(82 days)
Not Found
No
The description focuses on standard electrosurgical operation and components, with no mention of AI or ML.
No
Explanation: The device is described as an ESU pencil for delivering electrosurgical energy for tissue cutting and coagulation in general surgical procedures. While it performs a medical function, it does not fit the typical definition of a therapeutic device designed for treating or alleviating a medical condition through direct intervention or therapy (e.g., drug delivery, radiation therapy, or physical therapy). Instead, it's a surgical tool used during a procedure.
No
The device is described as an electrosurgical pencil for tissue cutting and coagulation in general surgical procedures. It delivers electrosurgical energy to the surgery site, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a physical "pencil" with a hand-controlled switch and a stainless steel electrode, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivering electrosurgical energy to the surgery site for tissue cutting and coagulation" in "general surgical procedures." This describes a device used on the patient during surgery, not a device used to test samples from the patient in a lab setting.
- Device Description: The description details a "disposable ESU pencil with hand controlled switch" and "uncoated stainless steel electrode or non-stick coated stainless steel electrode." This is consistent with a surgical tool, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In vitro diagnostics are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used directly on the patient's tissue.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
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)
Safety testing electrical
BioProtech, Inc. tested the PROPENCIL to the following standard: IEC 60601-2-2:2006 AAMI HF18:2001 Cable Strain Relief Test
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.
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
§ 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.
0
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
1
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
| 807.92(a)(6) | ||
|---|---|---|
| Parameters | Bio Protect Inc. | |
| (PROPENCIL) | CONMED CORP. | |
| (HAND CONTROLLED | ||
| ELECTROSURGICAL | ||
| PENCILS) | ||
| 510(k) Number | N/A | K896626 |
| Intended Use Statement | 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. | The Conmed ESU Pencils | |
| are intended for use in | ||
| general surgical procedures | ||
| to deliver electrosurgical | ||
| energy to the surgery site | ||
| for tissue cutting and | ||
| 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: | ||
| Shell | ABS Resin | ABS Resin |
| Electrode | SUS 304 1/2H or | |
| 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, | ||
| for Cable Strain Test | Pass | Pass |
| Sterile | Yes (only a disposable | |
| product) | Yes | |
| Single Use | Yes (only a disposable | |
| 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.
3
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.
4
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 (800) 638-2041 or (301) 796-7100 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
5
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
Page __ of ___________________________________________________________________________________________________________________________________________________________________