PROPENCIL™ Smoke pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Device Description

PROPENCIL Smoke Evacuation pencil consists of two types of disposable Smoke Evacuation monopolar pencils with finger controlled button switch or rocker switch for cutting and coagulation, and also suction cap, tube, hose are all included. All products are sterile, single-use, and disposable. The method of sterilization is Ethylene Oxide. The finger controlled switch is push button or rocker switch and the blade is an uncoated stainless steel electrode or ceramic coated non-stick blade.

PROPENCIL Smoke Evacuation pencil is designed to work with standard electrosurgical generators utilizing a 3-pin monopolar connection port and smoke evacuation units utilizing 8-to-22 hose connector. The tube is located near the electrode tip.

PROPENCIL Smoke Evacuation pencil is available with either a push button or a rocker switch, and some models include an optional holster. Most importantly the suction cap can be replaced with longer ones to extend the length of smoke pencil. The PROPENCIL smoke evacuation pencil has a shelf-life of 36 months.

AI/ML Overview

This document is a 510(k) summary for the PROPENCIL™ Smoke Evacuation Pencil, an electrosurgical cutting and coagulation device with smoke evacuation capabilities. It compares the device to two predicate devices: LiNA Medical SafeAir (K120454) and Conmed, Inc. ClearVac (K982309).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical thresholds in a dedicated table format for all performance aspects. Instead, it states that the device "outperformed the predicate device" or "passed" certain tests. The "Substantial Equivalence Chart" (page 5) serves as a comparative performance assessment against predicate devices.

Performance Characteristic/Test	Acceptance Criteria (Implicit)	Reported Device Performance (PROPENCIL™ Smoke Evacuation Pencil)
Smoke Evacuation Performance	Equivalent to or better than predicate devices.	Outperformed the predicate device (LiNA SafeAir and Conmed ClearVac).
Electrical Performance (Worst Case)	Equivalent to or better than predicate devices, or compliance with IEC 60601-2-2:2009.	Tested with worst-case blade (EBE65N) by INTERTEK and found to be equivalent or better. Other blades tested in-house.
Thermal Zone Damage (Cutting & Coagulation)	Equivalent to or better than predicate devices.	Outperformed the predicate device (LiNA SafeAir) in visually assessed thermal zone damage.
Sterility Assurance Level (SAL)	10⁻⁶	10⁻⁶
EO Residuals	Compliance with ISO 10993-7:2008.	Passed EO residual testing.
Shelf-Life	Not explicitly stated as a numerical criterion but implied satisfactory.	36 months (based on accelerated aging tests per ASTM F 1980:07).
Packaging Compliance	Compliance with EN ISO 11607-1:2006.	Met the requirements of EN ISO 11607-1:2006.
Electrical Safety	Compliance with IEC 60601-2-2:2009 and IEC 60601-1:2005.	Complies with IEC 60601-2-2:2009 and IEC 60601-1:2005 (tested by INTERTEK).
Biocompatibility	Compliance with ISO 10993.	Complies with ISO10993 (Yes in chart).

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

Smoke Evacuation Performance Test: The document states "Bio Protech performed smoke evacuation bench comparison testing" but does not specify the sample size (e.g., number of devices tested, number of tests performed).
Electrical Performance Test: For the worst-case EBE65N blade, it was "tested by INTERTEK." For other blades, "Bio Protech in-house" tested them. The sample size is not explicitly stated (e.g., how many units of each blade type were tested).
Thermal Zone Damage Test: The document states "Bio Protech performed the thermal zone damage... by comparing visually assessed" against a predicate. The sample size of devices or assessments is not provided.
Sterility and Shelf Life Testing: While accelerated aging tests and sterility validation were conducted, the sample size for these tests is not specified.

Data Provenance:

The tests were conducted by Bio Protech, Inc. (the manufacturer), and for certain electrical safety tests and the worst-case electrical performance test, by INTERTEK (a third-party testing organization).
The data is retrospective in the sense that it's generated from lab tests of the manufactured device.
The manufacturer's location is the Republic of Korea (Donghwa Medical Instrument Complex).

