FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The intended use of the Patient Safe® Luer Cap is to cover male luer fittings (luer lock and luer slip), to reduce the risk of touch contamination and medication leakage.

Device Description

The Patient Safe® Luer Cap is for use on luer tips of other devices to prevent leakage and contact and/or environment contamination during transport to patient area.

AI/ML Overview

The Patient Safe® Luer Cap is designed to cover male luer fittings (luer lock and luer slip) to reduce the risk of touch contamination and medication leakage.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Device Performance
Liquid Leakage Prevention	Confirmed through testing in accordance with FDA Recognized Standard ISO 594-1. The device effectively reduces medication leakage.
Touch Contamination Reduction	Satisfied all requirements of a simulated use study. The device protected the luer tip from touch contamination.
Ease of Use by Clinician	Satisfied all requirements of a simulated use study. The device demonstrated ease of use for clinicians while promoting aseptic technique.
Biocompatibility	Biocompatibility testing performed on all materials yielded acceptable results.
Substantial Equivalence	The device is substantially equivalent to the predicate device (K801311 - Burron Multi-AD Syringe Cap) in design, technological characteristics, materials, and intended use, raising no new issues of safety and effectiveness.
Aseptic Technique Promotion	Demonstrated in the simulated use study, where the device effectively supported aseptic technique.
Compatibility with Luer Tips	The simulated use study involved attachment to six (6) different types of luer tips, demonstrating effective use across these variations.
Prevention of Environmental Contamination (during transport)
The Patient Safe® Luer Cap's description and intended use specify it is for use on luer tips of other devices to prevent leakage and contact and/or environment contamination during transport to patient area. The simulated use study demonstrated its ability to protect the luer tip, which implicitly covers preventing environmental contamination during transport as part of preventing touch contamination.

2. Sample size used for the test set and the data provenance

Liquid Leakage Testing:

Sample Size: Not explicitly stated, but performed "in accordance with FDA Recognized Standard ISO 594-1." This standard would dictate the required sample size for such testing.
Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Retractable Technologies, Inc. (prospective).

Simulated Use Study:

Sample Size: The device was attached to "six (6) different types of luer tips." The number of unique clinicians or repeated trials per luer tip is not specified.
Data Provenance: Conducted by Retractable Technologies, Inc. (prospective, internal study). The country of origin is implicitly USA, where Retractable Technologies, Inc. is based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. The studies described are engineering and simulated use studies involving objective measurements and evaluations against a protocol, rather than subjective expert interpretation of data.
Qualifications of Experts: N/A

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. The studies described (liquid leakage and simulated use) appear to involve objective measurements and evaluation against predefined criteria from a protocol, rather than a consensus-based adjudication of subjective findings.

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

MRMC Study: No. This device is a passive mechanical luer cap, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Study: Yes, in effect. The liquid leakage testing and the simulated use study represent standalone performance evaluations of the device itself (analogous to "algorithm only" in the context of a physical device), without direct human intervention impacting the performance metrics being measured (though human clinicians were involved in the use during the simulated use study, their individual performance wasn't being measured, rather the device's ability to protect the luer tip).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Liquid Leakage Testing: The ground truth for leakage was established by the requirements and measurement methods defined in FDA Recognized Standard ISO 594-1. This is an objective, standardized metric.
Simulated Use Study: The "ground truth" for success was defined by the "requirements of the protocol" which addressed protection from touch contamination, liquid leakage, and ease of use. These are objective criteria established by the manufacturer.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is a passive mechanical component, not an AI/ML algorithm that requires training data.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).