Search Results

This product is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary arterial vasculature and peripheral vessels, to facilitate placement of guidewires and other interventional devices, for use during two guidewire procedures, and to subselectively infuse/deliver diagnostic or therapeutic agents. Not for use in the neurovasculature.

The ASAHI SASUKE® Dual Lumen Catheter is a sterile single use device designed for use in the arterial vasculature. The ASAHI SASUKE® is a catheter that has two lumens: an over-the-wire lumen that extends across the length of the catheter, and a rapid exchange lumen installed at the distal end. This product consists of a tip, shaft, protector and connector. The surface of the distal section of the shaft of this product is coated with hydrophilic coating. In addition, a radiopaque marker is provided between the tip and the shaft of the product, enabling the user to view the position of the tip under X-ray fluoroscopy. The device packaging includes a needle to flush the lumens prior to use.

The provided document describes a medical device, the ASAHI SASUKE®, and its 510(k) premarket notification for substantial equivalence to existing predicate devices. The document highlights the device's indications for use, description, and a comparison with predicate devices, along with non-clinical testing performed.

However, the document does not contain the level of detail requested for a comprehensive description of acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device. The ASAHI SASUKE® is a physical medical device (a catheter), and the information provided pertains to its mechanical and biological performance, not an AI/ML algorithm's performance.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance in the context of an AI/ML device (e.g., sensitivity, specificity, AUC).
• Sample sizes used for a test set (in the context of AI/ML validation) or data provenance.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI/ML model.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
• Details about a standalone AI algorithm performance study.
• The type of ground truth used for AI/ML development.
• Sample size for a training set or how ground truth was established for training (as these are not relevant for a physical catheter).

Instead, the document details non-clinical laboratory testing for a physical catheter. The "Non Clinical testing / Performance Data" section lists various bench tests, and states:

"The in vitro bench tests demonstrated that the ASAHI SASUKE® met all acceptance criteria. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate and reference devices."

The listed tests include:

• Appearance/Dimensions
• Corrosion Resistance
• Force at Break
• Liquid Leakage under Pressure
• Air Leakage
• Radio-Detectability
• Slide Durability
• Kink Resistance
• Particulate and Coating Integrity testing

It also mentions Biocompatibility testing in accordance with ISO 10993, including:

• Cytotoxicity
• Intracutaneous
• Sensitization
• Systemic Toxicity
• USP Pyrogen
• Hemolysis
• Sc5b-9 Complement Activation
• In Vivo Thrombogenicity
• Partial Thromboplastin Time
• Platelet and Leukocyte Binding

Conclusion from the Document:
The ASAHI SASUKE® has the same intended use and indications, and the same or similar technological characteristics (design, materials, sterilization method, performance, and operating principles) as the predicate and reference devices. Performance data from these non-clinical tests successfully demonstrated that the device functions as intended and is substantially equivalent to the predicate and reference devices.

Summary based on the document's content (not an AI/ML study):

1. Table of acceptance criteria and reported device performance: Not provided in a tabular format with specific numerical criteria or performance metrics beyond a general statement that "met all acceptance criteria" and "demonstrate that the device functions as intended."

   • Acceptance Criteria (General): Catheter meets specified mechanical, physical, and biological properties for safe and effective use (e.g., no liquid/air leakage, sufficient force at break, kink resistance, radiodetectability, biocompatibility).
   • Reported Device Performance: "The in vitro bench tests demonstrated that the ASAHI SASUKE® met all acceptance criteria." and "Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate and reference devices."

2. Sample size used for the test set and data provenance: Not applicable in the context of AI/ML. The tests are benchtop performance tests of physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for catheter performance is typically based on engineering specifications and standardized test methods.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.

7. The type of ground truth used: Not applicable in the context of discerning AI output. For the physical device, the "ground truth" would be established engineering and biological standards for catheter performance.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In essence, the provided text describes the regulatory clearance for a traditional medical device (catheter) based on non-clinical bench testing and biocompatibility assessments, rather than an AI/ML powered device requiring extensive clinical validation or sophisticated ground truth establishment for algorithm performance.

Ask a specific question about this device