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510(k) Data Aggregation
(379 days)
The Arterial Catheter permits access to the peripheral arterial circulation.
The Arterial Catheter is a lumen peripherally inserted catheter assembly designed to perform short term access to the peripheral arterial circulatory system for less than 7 days, it is also intended to be used for pressure monitoring. It consists of an introducer needle or catheter-over-needle assembly, spring guide wire, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a flex tube end cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique, which divided into three types according to structure: Standard Seedinger; Modified Seedinger-Integrated; Modified Seedinger-Sleeve. The Arterial Catheter is available in 18 ga, 20 ga, 21 ga, 22 ga and 24 ga, the corresponding diameter of guide wire is 0.025", 0.018", 0.015", 0.012". Configurations with usable lengths of 2.5 cm to 23 cm. The catheters are attached to an injection molded polyurethane hub with Luer lock fittings for access attachment. The Arterial Catheter is provided sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Arterial Catheter, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria (e.g., "flow rate must be > X mL/min"). Instead, it lists the types of performance tests conducted and generally states that the device "comply with" standards and that "performance is acceptable."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance (General) | Complies with FDA guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" and ISO 10555-1:2013 |
| Visual Assessment | Performed (implies satisfactory-unless stated otherwise) |
| Corrosion Resistance | Performed (implies satisfactory-unless stated otherwise) |
| Liquid Leakage Testing | Performed (implies satisfactory-unless stated otherwise) |
| Air Leakage Testing | Performed (implies satisfactory-unless stated otherwise) |
| Flow Rate Testing | Performed (implies satisfactory-unless stated otherwise) |
| Catheter Tensile Testing | Performed (implies satisfactory-unless stated otherwise) |
| Guidewire Tensile Testing | Performed (implies satisfactory-unless stated otherwise) |
| Dimensional Verification | Performed (implies satisfactory-unless stated otherwise) |
| Simulated Use and Simulated Blood Withdrawal | Performed (implies satisfactory-unless stated otherwise) |
| Kink Testing | Performed (implies satisfactory-unless stated otherwise) |
| Torque Strength Testing | Performed (implies satisfactory-unless stated otherwise) |
| Radiopacity Testing | Performed (implies satisfactory-unless stated otherwise) |
| Needle Testing (Visual assessment; Tensile strength of needle and hub; Penetration force) | Performed (implies satisfactory-unless stated otherwise) |
| Shelf Life | 3 years (validated by accelerated aging tests, "performance is acceptable") |
| Biocompatibility | Meets requirements of Biocompatibility, in compliance with ISO 10993-1. Material is biocompatible. |
| Sterilization Packaging | Complies with ISO 11607-1:2016 |
| Sterilization Process | Complies with ISO 11135:2014 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the non-clinical performance tests. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective) for these tests, as they appear to be laboratory-based engineering performance evaluations rather than clinical data involving human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable and not provided. The "ground truth" for these tests would be established by the physical and chemical properties of the device and its direct performance against defined engineering standards, not by expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for interpretation of results or image assessment, not for direct engineering performance tests.
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
No MRMC comparative effectiveness study was mentioned. The device is an arterial catheter, a physical medical device, not an AI-powered diagnostic tool. Therefore, human reader improvement with/without AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable, as the device is a physical medical instrument and not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the non-clinical performance tests (e.g., flow rate, tensile strength, leakage) is established by adherence to recognized engineering standards (e.g., ISO 10555-1, ISO 10993-1, ISO 11607-1, ISO 11135) and the physical properties and measured performance of the device against predefined specifications derived from those standards. For biocompatibility, it's based on the material's interaction with biological systems as assessed by specific tests.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical instrument, not a learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for a physical medical device like this catheter.
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