(72 days)
This Alta® Plating System line extension includes plates that are intended to provided temporary stabilization of intra- and extra-articular fractures of the distal femur. Types of fractures include simple and comminuted fractures of the femoral condyles, and selected femoral supracondylar fractures. The plates are used in conjunction with cortical and cancellous bone screws. During healing, the plate provides a buttress for the protection of the fracture fragments. Once healing is complete, the plate will generally be removed.
The Alta® Modular Trauma System includes various types of plates for internal fixation of fractures. This Alta plate line extension is a modification of the currently marketed Alta Distal Fracture Plates and Channel Plates cleared for under various 510(k) notifications.
The provided text is a 510(k) summary for the Alta® Plating System Line Extension. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain any information regarding specific acceptance criteria, device performance metrics, study designs (such as sample sizes, data provenance, expert ground truth, MRMC studies, or standalone performance), or training set details.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study that proves the device meets acceptance criteria, as this information is not present in the provided document.
The document focuses on the regulatory submission process and the determination of substantial equivalence, which is a different type of evaluation than a performance study with acceptance criteria.
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972479
Sept. 11, 1997
510(k) Summary
Alta® Plating System Proprietary Name: Bone Plate Common Name: Single/Multiple Component Metallic Bone Fixation Classification Name & Appliances and Accessories (21 CFR 888.3030) Reference: Proposed Regulatory Class: II 87HRS Device Product Code:
For information contact:
Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870
The Alta® Modular Trauma System includes various types of plates for internal fixation of fractures. This Alta plate line extension is a modification of the currently marketed Alta Distal Fracture Plates and Channel Plates cleared for under various 510(k) notifications.
These plates are intended to provided temporary stabilization of intra- and extra-articular fractures of the distal femur. Types of fractures include simple and comminuted fractures of the femoral condyles, and selected femoral supracondylar fractures. The plates are used in conjunction with cortical and cancellous bone screws. During healing, the plate provides a buttress for the protection of the fracture fragments. Once healing is complete, the plate will generally be removed.
The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to Howmedica's Alta® Distal Fracture Plates and the Alta® Channel Plates.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | | 1997
Ms. Vivian Kelly Manager, Regulatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K972479 Re : Alta® Plate Line Extension Requlatory Class: II Product Code: HRS Dated: June 30, 1997 Received: July 1, 1997
Dear Ms. Kelly:
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 The general controls provisions of the Act of the Act. include reguirements 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. ਸ 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Ms. Vivian Kelly
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 regulation (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 regulation 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,
M. Witten, Ph.D., M.D. Celi Director Division of General 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):
Device Name: ALTA® Plate Line Extension
Indications for Use:
This Alta® Plating System line extension includes plates that are intended to provided Trills Atlas Fiading Gystern into extra-articular fractures of the distal lemple of the contractions. to fractures include simple and comminuted fractures of the femoral condyles, und selected femoral supracondylar fractures. The plates are used in conjunction with selected remoral adplacerial. During healing, the plate provides a buttress for oon the can confection of the fragments. Once healing is complete, the plate will generally be removed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)
Division Sign-Off
Division of General Restorative Devices 510(k) Number
18
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.