(71 days)
The SheathLess Eaucath Coronary Guide Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced. The guide catheter is intended to be used in the coronary vascular system.
The SheathLess Eaucath Coronary Guide Catheter is intended for use in coronary vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.
The SheathLess Eaucath Coronary Guide Catheter consists of a "Catheter" and · "Dilator". The catheter consists of a tube, which is to be inserted into vasculature, a proximal hub/connector, and strain relief/protector. This product is being offered in two sizes: 6.5Fr and 7.5Fr.
The provided document is a 510(k) Premarket Notification for a medical device, the SheathLess Eaucath Coronary Guide Catheter. It describes non-clinical testing/performance data to establish substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the context of an AI/ML device.
Therefore, many of the requested fields regarding acceptance criteria and a study design for an AI/ML device are not applicable to this document. The document focuses on demonstrating physical, mechanical, and biological properties of the catheter.
Here's an interpretation based on the provided text, while acknowledging the limitations for an AI/ML-centric request:
1. Table of acceptance criteria and the reported device performance
The document lists various non-clinical tests performed. While it doesn't explicitly state quantitative acceptance criteria in a table, the implied acceptance criterion for each test is that the device performs equivalently to or within acceptable ranges demonstrated by predicate devices. The "reported device performance" is summarized as the device "functions as intended, and is as safe and effective as its predicate."
| Test/Assessment | Implied Acceptance Criterion (General) | Reported Device Performance (Summary) |
|---|---|---|
| Corrosion resistance | Comparable to predicate devices; no unacceptable corrosion | Device performs as intended |
| Force at break | Comparable to predicate devices; adequate mechanical strength | Device performs as intended |
| Liquid leakage under pressure test | No unacceptable leakage | Device performs as intended |
| Air leakage into hub assembly during aspiration | No unacceptable air leakage | Device performs as intended |
| Kinking short term test | Resists kinking under normal use | Device performs as intended |
| Coating integrity / Particulate Evaluation | Maintained coating integrity; minimal particulate generation | Device performs as intended |
| Radiopacity | Sufficiently radiopaque for visualization | Device performs as intended |
| Dimensional Verification | Meets specified dimensions | Device performs as intended |
| Cytotoxicity | Non-cytotoxic | Meets biocompatibility standards |
| Intracutaneous / Irritation | Non-irritating | Meets biocompatibility standards |
| Sensitization | Non-sensitizing | Meets biocompatibility standards |
| Systemic Toxicity | Non-systemically toxic | Meets biocompatibility standards |
| In Vitro Hemolysis | Non-hemolytic | Meets biocompatibility standards |
| In Vivo Thromboresistance | Resists thrombus formation in vivo | Meets biocompatibility standards |
| Plasma Recalcification Time Coagulation | No adverse effect on coagulation time | Meets biocompatibility standards |
| C3a Complement Activation | No significant C3a complement activation | Meets biocompatibility standards |
| SC5b-9 Complement Activation | No significant SC5b-9 complement activation | Meets biocompatibility standards |
| Pyrogen | Non-pyrogenic | Meets biocompatibility standards |
| Visual inspection (Package integrity) | No defects; package intact | Device performs as intended |
| Seal strength test (Package integrity) | Package seal integrity maintained | Device performs as intended |
| Ethylene oxide sterilization evaluation | Effective sterilization | Meets sterilization standards |
| EO residuals | EO residuals within acceptable limits | Meets sterilization standards |
| Endotoxin | Endotoxin levels within acceptable limits | Meets sterilization standards |
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 sample sizes for individual non-clinical tests. It states that "Non clinical laboratory testing was performed." The data provenance would be from laboratory tests conducted by or for Asahi Intecc Co., Ltd. The document does not specify the country of origin of the data for these tests, but the applicant and some facilities are in Japan. These tests are inherently prospective as they are conducted for the purpose of this premarket notification.
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)
Not applicable. This is a medical device (catheter) 510(k) submission, not an AI/ML device. Ground truth is not established by human experts in this context, but rather by standardized laboratory testing methods and measurements following established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human expert evaluations, typically for AI/ML performance assessment. For physical device testing, results are objective measurements from laboratory equipment and methods.
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
Not applicable. This is a medical device (catheter) 510(k) submission, not an AI/ML device. MRMC studies are used for evaluating diagnostic performance, often with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (catheter) 510(k) submission, not an AI/ML device. Standalone algorithm performance refers to the performance of an AI model without human intervention.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, "ground truth" for the non-clinical tests would be established by:
- Standardized measurements: Ensuring dimensions meet specifications, force at break values, etc.
- Established laboratory protocols: For biocompatibility (e.g., ISO standards for cytotoxicity, sensitization), sterility (e.g., EO residuals), and material properties.
- Comparison to predicate devices: Implicitly, the performance of the predicate devices in these tests sets a comparative "ground truth" for substantial equivalence.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which a training set would be used in this context.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model for which a training set ground truth would be established in this context.
§ 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).