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Permanent D-Aneurysm-Clips are intended for permanent occlusion of cerebral aneurysms. Temporary D-Aneurysm-Clips are intended for temporary occlusion of intracranial blood vessels and cerebral aneurysms.
The D-Aneurysm Clip Appliers are intended to be used for holding and applying D-Aneurysm-Clips. The D-Aneurysm Clip Appliers are not compatible with other systems.

Device Description

D-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.
D-Aneurysm Clip Appliers are designed to be used with both principle sizes of D-Aneurysm-Clips, Standard and Mini.
The D-Clip is manufactured out of three parts, two of those forming the body and one the spring. With D-Clip Appliers it is grasped from the outside to open, close and guide the clip.
The D-Clip Appliers exists in two versions: a version with double action handles and one version with memory effect. Both versions are applied the same way. Pressing the handle will open the jaw.

AI/ML Overview

This document describes the performance testing for the Peter Lazic GmbH D-Aneurysm-Clips and D-Aneurysm Clip Appliers, demonstrating their substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
D-Aneurysm-Clips
Microbiological performance qualification of gamma radiation sterilization	Sterility assurance level (SAL) 12) using standard parameters (121°C, 20 min, and 134°C, 4min).	All tested devices free of microbial growth in three independent half-cycle qualification runs. Sufficient spore log reduction (>12) demonstrated.
Bending test (Memory material in straight condition)	Material can be bent without much effort. Material properties not changed after repeated bending.	Approximately 40 N required to deform the shaft. Force required to bend the shaft was similar after 100 bends, indicating no change in material properties.
Defining the bending cycles to possible function restrictions	No functional limitations after repeated bending and straightening cycles.	All 10 tested appliers remained fully functional after 30 repetitions (15 times 90° bending, 15 times straightening).
Behavior of the D-Clip Applying forceps after repeated use and reprocessing	Full function maintained after maximum simulated use and reprocessing cycles.	All 10 tested Memory D-Aneurysm-Clip Appliers showed full function after 100 cycles of bending, cleaning, and sterilization.

2. Sample Sizes Used for the Test Set and Data Provenance

D-Aneurysm-Clips:
- Microbiological performance qualification: 10 samples of worst-case clips.
- Degradation of closing force tests: Not explicitly stated, but the test mentions "The tested D-Clips did fulfill..." and "The test results of the L-Clips and the Yasargil Clips fulfilled..." implying multiple samples for each.
D-Aneurysm Clip Appliers:
- Microbiological efficiency (automated/manual cleaning & disinfection): Three contaminated reference products for each method.
- Microbiological efficiency (steam sterilization): Three qualification runs with three inoculated test samples each.
- Defining the bending cycles to possible function restrictions: 10 applying forceps.
- Behavior after repeated use and reprocessing: 10 D-Clip appliers.

The data provenance is retrospective as the studies were conducted to support the 510(k) submission, referencing existing standards and predicate device data. The country of origin of the data is Germany, as the applicant is Peter Lazic GmbH in Tuttlingen, Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This submission does not involve a clinical study with human subject data requiring expert consensus for ground truth. The tests conducted are benchtop and laboratory performance tests, comparing the new device against established standards (e.g., ISO 9713, ISO 5832) and predicate device specifications. Therefore, the concept of "experts establishing ground truth for the test set" in a clinical sense does not apply here. The "ground truth" for these engineering and sterility tests is derived from adherence to recognized testing standards and validated methodologies.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study involving human readers or clinical data that would require an adjudication method. The results are from physical and microbiological tests.

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 submission is for a physical medical device (aneurysm clips and appliers), not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

International Standards: Adherence to standards like ISO 9713 (for closing force), ISO 5832 (for materials), and methods for sterility and cleaning validation.
Predicate Device Performance: Direct comparison of the D-Aneurysm-Clips and D-Aneurysm Clip Appliers against the performance characteristics of the legally marketed predicate devices (L-Clip, Yasargil Aneurysm Clip, and their appliers), which have established safety and effectiveness.
Validated Test Methodologies: Scientific and engineering principles applied in laboratory settings to determine physical properties, material compatibility, and biological safety.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set as this is not an AI/machine learning study.

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K Number

K081489

Device Name

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

Manufacturer

PETER LAZIC GMBH

Date Cleared

2008-09-25

(120 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

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-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.

Device Description

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.

AI/ML Overview

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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