(175 days)
The Electrosurgical Generator – Model FW-350A is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.
Electrosurgical Generator-Model FW-350A has Monopolar and Bipolar modes that can satisfy the general requirements of electrosurgical field. The CQMS function can monitor the area of patient body applied with ESU pad during the operation every 40ps. Once the pad loses or that area shrinks, the computer will cut off all outputs within 40us to prevent patient from getting burnt. The PPS system ensure the safety of a constant output that send out compulsory stimulation at the initial instant of every CUT or COAG to make the operation process go smoothly. Moreover, the memory function can decrease the medical staff workload and human errors. At last, the Power ON self diagnostics function can diagnosis whether all working modes and functions are working normally and feedback information by code displaying and alarm voice prompt that the operational safety is improved greatly.
The provided text describes a 510(k) premarket notification for an Electrosurgical Generator, Model FW-350A. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on novel acceptance criteria and comprehensive study results as would be typical for a de novo submission or a new technology.
Therefore, the information available in the document primarily addresses the safety and performance of the device relative to existing standards and a predicate device. It does not contain an "acceptance criteria" table in the classical sense, nor detailed study results that prove the device meets these criteria in a standalone, statistically robust manner. Instead, the "acceptance criteria" are implied by compliance with recognized standards and a demonstration of comparable performance to the predicate device through bench testing.
Here's a breakdown of the information that can be extracted, interpreted based on the context of a 510(k) submission:
1. Table of Implied Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating equivalence to the predicate device and compliance with relevant safety standards. The reported device performance is presented in comparison to the predicate.
| Implied Acceptance Criteria (Based on Compliance & Predicate Comparison) | Reported Device Performance (FW-350A) |
|---|---|
| Safety and EMC Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 | Complies with IEC 60601-1: 2012, IEC60601-1-2: 2014, and IEC60601-2-2: 2009. |
| System Performance and waveform outputs: Comparable to predicate | Monopolar CUT, COAG, and Bipolar modes described with specific power settings (e.g., Pure cut: 350Wmax), load (500Ω), and crest factors. Waveforms are primarily 431kHz sinusoids with varying duty cycles/burst patterns. Minor differences from predicate (e.g., max power, specific waveform parameters, output frequency, Vp-p) are deemed not to raise new safety/effectiveness concerns. |
| Thermal effects: Comparable thermal damage to predicate | Thermal effects testing conducted on ex vivo animal tissues (porcine muscle, liver, and kidney). Thermal damage (size: length, width, depth of thermal zone) was measured at minimum, default, and maximum power settings. Comparison indicated minor differences from predicate do not affect safety. |
| Software Validation: Developed according to FDA guidance | Software designed and developed according to a software development process and was verified and validated, in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005." |
| Intended Use: Match predicate | "A non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area." – identical to predicate in essence, with minor phrasing differences. |
| Working Theories: Match predicate | Monopolar and Bipolar modes described, consistent with predicate's working principles. |
| CQMS (Contact Quality Monitoring System) Functionality: Comparable | FW-350A (CQMS): Alarm range: > 113ohms (split ESU pad). Predicate (REM): Alarm range |
§ 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.