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510(k) Data Aggregation
(126 days)
The ASAHI Corsair Pro is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature, and can be used to exchange one guide wire for another. The ASAHI Corsair Pro is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. This device should not be used in neurovasculature.
The ASAHI Corsair Pro 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 Corsair Pro has a tapered shape and is designed to have increased flexibility towards the distal end. The inner lumen of the catheter is PTFE 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.
The provided text describes the ASAHI Corsair Pro, a percutaneous catheter, and its substantial equivalence to predicate devices (ASAHI Corsair Microcatheter K151103, K083127). The document outlines the testing performed to demonstrate that the device meets acceptance criteria.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document states that "The in vitro bench tests demonstrated that the ASAHI Corsair Pro met all acceptance criteria." However, specific numerical acceptance criteria for each test (e.g., "Force at Break > X N") are not explicitly provided in this document. The table below lists the tests performed and the general statement of performance.
| Test Performed | Reported Device Performance |
|---|---|
| Appearance/Dimensions | Met all acceptance criteria and performed similarly to predicate devices. |
| Radio-Detectability | Met all acceptance criteria and performed similarly to predicate devices. |
| Slide Durability | Met all acceptance criteria and performed similarly to predicate devices. |
| Kink Resistance | Met all acceptance criteria and performed similarly to predicate devices. |
| Force at Break | Met all acceptance criteria and performed similarly to predicate devices. |
| Flexibility | Met all acceptance criteria and performed similarly to predicate devices. |
| Torque Transmission | Met all acceptance criteria and performed similarly to predicate devices. |
| Liquid Leakage under Pressure | Met all acceptance criteria and performed similarly to predicate devices. |
| Leak and Damage under High Static Pressure | Met all acceptance criteria and performed similarly to predicate devices. |
| Air Leakage | Met all acceptance criteria and performed similarly to predicate devices. |
| Corrosion Resistance | Met all acceptance criteria and performed similarly to predicate devices. |
| Torque Durability | Met all acceptance criteria and performed similarly to predicate devices. |
| Biocompatibility | All materials used are identical to the predicate device, demonstrating comparable biocompatibility. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the non-clinical tests.
The data provenance is from in vitro bench tests conducted by ASAHI Intecc Co., Ltd. The company is based in Nagoya, Aichi, Japan, with various branch offices and research facilities globally. The specific location where these tests were performed is not detailed. The tests are prospective in nature, as they are conducted on the new device to demonstrate its performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the study described is a series of non-clinical, in vitro bench tests. These tests assess physical and mechanical properties of the device against predefined engineering specifications, not clinical outcomes requiring expert interpretation or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the described study involves non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of medical images or data to establish a ground truth or resolve discrepancies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The provided document pertains to the regulatory submission for a medical device (a microcatheter), and the studies described are non-clinical bench tests. It is not an AI-based diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this content.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical instrument (microcatheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench tests, the "ground truth" refers to predefined engineering specifications and performance standards. The device's performance in each test is measured and compared against these established criteria, which are derived from industry standards, regulatory requirements, and the performance characteristics of the predicate device. There is no biological or clinical "ground truth" derived from expert consensus, pathology, or outcomes data in this context.
8. The sample size for the training set
This section is not applicable. The document describes non-clinical testing of a physical medical device, not a machine learning model or algorithm that typically requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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(148 days)
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.
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