L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS

K081489 · Peter Lazic GmbH · HCH · Sep 25, 2008 · Neurology

Device Facts

• Record ID: K081489
• Device Name: L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
• Applicant: Peter Lazic GmbH
• Product Code: HCH · Neurology
• Decision Date: Sep 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permanent L-Aneurysm-Clips and YASARGIL aneurysm and vessel clips are intended for permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary L-Aneurysm-Clips and Yasargil aneurysm and vessel clips are intended for temporary occlusion of intra cranial blood vessels and cerebral aneurysms. The L-Aneurysm-Clip Appliers are intended to be used for holding and applying L-Aneurysm-Clips. The Yasargil-Aneurysm-Clip Appliers are intended to be used for holding and applying Yasargil-Aneurysm-Clips. The L-Aneurysm-Clip Appliers and the Yasargil-Aneurysm-Clip Appliers are not compatible to other traded systems.

Device Story

System comprises aneurysm clips and manual applier forceps; used in neurosurgery for permanent or temporary occlusion of cerebral aneurysms and intracranial vessels. Clips available in standard/mini sizes and various jaw geometries (straight, curved, angled, bayonet, fenestrated). Appliers are manual instruments designed to hold and apply specific clip systems; L-Clip and Yasargil systems are mutually incompatible. Surgeon operates applier to place clip on target vessel/aneurysm. Device provides mechanical occlusion to prevent blood flow; benefits patient by isolating aneurysm from circulation. No electronic or software components.

Clinical Evidence

Bench testing only. Conformance to ASTM F1542-94(2000), ASTM F2129(2004), and ISO 9713 standards.

Technological Characteristics

Manual surgical instruments. Materials conform to ASTM F1542-94(2000) and ASTM F2129(2004). Mechanical occlusion principle. Available in standard and mini sizes with various jaw configurations. Non-powered. Sterilization: Clips available sterile or non-sterile; appliers non-sterile.

Indications for Use

Indicated for permanent or temporary occlusion of intracranial blood vessels and cerebral aneurysms in patients requiring neurosurgical intervention.

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

• KIRWAN L-Aneurysm Clips and Appliers
• REBSTOCK Aneurysm Clips
• Perneczky Aneurysm Clips, Perneczky Clip Applier/Remover (Von Zeppelin GmbH)
• Yasargil Clip Appliers (Aesculap, Inc.)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/3 description: The image contains a logo and some text. The logo is a large, bold letter 'P' with the name 'PETER LAZIC' written below it in smaller letters. To the right of the logo is the number '51' and the word 'Lazic'.

510(k) Premarket Notification Lazic Aneurysm Clips & Appliers

Image /page/0/Picture/5 description: The image contains the letter 'K' in a bold, sans-serif font. A thick, black line is positioned directly beneath the letter. The line extends horizontally, slightly longer than the width of the letter 'K'.

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN ACCORDANCE WITH SMDA OF 1990

DATE: May 15, 2008

- Submitted by: Peter Lazic GmbH Immelmannweg 2 D-78532 Tuttlingen Germany Phone: [phone] Fax: [phone] Email: [e-mail] DEVICES: L-Aneurysm-Clip System & L-Aneurysm Clip Appliers Yasargil-Aneurysm-Clip System & Yasargil Clip Appliers Device Name Trade Name: L-Clip Yasargil Aneurysm Clip L-Clip Appliers Yasargil Aneurysm Clip Aplliers
Aneurysm Clips Common Name: Aneurysm Clip Appliers

# Classification

Our aneurysm clips and aneurysm clip appliers are classified as follows:

| Device: | L-Clips<br>Yasargil Aneurysm Clips | L-Clip Appliers<br>Yasargil Aneurysm Clip Appliers |
|---------------------|------------------------------------|----------------------------------------------------|
| Device description: | Aneurysm clip | Aneurysm clip applier. |
| Medical Specialty: | Neurology | Neurology |
| Product Code: | HCH | HCI |
| Regulation Number: | 882.5200 | 882.4175 |
| Device Class: | 2 | 2 |

K08xxxx_05_510k_Summary_v1_0.doc

{1}------------------------------------------------

K081489
2/2

Image /page/1/Picture/1 description: The image shows a logo with a large, bold letter 'P' at the top. Below the 'P', the name 'PETER LAZIC' is written in smaller, block letters inside a rectangular box. The text is black, and the background is white, creating a high-contrast design.

