(290 days)
The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
There are two main series of smoke evacuation pencil.
(1) Smoke Evacuation Fingerswitch (PS947): The device includes the active handle which connects with the active electrode. The diameter of the mating part is 2.36mm+/-0.02mm. The buttons on the active handle control cutting and coagulation, the yellow side activates the cutting function and the blue side activates the coagulation function. The active handle's end is connected to an insulation cord with an active connector. The EVA tubing at the rear of the active handle then leads to a filter and pump system that facilitates the removal of harmful "surgical smoke" from the site of operation. The switching controls are mounted onto an active handle that moves freely up and down the shaft of the device when the device is in vertical position (or moves freely forward and backward when the device is in horizontal position), when the switching control moves freely on the shaft, distance between the front end of the handle and the controls is reduced or increased that works like extending and retracting the suction tip on general smoke evacuation, allowing the surgeon a greater degree of control and removing the need for additional accessories to extend the length of the device when working in cavities and other areas with restrictive access. Furthermore, the electrode can be exchanged with 63.5mm, 69mm and 120mm long electrodes in diameter 2.36±0.2mm with corresponding nosecone for further extending the length of suction tip for smoke evacuation.
(2) Smoke evacuation system with electrosurgical pencil (CE809): The device includes electrosurgical pencil with electrode and smoke evacuation handle connected with EVA tubing with ID22mm tubing connector. Electrosurgical pencil (PD646 or PD631) with 69mm long electrodes in diameter 2.36±0.2mm, can be put into the handle that functions as smoke evacuation pencil.
This document is a 510(k) premarket notification for a medical device and therefore primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional clinical trial sense. The provided text describes non-clinical performance testing (bench testing) to support substantial equivalence.
Here's an analysis based on the information provided, specifically addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical quantitative AI/software sense (e.g., sensitivity, specificity, AUC thresholds). Instead, it compares the proposed device's characteristics and its tested performance against those of a predicate device to demonstrate substantial equivalence.
The "acceptance criteria" in this context are implicitly defined by the safety and performance standards met by the predicate device and the relevant international and national standards for electrosurgical devices and smoke evacuation systems. The "reported device performance" refers to the results of the bench testing that showed equivalence to the predicate device.
Here's a reinterpretation of the request based on the available information:
| Feature / Performance Aspect | Acceptance Criteria (Implicitly from standards/predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Same as predicate (electrosurgical cutting/coagulation with smoke evacuation) | Same as predicate: "The device is intended to be used as the active monopolar electrode in an electrosurgery generator system for cutting and coagulation, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system." |
| Indication for Use | Same as predicate: remove smoke plume, conduct electrosurgical current | Same as predicate: "To conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system." |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Product Code | GEI | GEI |
| OTC or Prescription | For prescription use | For prescription use |
| Energy Delivery | High frequency electrical current/energy | High frequency electrical current/energy |
| Technology | Monopolar electrosurgery and use of vacuum for smoke capture | Monopolar electrosurgery and use of vacuum source to capture smoke |
| Device Mode | Cut and Coag. | Cut and Coag. |
| Electrical Safety | Comply with dielectric strength per AAMI HF-18 (predicate) | Comply with dielectric strength in accordance with ES60601-1, IEC60601-1-2 & IEC60601-2-2 (Similar kinds of safety requirements) |
| Biocompatibility | Comply with ISO10993 | Comply with ISO10993 |
| Sterility | EO sterile SAL 10-6 | EO sterile SAL 10-6 (Validated according to ISO 11135) |
| Shelf Life | 3 years | 3 years (Packaging integrity and accelerated aging test completed to support) |
| Performance (Thermal Effects) | Equivalent thermal effects and thermal zone sizes as predicate on porcine tissue | Bench testing using porcine tissue (kidney, liver, muscle) for Cut and Coagulation modes confirmed equivalent thermal effects and thermal zone sizes compared to the predicate device. |
| Rated Accessory Voltage | 5kVp (Predicate) | 4.5kVp (PS947) / 5kVp (CE809) - "Similar, does not affect performance" |
| Max. Operation Power | 300W | 300W |
2. Sample size used for the test set and the data provenance
- Test Set (for performance testing): The document mentions "bench testing on the subject device and predicate devices by using porcine tissue: kidney, liver, muscle for both Cut mode and Coagulation mode".
- Sample Size: Not explicitly stated (e.g., number of porcine tissue samples, number of tests performed). It only specifies the types of tissue.
- Data Provenance: Porcine tissue (an animal model). The country of origin is not specified, but the applicant is based in Hong Kong, China. It is a prospective bench test, not retrospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study described is a non-clinical, bench testing study, not a study evaluating human performance or diagnostic accuracy that would require expert ground truth. The "ground truth" for the non-clinical performance evaluation was laboratory measurements and objective assessments (e.g., thermal zone size measurement, electrical safety compliance, sterilization validation).
4. Adjudication method for the test set
Not applicable. This was a non-clinical bench test. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for establishing expert consensus on patient data.
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 pencil with smoke evacuation, not an AI or imaging device that would involve human readers or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an algorithm-only device. It's a physical medical device. The "performance" evaluated was its physical and electrical characteristics and its ability to perform cutting, coagulation, and smoke evacuation, as operated by a user in a simulated environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" was established by:
- Laboratory measurements: Assessing thermal effects and thermal zone sizes on porcine tissue.
- Standard compliance: Verification against international and national standards (e.g., IEC, ISO, ASTM). This involves objective measurements and tests rather than expert consensus on subjective data.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as it is not an AI/ML algorithm.
§ 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.