Uterine Aspiration Set

The Uterine Aspiration Set is used with a vacuum system to remove products of conception or menstrual tissue from the uterus through transcervical aspiration. It consists of rigid and flexible uterine aspiration curettes and a tubing set with a swivel handle. All components are single-use, sterile, and ethylene oxide sterilized.

The proposed device uses materials including SBC propionate, ABS, LDPE, and PVC, with curette sizes ranging from 4–16 mm and tubing lengths of 1.8–3 m. It is compatible with devices complying with ISO 10079-1 and systems with maximum vacuum ranges below 98 kPa. The design includes adjustable suction control via a sliding ring on the vacuum control hole.

Biocompatibility testing per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (sensitization), and ISO 10993-23:2021 (irritation). Sterilization validation per ANSI/AAMI/ISO 10993-7:2008 for ethylene oxide residuals. Bench testing included appearance, dimensions, connection firmness, leak tests, negative pressure tests, and patency verification.

The device has identical intended use, regulatory classification (Class II), product code (HHK), and sterilization method (ethylene oxide) as the predicate Berkeley® vacuum curettage system components. Technological characteristics are substantially similar in materials, sizes, design, and function. Non-clinical bench testing demonstrates equivalent performance, and the device does not raise new safety or effectiveness concerns.