(15 days)
Aesculap's Scalpfix clip system is indicated for use in temporary hemostasis of the scalp edge.
Aesculap's scalp clip gun (FF012R) is a hand held manual instrument. It is used in conjunction with Aesculap's scalp clip (FF013P) to insert sterile plastic scalp clips at the margin of scalp wounds during operations on the cranium. The gun consists of a handle, trigger, magazine lock, and a maqazine suspension pin.
The scalp clips are used for temporary hemostasis of the opened scalp. It has proven useful to use plastic clips to ligate the scalp during trepanation or large exposures of relatively long duration, thereby avoiding bleeding at the wound margin. Aescular scalp clips are intended for single use only. They may not be resterilized. The scalp clips are packaged as 10 scalp clips per magazine in a box of 20 magazines.
This K017219 premarket notification for the Scalpfix Clip System does not include specific acceptance criteria or a study that proves the device meets such criteria.
The document states:
- "No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices."
- "The new Scalptix conforms to applicable ASTM and ISO standards." However, it does not specify which ASTM and ISO standards, nor does it provide data demonstrating compliance with them.
Therefore, the requested information elements cannot be extracted from the provided text for this specific device. The submission relies on substantial equivalence to predicate devices rather than independent performance studies with defined acceptance criteria.
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JUL 31 2000 K017219
Scalpfix Clip System
Page 1 of 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
SCALPFIX CLIP SYSTEM
July 13, 2001
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| CONTACT: | Lisa M. Millington, Regulatory Associate800-258-1946 (phone)610-231-3713 (fax)lisa.millington@aesculap.com (email) |
| TRADE NAME: | Scalpfix Clip System |
| COMMON NAME: | Scalp Clip and Applier |
| DEVICE CLASS: | SCALP CLIP - CLASS IISCALP CLIP GUN - CLASS I - EXEMPT |
| PRODUCT CODE: | Scalp Clip - 84 HBOScalp Clip Gun - 79 GDO |
| CLASSIFICATION: | Scalp Clip - 882.4150Scalp Clip Gun - 878.4800 |
| REVIEW PANEL: | Neurology |
INTENDED USE
Aesculap's Scalpfix clip system is indicated for use in temporary hemostasis of the scalp edge.
DEVICE DESCRIPTION
Aesculap's scalp clip gun (FF012R) is a hand held manual instrument. It is used in conjunction with Aesculap's scalp clip (FF013P) to insert sterile plastic scalp clips at the margin of scalp wounds during operations on the cranium. The gun consists of a handle, trigger, magazine lock, and a maqazine suspension pin.
The scalp clips are used for temporary hemostasis of the opened scalp. It has proven useful to use plastic clips to ligate the scalp during trepanation or large exposures of relatively long duration, thereby avoiding bleeding at the wound margin. Aescular scalp clips are intended for single use only. They may not be resterilized. The scalp clips are packaged as 10 scalp clips per magazine in a box of 20 magazines.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices. The new Scalptix conforms to applicable ASTM and ISO standards.
SUBSTANTIAL EQUIVALENCE
The new ScalpFix Clip System described in this premarket notification is substantially equivalent to those in Aesculap's current Caspar Scalp Clip System (subjected to K890443) and the following other predicate devices:
- . Acra-Cut (500-102 & 500-105) (K944311)
- Codman & Shurtleff Disposable Scalp Clip / Applier (K905433) .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be interconnected. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2001
Ms. Lisa M. Millington Regulatory Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K012219
KUTZEY
Trade/Device Name: Scalpfix Clip System Regulation Number: 882.4150, 878.4800 Regulatory Class: II Product Code: HBO, GDO Dated: July 12, 2001 Received: July 16, 2001
Dear Ms. Millington:
We have reviewed your Section 510(k) notification of intent to market the device referenced
in the indication in the includes in the photostially equivalent (for the indicat We have reviewed your Section 210(ck) notification of the the indications for use
above and we have determined the devices markets in interstate commerce above and we have determined the device is subsate devices marketed in interstate commerce
stated in the enclosure) to legally marketed predicate devices marketed in intersta stated in the enclosure) to legally marketed predical Device Amendments, or to devices that
prior to May 28, 1976, the enactment date of the Medical Drug, and prior to May 28, 1976, the enactment use or the Frederal Food, Drug, and
have been reclassified in accordance with the provisions of the Federal contr have been reclassified in accordance with the provisions or are as a controls
Cosmetic Act (Act). You may, theresisions of the Actively to the generals for Cosmetic Act (Act). You may, therefore, market use active, bactions nequirements for annual
provisions of the Act. The general controls provisions of the Activitions agains provisions of the Act. The general controls provisions of the Actual Co- p
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
n insideration in the makes at the work additional controls. Existing major reg If your device is classified (see abyect to such additional controls. Existing major regulations
(Premarket Approval), it may be subject to such additions Title 21, Parts 8 (Premarket Approval), it may be subject to such administrations, Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, affecting your device can be found in the occept compliance with the Current Good
A substantially equivalent determination assumes compliance with System Regulation ( A substantially equivalent determination assumes in System Regulation (QS) for
Manufacturing Practice requirements, as set forth in the Quality (OS) for Manufacturing Practice requirements, as set voltim and that, through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that, through periodic of Medical Devices: General regulation (ZTCA) will verify such assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify and assumptions. FDA may p inspections, the Food and Drug Administration in President in addition, FDA may publish
comply with the GMP regulation may result in regulatory action. Please note: this comply with the GMP regulation may result in the Federal Register. Please note: this further announcements concerning your device in the reast affect any obligation you might
response to your premarket notification submission ander the Flectronic Product response to your premarket nother submission devices under the Electronic Product
have under sections 531 through 542 of the Act for devices under the Electronic Product have under sections 551 through 942-01-24
Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Lisa M. Millington
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 noutication. The I Dr I imanig of costion 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 11 you desire specific a in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in the arr questions on the promotion and advertising of your device, (201) 594-4639. Nathlenkery, 10-44639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mformation on your respeat 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 N Millerson
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Scalpfix
Indication for Use:
Aesculap's Scalpfix is indicated for use in temporary hemostasis of the scalp edge.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | or Over-the-Counter Use | ||
|---|---|---|---|
| ------------------ | -- | ------------------------- | -- |
(per 21 CFR 801.109)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K012219 |
|---|---|
| --------------- | --------- |
(Optional Format 3-10-98)
0003
§ 882.4150 Scalp clip.
(a)
Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.(b)
Classification. Class II (performance standards).