(261 days)
The Supercath 5 is intended to access a vein or artery and to administer fluids and/or blood. The Supercath 5 is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.
The Supercath 5 (Proposed) is intended to access a vein or artery and to administer fluids and/or blood. The Supercath 5 (Proposed) is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi. The Supercath 5 (Proposed) 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finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture.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. The Supercath 5 (Proposed) introducer needle has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein, blood flows up and through the side-notch and returns down along the inside of the catheter tube. The Supercath 5 (Proposed) is available in 14G, 16G, 18G, 20G, 22G, 24G and 26G.
The provided text is a 510(k) summary for the Supercath 5, an intravascular catheter. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria for diagnostic output.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance for an AI/diagnostic algorithm.
- Sample sizes used for a test set or data provenance for such a study.
- Number of experts or their qualifications for establishing ground truth for a test set.
- Adjudication methods for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance data.
- Type of ground truth used for an AI/diagnostic algorithm.
- Sample size for a training set.
- How ground truth for a training set was established.
The performance data mentioned in section "i. Performance data" (page 9) refers to engineering and biological performance tests for the catheter device itself, such as:
- Biocompatibility testing (e.g., hemocompatibility, according to ISO 10993-1).
- Catheter burst pressure test (according to ISO 10555-1).
- Vent fitting test for the needle hub (according to ISO 10555-5).
- Flow rate test (according to ISO 10555-1).
- Ease of assembly performance testing for the plunger (according to ISO 594-2).
- Tensile strength testing for the cap.
- Sterilization validation (according to ISO 11135) and shelf-life testing.
These tests are standard for medical device safety and functionality but are not related to the acceptance criteria or study design for an AI-powered diagnostic device as requested in the prompt.
In summary, the provided text does not contain the information required to answer the prompt because it pertains to the regulatory submission for a physical medical device (an intravascular catheter) and its engineering performance, not an AI/diagnostic software or algorithm.
§ 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).