(96 days)
The Vascular Retrieval Snare is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including, but not limited to, wire guides, coils, balloons, catheters, and filters.
The Vascular Retrieval Snare consists of four petals composed of nitinol and tantalum. It is packaged with a coaxial sheath system and a dilator. Each of the sheaths of the coaxial system has radiopaque tips incorporated to identify the location of the distal tip of each sheath.
The Cook Incorporated FourSnare Vascular Retrieval Snare is a medical device intended for use in the cardiovascular system to manipulate and retrieve foreign objects. The 510(k) submission for this device outlines several tests performed to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Predetermined) | Reported Device Performance |
|---|---|---|
| Tensile Strength Testing | Strength during proper clinical use should not fracture or rupture the sheaths, catheter, or dilator, in conformance with ISO 11070 and ISO 10555-1. | The predetermined acceptance criteria were met. |
| Liquid Leakage Testing | No liquid leakage from the catheter and sheath during proper clinical use, in conformance with ISO 11070. | The predetermined acceptance criteria were met. |
| Retrieve Object Testing | The device can successfully manipulate and grasp foreign objects from a model to simulate clinical use. | The predetermined acceptance criteria were met. |
| Kink Resistance Testing | The catheter, dilator, and sheaths should not kink during proper clinical use. | The predetermined acceptance criteria were met. |
| Repeat Opening and Closing Testing | The device can repeatedly open and close the basket width during proper clinical use. | The predetermined acceptance criteria were met. |
| Snare Retraction Testing | The snare can be retracted during proper clinical use. | The predetermined acceptance criteria were met. |
| Radiopacity Testing | Applicable portions of the device shall be radiopaque during proper clinical use. | The predetermined acceptance criteria were met. |
| Packaging Validation Testing | The packaging system shall maintain packaging integrity. | The predetermined acceptance criteria were met. |
| Biocompatibility Testing | The device is biocompatible. | The predetermined acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each of the tests performed. It states "The following tests were performed to demonstrate that the Vascular Retrieval Snare meets applicable design and performance requirements."
The data provenance is from testing conducted by Cook Incorporated for the purpose of demonstrating substantial equivalence for regulatory clearance. The document does not specify a country of origin for the data or if the tests were retrospective or prospective, though performance testing for medical devices is typically prospective relative to the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The tests described are primarily engineering performance tests measuring physical characteristics and functional capabilities of the device against predefined specifications. These types of tests typically rely on objective measurements rather than expert human interpretation.
4. Adjudication Method for the Test Set
Since the tests described are objective engineering and performance tests, no adjudication method (e.g., 2+1, 3+1) was used or required for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or is mentioned in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices through design, intended use, materials, fundamental technology, principal of operation, and performance testing, rather than evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
The testing described is primarily for the standalone performance of the device itself (algorithm only without human-in-the-loop performance, though applicable to a medical device's functional integrity). The tests assess various physical and functional attributes of the snare, such as tensile strength, liquid leakage, kinking, radiopacity, and ability to retrieve objects. These are inherent device characteristics and do not involve human-in-the-loop performance evaluation in the context of diagnostic interpretation or AI assistance.
7. Type of Ground Truth Used
The ground truth for the device's performance was established by predetermined acceptance criteria for each test. These criteria are based on recognized standards (e.g., ISO 11070, ISO 10555-1) and expected performance for safe and effective clinical use, rather than expert consensus, pathology, or outcomes data in the traditional sense of clinical studies evaluating diagnostic accuracy.
8. Sample Size for the Training Set
The document does not describe a "training set" as would be relevant for machine learning or AI algorithms. The tests performed are engineering and performance validation tests for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of AI or machine learning for this device, the question of how ground truth was established for a training set is not applicable. The ground truth for the device's performance was defined by the predetermined acceptance criteria for each physical and functional test.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).