(69 days)
Synthes Craniofacial 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 Craniofacial Plate and Screw System consist of plates 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.
I am sorry, but based on the provided document, there is no information about the acceptance criteria and a study proving the device meets those criteria.
This document is a 510(k) summary for the Synthes (USA) Craniofacial Plate and Screw System. It primarily focuses on demonstrating substantial equivalence to predicate devices, the intended use, and the regulatory classification.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number of experts, adjudication methods, or ground truth for a study.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Sample size or ground truth establishment for a training set.
Therefore, I cannot fulfill your request for this specific information based on the text provided.
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510(k) Summary 3.0
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| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 |
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| Device Name: | Synthes (USA) Craniofacial Plate and Screw System |
| Classification: | Class II, 21 CFR §872.4760Bone plate |
| Class II, 21 CFR §872.4880Intraosseous fixation screw or wire | |
| Predicate Device: | Synthes Midfacial SystemSynthes Orbital Mesh Plates F/Synthes Midfacial SystemSynthes Maxillofacial Titanium Micro SetSynthes Cranial PlatesSynthes 1.5 mm Self-tapping cortex screws |
| Device Description: | Synthes Craniofacial Plate and Screw System consist of plates andmeshes that come in a variety of shapes and sizes to meet theanatomical needs of the patient. This system is designed for usewith 1.8 mm screws and 2.1 mm emergency screws. The screwswill be used with Synthes 1.8 mm hexagonal screwdriver blades.System components are manufactured in either titanium or titaniumalloy and are intended for single use only. |
| Intended Use: | Synthes Craniofacial 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 SynthesCraniofacial Plate and Screw System is substantially equivalent toother legally marketed devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2005
Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K050608
Trade/Device Name: Synthes (USA) Craniofacial Plate and Screw Systems Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZL Dated: March 9, 2005 Received: March 10, 2005
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 (111), and 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 Eederal 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/industry/support/index.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):
Device Name:
Indications:
Kosopor
Synthes (USA) Craniofacial Plate and Screw System
Synthes Craniofacial 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.
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)
Susan Russe
15000
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number.__
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§ 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.