(274 days)
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
The Electrosurgical Pencil with coated and non-coated electrode is the monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrosurgical pencil consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode. The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball and needle. The electrode tip is either coated or non-coated. The diameter of the conductive post is 2,36mm. The pencil with electrode is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure. The switching method of electrosuraical pencil may be push button, rocker switch or foot switch, cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug, the lengths of the blade, needle and ball electrode may be around 69mm to152mm, with coated or non-coated.
Here's a breakdown of the acceptance criteria and study information for the "Single Use Electrosurgical pencil with non-coated and non-stick electrode (Non-sterile and sterile)", based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly lay out acceptance criteria in a quantitative table format with corresponding reported performance for each criterion. Instead, it states that the device's performance "proved that the subject device and the predicate device are equivalent in the performance" through specific tests. The criteria are indirectly inferred from the performance tests conducted and the standards met.
Therefore, I will interpret the acceptance criteria as meeting the standards and demonstrating equivalence to the predicate device in the specified performance areas.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Device Sterility (Validation and Verification) | Complies with ISO 11135:2014 for EO sterilization. |
| Packaging (Validation and Verification) | Packaging integrity tested and found satisfactory. |
| Performance in Cut Mode (Thermal effects and thermal zone size on porcine tissue: kidney, liver, muscle) | Bench testing on subject and predicate devices using porcine tissue showed that the evaluation of thermal effects on tissues and measurement of thermal zone sizes proved that the subject device and the predicate device are equivalent in performance for Cut mode, in accordance with the "Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016". |
| Performance in Coagulation Mode (Thermal effects and thermal zone size on porcine tissue: kidney, liver, muscle) | Bench testing on subject and predicate devices using porcine tissue showed that the evaluation of thermal effects on tissues and measurement of thermal zone sizes proved that the subject device and the predicate device are equivalent in performance for Coagulation mode, in accordance with the "Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016". |
| Electrical Safety | Complies with: |
- IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) (General requirements for basic safety and essential performance)
- IEC60601-2-2: 2009 (Fifth Ed) (Particular requirements for basic safety and essential performance of high frequency surgical equipment and accessories)
- IEC60601-1-2:2014 (Electromagnetic Disturbances - Requirements and Tests) |
| Biocompatibility | Complies with ISO10993 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process). |
| Shelf Life (3 years) | Accelerated aging tests were completed and support the proposed 3-year shelf life. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for the "porcine tissue: kidney, liver, muscle" used in the performance testing. It only mentions that testing was performed on these tissue types. It also doesn't specify the number of devices tested for sterility, packaging, electrical safety, or biocompatibility, beyond implying multiple units to validate processes and claims.
- Data Provenance: The data is retrospective, as the tests were conducted to demonstrate equivalence for a 510(k) premarket notification. The country of origin of the data is not specified, but the applicant is based in Hong Kong, China. The testing itself doesn't inherently imply a specific country for data collection beyond the manufacturing location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The performance testing involved bench testing on porcine tissue and comparison to a predicate device, as well as compliance with international standards. This type of testing typically relies on predefined test methods and measurements rather than expert consensus on a "ground truth" in the way it might for a diagnostic AI device.
4. Adjudication Method for the Test Set:
This information is not provided as it's not applicable to the type of bench testing and standards compliance reported for this electrosurgical pencil. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often for diagnostic devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance with human readers, which is not the function of an electrosurgical pencil.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable to an electrosurgical pencil. This device is a physical tool used by a human surgeon; it does not involve any algorithms or AI component that would function in a standalone capacity.
7. The Type of Ground Truth Used:
For the performance tests on porcine tissue, the "ground truth" was established by direct measurement and observation of thermal effects and thermal zone sizes on the tissue, deemed equivalent to the predicate device. For other aspects, the "ground truth" was compliance with established international standards (e.g., ISO for sterilization and biocompatibility, IEC for electrical safety), which define acceptable performance parameters.
8. The Sample Size for the Training Set:
This question is not applicable. The device is an electrosurgical pencil, not an AI/ML-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set for this device.
§ 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.