510(k) Premarket Notification

#### Lazic Aneurysm Clips & Appliers

### Substantial Equivalence

Lazic's Aneurysm Clips and Aneurysm Clip Appliers are substantial equivalent to similar devices distributed by KIRWAN (KIRWAN L-Aneurysm Clips and Appliers), Rebstock GmbH (REBSTOCK Aneurysm Clips), Von Zeppelin GmbH (Perneczky Aneurysm Clips, Perneczky Clip Applier/Remover), Aesculap, Inc. (Yasargil Clip Appliers).

### Description of the Device

L-Aneurysm Clips and Yasargil-Aneurysm Clips are available in two principle sizes (Standard and Mini) and several forms of jaws (straight, curved, angled, bayonet, fenestrated, non-fenestrated). Both sizes are available for permanent or temporary occlusion.

L-Aneurysm Clip Appliers are designed to be used with both principle sizes of L-Aneurysm Clips. Yasargil Clip Appliers are available in two principle sizes (Standard and Mini), matching the respective size of the applied Yasargil Aneurysm Clip.

#### Intended Use

#### Aneuysm Clips

Permanent L-Aneurysm-Clips and YASARGIL aneurysm and vessel clips are intended for permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary L-Aneurysm-Clips and Yasargil aneurysm and vessel clips are intended for temporary occlusion of intra cranial blood vessels and cerebral aneurysms.

#### Aneurysm Clip Applying Forceps

The L-Aneurysm-Clip Appliers are intended to be used for holding and applying L-Aneurysm-Clips.

The Yasargil-Aneurysm-Clip Appliers are intended to be used for holding and applying Yasargil-Aneurysm-Clips.

The L-Aneurysm-Clip Appliers and the Yasargil-Aneurysm-Clip Appliers are not compatible to other traded systems.

# Performance Standards

The devices are conforming to following standards: ASTM F1542-94(2000), ASTM F2129(2004), ISO 9713

### Sterilization

Lazic's L-Aneurysm Clips and Yasargil Aneurysm Clips are available in sterile or non sterile conditions. Lazic's Aneurysm Clip Appliers are available in non-sterile conditions only.

#### Conclusion

Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that Lazic's L-Aneurysm Clips and Appliers as well as Yasargil Aneurysm Clips and Appliers, are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 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 pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP & 5 2008

Peter Lazic GmbH c/o Mr. Franz Menean Griesweg 47 D-78570 Mühlheim Germany

Re: K081489

Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: Class II Product Code: HCH Dated: September 21, 2008 Received: September 24, 2008

Dear Mr. Menean:

We have reviewed your Scction 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.

{3}------------------------------------------------

# Page 2 - Franz Menean

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket survcillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark H Millman

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

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number: K

Device Name:

L-Aneurysm-Clip system & Appliers / Yasargil-Aneurysm-Clip system & Appliers

#### Indication for Use - Aneuysm Clips

Permanent L-Aneurysm-Clips and YASARGIL aneurysm and vessel clips are intended for permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary L-Anaurysm-Clins and Yasargil aneurysm and vessel clips are intended for temporary occlusion of intra cranial blood vessels and cerebral aneurysms.

# Indication for Use - Aneurysm Clip Applying Forceps

The L-Aneurysm-Clip Appliers are intended to be used for holding and applying L-Aneurysm-Clips.

The Yasargil-Aneurysm-Clip Appliers are intended to be used for holding and applying Yasargil-Aneurysm-Clips.

The L-Aneurysm-Clip Appliers and the Yasargil-Aneurysm-Clip Appliers are not compatible to other traded systems.

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __NO_ (21 SFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mule A. Mchurran

Page 1 of 1

**510(k) Number** K0817