YASARGIL TITANIUM ANEURYSM CLIPS

K983758 · Aesculap, Inc. · HCH · Dec 18, 1998 · Neurology

Device Facts

• Record ID: K983758
• Device Name: YASARGIL TITANIUM ANEURYSM CLIPS
• Applicant: Aesculap, Inc.
• Product Code: HCH · Neurology
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Yasarail Titanium Alloy aneurysm clips is to occlude cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium allov iaws

Device Story

Yasargil Titanium Aneurysm Clips are surgical implants designed to occlude cerebral aneurysms. The device consists of titanium alloy clips applied by specialized Aesculap clip appliers featuring titanium alloy jaws. These clips are used by neurosurgeons in an operating room setting to secure the neck of an aneurysm, either temporarily or permanently, to prevent rupture or bleeding. The device functions as a mechanical clamp; it does not involve electronic inputs, software, or automated processing. The clinical benefit is the stabilization of cerebral vasculature during or after neurosurgical intervention.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Titanium alloy (Ti6AL4V) conforming to ISO 5832/3 and ASTM F136. Mechanical clamping device. No energy source, software, or connectivity. Form factor: Aneurysm clips for surgical implantation.

Indications for Use

Indicated for the occlusion of cerebral aneurysms in a temporary or permanent manner. Intended for prescription use.

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

• Spetzler Ti 100 Aneurysm Clips (K955064)
• Codman occlusion clips (K760771)
• Sugita Aneurysm clips (K782040)

Submission Summary (Full Text)

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DEC 1 8 1998

# K983758

#### 510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990

#### Yasargil Titanium Aneurysm Clips

October 23, 1998

Submitted by:

Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Victoria Mackinnon [phone] Phone: [phone] FAX:

Product: Common Name: Yasargil Titanium Aneurysm Clips Aneurysm Clips

A. Device Description These titanium alloy aneurysm clips will be available as temporary or permanent devices.

#### B. Intended Use: The intended use of the Yasarail Titanium Alloy aneurysm clips is to occlude cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium allov iaws

- C. Technological Characteristics: The additional patterns of Yasargil Titanium Alloy aneurysm clips do not incorporate any new technological characteristics when compared to Aesculap's current Yasargil Titanium or Phynox aneurysm clips, or to other legally marketed devices. The titanium alloy clips share similar tolerances, manufacturing controls, packaging and labeling as the current Phynox and
Titanium aneurysm clips.

- D. Material Composition / Biocompatibility The material composition is titanium alloy (Ti6AL4V). The alloy composition and properties conforms with ISO Standard 5832/3: "Implants for Surgery Metallic Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy" and ASTM standard F136: "Specification for Wrought Titanium 6AL-4V Eli Allov for Surgical Implant Applications".

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K983758

#### E. Substantial Equivalence

K983758

These additional patterns of Yasargil titanium aneurysm clips are very similar or are identical to the current Yasargil titanium alloy clip patterns.

Additionally, the titanium alloy aneurysm clips share similar features, dimensions and styles to Spetzler Ti 100 Aneurysm Clips, (subject to #K955064) by Elekta Instruments, Codman occlusion clips (#K760771) such as Sundt-Kees Slim-Line Aneurysm Clips and McFadden Vari-Angle Aneurysm clips as well as to Sugita Aneurysm clips (subject to #K782040) by Downs Surgical, manufactured by Mizuho Medical Co. Ltd.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 1998

Victoria Mackinnon Director, Regulatory Affairs AESCULAP, Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7030

K983758 Re: Trade Name: Yasargil Titanium Aneurysm Clips Regulatory Class: II Product Code: HCH Dated: October 23, 1998 Received: October 26, 1998

Dear Ms. Mackinnon:

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 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. Victoria Mackinnon

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

focella

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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K983758

Page 1 of 1

### INDICATION FOR USE STATEMENT

510(k) Number (if known): _______ N/A

#### Device Name:

Yasargil Titanium Aneurysm Clips.

### Indication for Use:

The Yasargil Titanium Aneurysm Clips presented in this submission are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium alloy jaws.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

tocoele

(Division Sign-Off) (Division of General Restorative Devices (_983768)
510(k) Number _____________________________________________________________________________________________________________

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