(250 days)
No
The description details a purely mechanical and electrical device for electrosurgery and smoke evacuation, with no mention of AI or ML components or functions.
Yes.
The device is used for cutting and coagulation of tissue, which are therapeutic effects.
No
The device is described as an electrosurgical pencil used for cutting and coagulation, and for smoke evacuation during surgery. Its function is to perform a surgical effect on tissue, not to diagnose a condition or disease.
No
The device description explicitly details numerous hardware components including a printed circuit board, electrical cable, switches, housing, nozzle, collett, tubing, and a physical electrode. It also mentions electrical safety and performance testing related to these hardware components. The "Software Verification and Validation Testing (Not applicable)" section further confirms that software is not a primary or standalone component of this device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery". This describes a surgical tool used directly on tissue, not a device used to examine specimens in vitro (outside the body) to diagnose conditions.
- Device Description: The description details a hand-held electrosurgical pencil that delivers electrical current to tissue and evacuates smoke. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status based on sample analysis
The device's function is to perform a surgical procedure and manage the byproducts of that procedure, not to diagnose a condition through in vitro testing.
N/A
Intended Use / Indications for Use
The ZIP PEN Smoke Evacuation Pencil is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. This device conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect.
Product codes
GEI
Device Description
The ZIP Pen Smoke Evacuation Electrosurgical Pencil is a sterile, single use hand held electrosurgical pencil and smoke evacuation handpiece. It is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
The device consists of a printed circuit board, flexible electrical cable, dome switches, button switch mechanisms and sealing materials. The circuit board and electrical cable provide the means for powering the device. The dome switches operate the Cut and Coag functions. These components are enclosed within an upper housing and lower molded carriage and nozzle. which snap together. The buttons sit on top of the dome switches and extend through the upper housing and facilitate activation of the device. The button proximal to the electrode is yellow and controls the cut function of the device. The button distal to the electrode is blue and controls the coagulate function of the device. Within the nozzle, there is a metal collett that holds the electrode in place. The housing and other components are designed and assembled to prevent liquid from entering the electrical connections (preventing an electrical short). This is accomplished by over molding the circuit board with nonconductive materials.
Clear tubing connects to the nozzle and provides a path for capturing electrosuraical smoke. The electro-surgical cable leaves the tubing through an open port and terminates at a 3-prong electro-surgical plug. The remaining portion of the tubing (without cable inside) terminates at a connector that attaches to the smoke evacuation filter. The connector is attached to the tubing and is included as part of the smoke evacuation pencil for connection to the filter.
The ZIP Pen Smoke Evacuation Electrosurgical Pencil is available with 10 ft. and 15 ft. cord/tubing (catalog numbers 2525-10 and 2525-15, respectively) and is supplied with two additional items:
- A holster, which is used to hold the device when it is not in use during the procedure. The holster is a component of the device and will not be sold separately.
- A 2.5 inch Megadyne E-Z Clean electrode. The electrode is a separate, currently marketed device that received clearance in 2008 via K081791.
The associated accessories include:
- Nozzle Extension can be used in electrosurgery procedures where a longer electrode is required to extend the smoke capture nozzle to the surgical site.
- Filter -- the ULPA and charcoal filters can be used with smoke evacuation units. They filter surgical smoke and odors removed from the surgical site.
- Adapter can be used to facilitate the tubing connection to a variety of smoke evacuation filter/units on the market.
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)
The following performance data were provided in support of the substantial equivalence determination.
Sterilization: The ZIP Pen Smoke Evacuation Electrosurgical Pencil and the nozzle extensions are sterilized by exposure to radiation to a Sterility Assurance Level (SAL) of 10^-6. Effectiveness of the sterilization cycle and sterilizing dose was qualified according to the requirements of ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose. These devices have a shelf life of 3 years.
Biocompatibility Testing: The biocompatibility testing for the ZIP Pen Smoke Evacuation Electrosurgical Pencil was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1, "Biological Evaluation of Medical Devices -- Part 1: Evaluating and Testing Within a Risk Management Process," as recognized by the FDA. The series of testing included the following tests: Cytotoxicity, Intracutaneous reactivity (Irritation), and Maximization sensitization (Sensitization). The ZIP Pen Smoke Evacuation Electrosurgical Pencil fulfilled all requirements of the test protocol and the standard.
