(39 days)
The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.
The Radius Snare is composed of two primary parts: an outer sheath tube and a core wire with a snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The outer sheath is a stainless steel coil with a PTFE overjacket. The stainless steel core is the same solid .0135" diameter stainless steel core wire in the FDA cleared Radius PTCA Guidewire. A stainless steel loop is soldered to the distal end of the core wire. The Radius Snare has loop sizes which range from 5 - 35 millimeters. The over-all length of the device is 150 centimeters. The Radius Snare will be packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-2.
The provided text describes specific performance tests conducted on the Radius Snare device. However, it does not explicitly state numerical acceptance criteria for these tests, nor does it provide detailed results demonstrating the device meets specific criteria. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and function, and then lists the types of performance tests performed.
Therefore, for aspects like "Table of acceptance criteria and reported device performance," "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone study," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," the information is not available within the provided text.
Here's a breakdown of what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified numerically. The document states that "in vitro performance tests were performed" to support substantial equivalence. | |
| Tensile Strength | "Performed" (Specific results not provided) |
| Torque Strength | "Performed" (Specific results not provided) |
| Torqueability | "Performed" (Specific results not provided) |
| Tip Flexibility | "Performed" (Specific results not provided) |
| Coating Adherence/Integrity | "Performed" (Specific results not provided) |
| Biocompatibility | "Performed" (Specific results not provided) |
| Sterilization | "ETO sterilized to SAL 10-2" |
Study Information (Based on Available Text):
- Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. The document only mentions that "in vitro performance tests were performed," but does not specify the number of units tested or any details about data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not available. The study described involves in vitro performance testing of the device's physical and mechanical properties, not an assessment of diagnostic performance that would require expert ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. As above, this is not a clinical study involving human assessment.
- 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. This is not an AI-powered device, nor is an MRMC study described. The device is a medical snare used in interventional procedures.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question pertains to AI/algorithm performance. The Radius Snare is a physical medical device. The "performance testing" referenced is for the device's mechanical and material properties.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not available in the context of clinical outcomes. For the in vitro performance tests, the "ground truth" would be established engineering or material science standards and specifications, but these are not detailed in the document.
- The sample size for the training set:
- Not applicable. This refers to a machine learning context.
- How the ground truth for the training set was established:
- Not applicable. This refers to a machine learning context.
In summary: The provided document is a 510(k) summary for a medical device (Radius Snare). It focuses on demonstrating substantial equivalence to predicate devices and lists types of in vitro performance tests conducted (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity, Biocompatibility). It explicitly states the sterilization method. However, it does not provide detailed acceptance criteria, specific test results, or any information related to clinical studies, human reader performance, or artificial intelligence algorithms.
§ 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).