(14 days)
The Q-Flo™ Closed Male Luer Connector is intended for use by healthcare professionals for connection with standard open female luers when reconstituting, dispensing/transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids.
The Q-Flo™ Closed Male Luer Connector is a sterile, non-pyrogenic, and single-use luer device. It enables clinical personnel to handle fluids, including hazardous materials such as chemotherapy, radioactive isotopes, and blood products when used in conjunction with a compatible female luer connector. This includes the preparation and administration of fluids to the patient and waste handling. This provides access for the administration of fluids from a container to a patient's vascular system through an administration needle or catheter which is inserted into an artery or vein.
The Q-Flo™ CML connector uses a sequential locking mechanism with a colored visual indicator to provide the user with confirmation of the status of the connection. There are three (3) connection states possible. When the device is not connected to a female luer it is closed and drip-less. When the device is connected to a female luer but the connection is deactivated, the visual indicator is not present and no flow is permitted. Continuing to turn the device and female luer connection together actuates the connection and opens the system to permit flow.
The Q-Flo™ CML connector utilizes the engagement of the luer threads to open the fluid path and, with the silicone sealing member, to provide a leak free state. The action of the thread engagement moves the male luer connector forward and visible to the used thus giving visual confirmation of full connection.
The Q-Flo™ CML connector has been designed with a weight and size to be consistent with IV administration set connections. It weighs less than 2.5 grams and is 12.8 mm in diameter.
The provided document describes the Q-Flo™ Closed Male Luer Connector and its nonclinical testing. This device is a medical apparatus and not an AI/ML device, therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) are not applicable to the information provided.
However, based on the nonclinical tests conducted, here's a summary of the acceptance criteria and the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Test Method | Acceptance Criteria | Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 | Met standard requirements | Passed |
| Dimensional and Performance | ISO 594-2 | Met standard requirements | Passed |
| Dimensional and Performance | ISO 8536-4 | Met standard requirements | Passed |
| Sterility Assurance | ISO 11137-2 | Met standard requirements | Passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The document indicates "Risk analyses were conduct for the Q-Flo™ Closed Male Luer Connector and design verification and validation tests were based on the results of those analyses." This implies multiple units were tested to ensure compliance with the standards, but the exact number is not given.
- Data Provenance: Not specified. It's internal testing conducted by the manufacturer, Infusion Innovations, Inc. The document is for a 510(k) submission to the FDA (USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnosis. The ground truth here is adherence to established international standards for medical devices.
4. Adjudication method for the test set:
- Not applicable. The testing involves standardized laboratory methods against established technical criteria, not human adjudication of results.
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 physical medical device, not an AI/ML system, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an AI/ML system. The device's performance is inherently "standalone" in that its physical properties and functionality are tested directly.
7. The type of ground truth used:
- The ground truth for this device is based on established international standards for medical devices (ISO 10993-1, ISO 594-2, ISO 8536-4, ISO 11137-2). Compliance with these standards indicates the device meets safety and performance requirements.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not an AI/ML system.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.