(246 days)
The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.
The device is an intravascular catheter known by the trade name SUPERCATH 5. It is available in two models, with a check valve and without a check valve. The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The SUPERCATH 5 catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. Pressing the button on the needle hub activates the coiled spring in the hub, retracting the metallic introducer needle into the needle hub to prevent needlestick injury. The SUPERCATH 5 is available in 18G, 20G, 22G and 24G.
The provided document describes the safety and effectiveness testing for the SUPERCATH 5, an intravascular catheter with a sharp needle injury prevention feature.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Metal introducer needle completely retracts into the plastic needle hub after firmly pressing the safety button. (Critical for sharp needle injury prevention) | "No failures were observed in over 500 tests, under different test conditions and five (5) different catheter sizes of the SUPERCATH 5." This indicates 100% success rate in the simulated use study for the needle retraction mechanism. |
| Compliance with ISO and USP standards (General safety and effectiveness) | "All samples were compliant with the ISO and USP standards." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: "No failures were observed in over 500 tests" for the needle injury prevention feature. This indicates at least 500 tests were performed.
- Data Provenance: The study was conducted by TOGO MEDIKIT CO., LTD., a Japanese company. The document does not specify the country of origin for the data collection itself, but it implies it was part of their internal testing for FDA submission. The study was a "simulated use clinical environment," suggesting prospective data collection for this specific evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Eight (8) healthcare professional volunteers.
- Qualifications of Experts: They were described as "health care professional volunteers who routinely use this type of catheter in their clinical practice." Specific qualifications like "radiologist with 10 years of experience" are not provided, but their routine use of such catheters implies relevant experience.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The primary evaluation parameter was a direct observation of whether the metal introducer needle completely retracted. Since "no failures were observed," it implies a clearpass/fail outcome where no adjudication among multiple observers was necessary for discrepant findings, or if multiple observers were present, they all agreed on the absence of failure.
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 document does not describe an MRMC comparative effectiveness study involving AI or human readers. The device is an intravascular catheter with a safety feature, not an AI-powered diagnostic tool. Therefore, these metrics are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This document does not describe a standalone algorithm performance study. The device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the sharp needle injury prevention feature, the ground truth was direct observation by healthcare professionals in a simulated clinical environment. The success criterion was the physical complete retraction of the needle, which is an objective measurement verified by "expert" users. For compliance with ISO and USP standards, the ground truth was adherence to published technical specifications and testing protocols.
8. The Sample Size for the Training Set
The document does not mention a "training set" as this device is a physical medical device and not a machine learning model. Therefore, this metric is not applicable.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the context of machine learning) was used or described, this information is not applicable.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).