The PenEvac SI is a multifunction handpiece that is meant to provide the following optional functions: monopolar electrode handpiece in an electrosurgery generator system, suction, and to facilitate the removal of smoke generated during the procedure. The intended use is the same as the predicate devices.

Device Description

The PenEvac SI is a multifunction device that optionally features suction, irrigation, electrosurgery "cut" or "coag, " and smoke evacuator functions. The device is intended to be used with an I.C. Medical Suction/Irrigator/Smoke Evacuator and common electrosurgery generators.

The PenEvac SI has a handpiece body that accepts various tips and endpieces to furnish different operating functions. The handpiece body will be available as either a sterile single use device or as a reusable device. The handpiece features two pushbutton switches and an electrosurgery cord and connector. The handpiece bodies are identical to the predicate Telescoping PenEvac bodies.

Changing the tip will change the function of the handpiece. There are three different configurations available: SIE (Suction, Irrigation, monopolar Electrode) Configuration, SI (Suction, Irrigation) 2 Channel, and SI (Suction, Irrigation) 1 Channel.

AI/ML Overview

This 510(k) summary describes a medical device called the "PenEvac SI," which is an electrosurgery, suction, and irrigation handpiece with smoke evacuation. The document focuses on demonstrating that the PenEvac SI is substantially equivalent to existing predicate devices already on the market (the "Telescoping PenEvac" by I.C. Medical and the "Disposable Laparoscopic Handswitch" by Valleylab).

Based on the provided text, there is no acceptance criteria or study that proves device performance in the way typically associated with AI/ML-driven medical devices. The document is a 510(k) summary for a physical surgical handpiece, not a software algorithm. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of device submission.

The "studies" mentioned are non-clinical engineering tests to ensure safety and fundamental operational equivalence to predicate devices, rather than performance metrics for an AI algorithm.

Here's a breakdown based on the categories, with explanations for why some are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device and not an AI/ML algorithm with performance metrics like sensitivity/specificity, acceptance criteria are generally focused on safety, functionality, and equivalence to predicate devices. The document implies that the "acceptance criteria" were met if the PenEvac SI performed similarly in fundamental engineering tests to the predicate devices and complied with relevant standards.

Acceptance Criteria (Implied)	Reported Device Performance
Flammability: Must not exhibit flammability issues when used with various electrosurgery generators.	Samples of all proposed tip materials passed the same flammability tests applied to the Lexan polycarbonate used with the predicate ESU shroud.
Smoke Evacuation & Electrocautery Pencil Functions: Must perform comparably to predicate devices.	The PenEvac SI was bench tested with different electrosurgery generators, and its smoke evacuation and electrocautery pencil functions were found to be the same as the predicate ESU shroud and pencils.
Electrical Safety (ANSI/AAMI HF-18): Must comply with applicable portions of the ANSI/AAMI HF-18:1993 Electrosurgical Device standard.	Prototype devices tested by the Chief Engineer and/or cable/connector/switches manufacturer complied with applicable portions of ANSI/AAMI HF-18: 1993. Validation on production devices planned.
Capacitive Resistance (for laparoscopic devices): Must have comparable capacitive resistance to predicate Valleylab laparoscopic devices.	Relative capacitive resistance between the PenEvac SI and the predicate Valleylab laparoscopic devices was evaluated by measuring current flow to the ground pad in a simulated normal use condition. It was concluded that both laparoscopic devices have "virtually identical capacitive resistance."
Sterilization Efficacy & Residuals: Must achieve required sterility assurance level and acceptable ETO residual levels (for single-use sterile devices).	Sterile disposable products will use the same contract sterilizer and sterilization validation method as the predicate I.C. Medical Telescoping PenEvac and ESU shrouds (which was reviewed and accepted by FDA in June 1995). The Sterility Assurance Level and ETO Residual Level will be the same as predicate ESU shrouds.
Sterilization Compatibility (for reusable devices): Must withstand specified sterilization methods without degradation (ETO, steam, steris, flash autoclave up to 134°C).	The reusable PenEvac SI body may be sterilized by ETO, steam, steris, or flash autoclave up to 134 degrees Centigrade. (Implicitly, it's expected to withstand these without failing continuity checks or showing signs of wear/damage).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a numerical sample size in the document for the non-clinical tests. The tests were performed on "samples of all proposed tip materials" and "prototype devices," as well as the PenEvac SI itself. This likely refers to a small number of physical units or components used for engineering verification.
Data Provenance: The tests were non-clinical bench tests performed by I.C. Medical (the submitter) or its manufacturing partners (Chief Engineer, manufacturer of cable/connector/switches). There's no mention of country of origin of patient data, as no patient data was used. These were laboratory/engineering tests.
Retrospective or Prospective: These were prospective engineering tests on prototypes and samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in the context of AI/ML algorithms refers to expert labels or definitive diagnoses. For this physical device, the "ground truth" for the tests was established by engineering standards (e.g., ANSI/AAMI HF-18), objective measurements (e.g., current flow, flammability observations), and comparison to the known performance of predicate devices. The "experts" involved were likely engineers, technicians, and potentially the Chief Engineer and relevant manufacturers, who defined and executed the tests based on objective criteria.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are used to reach consensus on labels for ground truth in clinical data. These were direct engineering measurements and observations.

