Vacuum Pump (Model: AD-VPUM-500)

The Vacuum Pump (Model AD-VPUM-500) is an electrically powered device used to collect egg cells (oocytes) from ovarian follicles during in vitro fertilization procedures. It provides vacuum levels ranging from -10 to -500 mmHg through intermittent suction and is supplied non-sterile for use with disposable vacuum lines, collection tubes, and retrieval needles.

Both subject and predicate devices use diaphragm pump technology with microprocessor electronic control, foot pedal activation, and multi-stage filtration. Key differences include ingress protection rating (IP42 vs IP41) and minor variations in operating/storage environmental specifications. Both achieve ±5 mmHg accuracy, 20-25 mL/min flow rate, and -500 mmHg boost capability.

Electric safety and EMC testing per ANSI AAMI ES60601-1:2005+A1:2012+A2:2021 and IEC 60601-1-2:2014+A1:2020; software validation per 2023 FDA guidance on device software; bench performance per ISO 10079-1:2022 and ISO 10079-4:2021 for medical suction equipment.

The subject device has identical indications for use, same fundamental vacuum generation technology, equivalent performance specifications, and same recommended clinical flow rates as the predicate COOK Vacuum Pump (K160753). Minor differences in ingress protection and environmental operating conditions do not raise safety or effectiveness concerns. Comprehensive testing demonstrates equivalent performance supporting substantial equivalence.