(58 days)
The ERBE APC Raspatory Handle and Tip's intended use is for the APC cutting and coagulation. The ERBE APC Raspatory Handle and Tip is used with the ERBOTOM ICC Series Electrosurgery Systems and Argon Plasma Coagulation devices (K963189). The Beacon Laboratories Argon Beam Laparoscopic Electrode also uses argon beam for coagulation, whereas the Valleylab Curved Spatula Tip Electrode uses general electrosurgical current for cutting and coagulation. All three devices target electrosurgical patients.
Argon Plasma Cutting and Coagulation
The ERBE APC Raspatory Handle and Tip and the two substantially equivalent devices meet the AAMI/ANSI HF-18 standard. The ERBE APC Raspatory Handle and Tip is made of a zytel shaft and a ceramic tip. Beacon Laboratories' Argon Beam Laparoscopic Electrode also uses a similar plastic shaft and a ceramic tip. The ERBE APC Raspatory Handle and Tip has a curved spatula-like configuration, which is substantially equivalent to Valleylab's Curved Spatula Tip Electrode. The Valleylab Curved Spatula Tip Electrode uses a similar plastic for the shaft, but uses a steel tip. ERBE has extensive experience in using ceramic tips for APC Applicators; ERBE APC Probes (K963189). The ERBE APC Raspatory Handle and Tip assembly's overall length is 8.5 inches. ERBE APC Raspatory Handle and Tip are two separate components that can be changed/replaced as required. The ERBE APC Raspatory Tip possesses three openings on the concave side of the palatine arch. The argon flows out of the middle opening of the raspatory tip while the side openings suction secretions and possible smoke plume.
ERBE APC Raspatory Handle and Tip is provided non-sterile and are reusable using steam sterilization, whereas the other devices are provided sterile (via Ethylene Oxide and Gamma Radiation) and are disposable. ERBE USA has conducted a sterilization validation per EN45001 to define and support the resterilization. ERBE's APC Raspatory Handle and Tip and Beacon's electrode use argon gas, whereas the Valleylab uses conventional electrosurgical current.
The provided text is a 510(k) summary for the ERBE APC Raspatory Handle and Tip. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study that demonstrates the device meets specific performance acceptance criteria.
Therefore, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria.
The 510(k) summary describes the device, its intended use, and identifies predicate devices. It mentions that the device and the predicate devices "meet the AAMI/ANSI HF-18 standard," and that "ERBE USA has conducted a sterilization validation per EN45001," but it does not provide details about the specific acceptance criteria within these standards, nor does it present a study report with performance metrics to prove the device met those criteria.
To answer the prompt, a different type of document, such as a detailed design validation report or a clinical study report, would be necessary.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.