Predicate Devices

K120454, K982309 (with K791137)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the electrosurgical and smoke evacuation functions, with no mention of AI or ML. The performance studies are bench tests comparing physical and electrical properties.

Therapeutic

Yes.
The device is used for electrosurgical applications, including cutting and coagulation, which are therapeutic medical procedures.

Diagnostic

No

This device is designed for general electrosurgical applications (cutting and coagulation) and smoke evacuation, not for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as disposable pencils, suction caps, tubes, hoses, switches, and blades, indicating it is a hardware device with integrated functions, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "general electrosurgical applications and for removing smoke generated by electrosurgery". This describes a surgical tool used directly on a patient during a procedure.
Device Description: The description details a "monopolar pencil with finger controlled button switch or rocker switch for cutting and coagulation" and a "suction cap, tube, hose" for smoke evacuation. These are components of a surgical device.
Performance Studies: The performance studies focus on "smoke evacuation performance", "electrical performance", and "thermal zone damage of the cutting and coagulation function". These are all related to the surgical function of the device.
Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. The device's function is entirely in vivo (within the body) during surgery.

Therefore, the PROPENCIL™ Smoke pencil is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

GEI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Sterility and Shelf Life Testing:

Study Type: Accelerated aging tests
Sample Size: Not specified
Data Source: Not specified
Annotation Protocol: Not specified
Key Results: 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:

Study Type: Safety testing electrical
Sample Size: Not specified
Data Source: Tested by INTERTEK
Annotation Protocol: Not specified
Key Results: Tested according to IEC 60601-2-2:2009 (Fifth Ed) for use in conjunction with IEC60601-1:2005.

Performance Testing Bench:

Study Type: Smoke evacuation performance test

Sample Size: Not specified
Data Source: Bio Protech
Annotation Protocol: Bench comparison testing to the LiNA SafeAir (K120454) and Conmed (K982309) detachable smoke evacuation accessory attached to ESU pencil (K791137).
Key Results: PROPENCIL Smoke Evacuation pencil outperformed the predicate device in smoke evacuation.

Study Type: Electrical performance test

Sample Size: EBE65N (6.5" evacuation blade extender with ceramic coating) for worst case, other blades (EB25, EB25N, EBE40, EBE40N and EBE65) tested in-house.
Data Source: INTERTEK for EBE65N, Bio Protech in-house for other blades.
Annotation Protocol: Not specified
Key Results: EBE65N performed as the worst case. The other blades for PROPENCIL Smoke Evacuation pencil have been tested by Bio Protech in-house to verify the electrical performance to be equivalent or better.

Study Type: Thermal zone damage of the cutting and coagulation function test

Sample Size: Not specified
Data Source: Bio Protech
Annotation Protocol: Comparing visually assessed of the Bio Protech PROPENSIL Smoke Evacuation Pencil against LiNA's SafeAir Smoke Pencil (K120454).
Key Results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120454, K982309 (with K791137)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that creates a sense of depth and unity. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

1

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

2

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

4

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:

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.

Manufacturer	Bio Protech Inc.	LINA	Conmed
Proprietary Name	PROPENCIL Smoke
Evacuation	SafeAir	ClearVac
510(k) Number	K143103	K120454	K982309 (with
K791137)
Regulation No.	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
Product Code	GEI	GEI	GEI

Substantial Equivalence Chart:

5

| Intended Use Evacuation pencil
is designed for
general
electrosurgical
applications and
for removing
smoke generated
by electrosurgery
when used in
conjunction with | Pencil is designed for
general
electrosurgical
applications and for
removing smoke
generated by
electrosurgery when
used in conjunction
with an effective
smoke | Used in conjunction
with the
electrosurgical pencil
of 510(k)
Notification
K791137, the
--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| button labeled
| button labeled
| button labeled
|
| Monopolar generator
| Monopolar generator
| Monopolar generator
|
| Max 5.0kV | Max 6.0kV | Max 5.5 kV |
| US 3-Pin | US 3-Pin | US 3-Pin |
| Yes | Yes | Yes |
| Yes | Yes | No |
| 15mm x 190mm | 25mm x 190mm |
| ABS Resin | PS Resin | ABS Resin |
| Polystyrene | Polystyrene | Polystyrene |
| 70 mm | 70 mm | 70 mm |
| 23 mm x 2.35 mm | 17 mm x 2.3 mm | 17 mm x 2.3 mm |
| Stainless steel and
| Stainless steel | Stainless steel |
| Yes | Yes |
| Yes | Yes |
| Yes | Yes |
| Yes | Yes | Yes |
| Ethylene Oxide | Ethylene Oxide | Radiation |

6

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

7

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

8

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