(83 days)
The Surns Electrosurgical Argon Beam Generator and Accessories are indicated for monopolar or bipolar surgery to achieve argon beam and cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.
Surn5 electrosurgical argon beam Generator and accessories have Monopolar Pure cut, Monopolar Bland Cut, Argon Beam, Bipolar functions. Surn5 electrosurgical argon beam Generator and accessories consists of HF generator and accessories. The device generates HF power, which is transmitted to the tissue through the output Pencil. Operator selects the output function and power with the front panel. The indicator is used to indicate the setup status and output status of the device. The output is controlled by foot or hand switch.
This document K203522 is a 510(k) premarket notification for an electrosurgical argon beam generator. This specific device is regulated under 21 CFR 878.4400, "Electrosurgical Cutting and Coagulation Device and Accessories," which falls under Class II.
The document does not describe a study involving human subjects, AI/algorithm performance, or the establishment of ground truth by expert consensus for medical imaging. Instead, it discusses the safety and effectiveness testing for an electrosurgical device, primarily focusing on non-clinical performance data to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested criteria regarding AI/ML performance, sample sizes for data sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable to the content provided in this 510(k) summary.
However, I can extract the information that is present regarding the non-clinical acceptance criteria and the tests performed.
1. Table of acceptance criteria and the reported device performance:
The document outlines the non-clinical performance tests performed. While it doesn't provide specific quantitative acceptance criteria or detailed numerical results, it lists the standards to which the device was tested and states that the tests were "successfully completed."
| Test Category | Acceptance Standard (Implicitly met if "successfully completed") | Reported Device Performance |
|---|---|---|
| General Safety Testing | IEC 60601-1:2005+C1+C2+A1:2012 Medical electrical equipment, Part 1 General requirements for basic safety and essential performance | "Medrange completed successfully the following non-clinical performance tests" - implying compliance with the standard for basic safety and essential performance. |
| EMC Safety Testing | IEC 60601-1-2:2014 (Edition 4.0) Medical electrical equipment, Part 1-2 General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests | "Medrange completed successfully the following non-clinical performance tests" - implying compliance with the standard for electromagnetic compatibility. |
| HF Safety Testing | IEC 60601-2-2:2017 Medical electrical equipment, Part 2-2 Particular requirements for the basic safety and essential performance of high frequency - Surgical equipment and high frequency surgical accessories | "Medrange completed successfully the following non-clinical performance tests" - implying compliance with the standard for high-frequency surgical equipment safety and performance. |
| Performance Testing | Applicable parts of FDA Guidance Document "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery”, May 2016 | "Medrange completed successfully the following non-clinical performance tests" - implying the device met the performance requirements outlined in the FDA guidance for electrosurgical devices. |
| Usability Testing | IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part 1-6 General requirements for safety - Collateral Standard: Usability | "Medrange completed successfully the following non-clinical performance tests" - implying the device met the usability requirements, ensuring that the device can be used safely and effectively as intended. The "software data" mentioned in the statement of substantial equivalence would likely fall under this, or be part of performance testing. |
Summary Judgement on Acceptance: The document states that the tests were "successfully completed" and concludes that the device is "as safe and effective as the predicate device," thus fulfilling "the requirements of a substantially equivalent device."
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable in the context of this 510(k). The tests are typically conducted on a single prototype or representative units of the device in a laboratory setting, not on a "test set" of patient data or images.
- Data provenance: Not applicable. The tests are in vitro or ex vivo engineering and electrical performance tests, not based on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is an electrosurgical generator, not an AI/ML algorithm requiring expert annotation of medical images for ground truth. The "ground truth" here refers to established engineering standards and device specifications.
4. Adjudication method for the test set:
- Not applicable. Testing is against predefined electrical, mechanical, and safety standards, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This document concerns a surgical energy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The performance of the device itself (e.g., power output, frequency, safety features) is tested in a standalone manner against engineering standards.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on International Electrotechnical Commission (IEC) standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6) and applicable sections of FDA Guidance Documents ("Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery”).
- Additionally, comparison to a legally marketed predicate device's technological characteristics (e.g., power outputs, waveforms, system voltage) serves as a comparative "ground truth" to establish substantial equivalence.
8. The sample size for the training set:
- Not applicable. There is no AI/ML component described, so no "training set."
9. How the ground truth for the training set was established:
- Not applicable, for the same reason as above.
§ 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.