(79 days)
The Gamma3 Target Devices are intended for use with the Trochanteric Nail or Long Length Gamma3 Nail. The Gamma3 and T2 Recon Distal Targeting Devices are intended for use with the Long Length Gamma3 Nail and T2 Recon Nail System. The Trochanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail indication may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures. The T2 Recon Nail System indications include fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
This Traditional 510(k) submission is being supplied to the US FDA to address modifications made to the Gamma3 Target Device and addition of a new Distal Targeting Device to the Gamma3 (K043431) and T2 Recon Nail Systems (K102992) as well as the inclusion of the existing target devices in the Gamma3 and T2 Recon Nail Systems.
Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the study that proves the device meets them:
Core Finding: This 510(k) pertains to a medical device accessory (targeting devices for intramedullary nails), and as stated in the document, clinical testing was not required. The "study" largely consists of non-clinical, bench-top testing and engineering evaluations. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study details) are not applicable in a clinical context.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as tested) | Study Details / Not Applicable (N/A) |
|---|---|---|
| Conditioning | Performed (details not explicitly stated in summary) | Non-clinical laboratory testing. The summary indicates "Conditioning" was performed, implying it met internal thresholds for material integrity or preparation. |
| Targeting Accuracy | Performed (details not explicitly stated in summary) | Non-clinical laboratory testing and engineering evaluations. This likely involved bench-top measurements to ensure the targeting devices guide the surgeon to the correct location within acceptable tolerances for the procedure. Specific numerical acceptable tolerances or reported accuracy are not provided in the summary. |
| Stiffness | Performed (details not explicitly stated in summary) | Non-clinical laboratory testing and engineering evaluations. This would ensure the targeting device maintains its structural integrity and precision during use and does not unduly flex or deform. Specific numerical acceptable tolerances or reported stiffness values are not provided in the summary. |
| Accommodation for 480mm Nails in Distal Targeting Device | Engineering Evaluations completed. The implication is that the design physically accommodates these nails as intended. | Engineering Evaluation. This would verify physical fit and functionality with longer nails without explicit numerical performance metrics in this summary. |
| Overall Substantial Equivalence | Demonstrated that the subject target devices are substantially equivalent to devices currently cleared for marketing. | Conclusion of the 510(k) process based on non-clinical testing and comparison to predicate devices. This is the overarching acceptance criterion for a 510(k). |
Detailed Breakdown of Study Information:
-
A table of acceptance criteria and the reported device performance:
- See table above. The detailed acceptance criteria, including specific numerical thresholds for accuracy and stiffness, are not explicitly stated in this 510(k) summary. The summary only lists the types of tests performed, implying they met internal or standard criteria for substantial equivalence.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable (N/A) for clinical test set, as no clinical testing was performed. For non-clinical (bench-top) testing, the sample sizes are not specified in the summary.
- Data Provenance: Not applicable for clinical data. Non-clinical testing would have been conducted by Stryker Trauma AG or a contracted lab.
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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):
- Number of Experts: N/A, as no clinical testing was performed requiring expert ground truth in a diagnostic or clinical outcome context. For engineering evaluations, the "experts" would be the engineers performing the tests and evaluations.
- Qualifications of Experts: N/A for clinical experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: N/A, as no clinical testing was performed requiring adjudication of clinical data.
-
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:
- MRMC Study: No, an MRMC study was not done. This device is a mechanical targeting accessory, not an AI-powered diagnostic tool, and no clinical comparative effectiveness study was performed or required.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: N/A. This device is a mechanical accessory; it does not have an "algorithm" in the sense of AI or image processing. Its performance is inherent to its mechanical design and function, used with a human surgeon.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: N/A for clinical types. For non-clinical testing (accuracy, stiffness), the "ground truth" would be established by engineering specifications, validated measurement tools, and physical standards.
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The sample size for the training set:
- Training Set Sample Size: N/A. This is a mechanical device, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Training Set Ground Truth: N/A. There is no training set for this type of device.
Summary Conclusion from the Document:
The 510(k) summary clearly states: "Clinical testing was not required for this submission."
Therefore, the demonstration of substantial equivalence for the Gamma3 and T2 Recon Target Devices relies entirely on:
- Comparison of intended use, materials, and performance characteristics to predicate devices (K043431 Gamma3 Nail System and K102992 T2 Recon Nail System).