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 surgical handpiece, not an AI system designed to assist human readers (e.g., radiologists). No such study was performed or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no algorithm to test in a standalone fashion. The device's function is a direct physical action (suction, irrigation, electrosurgery, smoke evacuation) controlled by the surgeon.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for these non-clinical tests was based on:

Engineering standards: e.g., compliance with ANSI/AAMI HF-18.
Predicate device performance: establishing that the PenEvac SI performed "the same as" or "virtually identical" to the legally marketed predicate devices, implying the predicate's performance is the accepted benchmark.
Objective physical measurements/observations: e.g., current flow for capacitive resistance, visual assessment of flammability, functional testing of smoke evacuation and electrocautery.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML algorithm, and therefore no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set exists.

In summary: The provided document is a 510(k) summary for a conventional medical device (a surgical handpiece). The "acceptance criteria" and "studies" are focused on demonstrating fundamental safety, functionality, and substantial equivalence to already-cleared predicate devices through non-clinical engineering and bench tests, in line with typical 510(k) requirements for such devices. The questions related to AI/ML performance metrics, clinical studies with human readers, and ground truth establishment for datasets are not relevant to this submission.

Summary

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510(k) Summary	I.C. Medical Telescoping PenEvac
	K 955166
	510(k) Summary

Submitter
Name:	I.C. Medical, Inc.
Address:	5170 West Phelps RoadGlendale, AZ 85306
Phone:	(602) 547-9200
FAX:	(602) 547-0750
Contact Person:	Kurt Hasper
Date Summary Was Prepared:	January 18, 1996
Device
Trade Name:	PenEvac SI
Common Name:	Electrosurgery, Suction & Irrigation Handpiecewith Smoke Evacuation Tube, TelescopingTip and Monopolar Electrodes.
Classification Name:	Unknown
Substantial equivalence to the following:	1. Telescoping PenEvac (I.C. Medical)2. Disposable Laparoscopic Handswitch.(Valleylab)

Description of the PenEvac SI:

The predicate device (Telescoping PenEvac) was modified by adding an irrigation channel to create the PenEvac SI. The modification required moving the suction/irrigation ports to an adapter at the front of the device and using an "end cap" when the smoke evacuation tubing is not used. The Valleylab Disposable Laparoscopic Handswitch was added as a predicate device only because it includes all three functions (monopolar electrosurgery, suction, & irrigation).

Changing the tip will change the function of the handpiece. There are three different configurations available:

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510(k) Summary I.C. Medical Telescoping PenEvac

SIE (Suction, Irrigation, monopolar Electrode) Configuration: Three components replace the telescoping tip on the PenEvac body. A (1) Suction/Irrigation Tip is attached to the (2) Suction Irrigation Adapter. Then the electrode on the end of the (3) ESU Electrode Adapter is inserted through the irrigation channel on the Suction/Irrigation Tip until the ESU Adapter is completely threaded onto the Tip. Both of these parts are then threaded onto the front of the PenEvac Body in place of the Telescoping Tip. Suction and irrigation tubing is then connected to the short pieces of tubing attached to the Suction/Irrigation Adapter. An endcap replaces the smoke evacuator tubing that is used with the Telescoping PenEvac. The ESU Electrode Adapter is available with the same types of electrodes available with the predicate Telescoping PenEvac.

In this configuration (SIE) suction, irrigation, and monopolar electrode functions are available whenever the surgeon desires them. Smoke is evacuated through the suction channel.

