(528 days)
The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.
The Disposable Electrosurgical pencils are used for the cutting and coagulation of soft tissue and have a conductive cable which is designed for use with high frequency surgical generator (Electrosurgical unit). The connector or plug fits into electrosurgical unit. The hand-pieces are made of plastic with two buttons (cutting and coagulation buttons) in the case of the handcontrolled pencils, while the foot controlled pencils is activated by a monopolar footswitch connected to the generator. One button or switch is to control the cutting mode, CUT, of the ESU while the other controls the coagulation mode, COAG. The applied electrosurgery, monopolar, is the emittance of the high frequency alternating current, HFAC, from the diathermy via an active electrode through the patient's body tissues and then returned back to the diathermy machine via a dispersive electrode (patient return pad). The proposed device mainly consists of electrode tip, hand piece handle, cable, and plug. For all applied device models, only one kind of dimension of electrode tip, standard hex blade electrode is available. However, two kind of cable length, 3m or 5m, and three kind of available hand-piece color, white/blue/green color, are available.
The provided text is a 510(k) Summary for the Cathay Manufacturing Corp.'s Disposable Electrosurgical Pencils (CP1001 Series). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for a novel AI/software medical device.
Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size and ground truth establishment for training set) are not applicable or not provided in this regulatory submission for a hardware device.
However, I can extract the acceptance criteria and the reported device performance based on the provided document within the context of a 510(k) submission, which relies heavily on bench testing and comparison to an existing device.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Description | Reported Device Performance and Conformance |
|---|---|
| Indications for Use: Used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. Disposable for single use, supplied sterile with electrode tip. | Conforms: The subject device has identical Indications for Use as the predicate device. |
| Classification: 21 CFR 878.4400, Class II, Product Code GEI. | Conforms: The subject device has identical Classification, Class, and Product Code as the predicate device. |
| Operational Characteristics (e.g., energy source, sterility, sterilization method, electrode type, materials, dimensions, cable, foot control): Consistent with the predicate device. | Conforms: The subject device is largely identical or highly similar to the predicate device in essential components, raw materials, physical features (e.g., RF Energy, Sterile and single use, EO sterilization, Monopolar electrode, Stainless steel electrode material, ABS insulation, standard hex blade electrode 2.36 x 70mm, ABS shaft material, Blue PVC cable, 3m/5m cable length, foot control option). Minor differences in handle length (95mm vs 90mm) and total length (145mm vs 140mm) were noted but not deemed to impact equivalence. The predicate device also had "other shape and dimensions" for electrodes, while the subject device specified "standard hex blade electrode." This was not highlighted as a non-conformance. |
| Biocompatibility: Conforms to ISO 10993. | Conforms: "Conforms to ISO10993." Biocompatibility performance equivalence evidence of the proposed electrode can be demonstrated. |
| Labeling: Conforms to 21 CFR Part 801. | Conforms: "confirm to 21 CFR Part 801." |
| Performance (Electrical Safety & Essential Performance): Conforms to IEC 60601-1 and IEC 60601-2-2, and requirements specified in 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery'. | Conforms: "Performed by Third party, TUV Rheinland, through testing following IEC 60601-1:2005+CORR. 1(2006) + CORR.2(2007) and IEC 60601-2-2:2009." Performance conforms to the requirements. |
| Thermal Effects on Tissues: Similar/equivalent performance to the predicate device. | Conforms: Evaluation performed using three tissue types (liver, kidney, muscle) by measuring thermal damage zone sizes (length, width, depth). "The comparison tests conclusively prove that the proposed electrode is similar / equivalence in the performance of thermal effects on tissues as the predicate device device." |
| Stability and Shelf Life: 3 years shelf life, with package integrity and functional performance maintained. | Conforms: "Stability and shelf life: 3 year." Package integrity and functional performance testing completed following aging and real-time stability tests to support the proposed shelf life. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a number of devices. The "bench testing" involved using "three tissue types, liver, kidney and muscle tissue" for thermal effects evaluation. The number of devices tested for electrical safety, biocompatibility, and shelf-life is not specified.
- Data Provenance: The device manufacturer (Cathay Manufacturing Corp.) is located in Shanghai, China. The testing was conducted by a "Third party, TUV Rheinland," which is a German-based certification body with global operations. The location of the specific testing labs is not mentioned. The studies were conducted specifically for this 510(k) submission, implying they were prospective relative to the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a hardware device. Ground truth, in the context of AI/software, refers to definitively correct outputs for comparison. For this device, ground truth relates to established engineering standards (IEC, ISO) and physical measurements in a lab setting, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretation, which is not relevant for the type of bench testing performed for this device.
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 is a hardware electrosurgical pencil, not an AI/software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware electrosurgical pencil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance evaluation is based on:
- International Electrotechnical Commission (IEC) Standards: IEC 60601-1 (General requirements for basic safety and essential performance) and IEC 60601-2-2 (Particular requirements for high-frequency surgical equipment and accessories).
- International Organization for Standardization (ISO) Standards: ISO 11135 (Sterilization of health-care products), ISO 11607 (Packaging for terminally sterilized medical devices), and ISO 10993 (Biological evaluation of medical devices).
- Regulatory Guidance: 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.'
- Physical Measurements: Measurements of thermal damage zones in tissue models.
- Predicate Device Comparison: Performance equivalence was established by comparing the subject device's thermal effects to those of the legally marketed predicate device (K092634).
8. The sample size for the training set
- Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this hardware 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.