The PenEvac® is intended to be used as the active Monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during procedures.

Device Description

The Non-Telescopic PenEvac is defined as monopolar electrosurgical pencil with smoke evacuation capabilities. The device is designed for general electrosurgical applications including cutting and coagulating and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The Non-Telescopic PenEvac is intended to be used by trained professionals and will be marketed as a single use device, having different configuration as far as: type of electrode, length of tubing and end connector.

The proposed device is the same as the predicate Telescoping PenEvac. The only modification is a change in the telescopic tip, as the Non-Telescopic PenEvac does not have the telescope capability.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Non-Telescopic PenEvac." This document focuses on demonstrating the device's substantial equivalence to a predicate device, the "Telescoping PenEvac" (K954088), rather than presenting a performance study with detailed acceptance criteria and results in the way typically seen for novel devices or AI/software.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from IEC Standards)	Reported Device Performance
IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)	The Non-Telescopic PenEvac met the acceptance criteria on all applicable clauses.
IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests)	The Non-Telescopic PenEvac met the acceptance criteria on all applicable clauses.
IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories)	The Non-Telescopic PenEvac met the acceptance criteria on all applicable clauses.
Overall Goal: Demonstrate the same function, design, manufacturing, materials, components, principle of operation, sterilization, biocompatibility, performance characteristics, and intended use as the predicate device.	The testing performed demonstrated that the Non-Telescopic PenEvac is as safe and effective as the referenced predicate device.

Explanation:
The acceptance criteria are not specified with numerical thresholds in this document, but rather refer to compliance with internationally recognized medical device safety and performance standards (IEC 60601 series). The reported performance is a general statement that the device met these criteria. This type of presentation is common for 510(k) submissions where the device is a modification of an already cleared product and the primary goal is to show "substantial equivalence."

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

The provided text only mentions "Performance Testing-Bench" and explicitly states there was no clinical testing required. Therefore, there is no sample size for an in-human test set or data provenance related to clinical data. The bench testing would have involved physical samples of the device, but the number of units tested is not specified.

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

Not applicable. Since no clinical testing was performed and the study focused on bench testing against IEC standards, there was no need for expert ground truthing of clinical data.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical testing required." This type of study is relevant for diagnostic devices or AI systems where human reader performance is being evaluated or compared, which is not the case here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The "Performance Testing-Bench" described is a standalone evaluation of the device's physical and electrical characteristics against predefined standards, without human interaction beyond operating the device for the test. However, this is not an "algorithm-only" performance as the device itself is a physical electrosurgical pencil, not primarily software/AI.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established by the requirements and acceptance criteria defined within the IEC 60601 series of standards. These standards stipulate acceptable ranges for electrical safety, electromagnetic compatibility, and specific performance characteristics of high-frequency surgical equipment.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 8, 2016

I.C. Medical, Inc. Elena Buiga Director of RA/OA/ISO 2340 W. Shangri La Rd. Phoenix, Arizona 85029

Re: K160160

Trade/Device Name: Non-Telescopic PenEvac Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 25, 2016 Received: January 27, 2016

Dear Elena Buiga:

This letter corrects our substantially equivalent letter of April 5, 2016.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160160

Device Name Non-Telescopic PenEvac

Indications for Use (Describe)

The PenEvac® is intended to be used as the active Monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during procedures.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter/Holder:

I.C. Medical, Inc. 2340 West Shangri La Road Phoenix AZ 85029 Phone: (623)-780-0700 Fax: (623)-780-0887

Contact Person:	Elena Simona Buiga
	Director of RA/QA/ISO
	simonab@icmedical.com

Date Prepared: January 25, 2016

Device:

Trade name:	Non-Telescopic PenEvac
Common Name:	Smoke Evacuation Electrosurgical Pencil
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Classification Regulation:	21 CFR 878.4400
Device class:	2
Product code:	GEI

Predicate Device:

Telescoping PenEvac K954088.

Device Description:

The proposed device is the same as the predicate Telescoping PenEvac. The only modification is a change in the telescopic tip, as the Non-Telescopic PenEvac does not have the telescope capability.

Intended Use:

The PenEvac® is intended to be used as the active Monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during procedure.

Comparison of Technological Characteristics with the Predicate Device:

This Special 510(k) is a modification to the dimensional specification (change in the telescopic tip) of the Telescoping PenEvac previously cleared by the FDA with the 510(k) number (K954088) as well as addition of different electrode material (PTFE).

No changes were made to the intended use, indication for use, energy type, performance specifications, materials, sterilization method or fundamental scientific technology.

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Performance Characteristics:

Performance Testing-Bench:

The Non-Telescopic PenEvac was exposed to performance bench testing to ensure conformance with: IEC 60601-1-Medical electrical equipment-Part 1: General requirements for basic safety and essential performance;

IEC 60601-1-2-Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests; IEC60601-2-2-Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories;

The Non-Telescopic PenEvac meet the acceptance criteria on all applicable clauses of above mention standards.

Clinical testing:

There was no clinical testing required to support the medical device, as the indication for use is to the predicate device Telescoping PenEvac. The descriptive information detailed in this submission supports the substantial equivalence of the device.

Conclusions:

The difference between the Non-Telescopic PenEvac and the predicate Telescoping PenEvac do not raise any questions regarding its safety and effectiveness.

Testing was performed to required standards to demonstrate that the Non-Telescopic PenEvac has the same function and is the same in terms of design, manufacturing, materials, components, principal of operation, sterilization, biocompatibility, performance characteristics, and intended use as the proposed Non-Telescopic PenEvac, as designed, is determined to be as safe and effective as the referenced predicate device, which supports a determination of substantial equivalence.

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.