SI (Suction, Irrigation) 2 Channel: All components are the SIE configuration except the ESU Electrode Adapter is not used. Instead, the Suction Adapter is directly attached to the PenEvac Body and the Suction Irrigation Tip is attached to the Adapter.

In this configuration (SI) suction are available and they can be made to occur simullaneously as the surgeon desires.

SI (Suction, Irrigation) 1 Channel: The components are the SI configuration except the 2 channel tip is replaced with a single channel tip. This is an economy set up for surgeons who do not need simultaneous suction and irrigation functions.

Plastic and metal materials used in the PenEvac SI are identical to those used in the predicate Telescoping PenEvac with the exception of one type of tubing that has been Class VI certified.

Intended Use of the PenEvac SI:

Summary of Technological Characteristics: PenEvac SI/Predicate Device(s)

The PenEvac SI is multifunction handpiece with the following uses: suction, irrigation, monopolar electrosurgery "cut" or "coag", smoke evacuation. The Telescoping PenEvac by I.C. Medical, Inc. is the predicate device for the telescoping tip, monopolar electrosurgery, and smoke evacuation (suction) features. The Valley)ab Disposable Laproscopic Handswitch handpiece is the predicate device for combining the electrosurgery and suctions with irrigation in the same handpiece.

The PenEvac SI consists of a handpiece body, interchangeable endpieces. The handpieces. The handpiece bodies will be available as sterile single use items and also as reusable items.

The sterile disposable products will be sent to the same contract sterilizer who currently provides that function for the I.C. Medical Telescoping PenEvac and ESU shrouds. The sterilization walidation method has been reviewed

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510(k) Summary I.C. Medical Telescoping PenEvac

and accepted by the FDA during a recent (June 1995) site inspection. The Sterility Assurance Level and the ETO Residual Level will be the same as the predicate ESU shrouds.

The reusable PenEvac SI body (includes: ESU shroud/handswitching pencil body, three conductor cord, & connector; does not include: telescope tip, electrode, smoke evacuator tube, or irrigation tube) may be sterilized by ETO, steam, steris, or flash autoclave up to 134 degrees centigrade. It fails a continuity check or shows signs of wear, damage, cracking, or chipping.

The predicate Telescoping PenEvac uses a single tip that telescopes to the length desired by the surgeon and the PenEvac SI uses tips with fixed lengths to accommodate the surgeon. The PenEvac SI smoke evacuator/pencil body will be molded from the same material as the predicate Telescoping PenEvac. The smoke evacuator tubing and connectors are identical to the predicate device.

The predicate electrosurgical pencil features optional electrodes of different lengths and shapes. The PenEvac SI has similar optional electrode shapes. Both pencils use the same electrode material.

The PenEvac SI and the predicate Teiescoping PenEvac are handswitching monopolar devices. They both have "cut" and a "coag" pushbuttons and are materials. The connectors on both devices fit common electrosurgery generators and the connecting cables are ten foot, flexible, three conductor products.

The electrical cord, generator, and switches (cut & coag) are the same for the PenEvac SI and Telescoping PenEvac.

The specifications of the PenEvac St are comparable to the predicate I.C. Medical Telescoping PenEvac and Valleylab Disposable Laparoscopic Handswitches.

I.C. Medical feels that the Telescoping PenEvac SI functions the same as the predicate devices and we have not identified any significant changes in safety and effectiveness.

Summary of Nonclinical Tests & How Results Support Equivalence:

Samples of all proposed tip materials have been tested for flammability when used with various electrosurgery generators and all have passed the same tests that were applied to the Lexan polycarbonate used with the predicate ESU shroud.

The PenEvac SI was also bench tested with a number of different electrosurgery generators and the smoke evacuation and electrocautery pencil functions of the PenEvac SI were the same as the predicate ESU shroud and pencils.

The Chief Engineer and/or the manufacturer of the cable/connector/switches tested the prototype devices and they comply with the applicable portions of ANSI/AAMI HF-18: 1993 Electrosurgical Device standard. Validation will also be performed on production devices prior to their initial release for compliance to the standard.

Relative capacitive resistance between the PenEvac SI and the predicate Valleylab laparoscopic devices was evaluated by measuring current flow from the device under test to the ground pad in a simulation of normal use conditions. It was concluded that both of the laparoscopic devices have virtually identical capacitive resistance.

END OF 510(K) SUMMARY

Regulation Number and Section

§ 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.