(82 days)
The PROPENCIL ESU Pencil is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation.
The PROPENCIL ESU pencil (and as also to be offered for sale under various private label trade names) is intended for standard electrosurgical operation such as cutting and coagulation. It is designed to work with standard electrosurgical generators. PROPENCIL consists of various types of disposable ESU pencils with hand controlled switch for cutting and coagulation. All of products are sterile device. The method of sterilization is Gamma sterilization. The hand controlled switch is pushbuttons or rocker button and the blade is an uncoated stainless steel electrode or non-stick coated stainless steel electrode.
Here's a breakdown of the acceptance criteria and study information for the Bio Protech, Inc. PROPENCIL ESU Pencil, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance (PROPENCIL ESU Pencil) | Predicate Device (CONMED CORP.) |
|---|---|---|
| Intended Use Statement | "The PROPENCIL ESU Pencil is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation." | "The Conmed ESU Pencils are intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation." |
| Styles: Button Switch | Yes | Yes |
| Styles: Rocker Switch | Yes | Yes |
| Styles: Smoke Evacuation Unit | No | No |
| Mode of Operation: Mode of Action | Cut and Coagulation | Cut and Coagulation |
| Tip Configuration(s) | General | General |
| Bipolar/Monopolar | Monopolar | Monopolar |
| Materials Used: Shell | ABS Resin | ABS Resin |
| Materials Used: Electrode | SUS 304 1/2H or FEP coated SUS 304 1/2H | Stainless steel |
| Materials Used: Insulating Material | Thermal Shrinking tube | Silicon tube |
| Removable Electrode | Yes | Yes |
| Hard Wire Cable | 3m 3p cord (3Φ) | 3m 3p cord (3Φ) |
| Standards: IEC 60601-2-2: 2006 | Pass | Pass |
| Standards: AAMI HF-18 (Cable Strain Test) | Pass | Pass |
| Sterile | Yes (only a disposable product) | Yes |
| Single Use | Yes (only a disposable product) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a test set with a specific sample size, data provenance (e.g., country of origin, retrospective/prospective), or a formal clinical study to prove performance against acceptance criteria in a traditional sense. The submission focuses on demonstrating substantial equivalence to a predicate device through comparison of technical characteristics and adherence to recognized electrical safety standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided in the document. The device's safety and effectiveness were evaluated based on engineering testing to established standards, not through expert-reviewed ground truth on a specific dataset.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. There was no "test set" in the context of a clinical performance study that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported. The submission does not involve human readers interpreting data, as it is an electrosurgical pencil. Therefore, there's no discussion of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A "standalone" study in the typical AI sense was not performed or reported. The evaluation of the device's technical characteristics and adherence to safety standards can be considered a form of standalone testing, as it assesses the device's inherent performance. However, there is no mention of an "algorithm" or AI in this context.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation was primarily engineering standards and direct comparison of technical specifications against a legally marketed predicate device. This includes:
- Adherence to electrical safety standards (IEC 60601-2-2:2006, AAMI HF-18:2001).
- Direct comparison of physical characteristics, materials, and modes of operation to the predicate device.
There is no mention of pathology, outcomes data, or expert consensus on clinical cases being used as ground truth for this submission.
8. Sample Size for the Training Set
This information is not applicable and not provided in the document. The device is a physical electrosurgical pencil, not an AI/software device that would involve a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As there is no training set mentioned, there is no ground truth establishment for it.
Summary of the Study Proving Acceptance Criteria:
The study proving the Bio Protech, Inc. PROPENCIL ESU Pencil meets acceptance criteria is primarily an engineering-based substantial equivalence comparison to a legally marketed predicate device (Conmed. Inc. Hand Controlled Electrosurgical pencils, K896626).
The key elements of this "study" are:
- Comparison of Technical Characteristics: A detailed table was presented comparing the PROPENCIL's specifications (intended use, styles, mode of operation, tip configuration, bipolar/monopolar, materials, removable electrode, cable) directly against those of the predicate device. The acceptance criterion here was that the PROPENCIL's characteristics are similar enough to the predicate to not raise new safety or effectiveness concerns.
- Safety Testing to Recognized Standards: The PROPENCIL underwent testing to established international and national standards for medical electrical equipment:
- IEC 60601-2-2:2006: A standard specifically for the safety of high-frequency surgical equipment. The device "Passed" this standard.
- AAMI HF-18:2001 Cable Strain Relief Test: This standard addresses the durability and safety of the cable connection. The device also "Passed" this test.
The acceptance criteria for these tests were successful compliance ("Pass") with the requirements outlined in each standard.
The conclusion drawn from this evaluation (as stated in the document) is that the PROPENCIL is similar to the predicate device in intended use, materials, and design, and introduces no new questions concerning safety and efficacy. This demonstrates that the device meets the regulatory acceptance criteria for substantial equivalence under a 510(k) pathway.
§ 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.