(57 days)
Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during intracranial aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the intracranial aneurysm.
The Spetzler™ Round-Handled Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.
There are two types of Spetzler™ Round Handle Appliers; Stainless Steel with Titanium Jaws and Pads and completely Titanium. Each type applier has two styles; straight and bayonet.
The provided text is a 510(k) Pre-Market Notification for a medical device called the "Spetzler™ Round Handle Aneurysm Clip Appliers". This type of document is generally about demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative acceptance criteria through a formal study with detailed statistical analysis as might be done for a novel device. Therefore, much of the requested information (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not typically found in such a submission because these types of studies are not usually required for a 510(k) clearance based on substantial equivalence.
Based on the provided text, here's an analysis of the acceptance criteria and related information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states, "No applicable performance standards have been promulgated under Section 514 of the FD&C Act for these devices." Instead, the device's "performance" is assessed against its conformity to established material and instrument standards, and its substantial equivalence to predicate devices. The "acceptance criteria" here are qualitative and relate to design, material composition, function, and intended use as compared to existing, cleared devices.
| Acceptance Criteria (Demonstrated through Conformance to Standards & Substantial Equivalence) | Reported Device Performance/Compliance |
|---|---|
| Conformance to Material Standards for Titanium and Titanium Alloys | ASTM B348-97: Standard Specification for Titanium and Titanium Alloy Bars and Billets (Complied) |
| ISO 5832 Part 3, 1978: Implants for Surgery - Metallic materials Part 3: wrought titanium 6-aluminum 4-vanadium alloy (Complied) | |
| Conformance to Handling Standards for Aneurysm Clips and Instruments | ASTM F700-93: Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments (Complied) |
| Conformance to Material Standards for Stainless Steel (for instruments) | ISO 7153-1:1991: Surgical Instruments - Metallic materials Part 1: Stainless Steel (Complied) |
| Substantial Equivalence in Design, Material, Function, and Intended Use | The Spetzler™ Round Handle Appliers are deemed substantially equivalent to the following predicate devices: |
- Elekta Clip Appliers (K955064)
- Aesculap Axial Clip Appliers (K984109)
- Yasargil, Caspar, Vario Clip Appliers (K940970)
- Sundt Slim-Line Aneurysm Clip Applier (K982379) |
| Device Description & Intended Use | "hold and sufficiently open the aneurysm clip for application during aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the aneurysm." (The device also states it is designed for use only with Spetzler™ Titanium Aneurysm Clips). |
| Technological Characteristics | "The new Spetzler™ round Handle Appliers do not impart any new technological feature in design or manufacturing. It is the same as to function and intended use when compared to the predicates. The Spetzler™ Clip Appliers is different in that its spring loaded squeeze mechanism is more compact than the "box" style. Therefore latch engagement and disengagement requires less travel." |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable in this context. A 510(k) submission generally relies on performance testing (e.g., mechanical, material) to demonstrate compliance with standards and equivalence, rather than a clinical "test set" of patient data. The provided document details compliance with industrial standards (ASTM, ISO) for materials and handling, not clinical data sets. The equivalence is demonstrated through comparison of technical characteristics to already-clezed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. The ground truth for this type of submission is typically based on established engineering principles, material science, and the performance history of predicate devices, rather than expert interpretation of clinical data in a test set.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
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 device is a surgical instrument (aneurysm clip applier), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a manual surgical instrument, not an algorithm.
7. The type of ground truth used:
The "ground truth" in this submission is the established performance and safety profiles of the predicate devices and the compliance with recognized industry standards for materials and surgical instruments. It's built upon:
- Engineering specifications and material properties.
- Functional design comparisons.
- Intended use equivalence to devices already cleared by the FDA.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable for the same reason as point 8.
§ 882.4175 Aneurysm clip applier.
(a)
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.(b)
Classification. Class II (performance standards).