The Tyber Medical Pin and Wire System is indicated for use in fixation of small bone fragment(s) of hand or foot), bone reconstructions, and as guide pins for inplants or implantation through the skin so that traction may be applied to the skeletal system.

Device Description

The Tyber Medical Pin and Wire System is designed for hand, foot, and small bone fragment repairs or fusions. Uses include fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants. It is manufactured from stainless steel, and Titanium Alloy. They are available in a variety of lengths, and tips to accommodate different anatomic sizes of patients. The devices are provided non-sterile, single use. Non-sterile devices are intended to be sterilized at the point of use. The pins and wires are made from stainless steel (316L per ASTM F-138) and titanium alloy (Ti-Al-4V ELI per ASTM F136).

AI/ML Overview

This FDA 510(k) summary provides limited information regarding formal acceptance criteria or a detailed study proving the device meets specific performance criteria. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a standalone performance study with predefined acceptance criteria.

However, based on the provided text, here's an analysis of what can be inferred and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or quantitative performance metrics are listed in the document. The submission is based on substantial equivalence, implying that the device's performance is considered acceptable if it is comparable to the predicate devices.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Indications for Use Equivalence	Similar indications for use to predicate devices	"The indications for use are similar in both the subject and predicate devices."
Technological Characteristics Equivalence	Similar design, material, chemical composition, and principle of operation to predicate devices	"The subject device has similar technological characteristics (design, material, chemical composition and principle of operation) as the predicate device identified above."
Safety and Effectiveness Equivalence	No new or different questions raised regarding safety and effectiveness when compared to the predicate devices	"The Tyber Medical Pin and Wires has been determined to be safe and effective as the predicatedevice and no new or different quereraised regarding the safety and effectiveness when compared to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. No "test set" in the context of an AI/algorithm performance study is mentioned as no clinical or performance study was conducted.
Data Provenance: Not applicable. No data or test sets were used for a performance study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No ground truth establishment by experts is mentioned as no performance study was conducted requiring such a process.

4. Adjudication Method:

Not applicable. No adjudication method is mentioned as no performance study was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was preformed."

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done. The document explicitly states: "No clinical testing was preformed." The device described is a physical medical device (Pin and Wire System), not an algorithm or AI.

7. Type of Ground Truth Used:

Not applicable. As no performance study was conducted, no ground truth was established for the purpose of validating the device's performance in a study setting. The "ground truth" in this context is the performance and safety profile of the predicate devices against which the new device is compared for substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI/algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device is a physical medical device, not an AI/algorithm that requires a training set and corresponding ground truth.

Summary of the Study (or lack thereof) to Prove Acceptance Criteria:

The provided document describes a 510(k) Premarket Notification for the Tyber Medical Pin and Wire System. The "study" proving the device meets "acceptance criteria" is based on the principle of Substantial Equivalence (SE) to legally marketed predicate devices (K083490 - BioPro K-Wire and K100736 - SMT Schilling Metalltechnik GmbH).

The core of the submission's argument is:

Indications for Use: The new device has similar indications for use as the predicate devices.
Technological Characteristics: The new device shares similar design, material (stainless steel, titanium alloy), chemical composition, and principle of operation with the predicate devices.
Manufacturing and Sterilization: The new device is manufactured and intended to be sterilized using the same materials and processes as the predicate devices (though the devices are provided non-sterile for point-of-use sterilization).

Based on these similarities, the FDA has determined that the Tyber Medical Pin and Wire System is substantially equivalent to the predicate devices. This determination implies that the new device is considered "safe and effective" without the need for new clinical or non-clinical performance studies, as no new or different questions regarding safety and effectiveness were raised compared to the predicate devices.

Key takeaway: This document is not about a performance study of an AI/algorithm. It's a regulatory submission for a physical medical device, demonstrating substantial equivalence to pre-existing, legally marketed devices. Therefore, many of the requested categories (like sample sizes, expert qualifications, and ground truth for AI performance) are not applicable to this type of submission.

Summary

{0}------------------------------------------------

July 6, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Tyber Medical, LLC Nicole Merlini Regulatory Affairs Specialist 83 South Commerce Way Suite 310 Bethlehem, Pennsylvania 18017

Re: K231339

Trade/Device Name: Tyber Medical Pin and Wire System (various) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: May 8, 2023 Received: May 8, 2023

Dear Nicole Merlini:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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 (QS) 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 medical devices and radiation-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,

Colin O'neill -S

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K231339

Device Name

Tyber Medical Pin and Wire System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K231339 - Page 1 of 2

Prepared on: 2023-05-08

Contact Details	21 CFR 807.92(a)(1)
Applicant Name	Tyber Medical, LLC
Applicant Address	83 South Commerce Way Suite 310 Bethlehem PA 18017 United States
Applicant Contact Telephone	484-274-4471
Applicant Contact	Mrs. Nicole Merlini
Applicant Contact Email	nmerlini@tybermed.com
Device Name	21 CFR 807.92(a)(2)
Device Trade Name	Tyber Medical Pin and Wire System (various)
Common Name	Smooth or threaded metallic bone fixation fastener
Classification Name	Pin, Fixation, Smooth
Regulation Number	888.3040
Product Code	HTY
Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K083490	BioPro K-Wire	HTY
K100736	SMT Schilling Metalltechnik GmbH	HTY

510(k) Summary

Device Description Summary

Intended Use/Indications for Use

Indications for Use Comparison

The indications for use are similar in both the subject and predicate devices.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(4)

21 CFR 807.92(a)(5)

{4}------------------------------------------------

Technological Comparison

21 CFR 807.92(a)(6)

The subject device has similar technological characteristics (design, material, chemical composition and principle of operation) as the predicate device identified above.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The Tyber Medical Pins and Wire have the same indications for use as the predicate device. The subject devices use the same operating principle, incorporate the same basic design, and are manufactured and sterilized using the same materials and processes as the predicate devices. As such, the Tyber Medical Pin and Wires has been determined to be safe and effective as the predicatedevice and no new or different quereraised regarding the safety and effectiveness when compared to the predicate device. Therefore, the devices have been found to be substantially equivalent.

No clinical testing was preformed.

The Tyber Medical Pin and Wire System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.