(22 days)
Gamma3 Trochanteric Nail: The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Gamma-Ti and Gamma® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
Long Length Gamma3 Nail: The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
This Special 510(k) submission is a line extension intended to address modifications to the Gamma-Ti Nail System and the Gamma3 Nail System cleared in K013468 and K032244 respectively. The new components in the Gamma3 Nail System include additional sizes of Trochanteric Nails, Long Nails, shorter Lag Screws, additional Cap Screws and additional lengths of Locking Screws. The new components will be fabricated from the same material, titanium alloy, as the components in the predicate nail systems.
The provided text is a 510(k) Summary for a medical device called the "Gamma3 Nail System Line Extension." It details the submission information, device identification, and indications for use. However, it does not contain the specific information required to answer your questions about acceptance criteria and a study proving those criteria are met.
This document is a regulatory submission for a line extension of an existing device, focusing on demonstrating substantial equivalence to predicate devices. It relies on the materials and mechanical properties being comparable, rather than presenting a performance study with acceptance criteria in the way you've outlined.
Here's why the required information isn't present in the provided text:
- Acceptance Criteria and Reported Device Performance (Item 1): The document states, "Testing demonstrates the comparable mechanical properties of the subject Gamma3 Nail System to the predicate devices." It does not provide specific acceptance criteria (e.g., minimum bending strength, fatigue life) or quantified performance results against those criteria. The comparison is qualitative ("comparable").
- Sample Size and Data Provenance (Item 2): Not mentioned. The "testing" likely refers to benchtop mechanical testing, not clinical data or a test set of data points derived from patients.
- Number of Experts and Qualifications (Item 3): Not applicable, as there's no mention of a study involving expert review or ground truth establishment in this context.
- Adjudication Method (Item 4): Not applicable.
- MRMC Comparative Effectiveness Study (Item 5): Not applicable. This is a medical implant, not an AI diagnostic tool requiring human-in-the-loop performance measurement.
- Standalone Performance (Item 6): Not applicable, as this is a physical medical device, not an algorithm.
- Type of Ground Truth (Item 7): Not applicable. The "ground truth" for this device's regulatory approval is its substantial equivalence to predicate devices based on material and mechanical properties, not clinical outcomes or expert consensus on image interpretation.
- Sample Size for Training Set (Item 8): Not applicable. This isn't an AI/ML model.
- Ground Truth for Training Set (Item 9): Not applicable.
In summary, the provided document is a regulatory filing for a medical implant line extension, focusing on demonstrating substantial equivalence through material and mechanical comparability. It does not include the type of performance metrics, study design, and ground truth establishment typically associated with the evaluation of diagnostic software or AI-powered devices.
{0}------------------------------------------------
Special 510(k) Summary of Safety and Effectiveness:
Gamma3 Nail System Line Extension
Submission Information
Devic
| Name and Address of the Sponsor of the 510(k) Submission: | Howmedica Osteonics Corp325 Corporate Dr.Mahwah, NJ 07430 |
|---|---|
| Contact Person: | Vivian KellyRegulatory Affairs Specialist |
| Date of Summary Preparation: | December 23, 2003 |
| Device Identification |
|---|
| ----------------------- |
| Proprietary Name: | Gamma3 Nail System |
|---|---|
| Common Name: | Intramedullary Nail |
This Special 510(k) submission is a line extension intended to address modifications to the Gamma-Ti Nail System and the Gamma3 Nail System cleared in K013468 and K032244 respectively. The new components in the Gamma3 Nail System include additional sizes of Trochanteric Nails, Long Nails, shorter Lag Screws, additional Cap Screws and additional lengths of Locking Screws. The new components will be fabricated from the same material, titanium alloy, as the components in the predicate nail systems.
Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020
The Trochanteric Gamma3 Nails are intended for use in stabilizing various types of intertrochanteric fractures of the femur. The Long Length Gamma3 Nails are intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar ncck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, pathological fractures, and impending pathological fractures.
The material used to manufacture the line extension is identical to that of the predicate. Testing demonstrates the comparable mechanical properties of the subject Gamma3 Nail System to the predicate devices.
2
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a bird or eagle with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K034002
Trade/Device Name: Gamma3 Trochanteric Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 23, 2003 Received: December 24, 2003
Dear Ms. Kelly:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); good manufacturing practice requirements as set 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.
{2}------------------------------------------------
Page 2 - Ms. Vivian Kelly
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark A. Milliman
Celia M. Witten. Ph.D., M.D. Director Division of Gencral, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known): K 034002
Device Name: Gamma 3 Nail System
Indications For Use:
Gamma3 Trochanteric Nail
The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Gamma-Ti and Gamma® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
Long Length Gamma3 Nail
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Monk n Milke
de of Gener retorative
ological I ses
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 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.