(79 days)
No
The summary describes mechanical targeting devices for orthopedic nails and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device described, the Gamma3 Target Devices, is an accessory intended for use with specific nail systems (Trochanteric Nail, Long Length Gamma3 Nail, T2 Recon Nail System) to assist in their proper placement for fixation of various femoral fractures and related conditions. The nail systems themselves are therapeutic devices, but the target devices are instruments that aid in the surgical procedure, rather than directly treating the medical condition.
No
The device is described as a "Target Device" intended for use with "Trochanteric Nail or Long Length Gamma3 Nail" and "T2 Recon Nail System." Its purpose is to aid in the fixation of various fractures of the femur. The "Summary of Performance Studies" indicates non-clinical laboratory testing for "Targeting Accuracy and Stiffness," which are mechanical properties, not diagnostic capabilities. There is no mention of the device being used to identify, measure, or analyze a medical condition.
No
The device description explicitly states it is a "Target Device" and describes non-clinical laboratory testing and engineering evaluations related to physical properties like "Targeting Accuracy" and "Stiffness," which are characteristic of hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the fixation of bone fractures in the femur. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description refers to "Target Devices" used with "Nail Systems," which are implants used in orthopedic surgery.
- Anatomical Site: The anatomical sites mentioned are parts of the femur, which are internal structures of the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device described is an orthopedic surgical instrument/implant system used for treating bone fractures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
87HSB
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck to the supracondylar regions of the femur.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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173
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'
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