(69 days)
General purpose solid state bipolar generator to supply RF signal to electrosurgical hand-pieces used on soft body tissue where a wide range of tissue types, patient conditions and load impedances are encountered. Where applicable (i.e., Auraplus, 28-2600) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.
The model 28-2000, Aura, 70 Watt Bipolar Electrosurgical Coagulator and the model 28-2600, Auraplus, 70 Watt Irrigating Bipolar Electrosurgical Coagulator model 20 2.000, haraphid state bipolar generators used to supply the RF signal to electrosurgical hand-pieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Where applicable (i.e., Auraplus) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.
This document describes Kirwan Surgical Products' 510(k) submission for their Models 28-2000 and 28-2600 Aura 70 Watt Bipolar Electrosurgical Coagulators. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in terms of clinical performance metrics. Therefore, several aspects of your request cannot be fully addressed from the provided text.
Here is the information that can be extracted or inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific clinical acceptance criteria (e.g., target accuracy, sensitivity, specificity) for the electrosurgical device itself, nor does it report device performance against such metrics. Instead, "acceptance criteria" are framed as compliance with recognized safety and performance standards for electrosurgical equipment.
| Acceptance Criteria Category | Specific Standard/Guideline | Reported Compliance |
|---|---|---|
| Electrical Safety | ANSI/AAMI/IEC 60601-1-2 (2001), Medical Electrical Equipment Part 1 | "found to comply with" |
| High Frequency Surgical Equipment Safety | IEC 60601-2-2 (1998), Medical Electrical Equipment Part 2 | "found to comply with" |
| Electrosurgical Devices | ANSI/AAMI HF 18 (2001), American National Standard for Electrosurgical Devices | "found to comply with" |
| Risk Management | ANSI/AAMI/ISO 14971:2000, Medical devices Application of risk management to medical devices | "hazard conditions for the Aura 70 range in the low-to-moderate level and for this reason are acceptable." |
| Software Validation | General Principles of Software Validation; Final Guidance for Industry and FDA Staff (issued January 11, 2002) | Implied compliance for aspects utilizing microprocessor technology |
| Premarket Submission Software Content | Guidance for FDA Reviewers and Industry. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 29, 1998) | Implied compliance for aspects utilizing microprocessor technology |
2. Sample Size for Test Set and Data Provenance
The document does not describe a clinical performance study using a "test set" in the context of typical AI/diagnostic device evaluation (e.g., a specific set of patient cases or images). The evaluation is based on engineering and safety standard compliance, which involves testing of the device hardware and software, rather than clinical data sets. Therefore, this information is not applicable or available in the provided text.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The ground truth for this type of device (an electrosurgical coagulator) is established through technical specifications, engineering validations, and adherence to recognized performance and safety standards, rather than expert consensus on clinical cases.
4. Adjudication Method for Test Set
Not applicable, as there is no described test set of clinical cases requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done because this is an electrosurgical device, not an imaging or diagnostic device that relies on human readers and AI assistance for interpretation.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical electrosurgical unit, not a standalone algorithm. While it contains microprocessor technology, its "performance" is assessed through its electrical and functional characteristics in accordance with engineering standards, not through "algorithm-only" performance in the sense of AI.
7. Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established by:
- Compliance with recognized electrical safety and performance standards (e.g., IEC 60601 series, ANSI/AAMI HF 18).
- Engineering validation of its specifications and operational parameters.
- Hazard analysis and risk management.
- Substantial equivalence to legally marketed predicate devices, implying that their proven safety and effectiveness extend to the new device given similar fundamental technology and compliance with standards.
8. Sample Size for Training Set
Not applicable. This device is not an AI/machine learning model where a "training set" of data is used in the traditional sense. The design and development process for an electrosurgical unit involves engineering design, component testing, and system integration, not training on a dataset.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning model. The analogous "ground truth" for the device's design and functionality would be the engineering specifications, performance requirements, and regulatory standards it was designed to meet.
§ 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.