(19 days)
The Synthes Low Profile Neuro 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.
The Synthes 1.6 mm 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) 1.6 mm or 1.9 mm emergency self-tapping & self-drilling screws.
This 510(k) premarket notification for the "Synthes Low Profile Neuro System" does not include any acceptance criteria or details of a study that proves the device meets such criteria.
The document is a clearance letter from the FDA (Form 510(k)) indicating that the device has been found substantially equivalent to a previously marketed predicate device. This type of submission primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed device, often through comparative information rather than new performance studies with pre-defined acceptance criteria.
Therefore, I cannot populate the requested table or provide answers to the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth. These elements are typically found in detailed design validation reports or clinical study summaries, which are not part of this 510(k) summary.
Key takeaway from the provided document:
- Substantial Equivalence: The FDA's clearance is based on the finding that the Synthes Low Profile Neuro System is substantially equivalent to the predicate device (also the Synthes Low Profile Neuro System, implying perhaps an update or modification rather than a completely new design) for the stated indications for use.
- No new performance data presented: This specific document does not describe new performance testing with acceptance criteria or a study designed to prove the device meets those criteria.
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510(k) Summary
3.0
:
NOV 17 2004
Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Synthes Low Profile Neuro System |
| Classification: | 21 CFR 882.5250: Cover, Burr Hole |
| Predicate Devices: | Synthes Low Profile Neuro System |
| Device Description: | The Synthes 1.6 mm burr hole covers come in various sizes toaccommodate various fracture and osteotomy sites, have a lowplate/screw head profile and use existing (previously cleared) 1.6mm or 1.9 mm emergency self-tapping & self-drilling screws. |
| Intended Use: | The Synthes Low Profile Neuro 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: | Comparative information presented supports substantialequivalence. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2004
Ms. Lisa Boyle Regulatory Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K042986
Trade/Device Name: Synthes (USA) Low Profile Neuro System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr hole cover Regulatory Class: II Product Code: GXR, HRS 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 we nave reviewed your bectorn o re(s) presses is substantially equivalent (for the indications relerenced above and nave decembers and a marketed predicate devices marketed in interstate for use stated in the encrosure) to regard to the Medical Device Amendments, or 10 commerce provision to May 20, 1976, the enaounce with the provisions of the Federal Food, Drug. devices that have been recidisention in acceraapproval of a premarket approval application (PMA). allo Cosmetic Act (1101) that do novice, subject to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classified (see above) and existing major regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the over concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I DTT of ibstantes over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any it call 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 CI IC Far 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality by systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Lisa Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yours over finding of substantial equivalence of your device to a legally promative headler 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 ir you usen of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisoraliding of Yelerenes to pur responsibilities under the Act from the Division of Small other general informational 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 A. Milkeum
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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2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) Low Profile Neuro System
Indications for Use:
The Synthes Cranial Plates are intended for use in selective trauma of the midface and The Synthes Cranial Plates are intended for use in sersen of 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)
Mark A. Mullens
Same Division of General, Restorative, and Neurological Devices
510(k) Number K04298
0004
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).