(90 days)
The ONE Snare Endovascular Microspare System is intended for use in adult and pediations for the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extracranial anatomy.
ONE Snare Endovascular Microsnare System contains: (1) Snare, (1) Snare Catheter, (1) Insertion Tool and (1) Torque Device. The snare is constructed of nitinol cable and a gold plated tungsten loop. The pre-formed snare loop can be introduced through catheters without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of polyether block amide (Pebax®) and contains a platinum/iridium radiopaque marker band.
The provided text describes the 510(k) premarket notification for the ONE Snare Endovascular Microsnare System. However, it does not explicitly define acceptance criteria or specific study results in the format requested. The document primarily lists performance attributes that were tested to demonstrate substantial equivalence to predicate devices, rather than providing quantitative acceptance criteria and corresponding detailed device performance data.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific numerical or quantitative acceptance criteria and corresponding performance metrics for the ONE Snare Endovascular Microsnare System. Instead, it lists a comprehensive set of tests performed and states that these tests were "successfully completed" or "designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use."
The identified performance attributes tested include (but are not limited to):
| Category | Tested Performance Attributes |
|---|---|
| Catheter & Insertion Tool | Surface Finish, Radiopacity, Catheter tip atraumatic, Marker band placement, Effective Length, ID & OD, Catheter stiffness, Markerband retention, Tip integrity, Torque Strength, Kink resistance, Buckling force, Freedom from Liquid leakage, Freedom form Air leakage, Peak tensile force of catheter at hub, Force at break insertion tool at hub, Hub with Female luer testing, Corrosion Resistance |
| ONE Snare Endovascular Microsnare System | Snare Loop Resistance, Guide Catheter resistance, Snare shape integrity, Insertion Tool Fitment, Snare insertion, Insertion Tool tear away force, Snare jacket after insertion tool removal inspection, Snare loop protruding |
| Snare | Size designation, Snare Head Assembly, Radio detectability, Surface Finish, Tensile strength, Torqueability, Torque Strength, Flexing Test, Fracture Test, Tip Flexibility, Corrosion Resistance |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemolysis, Thrombogenicity, Complement Activation, Chemical Tests |
| Packaging Performance | Before and after exposure to accelerated aging and simulated shipping and handling conditions (bubble emission, dye penetration, seal peel tensile strength, burst strength, visual inspection) |
The document implies that the device "meets critical design specifications as well as clinical performance attributes for its intended use" by successfully completing these tests, but the specific numerical "acceptance criteria" and "reported device performance" are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the tests conducted. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as the studies appear to be bench and laboratory-based performance tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as the studies described are in vitro or bench tests, not clinical studies requiring expert interpretation of medical images or patient outcomes for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned in the provided text. The studies focus on the device's physical and functional performance and biocompatibility.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical instrument (an endovascular microsnare system), not an algorithm or AI software. There is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
For the performance tests described (e.g., tensile strength, corrosion resistance, biocompatibility), the "ground truth" would be objective measurements and established standards (e.g., ISO, ASTM, FDA guidance documents). The tests were designed to demonstrate adherence to critical engineering specifications and regulatory requirements.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
Summary of Study Type:
The studies described are a series of bench testing, laboratory testing, and biocompatibility assessments to demonstrate the physical, chemical, and functional performance of the ONE Snare Endovascular Microsnare System. The purpose of these tests was to establish substantial equivalence to predicate devices under the 510(k) pathway, not to evaluate clinical efficacy or diagnostic accuracy using patient data or expert adjudicated ground truth. The acceptance of the device is based on its ability to perform robustly under various conditions and meet recognized standards (e.g., ISO, ASTM) and design specifications.
§ 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).