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K Number
K201689
Device Name
Riptide Aspiration System
Manufacturer
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Date Cleared
2020-07-21

(29 days)

Product Code
NRY
Regulation Number
870.1250
Type
Special
Panel
NE
Reference & Predicate Devices
K183185,K172448
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Device Description

The Riptide™ Aspiration System is composed of the following components:

  1. React™ Catheters
  2. Riptide™ Large Bore Aspiration Tubing
  3. Riptide™ Aspiration Pump
  4. RiptideTM Collection Canister with Intermediate Tubing
    No changes were made to the catheters, tubing or collection canister with intermediate tubing cleared in the predicate system under K172448 and, most recently, under K183185.
    The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide Aspiration System. The vacuum pressure of the Riptide Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.
AI/ML Overview

The provided text describes the 510(k) clearance for the Riptide™ Aspiration System, a medical device, and its performance data. However, it does not describe a study that proves the device meets acceptance criteria related to an AI/ML component. The document details the device's technical specifications, non-clinical bench testing, and comparison to a predicate device, which are standard for K201689. It is a traditional medical device submission and does not involve AI/ML.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as the provided text does not contain such a study or information.

If you have a document describing an AI/ML medical device and its validation study, please provide that, and I would be happy to analyze it according to your requested criteria.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).