(77 days)
Not Found
No
The summary describes a mechanical trauma screw and focuses on its MR compatibility, with no mention of AI or ML.
No.
The device is a trauma screw for bone reconstruction and fixation purposes, not a therapeutic device designed to cure, treat, or prevent disease through non-mechanical means. Its function is primarily structural.
No
The device is a trauma screw used for bone reconstruction and fixation. Its description and intended use do not involve diagnosing conditions; rather, it is a therapeutic/fixation device.
No
The device description clearly identifies the device as a "General trauma screw," which is a physical implantable medical device, not software. The submission is focused on adding MR Conditional information to the labeling of this physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "General trauma screw for compression and fixation of bone." Its intended uses are for "bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones." These are all surgical procedures performed directly on the body, not tests on samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
The information provided focuses on the mechanical function of the screw and its safety in an MRI environment, which are relevant to an implantable surgical device, not an IVD.
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical testing is provided to support the conditional safety of Tyber Medical Trauma Screw in the MR environment. The following MRI safety evaluations that were performed (in accordance with ASTM 2503-13) are listed below along with the associated 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 when exposed to the MR environment under specific MR conditions of use, the Tyber Medical Trauma Screw raises no new questions of safety or effectiveness.
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 — K153575
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.
Not Found
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
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
1
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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3
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 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 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 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 — K153575 |
| Device Description | 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. | |
| Intended Use | A trauma screw designed to apply compression and fixation |
| between two adjacent segments of cortical and/or cancellous | |
| bone. | |
| Indications for Use | The Tyber Medical Trauma Screws are 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 | 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 Testing
Summary | Non-clinical testing is provided to support the conditional safety
of Tyber Medical Trauma Screw in the MR environment. The
following MRI safety evaluations that were performed (in
accordance with ASTM 2503-13) are listed below along with the
associated 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 when
exposed to the MR environment under specific MR conditions
of use, the Tyber Medical Trauma Screw raises no new
questions of safety or effectiveness. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | n/a |
| 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. |
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|