(49 days)
This device is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators.
Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.
The MegaSoft Universal Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two symmetric layers of a viscoelastic polymer called Akton® The Akton polymer is encapsulated by a layer of urethane film. One twoconductor cable connects the conductive layer of the device to a two conductor DetachaCable . The DetachaCable is connected to a standard monopolar electrosurgical unit (ESU). The device cable is insulated, strain-relieved, and connected well inside the device to prevent patient or user burns. In use, this device will lay on the operating surface with the patient lying on either side of the pad.
The pad size is approximately 36" x 20" x 0.135" and is intended for patients weighing ≥ 0.8 lb (350 grams).
The provided text is related to a 510(k) submission for a medical device called the "MegaSoft Universal Patient Return Electrode." It describes the device, its intended use, and its technological characteristics, and references adherence to voluntary safety standards (IEC 60601-1:2005 and IEC 60601-2-2:2009).
However, the document does not contain information about:
- Specific acceptance criteria with numerical targets.
- A detailed study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Standalone algorithm performance or comparative effectiveness studies (MRMC study) for an AI device. The described device is a physical electrode, not an AI/software device.
- Training set details for an AI model.
Therefore, many of the requested fields cannot be populated from the provided text. The device is a physical electrosurgical accessory, and the regulatory submission heavily relies on demonstrating equivalence to a predicate device and adherence to industry safety standards through testing, rather than a clinical effectiveness study with AI-specific metrics.
Here is what can be extracted based on the provided text, and noted where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards: | |
| Conformance to IEC 60601-1:2005 (General requirements for safety and essential performance) | Megadyne has conducted extensive testing to ensure conformance to this standard. |
| Conformance to IEC 60601-2-2:2009 (Particular requirements for the safety of high frequency surgical equipment) | Megadyne has conducted extensive testing to ensure conformance to this standard. |
| Current Limiting: | |
| Current limiting to prevent patient return electrode site burns. | Device is designed to be current limiting ( |
§ 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.