(199 days)
The Guarded Luer Connector is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container.
The Guarded Luer Connector (GLC) is a polypropylene, sterile device, single use product intended to provide the fluid path for transferring large source container ingredients into smaller containers. The product is offered in two configurations; Female Luer lock (57-400) and Female-Male Luer Lock (57-401); both configurations meet the intended use. The Guarded Luer Connector is a connector for connecting two devices with fittings conforming to ISO 80369-7 for intravascular connectors and ISO 8536-10 for fluid line accessories.
The provided text describes a 510(k) summary for a medical device called the "Guarded Luer Connector." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria. Therefore, several of the requested categories of information, particularly those related to clinical studies, human readers, ground truth establishment, and training data, are not applicable or not present in this type of regulatory submission.
However, based on the context of a 510(k) for a connector, the acceptance criteria would primarily revolve around engineering and material performance standards to ensure safe and effective fluid transfer.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance |
|---|---|---|
| ISO 80369-7:2016 | Compliance with requirements for small-bore connectors (6% Luer taper) for intravascular/hypodermic applications. | Met the bench testing requirements per ISO 80369-7:2016. |
| ISO 8536-10:2015 | Compliance with requirements for accessories for fluid lines for single use with pressure infusion equipment. | Met the bench testing requirements per ISO 8536-10:2015. |
| Shipping Shelf Life Evaluation | Device functionality and integrity maintained over its shelf life. | Design verification of the shelf life was performed. |
| Resistance to Override | Engineering specification for torque performance (likely similar to predicate). | Engineering study of torque performance specification for evaluation was done. |
| ANSI/AAMI/ISO 11737-2:2009 (R) 2014 & ISO 11135:2014 | Sterility Assurance Level (SAL) of 10-6. | Met 10-6 SAL requirement. |
| ANSI/AAMI ST72:2011 | Bacterial endotoxin level -6) |
- Biocompatibility (based on specific test results like cytotoxicity, sensitization, etc.)
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device.
Study Proving Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is the collection of bench testing, design verification, and biocompatibility testing as summarized in the document. The document states:
- "Guarded Luer Connector meets the bench testing requirements per ISO 80369-7... and ISO 8536-10..."
- "Compliance with these international standards demonstrates that the proposed cap device is substantially equivalent to the predicate device."
- "All pre-determined acceptance criteria were met."
- "The device Guarded Luer Connector passed all biocompatibility tests."
The primary goal of this FDA 510(k) submission is to demonstrate substantial equivalence to an already legally marketed predicate device (TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP, K900585), rather than proving novel efficacy. The testing (bench tests and biocompatibility) is used to show that despite minor design differences, the new device performs equivalently and safely according to recognized standards.
§ 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.