Epic Medical Pte. , Ltd. · Class II · Cleared Jan 22, 2025
| K-number | K243976 |
| Device name | ZeroClear Bag Access (423100) |
| Applicant | Epic Medical Pte. , Ltd. |
| Product code | ONB |
| Device class | Class II |
| Decision date | Jan 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.5440 |
The ZeroClear™ Bag Access is a sterile, single-use component of the ProSeal™ Closed System drug Transfer Device (CSTD) used to safely transfer IV fluids and hazardous drugs from standard infusion bags to patients. It features a bi-directional Luer lock connector and mechanically prevents environmental contamination, drug vapor escape, and microbial ingress for up to 7 days when used as intended by healthcare professionals in clinical settings.
The subject device differs from the predicate in spike and medication port materials and connector types: the subject uses acrylonitrile butadiene styrene (ABS) spike and polycarbonate/silicone medication port versus the predicate's polypropylene spike and polyisoprene/polypropylene port. However, these materials are used in other cleared Epic devices (SMARTeZ™ Pump and eZSURE™ Empty Fluid Container) and undergo identical formulation, processing, sterilization, and geometry. Both devices maintain two access points, identical sterilization (ethylene oxide, SAL 10⁻⁶), and 3-year shelf-life.
ANSI AAMI CN27:2021, ISO 8536-4:2019, ISO 15747:2018, ISO 22413:2010, ISO 80369-7:2016, ISO 10993 series (biocompatibility), ISO 11135:2014 (sterilization), ASTM F88/F88M-21, ASTM F1980-21, ASTM F1929-23, EN 868-5:2009, ANSI/AAMI ST72/2019, USP <788>, and NIOSH 2016 CSTD performance test protocol.
Although materials differ from the predicate, the subject device's components are formulated, processed, and sterilized identically to materials already cleared in other Epic devices and perform equivalent functions. Comprehensive bench testing confirms the subject device meets or exceeds all applicable ISO and FDA-recognized standards for leak integrity, tensile strength, spike penetration, vapor containment, and microbial ingress. Biocompatibility and sterilization testing on related cleared devices support safety, and no new or different questions regarding safety or effectiveness arise from the material substitutions given equivalent performance validation over the device's shelf-life.
View the full FDA submission: accessdata.fda.gov