(24 days)
The subject and predicate devices are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty
- Nonunions and malunions
The T2 (Greater Trochanter Nail) is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 GTN may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The subject T2 GTN, like the predicate Osteo IC R/A Femoral Nail System known as the T2 Nail System, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. The subject and predicate devices are intended to assist with internal fracture fixation with minimal soft tissue irriation. This device is utilized as an aid to healing, not as a subsistute for normal intact bone and tissue.
This is a 510(k) premarket notification for a medical device (T2 Greater Trochanter Nail), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like MRMC studies, standalone performance, training data, and ground truth establishment) is not applicable.
The document describes a submission for a modified intramedullary nail and focuses on demonstrating substantial equivalence to a predicate device. The "study" mentioned refers to mechanical testing to ensure the modified device has comparable properties to the predicate, not a clinical study involving human or AI performance.
Here's a breakdown of why each requested point cannot be answered with the provided text, along with what information is provided:
1. A table of acceptance criteria and the reported device performance
- Applicability: Not applicable for an AI/ML device.
- Information Provided: The document states, "Testing demonstrated comparable mechanical properties of the subject T2 GTN Femoral Nail System to the predicate T2 Nail in K010801." The types of tests conducted are listed: Functionality test, influence of cannulated compression screws on Fatigue Strength, 4-Point Bending Test, Dynamic Testing of Nail Strength, End Cap Testing, Dynamic Fatigue Strength of T2 GTN Nails, End Product Test of fully threaded screw and shaft screw, and Screw Insertion Test. Specific numerical acceptance criteria and performance data are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Applicability: Not applicable for an AI/ML device. This refers to mechanical testing of the device itself, not data used for an algorithm.
- Information Provided: No sample sizes for mechanical testing are provided in this summary. Data provenance for such tests (e.g., origin country) is generally irrelevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Applicability: Not applicable. There is no "ground truth" to be established by experts for a mechanical device in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Applicability: Not applicable. No adjudication is relevant for mechanical testing.
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
- Applicability: Not applicable. This device is a physical medical implant, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicability: Not applicable. This device is a physical medical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Applicability: Not applicable. No "ground truth" in this sense is involved. The "truth" for mechanical testing is adherence to engineering standards and comparison against the predicate device's established mechanical properties.
8. The sample size for the training set
- Applicability: Not applicable. There is no AI training set for this device.
9. How the ground truth for the training set was established
- Applicability: Not applicable. There is no AI training set for this device.
Summary of Relevant Information from the Provided Text:
- Device: T2 Greater Trochanter Nail (GTN)
- Modification: The nail entry point is in the greater trochanter for T2 GTN, whereas for the predicate T2 Femoral Nail A/R, it is in the piriformis fossa.
- Predicate Device: T2 Femoral Nail A/R (cleared under K010801)
- Demonstration of Equivalence: "Testing demonstrated comparable mechanical properties of the subject T2 GTN Femoral Nail System to the predicate T2 Nail in K010801."
- Tests Conducted: Functionality test, influence of cannulated compression screws on Fatigue Strength, 4-Point Bending Test, Dynamic Testing of Nail Strength, End Cap Testing, Dynamic Fatigue Strength of T2 GTN Nails, End Product Test of fully threaded screw and shaft screw, Screw Insertion Test.
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K 101438
Special 510(k) Summary of Safety and Effectiveness
'JUN 1 7 2010
| Proprietary Name: | T2 Greater Trochanter Nail (GTN) |
|---|---|
| Common Name: | Intramedullary Nail, Femoral Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod21 CFR §888.3020 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | HSB: Rod, Fixation, Intramedullary and Accessories |
| For Information contact: | Melissa Matarese, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5116 Fax: (201) 831-4116 |
Date Prepared:
June 17, 2010
Predicate Device Identification
The T2 (Greater Trochanter Nail) is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 GTN may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.
Description of Device Modification
The predicate device is the T2 Femnoral Nail A/R which was cleared for sale under K010801 in April 2001. The intended use and indications are the same. The difference between T2 GTN and the predicate is that the nail entry point is in the grater trochater for T2 GTN, whereas for the T2 Femoral Nail A/R it is in the piriformisfossa.
Intended Use
The subject T2 GTN, like the predicate Osteo IC R/A Femoral Nail System known as the T2 Nail System, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. The subject and predicate devices are intended to assist with internal fracture fixation with minimal soft tissue irriation. This device is utilized as an aid to healing, not as a subsistute for normal intact bone and tissue.
Indications for Use
The subject and predicate devices are indicated for long bone fracture fixation, specifically
femoral fracture fixation, which may include the following:
- p. 1 of 2
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- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy ●
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Ipsilateral femur fractures ●
- Fractures proximal to a total knee arthoplasty .
- Nonunions and malunions .
Statement of Substantial Equivalence:
Testing demonstrated comparable mechanical properties of the subject T2 GTN Femoral Nail System to the predicate T2 Nail in K010801. The following tests were conducted: Functionality test and influence of cannulated complression screws on the Fatigue Strength, 4-Point Bending Test, Dynamic Testing of Nail Strength, End Cap Testing, and Dynamic Fatigue Strength of T2 GTN Nails, End Product Test of fully threaded screw and shaft screw, Screw Insertion Test.
. p. 2 of 2
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. c/o Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
Re: K101438
Trade/Device Name: T2 Greater Trochanteric Nail (GTN) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: May 19, 2010 Received: May 24, 2010
JUN 1 7 2010
Dear Ms. Matarese:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Melissa A. Matarese
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Buelun
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K |(143
Device Name: T2 GTN
Indications For Use:
The subject and predicate devices are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- ତ Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy 9
- Pathologic fractures, impending pathologic fractures, and tumor resections �
- Ipsilateral femur fractures o
- Fractures proximal to a total knee arthroplasty ග්රී
- Nonunions and malunions 0
Prescription Use - X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter_Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Omtte for mxm
(Division Sign-Off)
ivision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101438
§ 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.