Electrical Safety and Electromagnetic Compatibility (EMC): Electrical safety and EMC testing were conducted on the ZIP Pen Smoke Evacuation Electrosurgical Pencil. The system complies with the ANSI / AAMI / IEC 60601-1 and the ANSI / AAMI / IEC 60601-2-2 standards for safety and EMC.
Software Verification and Validation Testing: Not applicable. The ZIP Pen Smoke Evacuation Electrosurgical Pencil does not contain software.
Performance Testing - Bench: The ZIP Pen Smoke Evacuation Electrosurgical Pencil was exposed to performance bench testing to ensure conformance with the ANSI / AAMI / IEC 60601-1 and the ANSI / AAMI / IEC 60601-2-2 standards. The following tests were performed: High frequency dielectric withstand, Mains frequency dielectric withstand, Continuity, Leakage current, and Fluid Ingress.
Animal Study: Not applicable. Animal studies were not performed on the device.
Clinical Studies: Clinical studies were not performed as the indications for use are equivalent to the predicate device, and clinical testing is not required by applicable regulations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Telescoping PenEvac, K961616
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2015
Ms. Ronda K. Magneson Director of Regulatory Affairs Megadyne Medical Products, Incorporated 11506 South State Street Draper, Utah 84020
Re: K141587
Trade/Device Name: Zip Pen Smoke Evacuation Electrosurgical Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories Regulatory Class: Class II Product Code: GEI Dated: January 12, 2015 Received: January 14, 2015
Dear Ms. Magneson:
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141587
Device Name
ZIP PEN Smoke Evacuation Electrosurgical Pencil
Indications for Use (Describe)
The ZIP PEN Smoke Evacuation Pencil is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. This device conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect
|X | Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summarv
SUBMITTER 1.
Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 Phone: (801) 576-9669 Fax: (801) 576-9698
Contact Person (Primary): Ronda K. Magneson Director of Requlatory Affairs rmagneson@megadyne.com
Contact Person (Alternate): Katie Hoff Requlatory Affairs Specialist khoff@megadyne.com
Date Prepared: February 18, 2015
DEVICE II.
Name of Device: ZIP Pen Smoke Evacuation Electrosurgical Pencil (catalog numbers 2525-10 and 2525-15) Smoke Evacuation Electrosurgical Pencil Common Name: Electrosurgical cutting and coagulation device and Classification Name: accessories (21 CFR 878,4400) Requlatory Class: Class II GEI Product Code:
PREDICATE DEVICE lll.
Telescoping PenEvac, K961616 cleared May 28, 1996
DEVICE DESCRIPTION IV.
The ZIP Pen Smoke Evacuation Electrosurgical Pencil is a sterile, single use hand held electrosurgical pencil and smoke evacuation handpiece. It is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
4
The device consists of a printed circuit board, flexible electrical cable, dome switches, button switch mechanisms and sealing materials. The circuit board and electrical cable provide the means for powering the device. The dome switches operate the Cut and Coag functions. These components are enclosed within an upper housing and lower molded carriage and nozzle. which snap together. The buttons sit on top of the dome switches and extend through the upper housing and facilitate activation of the device. The button proximal to the electrode is yellow and controls the cut function of the device. The button distal to the electrode is blue and controls the coagulate function of the device. Within the nozzle, there is a metal collett that holds the electrode in place. The housing and other components are designed and assembled to prevent liquid from entering the electrical connections (preventing an electrical short). This is accomplished by over molding the circuit board with nonconductive materials.
Clear tubing connects to the nozzle and provides a path for capturing electrosuraical smoke. The electro-surgical cable leaves the tubing through an open port and terminates at a 3-prong electro-surgical plug. The remaining portion of the tubing (without cable inside) terminates at a connector that attaches to the smoke evacuation filter. The connector is attached to the tubing and is included as part of the smoke evacuation pencil for connection to the filter.
The ZIP Pen Smoke Evacuation Electrosurgical Pencil is available with 10 ft. and 15 ft. cord/tubing (catalog numbers 2525-10 and 2525-15, respectively) and is supplied with two additional items:
- A holster, which is used to hold the device when it is not in use during the � � procedure. The holster is a component of the device and will not be sold separately.
