(120 days)
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.
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.
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.
The provided document is a 510(k) Premarket Notification for Peter Lazic GmbH's Aneurysm Clips & Appliers. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study against defined acceptance criteria. Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets such criteria in the way a clinical trial for a novel device would.
Instead, the document details the following as part of its substantial equivalence argument:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The document lists "Performance Standards" to which the devices conform, specifically: ASTM F1542-94(2000), ASTM F2129(2004), and ISO 9713. These are industry standards for medical devices, but the document does not include specific pass/fail criteria or results from tests against these standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or associated sample size is mentioned, as this is not a clinical study. The submission relies on demonstrating equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no "ground truth" establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document is for medical devices (aneurysm clips and appliers), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The submission is based on demonstrating substantial equivalence to predicate devices, not on proving clinical efficacy against a "ground truth" derived from patient data.
8. The sample size for the training set:
Not applicable as there is no training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable as there is no training set.
Summary of what is provided in the document (relevant to device performance and regulatory approval):
- Conformance to Standards: The devices conform to ASTM F1542-94(2000), ASTM F2129(2004), and ISO 9713. These standards likely cover aspects like material safety, mechanical performance, and design requirements for aneurysm clips and appliers.
- Substantial Equivalence: The primary "proof" in this submission is the demonstration of substantial equivalence to several legally marketed predicate devices, including KIRWAN L-Aneurysm Clips and Appliers, REBSTOCK Aneurysm Clips, Von Zeppelin GmbH Perneczky Aneurysm Clips and Clip Applier/Remover, and Aesculap, Inc. Yasargil Clip Appliers. This means the device is considered as safe and effective as these previously cleared devices, implying their performance is acceptable.
- Device Description: Detailed descriptions of the L-Aneurysm Clips and Yasargil-Aneurysm Clips (sizes, forms of jaws, permanent/temporary) and their corresponding appliers are provided.
- Intended Use: Clearly defined intended uses for both permanent and temporary clips for occlusion of blood vessels and cerebral aneurysms, and for the appliers to hold and apply these clips.
- Sterilization: Information on sterile or non-sterile conditions for clips and non-sterile for appliers.
- Regulatory Clearance: The FDA's letter (SEP 25 2008) indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to proceed to the market.
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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: +49 (7461) 966430 Fax: +49 (7461) 8745 Email: info@lazic.de 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-ClipsYasargil Aneurysm Clips | L-Clip AppliersYasargil 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
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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.
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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.
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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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
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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
§ 882.5200 Aneurysm clip.
(a)
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.(b)
Classification. Class II (performance standards).