(118 days)
The Merit ASAPLP Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
The ASAPLP Aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014”/0.36mm guide wires. It is packaged with related accessories including a stiffening stylet. The catheter has a maximum outer diameter of 0.055"/0.140cm and a working length of 145cm. The catheter has a radiopaque marker band located approximately 2mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90cm, 100cm and 110cm proximal of the distal tip. The distal region has a hydrophilic coating. The rapid exchange lumen is 20cm in length.
The provided text describes the Merit ASAPLP Aspiration Catheter and its substantial equivalence to a predicate device, the ASAP Aspiration Catheter. It lists numerous safety and performance tests conducted to demonstrate this equivalence. However, it does not detail specific acceptance criteria with quantitative thresholds or reported device performance in the format of a table. While it states that "All testing was successfully completed" and "the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device," the document does not provide the specific numerical acceptance criteria or the actual measured performance data for each test.
Furthermore, the document does not contain information about:
- Sample sizes used for a test set for diagnostic performance, as this is a medical device for physical aspiration, not a diagnostic AI.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts and their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done involving human readers and AI, or if an effect size of human readers improving with AI vs. without AI assistance was calculated.
- Whether a standalone (algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (pathology, outcomes data, etc.) beyond stating testing was based on industry standards and risk analysis.
- The sample size for the training set.
- How the ground truth for the training set was established.
This document focuses on the mechanical, material, and biological safety and performance of a physical medical device (catheter) rather than the diagnostic performance of an AI algorithm. Therefore, the questions related to AI-specific evaluation metrics (like MRMC studies, ground truth establishment for training/test sets in diagnostic contexts, and sample sizes for diagnostic performance evaluation) are not applicable or addressed in this submission.
Summary of what can be extracted/inferred regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device." and "All testing was successfully completed." However, it does not provide a specific table with quantitative acceptance criteria and corresponding reported device performance values for each test. Instead, it lists the types of tests performed.
| Test Category | Specific Test | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|---|
| Physical/Mechanical | Surface Condition / Visual | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" |
| Corrosion Resistance | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Force at Break | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Catheter Liquid Leak under Pressure | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Catheter Air Aspiration Leak | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Dimensions | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Luer Gauging Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Liquid Leak Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Air Aspiration Leak Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Separation Force Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Unscrewing Torque Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Ease of Assembly Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Resistance to Overriding Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Luer Stress Cracking Test | Based on ISO 594-1:1986, ISO 594-2:1998 | "Successfully completed," "met acceptance criteria" | |
| Radio-Detectability | Based on ASTM F640-12 | "Successfully completed," "met acceptance criteria" | |
| Kink | Based on EN 13868:2002 | "Successfully completed," "met acceptance criteria" | |
| Stiffness | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Aspiration Flow | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Coating Lubricity and Coverage | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Marker Band Retention | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Guide Wire Friction Test | Based on industry standards, device risk analysis | "Successfully completed," "met acceptance criteria" | |
| Simulated Use Test in Anatomical Model | Clinical simulation of intended use | "Successfully completed," "met acceptance criteria" | |
| Simulated Aspiration and Use Test in Tortuous Path Model | Clinical simulation of intended use, specific challenging scenario | "Successfully completed," "met acceptance criteria" | |
| Biocompatibility | Cytotoxicity | Based on ISO 10993-5:2009 | "Successfully completed," "met acceptance criteria" |
| Sensitization | Based on ISO 10993-10:2010 | "Successfully completed," "met acceptance criteria" | |
| Irritation | Based on ISO 10993-10:2010 | "Successfully completed," "met acceptance criteria" | |
| Acute Systemic Toxicity | Based on ISO 10993-11:2006 | "Successfully completed," "met acceptance criteria" | |
| Rabbit Pyrogen Test | Based on USP 35-151:2012 | "Successfully completed," "met acceptance criteria" | |
| Genotoxicity | Based on ISO 10993-3:2003 | "Successfully completed," "met acceptance criteria" | |
| Hemocompatibility | Based on ISO 10993-4:2002 | "Successfully completed," "met acceptance criteria" | |
| Physicochemical Tests | Based on ISO 10993-7:2008 | "Successfully completed," "met acceptance criteria" | |
| Sterilization | Ethylene Oxide Sterilization (Residuals) | Based on ISO 11135-1:2007, ISO 10993-7:2008 (Residuals) | "Successfully completed," "met acceptance criteria" |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document lists the types of tests performed but does not quantify the number of devices or iterations per test. This is typically found in the full test reports, not a 510(k) summary.
- Data Provenance: Not specified. Likely conducted in a laboratory setting by the manufacturer, Merit Medical Systems, Inc. The nature of the device (physical catheter) points to in-vitro and ex-vivo testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI diagnostic device. Ground truth for device performance tests would be based on validated measurement methods and instrumentation, not expert consensus on diagnostic images.
4. Adjudication method for the test set:
- Not applicable for the types of tests described (physical, chemical, biological testing of a catheter).
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:
- Not applicable. This is a medical device (catheter) for physical intervention, not an AI diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used:
- For the physical and mechanical tests, the "ground truth" is defined by established international and national standards (e.g., ISO, ASTM, USP) and the device's design specifications. Measurements are compared against these predetermined standards and specifications.
- For biocompatibility, the "ground truth" is defined by the toxicological profiles and acceptable limits set forth in the ISO 10993 series and USP standards.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).