TEMPORARY TITANIUM ANEURYSM CLIP

K031468 · Cardinalhealth · HCH · Jun 20, 2003 · Neurology

Device Facts

• Record ID: K031468
• Device Name: TEMPORARY TITANIUM ANEURYSM CLIP
• Applicant: Cardinalhealth
• Product Code: HCH · Neurology
• Decision Date: Jun 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Placement in the intracranial space for the temporary occlusion of cerebral aneurysms and vessels to facilitate permanent occlusion. Placement of the clip requires the use of especially designed appliers.

Device Story

Temporary titanium aneurysm clip; bent wire design; provides spring-operated, self-closing occlusion. Used in intracranial space; applied by neurosurgeons using specialized V. Mueller titanium-coated appliers. Facilitates temporary occlusion of cerebral aneurysms and vessels during surgical procedures to allow for permanent occlusion. Benefits patient by enabling controlled temporary blood flow cessation during aneurysm repair.

Clinical Evidence

Bench testing only. Studies conducted on repeat sterilization performance to ensure no adverse effect on closing force. All acceptance criteria met.

Technological Characteristics

Titanium material per ASTM F136-98. Spring-operated, self-closing bent wire mechanism. Dimensions vary by length/size. Sterilization required.

Indications for Use

Indicated for temporary placement in the brain to facilitate occlusion of cerebral aneurysms. Clips are only to be applied with V. Mueller titanium coated clip appliers.

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

• PSI Titanium Aneurysm Clip (K991959)

Submission Summary (Full Text)

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JUN 2 0 2003

K031468 page 1/2

1500 Waukegan Road, Building MPWM
McGaw Park, IL 60085
tel [phone]
fax [phone]

MMARY OF SAFETY AND EFFECTIVENESS

Temporary Titanium Aneurysm Clip (As Required by 21 CFR §807.92)

Manufacturer:

Regulatory Affairs Contact

Telephone:

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification:

Predicate Device: (K991959)

Description:

Intended Use:

100

Cardinal Health Medical Products and Services V. Mueller

Lance Marconi 1500 Waukegan Road McGaw Park, Illinois 60085

[phone]

May 7, 2003

Temporary Titanium Aneurysm Clip

Aneurysm Clip

Clip, Aneurysm

PSI Titanium Aneurysm Clip

The temporary titanium aneurysm clip is bent wire that provides a spring operated, self-closing aneurysm clip of various lengths/sizes.

Placement in the intracranial space for the temporary occlusion of cerebral aneurysms and vessels to facilitate permanent occlusion. Placement of the clip requires the use of especially designed appliers.

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K03 1468 Page 2/2

## The Temporary Titanium Aneurysm Clip is Substantial Equivalence: substantially equivalent to the Titanium Aneurysm Clip by Cardinal Health in that the: Intended use is the same . . Material Clip Styles . Titanium material certification to ASTM F136-98, Summary of Testing: repeat sterilization performance study was conducted to ensure no adverse effect on closing force for the Temporary Titanium Aneurysm Clips and all acceptance criteria were met. Sterilization Performance studies were conducted Summary of Testing: for the Temporary Titanium Aneurysm Clip and all acceptance criteria were met. Conclusion:

The Temporary Titanium Aneurysm Clip is safe and effective for it's intended use and meets all regulatory requirements to be found substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with a symbolic representation of a wing or bird above them.

NOV 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health % Mr. Lance Marconi Manager, Regulatory Affairs 1500 Waukegan Road, Building MPWM McGaw Park, Illinois 60085

Re: K031468

Trade/Device Name: Temporary Titanium Aneurysm Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH, HCI Dated: May 7, 2003 Received: May 9, 2003

Dear Mr. Marconi:

This letter corrects our substantially equivalent letter of January 20, 2003.

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 (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 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. Lance Marconi

This letter will allow you to continue marketing your device as described in your Section 510(k) This letter will anow you to commune in and any and on your device of your device to a legally premarket notification. The PDA miding of basianal expanded on 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
rs of the may of the support on 10, 276, 11 for alsos mate the requilation If you desire specific advice for your do not of the Also, please note the regulation entitled, contact the Office of Comphalloo at (210) 276-677 Part 807.97). You may obtain "Misbranding by reference to premarket notified.com of the Act from the Division of Small other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at the largement html Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of four curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a simple, sans-serif font.

K031468

1500 Waukeoan Road Bu

Image /page/4/Picture/3 description: The image shows the words "INDICATIONS FOR USE" in bold, sans-serif font. The words are arranged on a single line, with "INDICATIONS FOR" appearing on the left and "USE" on the right. The background of the image is a textured pattern of black and white.

510(k) Number (if Known): Device Name:

Unknown

Temporary Titanium Aneurysm Clip

Indication For Use:

Temporary placement in the brain to facilitate occlusion of cerebral aneurysms. Clips are only to be applied with V. Mueller titanium coated clip appliers.

iriam C. Provost

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

510(k) Number_KO31468

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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