(250 days)
The ZIP PEN Smoke Evacuation Electrosurgical Pencil is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. This device conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect.
The ZIP Pen Smoke Evacuation Electrosurgical Pencil is a sterile, single use hand held electrosurgical pencil and smoke evacuation handpiece. It is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The device consists of a printed circuit board, flexible electrical cable, dome switches, button switch mechanisms and sealing materials. The circuit board and electrical cable provide the means for powering the device. The dome switches operate the Cut and Coag functions. These components are enclosed within an upper housing and lower molded carriage and nozzle. which snap together. The buttons sit on top of the dome switches and extend through the upper housing and facilitate activation of the device. The button proximal to the electrode is yellow and controls the cut function of the device. The button distal to the electrode is blue and controls the coagulate function of the device. Within the nozzle, there is a metal collett that holds the electrode in place. The housing and other components are designed and assembled to prevent liquid from entering the electrical connections (preventing an electrical short). This is accomplished by over molding the circuit board with nonconductive materials. Clear tubing connects to the nozzle and provides a path for capturing electrosuraical smoke. The electro-surgical cable leaves the tubing through an open port and terminates at a 3-prong electro-surgical plug. The remaining portion of the tubing (without cable inside) terminates at a connector that attaches to the smoke evacuation filter. The connector is attached to the tubing and is included as part of the smoke evacuation pencil for connection to the filter. The ZIP Pen Smoke Evacuation Electrosurgical Pencil is available with 10 ft. and 15 ft. cord/tubing (catalog numbers 2525-10 and 2525-15, respectively) and is supplied with two additional items: A holster, which is used to hold the device when it is not in use during the procedure. The holster is a component of the device and will not be sold separately. A 2.5 inch Megadyne E-Z Clean electrode. The electrode is a separate, currently marketed device that received clearance in 2008 via K081791. The associated accessories include: Nozzle Extension can be used in electrosurgery procedures where a longer electrode is required to extend the smoke capture nozzle to the surgical site. Filter -- the ULPA and charcoal filters can be used with smoke evacuation units. They filter surgical smoke and odors removed from the surgical site. Adapter can be used to facilitate the tubing connection to a variety of smoke evacuation filter/units on the market.
The provided text describes the 510(k) summary for the ZIP Pen Smoke Evacuation Electrosurgical Pencil and does not pertain to an AI/ML medical device. Therefore, a table of acceptance criteria and reported device performance as typically expected for such a device, and information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, are not available in this document.
Instead, the document details the safety and performance testing conducted to demonstrate substantial equivalence to a predicate device. Here's a summary of the performance data presented:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI device context):
| Acceptance Criteria / Test | Performance Demonstrated |
|---|---|
| Sterilization | Sterilized to a Sterility Assurance Level (SAL) of 10⁻⁶ by radiation. Effectiveness and sterilizing dose qualified per ANSI/AAMI/ISO 11137-2:2013. Shelf life: 3 years. |
| Biocompatibility (per FDA Blue Book Memo #G95-1 and ISO 10993-1) | Fulfilled all requirements of the test protocol and standard, including: Cytotoxicity, Intracutaneous reactivity (Irritation), Maximization sensitization (Sensitization). |
| Electrical Safety and Electromagnetic Compatibility (EMC) (per ANSI/AAMI/IEC 60601-1 and 60601-2-2) | Complies with ANSI/AAMI/IEC 60601-1 and ANSI/AAMI/IEC 60601-2-2 standards for safety and EMC. |
| Performance Testing - Bench (per ANSI/AAMI/IEC 60601-1 and 60601-2-2) | Conforms to standards for: High frequency dielectric withstand, Mains frequency dielectric withstand, Continuity, Leakage current, Fluid Ingress. |
Specifics not applicable to AI/ML context:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of medical device's performance testing. The description refers to physical tests on the device itself.
- 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 device does not have a "ground truth" derived from expert interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Further details from the provided text (beyond typical AI/ML criteria):
- Software Verification and Validation Testing: "Not applicable. The ZIP Pen Smoke Evacuation Electrosurgical Pencil does not contain software."
- Animal Study: "Not applicable. Animal studies were not performed on the device."
- Clinical Studies: "Clinical studies were not performed as the indications for use are equivalent to the predicate device, and clinical testing is not required by applicable regulations."
The study described here focuses on demonstrating the physical, electrical, and biological safety and performance of the device through bench testing and compliance with relevant international standards, rather than evaluating an algorithm's diagnostic or predictive performance.
§ 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.