(329 days)
Permanent GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for Permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary permianent occlusion of blood vessel clips are intended for temporary occlusion Gilvilli Aneurysin Olips (Tabargi) and cerebral aneurysms. They are also intended to be applied exclusively with the corresponding Clip Appliers.
GIMMI Aneurysm Clips and their Clip Applying Forceps are used for the occlusion of aneurysms. "Mini" and "Standard" Clips can only be applied with the according Applying forceps; these forceps are labelled with "Mini" or "Standard". Clips are available in different sizes and shapes, to have the right size and shape due to the size and shape of the aneurysm.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the GIMMI Aneurysm Clips and Applying Forceps:
Executive Summary:
The provided document (K081640) is an Abbreviated 510(k) submission for the GIMMI Aneurysm Clips and Applying Forceps. This means that the manufacturer is demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) rather than providing extensive de novo performance data. Crucially, the document explicitly states that "performance testing was not warranted" due to the device's equivalence in design and materials to predicate devices and their long use history. Therefore, there is no detailed study described that establishes explicit acceptance criteria beyond regulatory standards and then proves the device meets those criteria through novel testing.
The "acceptance criteria" can be inferred as compliance with relevant industry standards, material specifications, and the demonstration of substantial equivalence to predicate devices in terms of intended use, performance attributes, materials, and basic design.
1. Table of Acceptance Criteria and Reported Device Performance
As performance testing was not warranted, explicit quantitative acceptance criteria for device performance (e.g., clip strength, fatigue, closure force) are not detailed in this submission. The "reported device performance" is primarily based on the demonstrated equivalence to predicate devices and material biocompatibility.
| Acceptance Criterion (Inferred from Submission) | Reported Device Performance |
|---|---|
| Intended Use (Permanent/Temporary occlusion of blood vessels and cerebral aneurysms) | Identical to predicate devices. |
| Materials (Titanium per ISO 5832-2/3 or Phynox per ISO 5832-7) | Device manufactured from specified materials. Biocompatibility "given by use of these Clips for over 15 years for human applications" for both Titanium and Phynox materials (referring to predicate devices' material history). |
| Basic Design | "Identical and/or substantially equivalent to SE devices." Slight modifications in design "do not adversely affect the safety and effectiveness." |
| Performance Attributes | "Identical and/or substantially equivalent to SE devices." No specific quantitative performance data provided; relies on equivalence statement. |
| Compliance with Industry Standards (ISO/EN/ASTM/AAMI/ANSI) | GIMMI GmbH certifies compliance "with relevant ISO/EN/ASTM/AAMI/ANSI and other device-related standards that apply to the manufacture, packaging, labelling and reprocessing of subject devices including the validation of these processes." |
| Sterilization (Autoclavable, delivered non-sterile) | Clip and Applying Forceps are autoclaveable and delivered non-sterile, requiring cleaning and sterilization before use per Operating Instructions. |
| MR Compatibility (1.5 Tesla or less, 3 Gauss/cm or less, SAR 0.03 W/kg) | "Non-clinical testing has demonstrated that the GIMMI Aneurysm Clip system is MR compatible" under the specified conditions. • No temperature rise or movement observed in 10-minute non-clinical testing with EPI sequences in a SIEMENS MAGNETOM MAESTRO CLASS SYMPHONY MR scanner (1.5 Tesla). Image quality may be compromised if the area of interest is close to the implant. |
| Bacterial Endotoxins | Tests enclosed (Test 063633-10-A and 063633-10-B) – results not visible in provided text, but implied as compliant. |
| Safety and Effectiveness | "meet the same criteria of Safety and Effectiveness as SE-Devices." "The results of design validation raise no new issues of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Performance Testing: No dedicated test set in the traditional sense for evaluating device performance against new, quantitative acceptance criteria was used. The submission explicitly states, "Based on the equivalence in design and materials to predicate devices and their use since over 15 Years, performance testing was not warranted."
- MR Compatibility Test: A "non-clinical testing" was performed.
- Sample Size: Not explicitly stated for the number of clips tested, but it refers to the "GIMMI Aneurysm Clip system."
- Data Provenance: This was a prospective non-clinical test conducted internally (likely by GIMMI GmbH or a contracted lab) using a "SIEMENS MAGNETOM MAESTRO CLASS SYMPHONY MR scanner." Specific country of origin beyond "Germany" (GIMMI's location) for the testing facility is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as there was no "test set" requiring expert ground truth for evaluating novel performance. The FDA's substantial equivalence determination relies on comparing the device to existing predicate devices.
4. Adjudication Method for the Test Set
This is not applicable as there was no "test set" requiring adjudication of results against a ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study would compare human performance with and without AI assistance, which is irrelevant for this medical device submission, as it is a physical implant, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done. This device is a physical implant, not an algorithm or AI.
7. The Type of Ground Truth Used
For the overall submission, the "ground truth" for demonstrating safety and effectiveness relies on:
- Predicate Device History and Regulatory Approval: The long-standing safe and effective use (over 15 years) and prior regulatory approvals of the identified predicate devices made of similar materials (Titanium, Phynox) and having similar intended uses and designs.
- Material Standards and Biocompatibility: Compliance with ISO 5832 for materials and historical evidence of biocompatibility.
- Non-Clinical Testing for MR Compatibility: For MR safety, the "ground truth" was established by the experimental results of temperature rise and movement measurements in a specified MR scanner.
8. The Sample Size for the Training Set
This is not applicable as this is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for this device.
§ 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).