(121 days)
The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.
Halo™ Single-Loop Snare Kit contains: (1) Snare, (1) Snare Catheter, (1) Introducer and (1) Torque Handle. The snare is constructed of a flexible and radiopaque loop. The pre-formed snare loop can be introduced through the snare catheter without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of flexible tubing and contains a radiopaque marker band.
The provided text describes a 510(k) premarket notification for the Halo™ Single-Loop Snare Kit. This documentation is for a medical device (a snare kit), not an AI device or software. Therefore, the questions related to AI device performance, such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, and training set ground truth establishment, are not applicable to this submission.
The document discusses non-clinical performance tests conducted to demonstrate substantial equivalence to predicate devices. These tests are focused on the physical and material properties of the snare kit.
Here's an analysis based on the provided text, focusing on what is available:
Acceptance Criteria and Reported Device Performance (Non-Clinical):
The document states that "A series of testing was conducted in accordance with protocols based on requirements outlined in guidances and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence."
While specific numerical acceptance criteria and exact performance results are not provided in a table format, the document lists the types of tests performed and indicates that the device met the acceptance criteria for each.
| Acceptance Criteria (Test Category) | Reported Device Performance (Met/Not Met) |
|---|---|
| Tensile strength | Met Acceptance Criteria |
| Liquid leakage | Met Acceptance Criteria |
| Air leakage | Met Acceptance Criteria |
| Corrosion Resistance | Met Acceptance Criteria |
| System Tip Flexibility | Met Acceptance Criteria |
| Tip Flexibility – Snare & Catheter | Met Acceptance Criteria |
| Snare Flexing & Fracture Test | Met Acceptance Criteria |
| Catheter Flexural Modulus | Met Acceptance Criteria |
| Catheter Kink Test | Met Acceptance Criteria |
| Marker Band Pull Test | Met Acceptance Criteria |
| Torque Strength Test | Met Acceptance Criteria |
| Simulative Use | Met Acceptance Criteria |
| Radiopacity | Met Acceptance Criteria |
| Particulate | Met Acceptance Criteria |
| Luer Testing | Met Acceptance Criteria |
| Shipping Test | Met Acceptance Criteria |
| Cytotoxicity (ISO 10993-5) | Met Acceptance Criteria |
| Sensitization (ISO 10993-10) | Met Acceptance Criteria |
| Intracutaneous Irritation (ISO 10993-10) | Met Acceptance Criteria |
| Acute Systemic Toxicity (ISO 10993-11) | Met Acceptance Criteria |
| Material Mediated Pyrogen (ISO 10993-11) | Met Acceptance Criteria |
| Hemocompatibility (ISO10993-4) | Met Acceptance Criteria |
| - ASTM Hemolysis Direct and Indirect Contact | Met Acceptance Criteria |
| - Complement Activation, SC5b-9 | Met Acceptance Criteria |
| - Platelet and Leucocyte Counts | Met Acceptance Criteria |
| - Partial Thromboplastin Time (PTT) | Met Acceptance Criteria |
Regarding the AI-specific questions:
The questions provided pertain to the evaluation of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. The document describes a Halo™ Single-Loop Snare Kit, which is a physical device used for retrieving and manipulating foreign objects in the cardiovascular system or hollow viscous. This is a traditional medical device, not an AI/ML software or algorithm.
Therefore, the following questions are not applicable to this specific FDA submission:
- Sample sized used for the test set and the data provenance: Not applicable. This is for a physical device, not an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication of expert annotations is for AI model ground truth.
- 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. MRMC studies are for evaluating AI's impact on human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for an AI model is not relevant here.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable. There is no AI model to train.
In summary, the provided FDA document is for a traditional physical medical device, not an AI-powered one, hence most of the detailed questions regarding AI study methodology are not relevant to this specific submission. The performance assessment relied on non-clinical (bench and material) testing to demonstrate substantial equivalence.
§ 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).