(137 days)
The Suction Coagulator is a single use device intended for use in surgical procedures (such as general and ENT procedures) where the coagulation of tissue and suction of fluids are desired.
The Valleylab Suction Coagulators are hand held electrosurgical devices used for the coagulation of tissue and aspiration of fluids during electrosurgical procedures. The devices are activated by a plastic button with a spring contact located in the handle of the device. The suction is activated by the surgeon placing a finger over the suction vent hole also in the handle.
The Suction Coagulators are a disposable, hand held device used in electrosurgical procedures. It provides control of both monopolar coagulation of tissue and suction of fluids in a single handle. The coagulation mode of operation is activated by a depressing a plastic button located on the top of the body. The activation of suction is activated by the surgeon's finger covering the suction port. Coagulation takes place at the uninsulated end of the suction tube. The Suction coagulator consists of four main elements:
-a metal, insulated, French sized tube
-a switching mechanism
-a two piece molded plastic body
-a cord with plug
The Suction Coagulator is supplied sterile and can be used with various electrosurgical generators.
The provided text describes a 510(k) summary for the Valleylab Suction Coagulators. It details the device, its intended use, and non-clinical as well as clinical testing.
Here's the analysis of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria with numerical thresholds. Instead, it states that:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Proper Device Function | Bench Testing and verification testing was conducted to ensure proper device function. This included testing to the relevant electrical standards (IEC 60601-1 and IEC 60601-2-2). |
| Safe and Effective Use | No clinical testing was conducted. The use of Electrosurgical Suction Coagulators has been documented in the published literature and indicates safe and effective use in ENT procedures. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical testing was performed for this 510(k) submission to establish the safety and effectiveness of the new device itself. The submission relies on prior documented use of similar devices.
- Data Provenance: Not applicable for a test set specific to this device. The document mentions "published literature" documenting the use of similar Electrosurgical Suction Coagulators, implying retrospective evidence from various sources.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No new clinical test set was created for this submission. The effectiveness is based on existing published literature for similar devices.
4. Adjudication Method for the Test Set
Not applicable. No new clinical test set was created for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an electrosurgical instrument, not an AI-assisted diagnostic or interpretative tool. No MRMC study or AI assistance is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an electrosurgical instrument, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly define "ground truth" in the context of this device's performance. Instead, it relies on:
- Engineering Standards Compliance: IEC 60601-1 and IEC 60601-2-2 as benchmarks for electrical safety and performance.
- Published Literature: "Documented in the published literature" indicating "safe and effective use" of Electrosurgical Suction Coagulators in ENT procedures. This implies a reliance on clinical outcomes and expert observation from previously published studies on similar devices.
8. The Sample Size for the Training Set
Not applicable. This device is an electrosurgical instrument, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is an electrosurgical instrument, not a machine learning model.
§ 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.