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

This information is not provided in the document. The tests described are primarily bench tests and comparisons against predicate devices, not expert human evaluations of images or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable for the reported bench and performance tests, as these did not involve human interpretation or subjective assessment that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The studies mentioned are bench tests and comparisons, not studies involving human readers or clinical scenarios.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

No, this device is a physical electrosurgical pencil, not an algorithm. This question is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" for the performance comparisons seems to be based on:

Performance of predicate devices: The device performance was compared against established predicate devices (LiNA Medical SafeAir and Conmed ClearVac) in terms of smoke evacuation efficiency, electrical performance, and thermal zone damage.
Compliance with international standards: For sterility (ISO 10993-7, EN ISO 11607-1) and electrical safety (IEC 60601-1, IEC 60601-2-2), the "ground truth" is adherence to these recognized industry standards.
Visual assessment: For thermal zone damage, it was "visually assessed."

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical medical instrument, not an AI/ML algorithm that requires a "training set" of data.

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

This question is not applicable for the same reason as point 8.

Summary

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

July 16, 2015

Bio Protech Incorporated % Mr. Kevin Han Bio Protech USA Incorporated 2601 Walnut Avenue Tustin, California 92780

Re: K143103

Trade/Device Name: PROPENCIL™ Smoke pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 4, 2015 Received: June 12, 2015

Dear Mr. Han:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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" (21CFR 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.

Sincerelv vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices

For

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K143103

Device Name: PROPENCIL™ Smoke Pencil

Indications for Use:

PROPENCIL™ Smoke pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Prescription Use X AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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510 (k) Summary

K143103

SPONSOR:

Bio Protech, Inc.

Donghwa Medical Instrument Complex

151-3, Donghwagongdan-ro

Munmak-eup, Wonju-si

Gangwon-do, 200-801

Republic of Korea

Company Contact Person: Daniel Woo

Official Correspondent: Kevin Han, Bio Protech USA Inc.,

Telephone: (714) 730-9950

NEW DEVICE: K143103

Proprietary Name: PROPENCIL Smoke Evacuation Pencil

Common/Usual Name: ESU Smoke Evacuation Pencil

Classification Name: Electrosurgical, Cutting & Coagulation & Accessories

Regulation Number: 878.4400

Product Code: GEI

Device Class: Class II

PREDICATE DEVICES:

LiNA Medical SafeAir (K120454) Smoke pencil

Conmed, Inc. ClearVac (K982309) smoke evacuation accessory with ESU Pencil (K791137) Page 1 of 5

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Indications for Use:

PROPENCIL™ Smoke pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Device Description:

Manufacturer	Bio Protech Inc.	LINA	Conmed
Proprietary Name	PROPENCIL SmokeEvacuation	SafeAir	ClearVac
510(k) Number	K143103	K120454	K982309 (withK791137)
Regulation No.	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
Product Code	GEI	GEI	GEI

Substantial Equivalence Chart:

