(15 days)
The intended use of the modified Long Length Gamma® Nail is identical to that of the predicate Long Length Gamma® 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 intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.
The existing Long Length Gamma® Nail is an intramedually rod intended to be used in the 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. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The design modification involves changing the radius of curvature in the A-P plane. The modified device will allow the surgeon greater intraoperative flexibility in treating a variety of femoral The modified Long Length Gamma® Nails are substantially equivalent to the fractures. existing design of Long Length Gamma® Nails, which were cleared for marketing via the The materials used in the manufacture of the modified device are identical to 510(k) process. those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product.
This document is a Special 510(k) Summary for a device modification, not a study report detailing acceptance criteria and performance data from a clinical or analytical study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.
The document explicitly states: "This Special 510(k) submission is intended to address a design modification to the predicate Long Length Gamma® Nail." and "The modified Long Length Gamma® Nails are substantially equivalent to the existing design of Long Length Gamma® Nails, which were cleared for marketing via the 510(k) process. The materials used in the manufacture of the modified device are identical to those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product."
This indicates that the submission is based on substantial equivalence to a previously cleared device, meaning a comprehensive new study with defined acceptance criteria for device performance was likely not required or performed for this specific modification. Instead, the focus is on demonstrating that the design modification of the radius of curvature in the A-P plane does not alter the essential safety and effectiveness of the device as previously established by its predicate.
Here's a breakdown of the information that can be extracted or inferred, and what is absent:
-
A table of acceptance criteria and the reported device performance
- Not present in the document. This submission is for a design modification and relies on substantial equivalence. It does not detail specific performance metrics or acceptance criteria for the modified device in a clinical or analytical study.
-
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not present. No specific test set or study data is presented for the modified device. The submission focuses on the modification itself and its equivalence to a predicate.
-
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)
- Not applicable/Not present. No test set or ground truth establishment relevant to an AI/diagnostic device is discussed.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not present.
-
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
- Not applicable/Not present. This is hardware (intramedullary nail), not an AI/diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not present. This is hardware, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not present.
-
The sample size for the training set
- Not applicable/Not present. No AI algorithm is being described.
-
How the ground truth for the training set was established
- Not applicable/Not present. No AI algorithm is being described.
Summary of what the document does provide:
- Device: Modified Long Length Gamma® Nail
- Modification: Change in the radius of curvature in the A-P plane.
- Purpose of Modification: To allow the surgeon greater intraoperative flexibility in treating a variety of femoral fractures.
- Basis for Clearance: Substantial equivalence to the existing Long Length Gamma® Nail.
- Materials: Identical to the predicate device.
- Intended Use: Identical to the predicate device (fixation of femoral fractures from the base of the femoral neck to ~10 cm proximal to the intercondylar notch; fracture types include basilar neck, intertrochanteric, subtrochanteric, and femoral shaft fractures; for trauma, non-unions, mal-unions, pathological fractures, and impending pathological fractures).
- Regulatory Information:
- Proprietary Name: Long Length Gamma® Nail
- Common Name: Intramedullary Rod
- Classification Name and Reference: 21 CFR 888.3020 Intramedullary Fixation Rod
- Proposed Regulatory Class: Class II
- Device Product Code: 87 HSB
- 510(k) Number: K993670
- Date of Submission: October 29, 1999
- Date of Clearance: November 16, 1999
In conclusion, this document is a regulatory notice of substantial equivalence for a hardware modification, not a study report demonstrating meeting acceptance criteria through quantitative performance data.
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Image /page/0/Picture/2 description: The image contains a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'K993670'. The characters are written in a simple, clear style, with consistent stroke thickness. The image is in black and white, with the characters standing out against the background.
Nov | 6 1999
Special 510(k) Summary - Device Modification Summary of Safety and Effectiveness for the Modified Long Length Gamma® Nail
| Proprietary Name: | Long Length Gamma® Nail |
|---|---|
| Common Name : | Intramedullary Rod |
| Classification Name and Reference : | 21 CFR 888.3020 Intramedullary Fixation Rod |
| Proposed Regulatory Class : | Class II |
| Device Product Code : | 87 HSB |
| For Information contact: | Nancy Rieder |
| Regulatory Affairs | |
| Howmedica Osteonics Corp. | |
| 359 Veterans Boulevard | |
| Rutherford, N.J. 07070 | |
| (201) 507-7956 | |
| Fax: (201) 507-6870 |
This Special 510(k) submission is intended to address a design modification to the predicate Long Length Gamma® Nail. The existing Long Length Gamma® Nail is an intramedually rod intended to be used in the 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. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The design modification involves changing the radius of curvature in the A-P plane. The modified device will allow the surgeon greater intraoperative flexibility in treating a variety of femoral The modified Long Length Gamma® Nails are substantially equivalent to the fractures. existing design of Long Length Gamma® Nails, which were cleared for marketing via the The materials used in the manufacture of the modified device are identical to 510(k) process. those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product.
' Historically, Howmedica Osteonics has intended this product to be used in fracture management as a result of trauma, non-unions, mal-unions, pathological fractures, and impending pathological fractures.
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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 stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Ms. Margaret Crowe Howmedica Osteonics 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
K993670 Re: Long Length Gamma® Nail Trade Name: Regulatory Class: II Product Code: HSB October 29, 1999 Dated: Received: November 1, 1999
Dear Ms. Crowe:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Margaret Crowe
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993670
Long length Gamma® Nail Device Name:
Indications For Use:
The intended use of the modified Long Length Gamma® Nail is identical to that of the predicate Long Length Gamma® 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 intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, 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)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(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.