Search Results
Found 1 results
510(k) Data Aggregation
(148 days)
ASAHI Caravel
This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.
Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.
The ASAHI Caravel consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Caravel has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.
The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.
This document is a 510(k) Pre-Market Notification for the ASAHI Caravel microcatheter. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical effectiveness through a study with human readers or AI. Therefore, most of the requested information regarding AI performance, human expert adjudication, and MRMC studies is not applicable to this particular document.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "The in vitro bench tests demonstrated that the ASAHI Caravel met all acceptance criteria and performed similarly to the predicate devices." However, it does not provide a specific table with numerical acceptance criteria and corresponding performance metrics for each test. Instead, it lists the types of tests performed.
| Test Performed | Reported Device Performance | Acceptance Criteria (Not Explicitly Stated Numerically) |
|---|---|---|
| Appearance/Dimensions | Met all acceptance criteria | Implicitly, within specified design tolerances |
| Corrosion Resistance | Met all acceptance criteria | Implicitly, no significant corrosion observed |
| Force at Break | Met all acceptance criteria | Implicitly, sufficient mechanical strength |
| Liquid Leakage under Pressure | Met all acceptance criteria | Implicitly, no leakage under specified pressure |
| Air Leakage | Met all acceptance criteria | Implicitly, no air leakage |
| Leak and Damage under High Static Pressure | Met all acceptance criteria | Implicitly, integrity maintained under pressure |
| Radio-Detectability | Met all acceptance criteria | Implicitly, visible under fluoroscopy |
| Slide Durability | Met all acceptance criteria | Implicitly, maintained functional sliding over time |
| Kink Resistance | Met all acceptance criteria | Implicitly, resisted kinking under expected conditions |
| Shaft Flexibility | Met all acceptance criteria | Implicitly, possessed appropriate flexibility |
| Biocompatibility (Cytotoxicity, Intracutaneous Study, Sensitization, Systemic Toxicity, Hemolysis, In Vivo Thromboresistance, Partial Thromboplastin Time, C3a Complement Activation, Sc5b-9 Complement Activation, USP Pyrogen) | Found to be biocompatible (in accordance with ISO 10993) | Implicitly, no adverse biological reactions |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample size for each bench test conducted. It generally refers to "non clinical laboratory testing."
- Data Provenance: The tests were "non clinical laboratory testing" performed by the applicant (ASAHI Intecc Co., Ltd.), which is a Japanese company with research facilities and factories in various locations including Japan and Thailand. The data is retrospective in the sense that it was generated prior to this submission for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This document describes bench testing of a microcatheter, not an AI device requiring expert ground truthing of medical images or diagnoses.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, no expert adjudication was involved in establishing ground truth for this type of device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance:
- Not Applicable. This document is for a medical device (microcatheter), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
- Not Applicable. This is not an AI device.
7. The Type of Ground Truth Used:
- For the non-clinical bench tests (e.g., Force at Break, Corrosion Resistance, Leakage), the "ground truth" would be established by the physical and chemical properties of the materials and device design, measured directly or through standardized test methods.
- For Biocompatibility, the ground truth was established by adherence to ISO 10993 standards and the results of various biological tests.
8. The Sample Size for the Training Set:
- Not Applicable. This document does not describe the development or testing of an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As per point 8, no training set was used.
Ask a specific question about this device
Page 1 of 1