PSI TITANIUM ANEURYSM CLIP

K991959 · V. Mueller Neuro/Spine · HCH · Jan 6, 2000 · Neurology

Device Facts

• Record ID: K991959
• Device Name: PSI TITANIUM ANEURYSM CLIP
• Applicant: V. Mueller Neuro/Spine
• Product Code: HCH · Neurology
• Decision Date: Jan 6, 2000
• 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 occlusion of a cerebral aneurysm (a balloon like sac formed on a blood vessel) to prevent it from bleeding or bursting. Placement of the clip requires the use of especially designed appliers

Device Story

PSI Titanium Aneurysm Clip is a bent titanium wire device providing spring-operated, self-closing occlusion of cerebral aneurysms. Used in intracranial surgery; operated by neurosurgeons using specialized appliers. Device functions by clamping the aneurysm neck to prevent bleeding or rupture. Titanium alloy construction ensures MRI compatibility and reduced imaging artifacts compared to cobalt-based clips. Benefits include secure vessel occlusion and improved diagnostic imaging post-procedure.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, material composition, and functional performance comparisons to predicate devices.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V) conforming to ISO 5832/3 and ASTM F-136. Form factor: Bent wire, spring-operated, self-closing clip. Energy source: Mechanical (spring tension). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for permanent placement in the brain for occlusion of cerebral aneurysms. Requires application with PSI clip appliers with titanium alloy jaw inserts.

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

• Aesculap Titanium Aneurysm Clip (K983758)
• Taka Aneurysm Clip (K972750)

Submission Summary (Full Text)

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K991959

JAN - 6 2000

### SECTION 6 510(k) SUMMARY

Page 14

| Submitter Name: | Pacific Surgical Innovations, Inc. |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 360 Industrial Road<br>San Carlos, CA 94070 |
| Contact Person: | Terry Johnston, President |
| Phone Number: | 650-802-6988 |
| Facsimile Number: | 650-802-0120 |
| Date Prepared: | April 15, 1999 |
| Device Trade Name: | PSI Titanium Aneurysm Clip |
| Device Common Name: | Aneurysm Clip |
| Classification Name: | Aneurysm Clip, 21 CFR 882.5200 |
| Predicate Device: | Aesculap Titanium Aneurysm Clip (K983758)<br>Taka Aneurysm Clip (K972750) |
| Device Description: | Bent titanium wire which provides a spring operated, self<br>Closing aneurysm clip of various lengths/sizes. |
| Intended Use: | Placement in the intracranial space for the occlusion of a<br>cerebral aneurysm (a balloon like sac formed on a<br>blood vessel) to prevent it from bleeding or bursting.<br>Placement of the clip requires the use of especially<br>designed appliers |
| Technological Characteristics<br>And Comparison to Predicate | The PSI Titanium Aneurysm Clip is manufactured from<br>the same materials, to equivalent functional and<br>dimensional specifications as the predicate clips.<br>The material composition is titanium alloy (Ti-6Al-4V).<br>The alloy composition and properties conform with ISO<br>Standard 5832/3: "Implants for Surgery Metallinc<br>Materials - Part 3: WroughtTitanium 6 - Aluminum 4 -<br>Vanadium Alloy" and ASTM Standard F - 136:<br>"Specification for Wrought Titanium 6AL-4V ELI Alloy<br>for Surgical Applications". The PSI clips share similar<br>tolerances, manufacturing controls, packaging and<br>labeling as the predicate Taka clips. |
| Performance Data: | When used with the appropriate clip applier, as with<br>the predicate device, the PSI Titanium Aneurysm Clip<br>functions in the same manner as the predicate device in<br>the occlusion of cerebral aneurysms. When used in<br>the MRI environment, the device presents no additional<br>risk to the patient or other personnel, is compatible with<br>current diagnostic imaging equipment and provides<br>substantially reduced image artifacts over cobalt-based<br>predicate clips. |
| Conclusion: | The Titanium Aneurysm Clip is safe and effective for it's<br>intended use and meets all regulatory requirements to be<br>found substantially equivalent to the predicate device. |

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# K991959

## Page 15

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with three overlapping profiles suggesting community and support. The seal is presented in black and white.

NOV 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pacific Surgical Innovations, Inc. % Mr. Terry Johnston Vice President and General Manager 360 Industrial Road, Unit H San Carlos, California 94070

Re: K991959

Trade/Device Name: Titanium Aneurysm Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH, HCI Dated: October 28, 1999 Received: November 1, 1999

Dear Mr. Johnston:

This letter corrects our substantially equivalent letter of January 6, 2000.

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. Terry Johnston

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated notification "ceresults 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 If you doors operio as no liance 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 other general 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

FOR Patat Ruma

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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K991959

Page 13

### SECTION 5

# INDICATIONS FOR USE

PSI TITANIUM ANEURYSM CLIP

Device Name:

11:4

Indication for Use:

Permanent placement in the brain for occlusion of cerebral aneurysms. They are only to be applied with PSI clip appliers with titanium alloy jaw inserts

Prescription Use

OR

Over the Counter

to

(Division Sign) Off) Division of General Restor K991959 510(k) Number