(151 days)
The Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils and adenoids.
The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.
The provided text describes the 510(k) submission for the PEAK Suction Coagulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the manner typically seen for novel diagnostic or AI-driven devices.
Therefore, the information required to populate most of the acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not available in the provided document.
Instead, the submission relies on:
- Comparison to a predicate device (Valleylab Suction Coagulator): The primary claim is that the PEAK Suction Coagulator is "substantially equivalent" due to similar output energy, delivery system, blade specifications, and the use of monopolar electrosurgery for tissue coagulation.
- Compliance with recognized standards: The device met various IEC and ISO standards related to electrical safety, electromagnetic compatibility, surgical equipment safety, sterilization, and biocompatibility.
- Histological studies: These were conducted to compare the thermal effects of the PEAK Suction Coagulator to the predicate device, aiming to show similar safety and effectiveness. The specific acceptance criteria for these histological studies are not detailed, nor are the number of samples, ground truth establishment, or expert involvement.
Here's a breakdown of what can be gathered from the document, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as inferred/stated) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Similar output energy | Similar to predicate device |
| Similar delivery system | Similar to predicate device | |
| Similar blade specifications | Similar to predicate device | |
| Monopolar electrosurgical device | Similar to predicate device | |
| RF powered distal ends | Similar to predicate device | |
| Safety (Thermal Effects) | Thermal effects comparable to predicate device | Histological studies demonstrated substantial equivalence to predicate device. |
| Functionality | Function as intended (coagulation of tissue, aspiration of fluids) | Laboratory and performance tests executed to ensure function as intended. |
| Electromedical Standards | IEC 60601-1 (General Safety) | Complies with standard |
| IEC 60601-1-2 (EMC) | Complies with standard | |
| IEC 60601-2-2 (HF Surgical Eq.) | Complies with standard | |
| Sterilization | ISO 11135-1 (EO Sterilization) | Complies with standard |
| Biocompatibility | ISO 10993-1 (Guidance on Tests) | Complies with standard |
| ISO 10993-7 (EO Residuals) | Complies with standard |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified for the histological studies or laboratory/performance tests.
- Data Provenance: Implied to be laboratory tests and histological studies, conducted for this regulatory submission. No information on country of origin or whether it's retrospective/prospective.
3. Number of Experts Used to Establish Ground Truth & Qualifications
- Number of Experts: Not specified.
- Qualifications: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of histological comparisons, it would typically involve expert pathologist review, but the method isn't described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, this type of study is not mentioned. The device is a surgical instrument, not a diagnostic imaging AI, so an MRMC study comparing human readers with and without AI assistance is not applicable here. The comparison is between the device and a predicate device/standards.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable in the context of an electrosurgical device. The device itself is a tool used by a human surgeon. Its performance is evaluated through its physical and electrical characteristics, and its effects on tissue.
7. The Type of Ground Truth Used
- For the "Safety (Thermal Effects)" criterion, the ground truth was likely derived from histological examination by qualified personnel (e.g., pathologists) comparing tissue effects between the PEAK Suction Coagulator and the predicate device.
- For other criteria, the "ground truth" would be established by compliance with published international standards (IEC, ISO) and internal design specifications.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This document describes a medical device requiring regulatory clearance based on substantial equivalence, not an AI/ML algorithm that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no "training set" in this context.
§ 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.