AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP

K032198 · Aesculap, Inc. · HCH · Aug 20, 2003 · Neurology

Device Facts

• Record ID: K032198
• Device Name: AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
• Applicant: Aesculap, Inc.
• Product Code: HCH · Neurology
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms.

Device Story

The Aesculap Yasargil Aneurysm Clip Booster Clip is a mechanical accessory designed for use during neurosurgical procedures to augment the closing force of standard permanent aneurysm clips. The device is applied to the aneurysm clip to provide additional pressure for the occlusion of cerebral aneurysms. It is intended for use exclusively with Phynox aneurysm clips. The device is operated by a neurosurgeon in a clinical or operating room setting. By increasing the clamping force, the booster clip assists in ensuring secure occlusion of the aneurysm, potentially improving patient outcomes by preventing aneurysm rupture or recurrence.

Clinical Evidence

Bench testing only. Biomechanical testing was performed in accordance with FDA guidance to demonstrate that the device provides effective clip force enhancement.

Technological Characteristics

Material: Phynox (cobalt alloy) per ISO 5832/7. Function: Mechanical clip force enhancement. Compatibility: Designed for use with Phynox aneurysm clips only. Form factor: Booster/reinforcement clip.

Indications for Use

Indicated for use in neurosurgical procedures to increase the closing force of standard permanent aneurysm clips for the occlusion of cerebral aneurysms.

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.

Predicate Devices

• Yasargil Aneurysm Clip Titanium Booster Clip

Submission Summary (Full Text)

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AUG 2 0 2003esculap Yasargil Aneurysm Clip Phynox Booster Clip

\$\phi\$32198

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

AESCULAP YASARGIL ANEURYSM CLIP BOOSTER CLIP

July 17, 2003

| 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 Yasargil Aneurysm Clip Phynox Booster Clip |
| COMMON NAME: | Aneurysm Clip Booster or Reinforcement Clip |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 84 HCH |
| CLASSIFICATION: | 882.5200 - Clip, Aneurysm |
| REVIEW PANEL: | Neurology |

## INDICATIONS FOR USE

The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms.

#### DEVICE DESCRIPTION

The Aesculap Yasarqil Aneurysm Clip Booster Clip is designed to provide additional pressure for occlusion of cerebral aneurysms when used with a standard aneurysm clip during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are for use with Phynox aneurysm clips only.

#### PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)" for the Aesculap Yasargil Aneurysm Clip Booster Clip was completed. Biomechanical testing results demonstrate the Aesculap Yasarqil Aneurysm Clip Phynox Booster Clip provides effective clip force enhancement and is substantially equivalent to Yasargil Aneurysm Clip Titanium Booster Clip currently on the market.

#### SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Aesculap Yasarqil Aneurysm Clip Booster Clip are substantially equivalent to our currently marketed Yasargil Aneurysm Clip Titanium Booster Clip.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

AUG 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032198

Trade/Device Name: Aesculap Yasargil Aneurysm Clip Phynox Booster Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: II Product Code: HCH Dated: July 17, 2003 Received: July 24, 2003

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. Iisting 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

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,

Sincerely yours,

for Mark A. Milhens

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.

510(k) Number: K432198

# Device Name: Aesculap Yasargil Aneurysm Clip Phynox Booster Clip

#### Indication for Use:

The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the rne hosodiap Tradard permanent aneurysm clips to occlude cerebral aneurysms.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------------------------|---------|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K032198 |

| Prescription Use | | or Over-the-Counter Use | |
|----------------------|--|-------------------------|--|
| (per 21 CFR 801.109) | | | |