21 CFR 880.6512 — Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves

General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6512

Identification

The HAI Solutions QIKCAP Device, used in conjunction with the single-use QIKCAP Cap, is a UVC treatment device intended to supplement manual needle-free luer connector instructions to 'scrub the hub' with CHG/IPA wipes. After conducting the protocol in the needle-free connector instructions for use, the QIKCAP Device applies UVC to the connector septum for 10 seconds to assist in reducing microbial contamination. The single use QIKCAP Cap also functions as a physical barrier, helping protect the connector from environmental contamination for up to 7 days if not removed.

Classification Rationale

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the QIKCAP System, and substantially equivalent devices of this generic type, into Class II under the generic name ultraviolet light-based microbial reduction device for luer-activated valves. FDA has determined that, for the previously stated indications for use, the QIKCAP System can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes

Special Controls

SGX — Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves

In combination with the general controls of the FD&C Act, the ultraviolet light-based microbial reduction device for luer-activated valves is subject to the following special controls: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Design verification testing to ensure the device meets its design specifications and performs as intended over its indicated shelf life and use life; (ii) Simulated use testing to demonstrate microbial reduction under worst-case conditions, including soiling and inoculation with clinically relevant microorganisms throughout the shelf life and use life of the device; (iii) Ultraviolet light safety evaluation, including ocular safety and byproduct evaluation that includes quantification of potentially hazardous byproducts (e.g., ozone per 21 CFR 801.415, reactive oxygen species) generated during the treatment cycle and demonstration that any identified byproducts remain below established safety limits; and (iv) An assessment demonstrating that ultraviolet light exposure does not adversely affect neither the luer-activated valve’s mechanical integrity or biocompatibility over its use life, nor the biocompatibility of the entrained fluid. (2) Reprocessing validation, including cleaning validation and validation of an appropriate microbicidal process, must be performed for reusable components. (3) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed for all software components of the device. (5) Human factors testing must demonstrate that the intended users can correctly and safely use the device for its intended use, based solely on its labeling. (6) Labeling must include the following: (i) A summary of the device's technical parameters and performance specifications; (ii) Validated reprocessing instructions; (iii) Shelf life and/or use life information; (iv) A statement regarding user adherence to both the luer-activated valve manufacturer's instructions for use and the manufacturer's instructions for use for any physical processing devices used on the luer-activated valve; (v) Instructions for any required maintenance; and (vi) Information about the luer-activated valves that can be used with the device.

De Novo Order DEN250004