(112 days)
The Merit ASAP® Aspiration Catheter is intended for the removal and thrombi and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
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 Merit ASAP aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm quide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm, 100 cm, and 110 cm proximal of the distal tip. The distal reqion has a hydrophilic coating. The rapid exchange lumen is 12cm in length. The ASAPLP Aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires. It is packaged Device with related accessories including a stiffening stylet. The catheter has Description a maximum outer diameter of 0.055"/0.140 cm and a working length of 145cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm. 100 cm and 110 cm proximal of the distal tip. The distal region has a hydrophilic coating. The rapid exchange lumen is 20 cm in length. The associated accessories packaged with the device include: Tubing Connector Set with (1) Large Bore Stopcock ● RXP® Rapid Exchange Prep Syringe ● (2) 30 mL VacLok™ syringes ● Microstop Waste Basin with Lid and (2) 70 Micron Pore Filter . Baskets
This document is a 510(k) premarket notification for a medical device (ASAP® Aspiration Catheter and ASAPLP™ Aspiration Catheter). The document does not describe a study that proves the device meets specific performance acceptance criteria for an AI/ML or diagnostic application.
Instead, this 510(k) notification focuses on demonstrating substantial equivalence to a predicate device. The "Performance Data" section primarily addresses biocompatibility and bench testing related to the physical integrity and safety of the catheter, rather than clinical or diagnostic performance criteria as you might see for an AI/driven device.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, human reader improvement with AI, ground truth, or training/test set data because this type of information is not present in the provided text.
The document states:
- "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." (Page 5)
- Performance testing was "conducted based on the risk analysis and based on the requirements of the following international standards" related to biocompatibility and physical characteristics (ISO 10555-1, ISO 80369-7, ISO 10993 series, USP 43-NF 37). (Page 5-6)
- "The results of the testing demonstrated that the subject ASAP® and ASAPLP™ Aspiration Catheters met the predetermined acceptance criteria applicable to the safety and efficacy of the device." However, the specific quantitative acceptance criteria for "safety and efficacy" related to the device's function (e.g., thrombus removal capabilities) are not detailed, nor is there a study described as you might see for a diagnostic AI. (Page 6)
The document is a regulatory submission for a physical medical device (catheter) based on substantial equivalence, not a performance study of a diagnostic or AI-powered device.
§ 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).