Search Results

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.

Ask a specific question about this device