(49 days)
Synthes Cranial Flap Twist Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.
Synthes Cranial Flap Twist Clamp consists of two clamp discs with a clamp shaft in between the discs. The disc diameters range between 8.0 mm to 20 mm. The Cranial Flap Twist Clamp is MRI safe and is for single use only.
This document is a 510(k) summary for the Synthes Cranial Flap Twist Clamp. It does not contain information about studies proving the device meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. This is typical for Class II devices that demonstrate substantial equivalence to a predicate device rather than providing new clinical study data.
Based on the provided text, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) can be extracted.
The document only states the following:
- Device Name: Synthes Cranial Flap Twist Clamp
- Intended Use: To reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
- Predicate Device: Aesculap's Craniofix Titanium Clamp System
- Classification: Class II
- Safety Information: "The Cranial Flap Twist Clamp is MRI safe and is for single use only."
The FDA's letter (K991860) indicates that the device was found substantially equivalent to legally marketed predicate devices, meaning it does not require new clinical studies to demonstrate safety and effectiveness for its intended use, as its design, materials, and intended use are considered similar enough to an already approved device. Therefore, a clinical trial with specific acceptance criteria and performance metrics would not typically be part of a 510(k) submission for such a device.
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SYNTHES JUL 20 1999
| Attachment VII: | Summary of Safety and Effectiveness Information[510(k) Summary] |
|---|---|
| SUBMITTER | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
| Contact: Sheri L. Musgnung | |
| DEVICE NAME: | Synthes Cranial Flap Twist Clamp |
| COMMON OR USUALNAME | Plate, Cranioplasty, Preformed, Alterable;Fastener, Plate, Cranioplasty |
| DEVICECLASSIFICATION: | Class II, 21 CFR 882.5320 and 882.5360 |
| PREDICATE DEVICE: | Aesculap's Craniofix Titanium Clamp System |
| DESCRIPTION: | Synthes Cranial Flap Twist Clamp consists of two clamp discswith a clamp shaft in between the discs. The disc diametersrange between 8.0 mm to 20 mm. The Cranial Flap Twist Clampis MRI safe and is for single use only. |
| INTENDED USE: | Synthes Cranial Flap Twist Clamp is intended to reattach acranial bone flap to the surrounding Cranium after a craniotomyprocedure. |
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CONFIDENTIAL
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 1999
Ms. Sheri L. Musgnung Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K991860 Trade Name: Synthes Cranial Flap Twist Clamp Regulatory Class: II Product Code: GXN Dated: May 27, 1999 Received: June 1, 1999
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.0
Page l of
510(k) Number (if known): __ K 991860
Synthes Cranial Flap Twist Clamp Device Name:
Indications For Use:
Synthes Cranial Flap Twist Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of General Restorative Devices K99186 510(k) Number
CONFIDENTIAL
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).