench testing). Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (trauma screw) and its MRI compatibility, not an AI-powered diagnostic tool. The document states "Clinical Test Summary: n/a".
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this study was established by objective measurements and adherence to international recognized ASTM standards for MRI safety testing. These standards define the parameters and methods for evaluating magnetic field interactions, torque, heating, and artifact generation.
8. The Sample Size for the Training Set
- This information is not applicable. There was no "training set" as this was non-clinical bench testing of a physical device, not an AI model requiring training data.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable as there was no training set.
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January 9, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Tyber Medical LLC Jessica Stigliano Regulatory Affairs Specialist 83 South Commerce Way Bethlehem, Pennsylvania 18017
Re: K192975
Trade/Device Name: Tyber Medical Trauma Screws 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 Acting Assistant Director DHT6A: Division of 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) K192975
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
K192975
| Submitted | 10/23/2019 |
|---|---|
| Submitter: | Tyber Medical LLC |
| 83 South Commerce Way, Suite 310 | |
| Bethlehem, PA 18017 | |
| Contact Person | Primary Contact:Jessica StiglianoRegulatory Affairs SpecialistPhone: 866-761-0933 (ext. 424) Fax: (866) 889-9914Email: jstigliano@tybermed.com |
| Secondary Contact:Mark Schenk | |
| V.P. Regulatory Affairs | |
| 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 — K153575 |
| 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 K153575. 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 | 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. |
|---|---|
| Clinical Test Summary | n/a |
| Conclusion | The purpose of this submission is to add MR Conditionalinformation to the device labeling. Tyber Medical TraumaScrew and its predicate device have the same indications foruse, similar design, and technology principles of operation. |
|---|---|
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.