(142 days)
The ONE Snare™ endovascular snare system is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.
The ONE Snare™ System contains: (1) Snare, (1) Snare Catheter, (1) Introducer 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 a traditional Premarket Notification 510(k) for the Merit ONE Snare™ system. This type of submission focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than clinical study data. Therefore, many of the requested data points related to clinical trials, ground truth, expert adjudication, and separate training/test sets are not applicable or explicitly stated in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "a battery of tests performed on the Merit ONE Snare™ system were designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use." It then lists numerous safety and performance tests. However, specific numerical acceptance criteria and their corresponding reported device performance values are NOT provided in this summary. The summary only states that these tests were "successfully completed."
Below is a table summarizing the types of tests performed. Note that specific quantitative acceptance criteria and performance metrics are not detailed in the provided text.
| Test Category | Specific Tests Mentioned (Examples) | Acceptance Criteria (Not Explicitly Stated - Assumed Success) | Reported Device Performance (Not Explicitly Stated - Assumed Success) |
|---|---|---|---|
| Device (General) | Surface Finish, Torque Strength, Torqueability, Compatibility of snare with snare catheter, Snare Catheter to Guiding Catheter compatibility, Snare introducer fit, Introducer Removal Force from Snare, Dimensional Inspection | Met critical design specifications | Successfully completed all tests |
| Snare Specific | Radiodetectability (Snare wire), Size Designation, Tensile Test, Tip Flexibility, Fracture Test, Flexing Test, Corrosion resistance | Met critical design specifications | Successfully completed all tests |
| Catheter & Introducer Specific | Radiodetectability (Snare catheter / marker bands), Catheter Atraumatic Tip Finish, Marker Band Retention, Force at break (at Catheter Tip and Junction), Catheter Pushability (kink or accordion resistance), Catheter flexibility (buckling resistance), Hub with Female Luer testing, Dimensions, Freedom from leakage, Surface Finish, Force at break (Junction), Corrosion resistance, Snare Torque Strength | Met critical design specifications | Successfully completed all tests |
| Biocompatibility | L929 MEM Elution, Kligman Maximization, Irritation Intracutaneous Injection Test, Systemic Injection, Material Medicated Rabbit Pyrogen Test, Genotoxicity (Salmonella typhimurium and Escherichia Coli), Hemocompatibility (Rabbit Blood - indirect & direct, Complement Activation Assay, In Vivo Thrombogenicity study in Dogs), USP Physicochemical Tests | Met biological safety standards and regulations | Successfully completed all tests |
| Packaging | Bubble emission, dye penetration, seal peel tensile strength, burst strength, visual inspection (before and after accelerated aging and simulated shipping) | Maintained sterile barrier integrity and physical properties | Successfully completed all tests |
2. Sample Size Used for the Test Set and Data Provenance
The text describes a "battery of tests" performed to demonstrate the device meets critical design specifications and clinical performance attributes. These are bench and laboratory tests, not typically clinical trials involving human subjects or extensive clinical data sets. Therefore:
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." The sample size would refer to the number of individual devices or components tested for each specific bench test. This information is not detailed in the summary.
- Data Provenance: The tests are laboratory-based, implying the data is generated in a controlled testing environment, consistent with product development and regulatory submission requirements for a device of this nature. It is not clinical data in the sense of patient records or imaging. Likely, the tests were conducted at Merit Medical's facilities or accredited testing labs. It is not retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this 510(k) summary. The "ground truth" for bench and lab testing of a medical device like a snare system involves meeting engineering specifications, material properties, and functional performance metrics established by industry standards (e.g., ISO, ASTM) and internal design requirements. There typically isn't a need for "experts" to establish a clinical ground truth in the way it's done for diagnostic AI.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of complex diagnoses, particularly for AI performance evaluation. For bench testing of a device, performance is evaluated against predefined pass/fail criteria for each test, not by expert consensus or adjudication on clinical cases.
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
This question is not applicable. The Merit ONE Snare™ system is a physical medical device (a retrieval snare), not an AI algorithm or a diagnostic tool that assists human "readers" in interpreting data. Therefore, an MRMC study or AI assistance effect size is irrelevant to this device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This question is not applicable as the Merit ONE Snare™ system is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" refers to the established engineering specifications, material properties, and functional performance requirements (e.g., tensile strength, flexibility, biocompatibility, dimensions, seal integrity). These are defined by relevant international (ISO) and national (ASTM, FDA guidance) standards, as well as the manufacturer's internal design controls. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This question is not applicable. Bench testing for a medical device like this does not involve a "training set" in the context of machine learning or AI. Performance is evaluated against predefined criteria, not by training a model.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
§ 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).