(270 days)
The Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
Halo™ Single-Loop Microsnare Kit contains: (1) Microsnare, (1) Microsnare Catheter, (1) Introducer and (1) Torque Handle. The microsnare is constructed of a flexible and radiopaque loop. The pre-formed microsnare loop can be introduced through the microsnare catheter without risk of microsnare deformation because of the snare's super-elastic construction. The microsnare catheter is constructed of flexible tubing and contains a radiopaque marker band.
The Halo™ Single-Loop Microsnare Kit underwent a series of non-clinical performance tests to demonstrate substantial equivalence to its predicate devices. No clinical studies were conducted, thus, information regarding human readers or effect sizes with AI assistance is not available.
1. A table of acceptance criteria and the reported device performance:
The document indicates that acceptance criteria were determined to demonstrate substantial equivalence, and the device was shown to meet these acceptance criteria. However, specific numerical acceptance criteria and reported performance values for each test are not provided in the given text. Instead, the document lists the types of performance tests conducted.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing | |
| 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 Microsnare & Microsnare 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 |
| Biocompatibility Testing | |
| 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 |
| o ASTM Hemolysis – Direct and Indirect Contact | Met acceptance criteria |
| o Complement Activation, SC5b-9 | Met acceptance criteria |
| o Platelet and Leucocyte Counts | Met acceptance criteria |
| o Partial Thromboplastin Time (PTT) | Met acceptance criteria |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for each non-clinical test. The data provenance is non-clinical, meaning it comes from laboratory or bench testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies involving expert assessment of medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the studies were non-clinical performance and biocompatibility 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:
No MRMC study was conducted. The device is a medical instrument (microsnare kit), not an AI-powered diagnostic tool. The document focuses on demonstrating the physical and biological characteristics of the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable since the device is a medical instrument, not an algorithm. The performance tests evaluate the physical characteristics and biocompatibility of the device itself.
7. The type of ground truth used:
For performance testing, the "ground truth" would be established engineering specifications, industry standards, and regulatory requirements against which the device's physical and mechanical properties are measured. For biocompatibility testing, the "ground truth" is established biological responses as defined by ISO standards.
8. The sample size for the training set:
This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.
§ 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).