← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K143103 # PROPENCIL Smoke Pencil (K143103) _Bio Protech, Inc. · GEI · Jul 16, 2015 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K143103 ## Device Facts - **Applicant:** Bio Protech, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Jul 16, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## 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 Story Disposable monopolar electrosurgical pencil with integrated smoke evacuation; features finger-controlled push-button or rocker switches for cutting and coagulation. Device connects to standard electrosurgical generators via 3-pin port and smoke evacuation units via 8-to-22mm hose connector. Includes suction cap, tube, and hose; available with uncoated stainless steel or ceramic-coated non-stick electrodes. Used by surgeons/clinicians in OR settings to perform tissue cutting/coagulation while simultaneously evacuating surgical smoke. Smoke evacuation improves visibility and reduces inhalation of surgical byproducts. Device is sterile, single-use, and EO-sterilized. ## Clinical Evidence No clinical data. Bench testing only. Performance verified via smoke evacuation comparison, thermal zone damage assessment, and electrical performance testing (IEC 60601-2-2). Sterility and shelf-life (36 months) validated per ASTM F 1980:07 and ISO 10993-7. ## Technological Characteristics Monopolar electrosurgical pencil; ABS resin housing; stainless steel or ceramic-coated stainless steel electrodes. 3-pin monopolar electrical connection; 8-22mm smoke evacuation hose interface. Sterilized via Ethylene Oxide (EO). Complies with IEC 60601-1, IEC 60601-2-2, and ISO 10993. Shelf life 36 months. ## Regulatory 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. ## Predicate Devices - LiNA Medical SafeAir ([K120454](/device/K120454.md)) - Conmed, Inc. ClearVac ([K982309](/device/K982309.md)) with ESU Pencil ([K791137](/device/K791137.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. 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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 {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 {3}------------------------------------------------ #### 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 | PROPENCIL Smoke
Evacuation pencil
is designed for
general
electrosurgical
applications and
for removing
smoke generated
by electrosurgery
when used in
conjunction with | The SafeAir Smoke
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
accessory is intended
to remove smoke
generated by
electrosurgery. | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Operation Function Switches | button labeled
yellow and proximal
to electrode;
button
labeled blue and
distal to electrode | button labeled
yellow and proximal
to electrode;
button
labeled blue and
distal to electrode | button labeled
yellow and proximal
to electrode;
button
labeled blue and
distal to electrode | | Power Supply | Monopolar generator
supplied by user | Monopolar generator
supplied by user | Monopolar generator
supplied 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 and
Ceramic coated non-
stick blade. | Stainless steel | Stainless steel | | Complies with
ISO10993 | Yes | Yes | Yes | | Complies with
IEC60601-1 | Yes | Yes | Yes | | Complies with
IEC60601-2-2 | Yes | Yes | Yes | | Single Use | Yes | Yes | Yes | | Sterile Processing | 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: 1) 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. 2) 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}------------------------------------------------ 3) 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K143103](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K143103) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com