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Intended Use	PROPENCIL SmokeEvacuation pencilis designed forgeneralelectrosurgicalapplications andfor removingsmoke generatedby electrosurgerywhen used inconjunction with	The SafeAir SmokePencil is designed forgeneralelectrosurgicalapplications and forremoving smokegenerated byelectrosurgery whenused in conjunctionwith an effectivesmoke	Used in conjunctionwith theelectrosurgical pencilof 510(k)NotificationK791137, theaccessory is intendedto remove smokegenerated byelectrosurgery.
Operation Function Switches	button labeledyellow and proximalto electrode; buttonlabeled blue anddistal to electrode	button labeledyellow and proximalto electrode; buttonlabeled blue anddistal to electrode	button labeledyellow and proximalto electrode; buttonlabeled blue anddistal to electrode
Power Supply	Monopolar generatorsupplied by user	Monopolar generatorsupplied by user	Monopolar generatorsupplied by user
Monopolar Generator Setting	Max 5.0kV	Max 6.0kV	Max 5.5 kV
Electrical Connector	US 3-Pin	US 3-Pin	US 3-Pin
Smoke Evacuation System	Yes	Yes	Yes
Adjustable Suction Sleeve	Yes	Yes	No
Handpiece Dimensions(Dia x Length)	15.5mm x 190mm	15mm x 190mm	25mm x 190mm
Handpiece Housing Material	ABS Resin	PS Resin	ABS Resin
Suction Sleeve Material	Polystyrene	Polystyrene	Polystyrene
Electrode Length	70 mm	70 mm	70 mm
Electrode Dimension	23 mm x 2.35 mm	17 mm x 2.3 mm	17 mm x 2.3 mm
Electrode Material	Stainless steel andCeramic coated non-stick blade.	Stainless steel	Stainless steel
Complies withISO10993	Yes	Yes	Yes
Complies withIEC60601-1	Yes	Yes	Yes
Complies withIEC60601-2-2	Yes	Yes	Yes
Single Use	Yes	Yes	Yes
Sterile Processing	Ethylene Oxide	Ethylene Oxide	Radiation

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Sterility and Shelf Life Testing:

The method of sterilization for PROPENCIL Smoke Evacuation pencil is EO sterilization. Accelerated aging tests were conducted according to ASTM F 1980:07, "Accelerated aging of sterile barrier systems for medical devices." The test results indicate The PROPENCIL smoke evacuation pencil has a shelf-life of 36 months.

Validation testing has been completed which confirms the packaging material and meets the requirements of EN ISO 11607-1:2006 "Packaging for terminally sterilized medical devices -Part1: Requirements for materials, sterile barrier systems and packaging systems."

The sterility assurance level (SAL) is 10-6.

The PROPENCIL Smoke Evacuation pencil passed EO residual testing performed according to ISO 10993-7: 2008 Ethylene Oxide Residuals.

Safety and Effectiveness Testing:

Safety testing electrical

Bio Protech, Inc. tested by INTERTEK for the PROPENCIL Smoke Evacuation pencil according to the following standard:

IEC 60601-2-2:2009 (Fifth Ed) for use in conjunction with IEC60601-1:2005

Performance Testing Bench:

Smoke evacuation performance test: Bio Protech performed smoke evacuation bench comparison testing to the LiNA SafeAir (K120454) and Conmed (K982309) detachable smoke evacuation accessory attached to ESU pencil (K791137). PROPENCIL Smoke Evacuation pencil outperformed the predicate device in smoke evacuation.
Electrical performance test: For this test, EBE65N (6.5" evacuation blade extender with ceramic coating) has been tested by INTERTEK as the worst case (The resistance of the blade increases if the length of the blade is increased. The efficiency of electrical performance is lowered. Therefore we tested EBE65N (6.5" evacuation blade extender with ceramic coating) since EBE65N is longest blade as the worst case). The other blades for PROPENCIL Smoke Evacuation pencil have been tested by Bio Protech inhouse to Page 4 of 5

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verify the electrical performance to be equivalent or better. The other blades are EB25, EB25N, EBE40, EBE40N and EBE65.

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Thermal zone damage of the cutting and coagulation function test: Bio Protech performed the thermal zone damage of the cutting and coagulation function testing by comparing visually assessed of the Bio Protech PROPENSIL Smoke Evacuation Pencil against LiNA's SafeAir Smoke Pencil (K120454). PROPENCIL Smoke Evacuation pencil outperformed the predicate device in thermal zone damage of the cutting and coagulation.

Performance Testing Animal: Animal testing is not required for this device.

Performance Testing Clinical: Clinical testing is not required for this device.

Conclusion:

PROPENCIL Smoke Evacuation pencil is similar to the predicate devices in intended use, materials and design. The PROPENCIL Smoke Evacuation pencil can be considered an adequate smoke evacuation pencil device concerning safety and efficacy

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.