(264 days)
No
The device description and intended use focus on the physical components and mechanical function of an intramedullary nail system for fracture stabilization. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus, which is a therapeutic function.
No
The device is an intramedullary nail system intended for the temporary stabilization of humerus fractures, making it a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the device includes intramedullary nails and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus." This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an "intramedullary nail system" made of metal and plastic components. This is a physical implant used to stabilize bone, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
The device is a surgical implant used to treat bone fractures.
N/A
Intended Use / 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 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).
Product codes
HSB
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
(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
2
Indications for Use
510(k) Number (if known) K230352
Device Name
Tornier Humeral Nail and Tornier Long Humeral Nail
Indications for Use (Describe)
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).
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 South |
| Bloomington, MN 55437 | |
| United 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
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).
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/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).