(79 days)
Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Synthes Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
The provided document is a 510(k) summary for the Synthes (USA) Neuro Plate and Screw System and a letter from the FDA determining substantial equivalence. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it's a medical device clearance submission, not a performance study report.
The content within the provided text focuses on:
- Device Identification: Product name, sponsor, classification, predicate devices.
- Device Description: Components, materials, intended use.
- Regulatory Information: Substantial equivalence determination by FDA.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details, as these are not present in the provided text.
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NOV 1 8 2004
3.0 510(k) Summary
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 | |
|---|---|---|
| Device Name: | Synthes (USA) Neuro Plate and Screw System | |
| Classification: | Class II, 21 CFR §872.4760Bone plate | |
| Class II, 21 CFR §882.5250Burr hole cover | ||
| Class II, 21 CFR §872.4880Intraosseous fixation screw or wire | ||
| Predicate Device: | Synthes Midfacial SystemSynthes Maxillofacial Titanium Micro SetSynthes 1.5 mm Self-tapping cortex screws | |
| Device Description: | Synthes Neuro Plate and Screw System consists of plates, burr holecovers, and meshes that come in a variety of shapes and sizes tomeet the anatomical needs of the patient. This system is designedfor use with 1.8 mm screws and 2.1 mm emergency screws. Thescrews will be used with Synthes 1.8 mm hexagonal screwdriverblades. System components are manufactured in either titanium ortitanium alloy and are intended for single use only. | |
| Intended Use: | Synthes Neuro Plate and Screw System is intended for use inselective trauma of the midface and craniofacial skeleton;craniofacial surgery; reconstructive procedures; and selectiveorthognathic surgery of the maxilla and chin. | |
| SubstantialEquivalence: | Documentation is provided which demonstrates that the SynthesNeuro Plate and Screw System is substantially equivalent to otherlegally marketed devices. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli. Pennsylvania 19301
Re: K042365
Trade/Device Name: Synthes (USA) Neuro Plate and Screw System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 30, 2004 Received: August 31, 2004
Dear Ms. Musgnung:
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.
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Page 2 - Ms. Musgnung
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.
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) 276-0115. 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,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K042365 |
|---|---|
| Device Name: | Synthes (USA) Neuro Plate and Screw System |
| Indications: | Synthes Neuro Plate and Screw System is intended for use inselective trauma of the midface and craniofacial skeleton;craniofacial surgery; reconstructive procedures; and selectiveorthognathic surgery of the maxilla and chin. |
Prescription Use X (Per 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)
Kari Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
000004
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.