(87 days)
The MegaDyne Mega 2000™ reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.
The MegaDyne Mega 2000™ reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. A two conductor cable to connect the device to a standard monopolar electrosurgical unit (ESU) is connected to the conductive layer of the electrode. This cable is insulated and strain-relieved well inside the device to prevent possible patient or user burns. The electrode is approximately 20'' x 36". This size is large enough to extend at least half the length and full width of the typical patient torso. The device is not intended to be attached to the patient. A clear plastic sheath is placed over the device. This sheath, which is replaced at a minimum each day, provides a second layer of dielectric protection.
This document is a 510(k) summary for the MegaDyne Mega 2000™ reusable patient return electrode. It outlines the device's description, intended use, and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Safety: Prevention of Patient Burns (low current density) | The current density of capacitively-coupled current flow is designed to be less than 100 mA per square inch at an ESU output of 700 mA rms. This low current density prevents the patient from getting return electrode site burns. |
| Functionality: Sufficient Current Flow for Electrosurgery | The large capacitive contact area between the electrode and the patient allows for enough current flow for electrosurgery to be performed at the surgical site. |
| Conformance to Standards (ANSI/AAMI HF 18-1993): Minimum Capacitance Requirement | Conformance to the minimum capacitance requirement of the ANSI / AAMI HF 18 standard is no longer claimed for the Mega 2000™. (This is a change from the predicate device). |
| Conformance to Standards (ANSI/AAMI HF 18-1993): Other applicable sections | With the exception of the requirement for minimum capacitance, the device conforms with all applicable sections of ANSI / AAMI HF 18-1993. |
| Sheath Replacement Frequency | The electrode sheath is to be replaced on at least a daily basis (as a maximum interval between changes). |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a test set in the conventional sense for a medical imaging or diagnostic device. The evaluation presented here is for an electrosurgical patient return electrode, focusing on electrical safety and functional characteristics, primarily through design specifications and conformance to standards. Therefore, information about a "test set" sample size or data provenance (country, retrospective/prospective) for a clinical performance study is not applicable to this submission. The "testing" appears to be engineering design and validation focused on achieving specific electrical and safety parameters.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As noted above, this submission does not describe a clinical study involving experts establishing ground truth for a test set. The safety and functional claims are based on engineering design, specified current densities, and expected adherence to industry standards.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as no clinical test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, and the document describes an electrosurgical patient return electrode.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Not applicable. This device is an electrosurgical patient return electrode, not an algorithm or AI system. Its function is physical and electrical contact for current return during electrosurgery, not the standalone processing of data or images.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on:
- Engineering Design Specifications: Such as designing for a current density of less than 100 mA per square inch.
- Conformance to Industry Standards: Specifically, ANSI / AAMI HF 18-1993 for electrosurgical devices, with the exception of the minimum capacitance requirement.
- Predicate Device Equivalence: The primary assertion for clearance is that the device is substantially equivalent to a legally marketed predicate device (K972273), implying that the predicate device's established safety and effectiveness serve as the "ground truth" for the new device's performance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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.