AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)

K043041 · Aesculap, Inc. · HCH · Dec 9, 2004 · Neurology

Device Facts

• Record ID: K043041
• Device Name: AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
• Applicant: Aesculap, Inc.
• Product Code: HCH · Neurology
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap T-Bar Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner.

Device Story

Aesculap T-Bar Aneurysm Clips are surgical implants used for temporary or permanent occlusion of cerebral aneurysms. Devices are fenestrated clips with jaws at 90 and 45-degree angles. Used in neurosurgical procedures; applied by surgeons using previously cleared Aesculap aneurysm clip appliers. Clips provide mechanical vessel occlusion to prevent aneurysm rupture or facilitate surgical access. No electronic or software components.

Clinical Evidence

Bench testing only. Biomechanical testing performed per FDA guidance demonstrated substantial equivalence to currently marketed predicate devices.

Technological Characteristics

Materials: Phynox (cobalt alloy) per ISO 5832/7 or Titanium Alloy per ISO 5832/3. Design: Fenestrated clips with 90 and 45-degree jaw angles. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for occlusion of cerebral aneurysms in patients requiring temporary or permanent vessel occlusion during neurosurgical procedures.

Regulatory Classification

Identification

An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.

Submission Summary (Full Text)

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# C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)

DEC - 9 2004

#### Aesculap T-Bar Aneurysm Clips October 2004

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull<br>800-258-1946 x 5072 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | Aesculap T-Bar Aneurysm Clips |
| COMMON NAME: | Aneurysm Clips |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 84 HCH |
| CLASSIFICATION: | 882.5200 - Clip, Aneurysm |
| REVIEW PANEL: | Neurology |

## INDICATIONS FOR USE

The Aesculap T-Bar Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner.

## DEVICE DESCRIPTION

The Aesculap T-Bar Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are made from either Phynox (oobalt alloy) per ISO 5832/7 or Titanium Alloy per ISO 5832/3. The clips are a fennstrated design with the jaws at 90 and 45 degree angles. They are applied with previously cleared Aesculap aneurysm clip appliers.

## PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)" was completed for Aesculap T-Bar Aneurysm Clips. Biomechanical testing results demonstrate the Aesculap T-Bar Aneurysm Clips are substantially equivalent to our current aneurysm clips currently on the market.

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Aesculap T-Bar Aneurysm Clips are substantially equivalent to our currently marketed Aneurysm Clips.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2004

Mr. Matthew M. Hull, RAC Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K043041

Trade/Device Name: Aesculap T-Bar Aneurysm Clips Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: II Product Code: HCH Dated: November 1, 2004 Received: November 9, 2004

Dear Mr. Hull:

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.

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.

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#### Page 2 - Mr. Matthew M. Hull, RAC

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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 B.

K043041 510(k) Number:

Device Name: Aesculap T-Bar Aneurysm Clips

Indication for Use:

The Aesculap T-Bar Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

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**510(k) Number** K043041