(134 days)
The device is a helium gas electrosurgical cutting and coagulator for use in all soft tissue surgery- laparoscopic, endoscopic and open.
The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery-laparoscopic, endoscopic and open. It consists of two parts: A power generator control unit with a Helium gas supply and an application probe. An ionised gas plasma flame is generated in a controlled Helium gas flow at the end of a 4mm PTFE application tube (the probe). This produces a corona-type flame issuing from the open end of the probe with a high electron temperature but low molecular temperature of about 20C. When the probe is brought close (within 3 mm) to a surface connected to earth - such as human tissue - the corona-type flame changes to an arc discharge flame with a temperature of approx. 800C. The inert Helium gas flow in which the discharge takes place protects the area of discharge and minimises oxidation. This plasma flame can be used to stop blood flow from damaged tissue by cauterisation. The electrical generator provides an alternating current at a fixed frequency in the kilo hertz range with a power supply range of between 2 and 30W. The new probe is the LTC. This is a cutting probe where the 4mm PTFE tube retracts, exposing the point which is approximately 8-10mm long. This probe works by using the Corona flame passing between the point and the tissue at the nearest point which could be on the side of the probe. The point area which is hot then cuts through the tissue and cauterises small blood vessels as it passes through.
The provided text describes a 510(k) premarket notification for the Helica Laparoscopic Cutting & Cauterising (LTC) Probe. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical trial data or performance against detailed acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, study details, and extensive performance metrics for a novel, standalone AI device (which this is not) is not present in the provided document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal acceptance criteria in the manner one would typically find for a new, innovative device requiring extensive clinical validation. Instead, the "acceptance" hinges on demonstrating substantial equivalence to the predicate device. The performance comparison focuses on qualitative characteristics and a single in-vitro comparison rather than quantitative metrics against predefined thresholds.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (from "Summary of Non Clinical Tests") |
|---|---|
| Equivalence in Indicated Use: Same intended use as predicate. | "The device is a helium gas electrosurgical cutting and coagulator for use in all soft tissue surgery-laparoscopic, endoscopic and open." This is the same as the predicate (Helica "TC" Laparoscopic Cauterising Probe, K972267), with the addition of the "cutting" function. |
| Equivalence in Operating Principle: Uses the same fundamental technology. | "use the same operating principle" (Helium gas electrosurgical cauterization, now with a cutting mechanism via a retracting sheath and exposed point). |
| Equivalence in Design: Similar overall construction. | "incorporate the same design" (basic Helica probe design, with modification to the handle for sheath retraction). |
| Equivalence in Materials: Made from similar components. | "incorporate the same materials" |
| Equivalence in Shelf Life: Similar stability over time. | "have the same shelf life" |
| Equivalence in Packaging: Similar packaging methods. | "are packaged using the same materials and processes" |
| Safety (qualitative comparison): Should be at least as safe, preferably safer, than the predicate. | The helium unit has "much better control of the depth of necrosis" than the Argon Beam Coagulator (ABC) (a competitor, not necessarily the predicate, but used for comparison). It implies "much lower power at point of application" than ABC, leading to a conclusion of being "safer" than ABC. While the comparison is with ABC, it supports the non-inferiority/safety argument for the new device. |
| Effectiveness (qualitative comparison): Should achieve similar therapeutic effects. | "similar results" to the ABC in terms of effect, implying effectiveness for the intended use. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions an "in vitro comparison." Typically, "in vitro" studies do not involve human subjects or a "test set" in the clinical trial sense. If there were tissue samples, the number is not provided.
- Data Provenance: The study was an "in vitro comparison." No country of origin is specified for the data as it was likely laboratory-based. It is retrospective in the sense that it's a comparison study performed on existing technology principles, not a prospective human clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: One expert is named: "Dr. John Webb, Ph.D."
- Qualifications: "Ph.D." The specific field of his Ph.D. or his medical specialization (e.g., surgeon, pathologist) is not stated. The context implies expertise in the technical aspects of electrosurgery.
4. Adjudication Method for the Test Set:
Not applicable. This was an in-vitro comparison, not a study requiring adjudication of expert interpretations of medical images or conditions.
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 tool, not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant or described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical electrosurgical device, not a standalone algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the in-vitro comparison appears to be macroscopic and microscopic assessment of tissue effects (depth of necrosis, width of effect) under controlled laboratory conditions, as observed and interpreted by Dr. John Webb. This would be a form of objective measurement and expert observation.
8. The Sample Size for the Training Set:
Not applicable. This device did not involve machine learning or an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set was used.
§ 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.