The Tornier Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

Device Description

The Tornier Humeral Nail and Tornier Long Humeral Nail include intramedullary nails and screws. The Tornier Humeral Nail is a straight, cannulated intramedullary nail available in 9mm proximal diameter with a tapered 7mm distal diameter with nail lengths of 210mm, 230mm, 250mm, and 270mm long and a tapered 8mm distal diameter with nail lengths of 130mm, 210mm. 230mm. 250mm, and 270mm long. Both distal diameter sizes are available in right and left configurations. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm cannulated screws. The proximal end of the nail also contains a cannulated polyethylene insert with screw holes aligned with those of the nail. This insert is intended to help prevent the proximal screws from backing out. The distal end of the 130mm nails incorporate two or three screw holes for distal stabilization using 4.3mm screws. The nails and screws are manufactured from anodized titanium alloy. The polyethylene insert is manufactured from ultrahigh molecular weight polyethylene (UHMWPE).

AI/ML Overview

This document is a 510(k) premarket notification for the Tornier Humeral Nail and Tornier Long Humeral Nail. It seeks to establish substantial equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance:

The document does not provide specific acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or other quantitative measures typically associated with AI/ML device evaluations. The submission focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing for MR compatibility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No test set for an AI/ML component is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no AI/ML component requiring ground truth establishment is described.

4. Adjudication method for the test set:

Not applicable, as no AI/ML component requiring a test set or adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable, as this submission does not involve an AI assist feature for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this submission does not involve a standalone algorithm for performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable, as no ground truth is required for the evaluation presented in this document.

8. The sample size for the training set:

Not applicable, as this submission does not involve an AI/ML component with a training set.

9. How the ground truth for the training set was established:

Not applicable, as this submission does not involve an AI/ML component requiring ground truth for a training set.

Summary of Device Evaluation:

The Tornier Humeral Nail and Tornier Long Humeral Nail were evaluated for Magnetic Resonance (MR) compatibility through non-clinical testing. The submission explicitly states:

"The Tornier Humeral Nail and Tornier Long Humeral Nail has been evaluated in a Magnetic Resonance Environment through non-clinical testing as outlined in the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff', dated October 10, 2023."
"This testing was conducted to characterize the compatibility of the Tornier Humeral Nail System in the MR environment."
"No clinical studies were performed."

The conclusion is that "The Tornier Humeral Nail System does not raise different questions of safety or effectiveness. Based upon a comparison of the intended use, materials, summary of technological characteristics, and non-clinical evaluation, the subject Tornier Humeral Nail and Tornier Long Humeral Nail is considered substantially equivalent to the current Tornier Humeral Nail and Tornier Humeral Long Nail (cleared as Aequalis Humeral Nail System on K133376)."

This document focuses on regulatory clearance for a medical device (intramedullary fixation rod) by demonstrating substantial equivalence to a predicate device, specifically addressing MR compatibility. It does not involve the evaluation of an AI/ML component or associated criteria like performance metrics for an AI system.

Summary

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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Tornier, Inc. Lisa Stahl Principal Specialist, Regulatory Affairs 10801 Nesbitt Ave South Bloomington, Minnesota 55437

Re: K230352

Trade/Device Name: Tornier Humeral Nail and Tornier Long Humeral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 21, 2023 Received: September 22, 2023

Dear Lisa Stahl:

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 (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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

October 31, 2023

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Farzana Sharmin -S s
S s - S

Farzana Sharmin, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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) K230352

Device Name

Tornier Humeral Nail and Tornier Long Humeral Nail

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)

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Image /page/3/Picture/0 description: The image shows the word "TORNIER" in a blue serif font, followed by a blue hexagon containing a stylized letter "T". The word "TORNIER" is in all capital letters and is the most prominent element in the image. The hexagon with the "T" is located to the right of the word and serves as a logo or symbol associated with the brand.

Date Prepared: October 31, 2023

Administrative Information

Name:	Tornier, Inc.
Address:	10801 Nesbitt Avenue SouthBloomington, MN 55437United States of America
Contact Person:	Lisa Stahl
Title:	Principal Specialist, Regulatory Affairs
Phone:	612-849-9970
Email:	lisa.stahl@stryker.com

Device Information

Name of Device:	Tornier Humeral Nail and Tornier Long Humeral Nail
Common Name(s):	Intramedullary Fixation Rod
Regulatory Class:	II
Regulation:	21 CFR 888.3020
Product Codes:	HSB

Predicate Device Information

Predicate:	Aequalis® Humeral Nail System
510(k) Number:	K133376

Device Description

Indications for Use

The Tornier Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not

Tornier, Inc. Tornier Humeral Nail and Tornier Long Humeral Nail

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Image /page/4/Picture/0 description: The image shows the text 'K230352-Page 2 of 2'. The text appears to be a document identifier and page number. The document identifier is K230352, and the page number is 2 of 2, indicating that this is the second page of a two-page document. The text is written in a clear, sans-serif font.

Image /page/4/Picture/1 description: The image shows the word "TORNIER" in large, blue, serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside. The letter "T" is also blue and has a unique design.

limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

Comparison of Technological Characteristics with the Predicate Device

There have been no changes to the technological characteristics of the Tornier Humeral Nail and Tornier Long Humeral Nail as a result of the revision to the labeling to add MR conditional language. The subject devices have the same design and are manufactured from the same materials as the predicate devices.

Non-clinical Performance Testing

The Tornier Humeral Nail and Tornier Long Humeral Nail has been evaluated in a Magnetic Resonance Environment through non-clinical testing as outlined in the FDA guidance document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff", dated October 10, 2023. This testing was conducted to characterize the compatibility of the Tornier Humeral Nail System in the MR environment.

Clinical Testing

No clinical studies were performed.

Conclusion

The Tornier Humeral Nail System does not raise different questions of safety or effectiveness. Based upon a comparison of the intended use, materials, summary of technological characteristics, and non-clinical evaluation, the subject Tornier Humeral Nail and Tornier Long Humeral Nail is considered substantially equivalent to the current Tornier Humeral Nail and Tornier Humeral Long Nail (cleared as Aequalis Humeral Nail System on K133376).

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.