(58 days)
The ERBE APC Applicators' intended use is for the delivery of argon gas plasma energy for coagulation of tissue.
The APC Applicators are used with the ERBOTOM ICC Series Electrosurgery Units and ERBE's APC 300 (K963189) Argon Plasma Coagulator.
The APC Applicators are provided in various shaft lengths, shaft diameters, and bend angles to accommodate the variations in anatomical configuration of the target population and surgeon preference. The shaft lengths vary from 110 mm to 500 mm. The shaft diameters vary from 1.5 mm to 2.3 mm.
The APC Applicators work by using argon gas with a monopolar power source. The electrode in the argon channel of the applicator is connected to an electrosurgical generator. When high frequency voltage is high enough, and the proximity to tissue is close enough, electrically conductive argon plasma forms in the gas stream. This allows the current to flow between the applicator and the tissue. Current density upon arrival at the tissue surface causes coagulation. The application of the energy to the tissue is uniform and contact free. A silicon sleeve is available for APC Applicators with lateral openings at the distal end that are used in small lumen.
The APC Applicators' tips are either straight, curved, angled, or needle. The APC Applicators are made of PTFE shafts, ceramic tips, and Zytel and steel connector assemblies.
Both the flexible and rigid APC Applicators are provided non-sterile and are reusable using steam sterilization, whereas the other devices are provided sterile and are disposable. ERBE USA has conducted a sterilization validation per EN45001 to define and support the resterilization.
This 510(k) summary describes a device, ERBE APC Applicators, which is a reusable accessory for electrosurgery systems. The submission asserts substantial equivalence to predicate devices. However, the provided document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth, or adjudication methods.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is absent from the provided text.
The document primarily focuses on:
- Device Identification: Trade name, proprietary name, common name, classification, and product code.
- Predicate Devices: Listing of substantially equivalent legally marketed devices.
- Device Description: Explanation of how the APC Applicators work, their physical characteristics (shaft lengths, diameters, tips), materials, and reusability/sterilization.
- Intended Use: For the delivery of argon gas plasma energy for coagulation of tissue, specifically with ERBOTOM ICC Series Electrosurgery Units and ERBE's APC 300.
- Regulatory Correspondence: An FDA letter confirming the substantial equivalence determination and allowing the device to be marketed.
To answer your questions, details of performance testing or clinical studies would need to be present in the submission. For a device like this (an accessory to an electrosurgical unit), the focus of a 510(k) submission is typically on substantial equivalence to existing devices based on technological characteristics and intended use, rather than extensive clinical performance studies. Performance data, if any, would likely relate to safety aspects (e.g., electrical safety, biocompatibility, sterilization validation) and functional performance to demonstrate it performs as intended and is equivalent to predicates, usually through bench testing or limited animal/cadaver studies, not necessarily large-scale clinical trials with acceptance criteria for diagnostic accuracy or treatment efficacy as might be seen for AI/diagnostic devices.
§ 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.