(25 days)
The Synthes Cranial Plates are intended for use in selective trauma of the midface and Craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Synthes burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.3 mm (1.7 mm emergency) or 1.5 mm (2.0 mm emergency) self-tapping bone screws.
The provided text is related to the 510(k) summary for Synthes Cranial Plates as submitted to the FDA in 2004. This document primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies and acceptance criteria for a new medical device technology, especially one involving AI or diagnostic capabilities.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or ground truth establishment.
The document states:
- "Comparative information presented supports substantial equivalence."
- The device is a "Bone Plate" (21 CFR 872.4760).
- The "Predicate Devices" are "Synthes Cranial Plates," indicating a comparison to their own existing devices.
This suggests that the approval was based on demonstrating that the new Synthes Cranial Plates are similar enough to previously approved Synthes Cranial Plates, rather than extensive new performance studies against specific acceptance criteria like those expected for a diagnostic or AI-driven device. Device effectiveness for such products is often based on material properties, design specifications, and manufacturing processes, which are not detailed in this summary.
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510(k) Summary
3.0
NOV 2 3 3 2004
Page ________ of ____ of __1
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Synthes Cranial Plates |
| Classification: | 21 CFR 882.5250: Cover, Burr Hole |
| Predicate Devices: | Synthes Cranial Plates |
| Device Description: | The Synthes burr hole covers come in various sizes toaccommodate various fracture and osteotomy sites, have a lowplate/screw head profile and use existing (previously cleared) 1.3mm (1.7 mm emergency) or 1.5 mm (2.0 mm emergency) self-tapping bone screws. |
| Intended Use: | The Synthes Cranial Plates are intended for use in selective traumaof the midface and craniofacial skeleton; craniofacial surgery;reconstructive procedures; and selective orthognathic surgery ofthe maxilla and chin. |
| Substantial Equivalence: | Comparative information presented supports substantial equivalence. |
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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 2 3 2004
Ms. Lisa M. Boyle Regulatory Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K042987
Trade/Device Name: Synthes (USA) Cranial Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, GXR Dated: October 28, 2004 Received: October 29, 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 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 (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-Ling, 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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Page 1 of l
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) Cranial Plates
Indications for Use:
The Synthes Cranial Plates are intended for use in selective trauma of the midface and I no bynnitos Craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Prescription Use X (Per 21 CFR 801.109) 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)
Suna Rmn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042987
§ 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.