(82 days)
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 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.
Here's a breakdown of the acceptance criteria and study information for the Bio Protech, Inc. PROPENCIL ESU Pencil, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance (PROPENCIL ESU Pencil) | Predicate Device (CONMED CORP.) |
|---|---|---|
| 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 |
| Styles: Rocker Switch | Yes | Yes |
| Styles: Smoke Evacuation Unit | No | No |
| Mode of Operation: Mode of Action | Cut and Coagulation | Cut and Coagulation |
| Tip Configuration(s) | General | General |
| Bipolar/Monopolar | Monopolar | Monopolar |
| Materials Used: Shell | ABS Resin | ABS Resin |
| Materials Used: Electrode | SUS 304 1/2H or FEP coated SUS 304 1/2H | Stainless steel |
| Materials Used: Insulating Material | Thermal Shrinking tube | Silicon tube |
| Removable Electrode | Yes | Yes |
| Hard Wire Cable | 3m 3p cord (3Φ) | 3m 3p cord (3Φ) |
| Standards: IEC 60601-2-2: 2006 | Pass | Pass |
| Standards: AAMI HF-18 (Cable Strain Test) | Pass | Pass |
| Sterile | Yes (only a disposable product) | Yes |
| Single Use | Yes (only a disposable product) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a test set with a specific sample size, data provenance (e.g., country of origin, retrospective/prospective), or a formal clinical study to prove performance against acceptance criteria in a traditional sense. The submission focuses on demonstrating substantial equivalence to a predicate device through comparison of technical characteristics and adherence to recognized electrical safety standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided in the document. The device's safety and effectiveness were evaluated based on engineering testing to established standards, not through expert-reviewed ground truth on a specific dataset.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. There was no "test set" in the context of a clinical performance study that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported. The submission does not involve human readers interpreting data, as it is an electrosurgical pencil. Therefore, there's no discussion of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A "standalone" study in the typical AI sense was not performed or reported. The evaluation of the device's technical characteristics and adherence to safety standards can be considered a form of standalone testing, as it assesses the device's inherent performance. However, there is no mention of an "algorithm" or AI in this context.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation was primarily engineering standards and direct comparison of technical specifications against a legally marketed predicate device. This includes:
- Adherence to electrical safety standards (IEC 60601-2-2:2006, AAMI HF-18:2001).
- Direct comparison of physical characteristics, materials, and modes of operation to the predicate device.
There is no mention of pathology, outcomes data, or expert consensus on clinical cases being used as ground truth for this submission.
8. Sample Size for the Training Set
This information is not applicable and not provided in the document. The device is a physical electrosurgical pencil, not an AI/software device that would involve a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As there is no training set mentioned, there is no ground truth establishment for it.
Summary of the Study Proving Acceptance Criteria:
The study proving the Bio Protech, Inc. PROPENCIL ESU Pencil meets acceptance criteria is primarily an engineering-based substantial equivalence comparison to a legally marketed predicate device (Conmed. Inc. Hand Controlled Electrosurgical pencils, K896626).
The key elements of this "study" are:
- Comparison of Technical Characteristics: A detailed table was presented comparing the PROPENCIL's specifications (intended use, styles, mode of operation, tip configuration, bipolar/monopolar, materials, removable electrode, cable) directly against those of the predicate device. The acceptance criterion here was that the PROPENCIL's characteristics are similar enough to the predicate to not raise new safety or effectiveness concerns.
- Safety Testing to Recognized Standards: The PROPENCIL underwent testing to established international and national standards for medical electrical equipment:
- IEC 60601-2-2:2006: A standard specifically for the safety of high-frequency surgical equipment. The device "Passed" this standard.
- AAMI HF-18:2001 Cable Strain Relief Test: This standard addresses the durability and safety of the cable connection. The device also "Passed" this test.
The acceptance criteria for these tests were successful compliance ("Pass") with the requirements outlined in each standard.
The conclusion drawn from this evaluation (as stated in the document) is that the PROPENCIL is similar to the predicate device in intended use, materials, and design, and introduces no new questions concerning safety and efficacy. This demonstrates that the device meets the regulatory acceptance criteria for substantial equivalence under a 510(k) pathway.
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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
{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 CHARACTERISTICS807.92(a)(6) | ||
|---|---|---|
| Parameters | Bio Protect Inc.(PROPENCIL) | CONMED CORP.(HAND CONTROLLEDELECTROSURGICALPENCILS) |
| 510(k) Number | N/A | K896626 |
| Intended Use Statement | The PROPENCIL ESUPencil is intended for use ingeneral surgical proceduresto deliver electrosurgicalenergy to the surgery sitefor tissue cutting andcoagulation. | The Conmed ESU Pencilsare intended for use ingeneral surgical proceduresto deliver electrosurgicalenergy to the surgery sitefor tissue cutting andcoagulation |
| 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 orFEP 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 disposableproduct) | Yes |
| Single Use | Yes (only a disposableproduct) | 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 (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
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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
Page __ of ___________________________________________________________________________________________________________________________________________________________________
§ 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.