(63 days)
The Synthes (USA) 2.4mm LCP Wrist Plate is intended for colles' and distal radius fractures with dorsal angulation of the distal fragment.
The 2.4 mm LCP Wrist Plate is a pre-contoured plate which is positioned dorsolaterally on the distal radius and affixed to the second metacarpal to span the wrist. A low profile construct is maintained by incorporating a 2.6 mm thickness, and a width of 7.5 mm. The plate has combination and DCU holes which accept 2.4 mm cortex and 2.4 mm locking screws. The plate is made out of Stainless Steel with tapered ends and is 170 mm in length.
The provided text is a 510(k) summary for the Synthes (USA) 2.4 mm LCP Wrist Plate. This document describes a medical device, its intended use, and its substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices in the US.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory filing, not a clinical or performance study report.
Therefore, I cannot provide the requested information, specifically:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- MRMC comparative effectiveness study: Not present. This device is a bone fixation plate, so an MRMC study related to AI assistance would not be applicable.
- Standalone performance study: Not present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
The document discusses the device's name, classification, predicate device, description, and intended use for regulatory purposes, concluding with an FDA letter finding substantial equivalence. There are no performance metrics or study details to extract for the questions asked, as these are typically found in separate performance reports or clinical data submissions, not in a 510(k) summary itself for this type of device.
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MAY - 7 2004
040588
page 1 of 1
Summary of Safety and Effectiveness Information - 510(k) Summary 3.0
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | 2.4 mm LCP Wrist Plate |
| CLASSIFICATION: | Class II, § 888.3030 – Single / multiple component metallic bone fixationappliance and accessories |
| PREDICATE DEVICE: | • Biomet® Colles Fracture Plate |
| DEVICE DESCRIPTION: | The 2.4 mm LCP Wrist Plate is a pre-contoured plate which is positioneddorsolaterally on the distal radius and affixed to the second metacarpal tospan the wrist. A low profile construct is maintained by incorporating a 2.6mm thickness, and a width of 7.5 mm. The plate has combination and DCUholes which accept 2.4 mm cortex and 2.4 mm locking screws. The plate ismade out of Stainless Steel with tapered ends and is 170 mm in length. |
| INTENDED USE: | The Synthes (USA) 2.4mm LCP Wrist Plate is intended for Colles' anddistal radius fractures with dorsal angulation of the distal fragment. |
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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 a stylized eagle emblem with three wavy lines representing the feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 7 2004
Lisa M. Boyle Regulatory Associate Synthes USA 1690 Russel Road P.O. Box 1766 Paoli. Pennsylvania 19301
Re: K040588
Trade/Device Name: Synthes (USA) 2.4 mm LCP Wrist 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: March 04, 2004 Received: March 05, 2004
Dear Ms. Boyle:
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 cither 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 - Lisa M. Boyle
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 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/dsma/dsmamain.html
Sincerely yours,
Mark N. Millkann
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 Statement 2.0
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
| 510(k) Number (if known): | K040588 |
|---|---|
| Device Name: | Synthes (USA) 2.4 mm LCP Wrist Plate |
| Indications/Contraindications: |
The Synthes (USA) 2.4mm LCP Wrist Plate is intended for colles' and distal radius fractures with dorsal angulation of the distal fragment.
Division Sign-Off
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K040588 |
|---|---|
| --------------- | --------- |
| Prescription Use X (Per 21 CFR 801.109) | OR | Over-The-Counter Use __________ |
|---|---|---|
| ------------------------------------------------ | ---- | --------------------------------- |
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
:
Confidential
§ 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.