(60 days)
This microcatheter is a medical device intended for angiography and/or infusion of various substances including diagnosis, embolization and treatment in the peripheral vasculature using an appropriate guide wire. The microcatheter is not intended for use in neurovasculature, coronary arteries and carotid arteries.
The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 Microcatheters are sterile single use devices designed for use in the peripheral vasculature. The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 consist of a catheter shaft that is reinforced with braid wires to enhance pushability and maintain patency of the inner lumen. A radiopaque marker is fixed on the distal end of the catheter shaft to facilitate location of the catheter during angiography. The distal portion of the catheter shaft is flexible and available in two shapes, straight and angled, to provide improved trackability in tortuous vessels. A hydrophilic coating is applied on the outer surface of the catheter to provide a smooth transition. In addition, accessories, including either a stylet, syringe and RHV (rotating hemostasis valve), or a stylet, syringe, inserter and hemostasis valve are available for use with the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3.
The provided text describes a 510(k) premarket notification for various microcatheters (ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus, ASAHI Tellus C3). This document serves as a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets acceptance criteria for an AI/ML medical device.
Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device cannot be extracted from this document. The document primarily focuses on the mechanical, material, and biocompatibility performance of a physical medical device (microcatheter) and its substantial equivalence to existing devices.
However, I can extract the information related to the performance testing and acceptance criteria for the physical microcatheter device as detailed in the document.
Acceptance Criteria and Device Performance (for the physical microcatheter device)
The document details non-clinical laboratory testing and biocompatibility testing conducted to demonstrate the substantial equivalence of the ASAHI microcatheters.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from 'Result' column for non-clinical) / Explicit for Biocompatibility | Reported Device Performance |
|---|---|---|
| Non-Clinical Laboratory Testing | ||
| Appearance/Dimensions/Tip Shape | Met specified requirements | Pass |
| Corrosion resistance | Met specified requirements | Pass |
| Peak tensile Strength | Met specified requirements | Pass |
| Tip Flexibility | Met specified requirements | Pass |
| Liquid leakage | Met specified requirements | Pass |
| Radio-detectability | Met specified requirements | Pass |
| Air Leakage | Met specified requirements | Pass |
| Burst Pressure | Met specified requirements | Pass |
| Flow Rate | Met specified requirements | Pass |
| Power Injection | Met specified requirements | Pass |
| Kink Resistance | Met specified requirements | Pass |
| Slidability | Met specified requirements | Pass |
| Connector | Met specified requirements | Pass |
| Coat integrity / Particulate Evaluation in a clinically relevant model | For characterization only (not a pass/fail acceptance) | This testing is for characterization only. |
| Torque Strength | Met specified requirements | Pass |
| Biocompatibility Testing (for ASAHI Tellus, representative model) | ||
| Cytotoxicity (MEM Elution Test) | No signs of cellular reactivity (Grade 0) for both negative control and medium control | Non-cytotoxic |
| Sensitization (KLIGMAN Maximization Test) | No evidence of causing delayed dermal contact sensitization in guinea pig | Non-Sensitizing |
| Irritation (Intracutaneous Injection Test) | Test extract and negative control must exhibit similar edema and erythema scores | Non-Irritant |
| Systemic Toxicity (Acute Systemic Toxicity Test) | Must not show significantly greater biological activity than the control | No Systemic Toxicity |
| Systemic Toxicity (Rabbit Pyrogen Test - material mediated) | Not increase rectal temperature of any animals by more than 0.5 degrees Celsius | Non-pyrogenic |
| Hemocompatibility (Rabbit Blood Hemolysis Test) | Non-hemolytic | Non-hemolytic |
| Hemocompatibility (Unactivated Partial Thromboplastin Time Test) | UPTT of plasma exposed to test article extract should not significantly decreased compared to untreated and negative controls | Minimal activator |
| Hemocompatibility (Complement Activation Assay - SC5b-9) | No significant increase in SC5b-9 when compared to activated NHS and negative control after 60 minutes exposure | Not an Activator |
| Hemocompatibility (Thrombogenicity Study in Dogs) | Compare results of test article to predicate control for Thrombogenic response. Determine acceptability as part of risk management. | Thromboresistant |
Regarding the AI/ML-specific details (Items 2-9 from your prompt):
The provided document is a 510(k) summary for a physical medical device (microcatheter), not an AI/ML-driven software device. Therefore, information related to:
- Sample size for test set and data provenance: Not applicable. Tests were bench/in-vitro and animal studies for device performance and biocompatibility.
- Number of experts and qualifications for ground truth: Not applicable. Performance data is from physical tests. Biocompatibility standards are specific laboratory tests.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human reading.
- Standalone (algorithm only) performance: Not applicable. This is a physical device.
- Type of ground truth used: For non-clinical tests, the ground truth is the physical measurement and functional assessment against specified engineering criteria. For biocompatibility, it's defined by the specific ISO standards and their pass/fail criteria.
- Sample size for training set: Not applicable (no AI/ML model training).
- How ground truth for training set was established: Not applicable.
In conclusion, this document demonstrates the safety and effectiveness of a microcatheter through standard predicate comparison, non-clinical bench testing, and biocompatibility studies, which are typical requirements for such devices. It does not contain any information about an AI/ML component or its associated validation studies.
§ 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).