(24 days)
The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.
The suction coagulator is a hand held electrosurgical device used for coagulation and aspiration during electrosurgical procedures. The device is available in two different configurations: hand controlled and foot controlled models. Both models are supplied with holsters.
The provided 510(k) submission (K072559) for the Megadyne Suction Coagulator does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This submission is a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical efficacy or performance studies with specific acceptance criteria as you might find for novel or higher-risk devices.
Here's a breakdown based on the provided text, indicating what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not present in the document. The submission discusses conformance to voluntary standards but does not list specific acceptance criteria or quantitative performance results from a device-specific study compared against those criteria.
2. Sample Size for Test Set and Data Provenance
Not present in the document. There is no mention of a test set, its sample size, or any data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not present in the document. No information about experts, ground truth establishment, or their qualifications is provided as there is no specific performance study detailed.
4. Adjudication Method for the Test Set
Not present in the document. Since no test set or expert evaluation is described, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not present in the document. No MRMC study or any comparison of human readers with/without AI assistance is mentioned. This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not present in the document. This device is a physical electrosurgical instrument; there is no "algorithm only" performance to evaluate.
7. Type of Ground Truth Used
Not present in the document. No ground truth establishment is described.
8. Sample Size for the Training Set
Not present in the document. As an electrosurgical device, it would not have a "training set" in the context of an algorithm or diagnostic model.
9. How the Ground Truth for the Training Set Was Established
Not present in the document. No ground truth for training is relevant or mentioned.
Summary of what is present and relevant to safety/performance, though not matching the requested structure:
- Conformance to Standards: "Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices." This indicates safety and basic performance testing was done against recognized industry standards, which is a common way to demonstrate safety and effectiveness for predicate-based devices.
- Substantial Equivalence: The primary "proof" in this 510(k) is the demonstration of substantial equivalence to predicate devices (MegaDyne Suction Coagulator K946327 and Valleylab's Lectrovac K791752) based on shared technological characteristics and intended use. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".
In essence, for this type of device and submission, the "acceptance criteria" are generally met by demonstrating compliance with established voluntary consensus standards and showing that the device is technologically similar and has the same intended use as a legally marketed predicate. Specific numerical performance metrics against detailed acceptance criteria from a dedicated clinical study are typically not required or provided in a 510(k) for such a device.
§ 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.