- A 2.5 inch Megadyne E-Z Clean electrode. The electrode is a separate, . currently marketed device that received clearance in 2008 via K081791.
The associated accessories include:
- Nozzle Extension can be used in electrosurgery procedures where a longer 0 electrode is required to extend the smoke capture nozzle to the surgical site.
- Filter -- the ULPA and charcoal filters can be used with smoke evacuation � units. They filter surgical smoke and odors removed from the surgical site.
- Adapter can be used to facilitate the tubing connection to a variety of smoke � evacuation filter/units on the market.
5
V. INDICATIONS FOR USE
The ZIP Pen Smoke Evacuation Electrosurgical Pencil is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The device conducts electrosurgical current from an electrosurqical generator and delivers it to the target tissue to achieve the desired surgical effect.
The indications for use for the subiect device are fundamentally identical to that of the predicate device, and any minor variations in wording do not affect the safety and effectiveness of the device when used as labeled.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The ZIP Pen Smoke Evacuation Electrosurgical Pencil shares the same technological characteristics and is constructed of similar materials, chemical composition, and use the same energy source found in the predicate device. It is a handheld electrosurgical device used for cutting, coagulation and smoke removal during electrosurgical procedures. At a high level, the subject and predicate devices are based on the following same technological elements:
- Operation function switches used to switch between "Cut" and "Coag" .
- Electrode monopolar 0
- Nozzle construction polvcarbonate �
- Power supply monopolar electrosurgical generator o
- Electrical connector US-3-pin �
- Use of a smoke evacuation svstem �
- Use of filters to filter surgical smoke removed from the surgical site. o
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Sterilization
The ZIP Pen Smoke Evacuation Electrosurgical Pencil and the nozzle extensions are sterilized by exposure to radiation to a Sterility Assurance Level (SAL) of 10° Effectiveness of the sterilization cycle and sterilizing dose was qualified according to the requirements of ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose.
These devices have a shelf life of 3 vears.
6
Biocompatibility Testing
The biocompatibility testing for the ZIP Pen Smoke Evacuation Electrosurgical Pencil was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1, "Biological Evaluation of Medical Devices -- Part 1: Evaluating and Testing Within a Risk Management Process," as recognized by the FDA. The series of testing included the following tests:
- o Cytotoxicity
- 0 Intracutaneous reactivity (Irritation)
- Maximization sensitization (Sensitization) 0
The ZIP Pen Smoke Evacuation Electrosurgical Pencil fulfilled all requirements of the test protocol and the standard.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the ZIP Pen Smoke Evacuation Electrosurgical Pencil. The system complies with the ANSI / AAMI / IEC 60601-1 and the ANSI / AAMI / IEC 60601-2-2 standards for safety and EMC.
Software Verification and Validation Testing
Not applicable. The ZIP Pen Smoke Evacuation Electrosurgical Pencil does not contain software.
Performance Testing - Bench
The ZIP Pen Smoke Evacuation Electrosurgical Pencil was exposed to performance bench testing to ensure conformance with the ANSI / AAMI / IEC 60601-1 and the ANSI / AAMI / IEC 60601-2-2 standards. The following tests were performed:
- 0 High frequency dielectric withstand
- 0 Mains frequency dielectric withstand
- � Continuity
- Leakage current 6
- Fluid Ingress 0
Animal Study
Not applicable. Animal studies were not performed on the device.
7
Clinical Studies
Clinical studies were not performed as the indications for use are equivalent to the predicate device, and clinical testing is not required by applicable requlations.
CONCLUSIONS VIII.
The ZIP Pen Smoke Evacuation Electrosurgical Pencil has the same intended purpose, indications and technological characteristics as the Telescoping PenEvac (K961616). The subject device also successfully passed all applicable performance and biocompatibility testing and is appropriate for its intended use.
The ZIP Pen Smoke Evacuation Electrosurgical Pencil does not raise different questions regarding safety and effectiveness as compared to predicate device. The ZIP Pen Smoke Evacuation Electrosurgical Pencil fuifills the relevant requirements of IEC 60601-2-2 and ISO 10993-1. Therefore, the subject device is as safe, as effective, and performs as well as or better than the predicate device, and is substantially equivalent to the predicate device.