(20 days)
The Synthes 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates are 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.
The Synthes 1.3 & 1.5mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile / non-sterile and for single use only.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The text is a 510(k) summary and FDA clearance letter for a medical device (Synthes 1.3 & 1.5mm Contourable Titanium Mesh Plates). This type of document primarily focuses on establishing substantial equivalence to a predicate device, not on specific performance acceptance criteria or detailed study results demonstrating the device meets those criteria.
Therefore, I cannot provide a response to your request as the information is not present in the given document.
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OCT 2 0 2003
Summary of Safety and Effectiveness Information [510 Summary] 3.0
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates |
| CLASSIFICATION: | Class II , 21 CFR 872.4760: Bone Plate |
| PREDICATE DEVICE: | Synthes Midfacial System |
| DEVICE DESCRIPTION: | The Synthes 1.3 & 1.5mm Contourable Ti. Mesh Plates come in a varietyof shapes and sizes to meet the anatomical need of the patient. The platesare sterile / non-sterile and for single use only. |
| INTENDED USE: | The Synthes 1.3 & 1.5mm Contourable Ti. Mesh Plates are intended for usein selective trauma of the midface and craniofacial skeleton; craniofacialsurgery; reconstructive procedures; and selective orthognathic surgery ofthe maxilla and chin. |
| MATERIAL: | CP Titanium |
| SUBSTANTIALEQUIVALENCE: | Documentation is provided which demonstrates that the Synthes 1.3 &1.5mm Contourable Ti. Mesh Plates are substantially equivalent to otherlegally marketed Synthes devices. |
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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 features a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2003
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re: K033121
Trade/Device Name: Synthes (USA) 13 &15mm Contourable Titanium (Ti.) Mesh Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 26, 2003 Received: September 30, 2003
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 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. Boyle
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 (301) 594-4613. 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.
Suse Runne
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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2.0 Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | K033121 |
|---|---|
| Device Name: | Synthes (USA) 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates |
Indications:
19 11:44
The Synthes 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates are 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Susan Rumm
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
Special 510(k) - Device Modifications Synthes (USA) 1.3 & 1.5 mm Contourable Ti. Mesh Plates
§ 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.