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VOMED insufflation needles are reusable devices for temporary use in conjunction with FDA-cleared insufflators to blow gas or powder into a tube, cavity, or organ. They are generally used as accessories to devices that provide access, illumination and visualization of internal structures and for manipulating soft tissuc. The devices are indicated for therapeutic and diagnostic laparoscopic and urological procedures.

VOMED suction and irrigation tubes and handles are reusable accessories designed for the suction of fluids from wounds and body cavities and/or the irrigation of surgical sites. They are general accessories of devices that provide access, illumination and visualization of internal structures and for manipulating soft tissue. The suction and irrigation devices are indicated for therapeutic laparoscopic and urologic procedures.

VOMED insufflation needles are reusable devices for temporary use in conjunction with FDA-cleared insufflators. VOMED suction and irrigation tubes and handles are reusable accessories.

The provided document is a 510(k) premarket notification letter from the FDA to VOMED Volzer Medizintechnik GmbH & Co. concerning their Endoscopic and Urologic Accessories, specifically VOMED Insufflation Needles and VOMED Suction & Irrigation Devices. This type of document declares substantial equivalence to a predicate device, allowing the device to be marketed.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter focuses on regulatory approval based on substantial equivalence, meaning the device is considered as safe and effective as a legally marketed predicate device. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and performance characteristics (if applicable) as the predicate.

Therefore, I cannot provide the requested information from this document. The document primarily serves as an FDA clearance letter and does not detail the technical studies that would typically lead to acceptance criteria and performance data.

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