(51 days)
The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
Not Found
The provided document is a 510(k) summary for a medical device called the "TriMed Ulnar Osteotomy Plate." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove effectiveness or meeting specific performance acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The 510(k) process for this device relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.
Here's why the requested information is absent:
- Acceptance Criteria & Device Performance: This document does not define specific performance metrics or acceptance criteria for the TriMed Ulnar Osteotomy Plate because its approval is based on substantial equivalence to existing devices (K952766 Rayhack Osteotomy System and K030310 Synthes 3.5/4.5 mm. LCP Metaphyseal Plates).
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone): No clinical trials or performance studies are described in this 510(k) summary. The submission relies on a comparison of the new device's characteristics to those of the predicate devices.
- Ground Truth: Since no performance study is detailed, there's no mention of how "ground truth" would be established.
- Training Set Information: This is relevant for machine learning or AI-driven devices, which this medical plate is not.
In summary, the provided K043263 document describes a traditional medical device submission through the 510(k) pathway, which primarily assesses substantial equivalence and does not typically include the detailed clinical or performance study data you've requested.
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JAN 1 4 2005
510(K) Summary of Safety and Effectivenss TRIMED, INC. ULNAR OSTEOTOMY PLATE
| Submitted By: | TriMed, Inc.25768 Parada DriveValencia, CA 91355(800)633-7221 |
|---|---|
| Registration #: | 2031009 |
| Prepared By/Contact Person: | Kelli AndersonPhone: (661) 312-7150Fax: (661) 254-8485 |
| Proprietary Name: | TriMed Ulnar Osteotomy Plate |
| Classification: | Class II: Bone Fixation PlatesSection 888.3030 |
| Classification Code: | HRS |
| Summary Preparation Date: | November 22, 2004 |
Intended Use:
The TriMed Unlar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
Substantial Equivalence:
K952766 Rayhack Osteotomy System K030310 Synthes 3.5/4.5 mm. LCP Metaphyseal Plates
Lilli Anderson
Kelli Anderson Regulatory Affairs Specialist
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 that resembles an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2005
TriMed, Inc. C/o Kelli Anderson Regulatory Affairs Specialist 25768 Parada Drive Valencia, California 91355
Re: K043263
Trade Name: TriMed Ulnar Osteotomy Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 22, 2004 Received: November 24, 2004
Dear Ms. Anderson:
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.
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Page 2 – Ms. Kelli Anderson
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket 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/industry/support/index.html.
Sincerely vours,
Mark A. Milkenon
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K043263
Device Name: TriMed Ulnar Osteotomy Plate
Indications For Use: The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ____ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Nelsen
Division of General, Restorative, and Neurological Devices
043263
Page 1 of _1
510(k) Number_
§ 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.