(386 days)
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.
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.
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.
§ 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).