- Non-clinical laboratory testing (Conditioning, Targeting Accuracy, Stiffness).
- Engineering Evaluations (Accomodation for 480mm Nails in Distal Targeting Device).
The "study" proving the device meets acceptance criteria is the sum of these non-clinical tests and evaluations, which determined that the modified and new components were substantially equivalent to existing, cleared devices and did not alter the fundamental technology or safety/effectiveness.
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510(k) Summary
Gamma3 and T2 Recon Target Devices Proprietary Name: Common Name: Intramedullary Fixation Rod Classification Name and Reference: Intramedullary Fixation Rod 21 CFR §888.3020 Regulatory Class: Class II Product Codes: 87HSB: Rod, Fixation, Intramedullary and Accessory Estela Celi, Regulatory Affairs Specialist For Information contact: Stryker Trauma AG Bohnackerweg 1
Date Prepared:
November 2, 2012
Phone: (201) 831-6461 Fax: (201) 831-3461
CH-2545 Selzach Switzerland
Description
This Traditional 510(k) submission is being supplied to the US FDA to address modifications made to the Gamma3 Target Device and addition of a new Distal Targeting Device to the Gamma3 (K043431) and T2 Recon Nail Systems (K102992) as well as the inclusion of the existing target devices in the Gamma3 and T2 Recon Nail Systems.
Intended Use
The Gamma3 Target Devices do not alter the intended use of the predicate Gamma3 Nail System as cleared in K043431. The indications for use for the subject device is provided below.
The Distal Targeting Devices do not alter the intended use of the predicate Gamma3 and T2 Recon Nail Systems as cleared in K043431 and K102992, respectively. The indications for use for the subject devices are provided below.
JAN 2 3 2013
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Indications
The line extension to the T2 Recon Nail System and Gamma3 Nail System does not alter the indications for use of the predicate system as cleared in its' respective premarket notifications.
The Gamma3 Target Devices are intended for use with the Trochanteric Nail or Long Length Gamma3 Nail.
The Gamma3 and T2 Recon Distal Targeting Devices are intended for use with the Long Length Gamma3 Nail and T2 Recon Nail System. '
Gamma3 Nail System
The Trochanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail inidcation may include fractures resulsting from trauma, nonunion, pathological fractures, impending pathological fractures, turnor resections and revision procedures.
T2 Recon Nail System
The T2 Recon Nail System indications include fixation of subtrochanteric. intertrochanteric, ipsilateral neck/shaft, communited femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Summary of Technologies
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following predicate devices and that the target devices as an accessory to the Gamma3 and T2 Recon Nail System does not alter the technology.
Non-Clinical Testing
Non-clinical laboratory testing and engineering evaluations were performed on the target devices to determine substantial equivalence. Testing and evaluations demonstrated that the subject target devices are substantially equivalent to devices currently cleared for marketing.
The following testing was performed:
- Conditioning
- Targeting Accuracy and Stiffness ●
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Engineering Evaluations were completed for the following:
- Accomodation for 480mm Nails in Distal Targeting Device ◆
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The Gamma3 Target Devices and the Gamma3 and T2 Recon Distal Targeting Devices are substantially equivalent to the predicate devices identified in this premarket notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 23, 2013
Stryker Trauma AG % Howmedica Osteonics Corporation Ms. Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430
Re: K123401
Trade/Device Name: Gamma3 and T2 Recon Target Devices Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 2, 2012 Received: November 28, 2012
Dear Ms. Celi:
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 Or ic Fat 607); acomig (21 CFR 803); good manufacturing practice requirements as set
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Page 2 -- Ms. Estela Celi
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123401
Device Name: Gamma3 and T2 Recon Target Devices
The Gamma3 Target Devices are intended for use with the Trochanteric Nail or Long Length Gamma3 Nail.
The Gamma3 and T2 Recon Distal Targeting Devices are intended for use with the Long Length Gamma3 Nail and T2 Recon Nail System.
Gamma3 Nail System
The Trochanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor mesections, while the Long Length Gamma3 Nail inidcation may include fractures resulsting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, turnor resections and revision procedures.
T2 Recon Nail System
T2 Recon Nail System indications include fixation of subtrochanteric, The intertrochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, microonameric, 'ipshatera' neesult of pathological disease, and temporary stabilization femoral namen of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 2013.01.18 11:16:42 Anton E. Dmitriev, PhD Division of Orthopedic Devices -05'00'
35
§ 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.