PROPENCIL ESU PENCIL

K092732 · Bio Protech, Inc. · GEI · Nov 25, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K092732
• Device Name: PROPENCIL ESU PENCIL
• Applicant: Bio Protech, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The PROPENCIL ESU Pencil is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation.

Device Story

Disposable electrosurgical pencil; delivers electrosurgical energy to surgical site for tissue cutting and coagulation. Operates as monopolar device; connects to standard electrosurgical generators. Features hand-controlled switches (pushbutton or rocker) for mode selection. Includes uncoated or non-stick coated stainless steel electrode. Used in general surgical procedures by clinicians. Provides mechanical interface for energy delivery; output controlled by generator settings. Benefits patient through precise tissue management during surgery.

Clinical Evidence

Bench testing only. Device performance validated against IEC 60601-2-2:2006 and AAMI HF-18:2001 (Cable Strain Relief Test). No clinical data provided.

Technological Characteristics

Monopolar electrosurgical pencil. Shell: ABS resin. Electrode: SUS 304 1/2H stainless steel (uncoated or FEP coated). Insulation: Thermal shrinking tube. Connectivity: 3m 3p cord. Sterilization: Gamma. Standards: IEC 60601-2-2:2006, AAMI HF-18.

Indications for Use

Indicated for use in general surgical procedures requiring tissue cutting and coagulation via electrosurgical energy delivery.

Regulatory Classification

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

• Conmed, Inc. Hand Controlled Electrosurgical pencils (K896626)

Submission Summary (Full Text)

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KC092732

### 510(k) Summary 807.92(c)

・

#### SPONSOR

Bio Protech, Inc. 1720-26, Taejang 2 - Dong, Wonju Woonju-Si, Gangwon-Do Republic of South Korea

Telephone: Fax:

310-515-1799

Kevin Han

Contact Person:

Summary Preparation Date: March 13, 2009

#### DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

#### 807.92(a)(2)

807.92(a)(1)

Propencil ESU Pencil Electrosurgical Pencil Electrosurgical, Cutting & Coagulation & Accessoriess 878.4400 GEI Class II

#### PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device Company Product 510(k) # Conmed. Inc. Hand Controlled Electrosurgical pencils K896626

#### DEVICE DESCRIPTION

#### 807.92(a)(4)

The PROPENCIL ESU pencil (and as also to be offered for sale under various private label trade names) is intended for standard electrosurgical operation such as cutting and coagulation. It is designed to work with standard electrosurgical generators.

PROPENCIL consists of various types of disposable ESU pencils with hand controlled switch for cutting and coagulation. All of products are sterile device. The method of sterilization is Gamma sterilization. The hand controlled switch is pushbuttons or rocker button and the blade is an uncoated stainless steel electrode or non-stick coated stainless steel electrode.

Company Name: Company Address NOV 2 5 2009

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### DEVICE INTENDED USE

### 807.92(a)(5)

The PROPENCIL ESU Pencil is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation.

| COMPARISON OF TECHNICAL CHARACTERISTICS<br>807.92(a)(6) | | |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameters | Bio Protect Inc.<br>(PROPENCIL) | CONMED CORP.<br>(HAND CONTROLLED<br>ELECTROSURGICAL<br>PENCILS) |
| 510(k) Number | N/A | K896626 |
| Intended Use Statement | The PROPENCIL ESU<br>Pencil is intended for use in<br>general surgical procedures<br>to deliver electrosurgical<br>energy to the surgery site<br>for tissue cutting and<br>coagulation. | The Conmed ESU Pencils<br>are intended for use in<br>general surgical procedures<br>to deliver electrosurgical<br>energy to the surgery site<br>for tissue cutting and<br>coagulation |
| Styles: | | |
| Button Switch | Yes | Yes |
| Rocker Switch | Yes | Yes |
| Smoke Evacuation Unit | No | No |
| Mode of Operation: | | |
| Mode of Action | Cut and Coagulation | Cut and Coagulation |
| Tip Configuration(s) | General | General |
| Biopolar/Monopolar | Monopolar | Monopolar |
| Materials Used:<br>Shell | ABS Resin | ABS Resin |
| Electrode | SUS 304 1/2H or<br>FEP coated SUS 304 1/2H | Stain less steel |
| Insulating Material | Thermal Shrinking tube | Silicon tube |
| Removable Electrode | Yes | Yes |
| Hard Wire Cable | 3m 3p cord (3Φ) | 3m 3p cord (3Φ) |

{2}------------------------------------------------

| Standards: | | |
|--------------------------------------|------------------------------------|------|
| IEC 60601-2-2: 2006 | Pass | Pass |
| AAMI HF-18,<br>for Cable Strain Test | Pass | Pass |
| Sterile | Yes (only a disposable<br>product) | Yes |
| Single Use | Yes (only a disposable<br>product) | Yes |

### NONCLINICAL AND CLINICAL TEST

807.92(b)

### SAFETY and EFFECTIVENESS

#### Safety testing electrical

BioProtech, Inc. tested the PROPENCIL to the following standard: IEC 60601-2-2:2006 AAMI HF18:2001 Cable Strain Relief Test

### CONCLUSION

#### 807.92(b)(3)

PROPENCIL Electrosurgical Pencil is similar to the predicate device in

- · intended use,
- materials and . •
- . design.

The PROPENCIL Electrosurgical Pencil introduces no new questions concerning safety and efficacy.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its wing and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Bio Protech. Inc. % Underwriters Laboratories Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, IL 60062

NOV 2 5 2009

Re: K092732

Trade/Device Name: Propencil Electrosurgical Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: November 11, 2009 Received: November 12, 2009

Dear Mr. Devine:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 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.

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Page 2- Mr. Ned Devine

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark M. Millikin

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Propencil Electrosurgical Pencil (also offered for sale under various private label trade names) .

Indications for Use:

The PROPENCIL ESU Pencil is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M.MELKERSON

Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092732

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