(43 days)
No
The device description and performance studies focus on standard electrosurgical functions, smoke evacuation, and lighting, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as an electrosurgical pencil used for cutting and coagulation, and for removing smoke, which are surgical functions, not therapeutic ones.
No
The device is described as a monopolar electrosurgical device for cutting and coagulation, and for removing smoke during surgery. Its primary functions are therapeutic (surgical effect) and operational (smoke removal, illumination), not for diagnosing medical conditions.
No
The device description clearly outlines a physical electrosurgical pencil with integrated hardware components (LED light, suction ability, buttons, cable, batteries, retractable blade, tubing). The performance studies also focus on physical and electrical characteristics of the hardware.
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 "general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgical current when used in conjunction with an effective smoke evacuation system." This describes a surgical tool used directly on a patient's tissue.
- Device Description: The description details a "monopolar electrosurgical pencil" that "conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue." This further confirms its use in surgical procedures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a surgical instrument used on the body.
Therefore, the Cut-Vac® Smoke Evacuation Electrosurgical is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cut-Vac® Smoke Evacuation Electrosurqical is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgical current 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 Precision Surgical Cut-Vac® Lighted Smoke Evacuation Electrosurgical Pencil is a standard monopolar electrosurgical pencil with incorporated LED light, and suction ability for cautery smoke. It is a sterile single use device. It performs all standard functions of an electrosurgical pencil with separate buttons for Cutting and Coagulation. Cut-Vac connects to all standard electrosurgical generator units with a standard 3-prong plug. The Cut and Coag buttons, and light switch are on the top of the device. The proximal button to the tip/blade is yellow and controls Cutting. The blue button distal to the tip controls Coagulation. The green slider switch turns the LED light on and off. The LED light does not interfere with the function of the pencil and is encased in clear thermoplastic and does not contact liquid. The light allows the operator to visualize areas during surgeries or overcome shadows despite surgical Operating Room lights. It has removable separate small batteries that are located in the distal plug that attaches to the ESP, and thus are disposable in an environmentally safe method.
The retractable blade allows the operator to better control smoke evacuation by shortening the effective blade length. Cut-Vac does not have irrigation capability.
It has an 8.5 foot suction tube to attach to any suction with an additional 5 feet of electro-surgical cable from the end of the suction tube to attach to an ESP generator. The first 8.5 feet of the suction tube incorporates the electro-surgical cable to eliminate clutter on the surgical field. The electrical-surgical cable leaves the tubing through a sealed and molded closed port and terminates in a standard 3-prong electro-surgical plug. The remaining portion of the suction tubing terminates to a flexible connector that attaches to different suction canister ports. The integrated device enables the operator to cut, coagulate, evacuate smoke and illuminate the surgical site without the need for separate tools.
The Cut-Vac® device must be used in conjunction with an electrosurgical generator and grounding pads in order to power up the device.
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
Non-Clinical Performance Data: Precision Surgical completed a number of non-clinical performance tests to demonstrate safety and effectiveness and substantial equivalence. The Cut-Vac meets all requirements for design, sterilization, biocompatibility, and electrical safety. The device passed testing in accordance with internal requirements, national standards, and international standards for substantial equivalence.
Specific tests performed:
- Biocompatibility testing per ISO 10993-1
- Electrical safety testing per AAMI ANSI EC 60601-1
- Electrical safety of high frequency surgical equipment testing per AAMI ANSI EC 60601-2-2
- Smoke evacuation testing per FDA Guidance document "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery"
- Simulated smoke evacuation was performed using methane as a surrogate marker. The test sampled the amount of methane drawn through the test articles, with vacuum on, for 30 seconds with performance compared to the predicate device. Tests were performed at 3 vacuum levels. The Cut-Vac performed equivalent to the predicate.
- Thermal Zone testing per FDA Guidance document "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery"
- Thermal effects of Cut and Coag functions were evaluated in muscle, kidney, and liver at minimum, default, and maximum generator settings. The Cut-Vac performed equivalent to the predicate.
- Tubing leak test
- Quantitative analyses was performed using water. No leaks were detected.
- Shelf Life Testing
- 12 month Accelerated Aging was performed on the Cut-Vac devices followed by performance testing. All units passed protocol acceptance criteria.
- Storage and Transport Testing
- Packaging Drop Test was performed per ASTM D5276-98 and passed per the standard.
- Transport testing was performed and passed.
Clinical Performance Data: No human clinical testing was required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices have been on the market for many years with proven safety and efficacy. The non-clinical testing supports the substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/2 description: The image is a black and white 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that resemble fabric or water.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2017
Precision Surgical. LLC % Mr. Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K170721
Trade/Device Name: Cut-Vac Lighted Smoke Evacuation 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: March 7, 2017 Received: March 9, 2017
Dear Mr. Yungvirt:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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.
Sincerely,
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) Unassigned к170721
Device Name Cut-Vac® Lighted Smoke Evacuation Pencil
Indications for Use (Describe)
The Cut-Vac® Smoke Evacuation Electrosurqical is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgical current 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.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Cut-Vac® Lighted Smoke Evacuation Electrosurgical Pencil
K170721
1. Submission Sponsor
Precision Surgical, LLC
245E Warm Springs Rd #132
Las Vegas
Nevada
89119
USA
Contact: Prash Jayaraj, MD Title: Chief Executive Officer
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327.9997
Contact: Rick Gillis, PhD
Title: Senior Consultant, RA
3. Date Prepared
15 March, 2017
4. Device Identification
Trade/Proprietary Name: Cut-Vac® Lighted Smoke Evacuation Electrosurgical Pencil Common/Usual Name: Electrosurgical Pencil
4
| Classification Name: | Electrosurgical Pencil |
|---|---|
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI, Electrosurgical, Cutting & Coagulation & Accessories |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
5. Legally Marketed Predicate Device(s)
K141587
Zip-Pen Smoke Evacuation Electrosurgical Pencil, Megadyne Medical Products, Inc.
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.
6. Indication for Use Statement
The Cut-Vac® Smoke Evacuation Electrosurgical Pencil is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgical current 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.
7. Device Description
The Precision Surgical Cut-Vac® Lighted Smoke Evacuation Electrosurgical Pencil is a standard monopolar electrosurgical pencil with incorporated LED light, and suction ability for cautery smoke. It is a sterile single use device. It performs all standard functions of an electrosurgical pencil with separate buttons for Cutting and Coagulation. Cut-Vac connects to all standard electrosurgical generator units with a standard 3-prong plug. The Cut and Coag buttons, and light switch are on the top of the device. The proximal button to the tip/blade is yellow and controls Cutting. The blue button distal to the tip controls Coagulation. The green slider switch turns the LED light on and off. The LED light does not interfere with the function of the pencil and is encased in clear thermoplastic and does not contact liquid. The light allows the operator to visualize areas during surgeries or overcome shadows despite surgical Operating Room lights. It has removable separate small batteries that are located in the distal plug that attaches to the ESP, and thus are disposable in an environmentally safe method.
The retractable blade allows the operator to better control smoke evacuation by shortening the effective blade length. Cut-Vac does not have irrigation capability.
5
lt has an 8.5 foot suction tube to attach to any suction with an additional 5 feet of electro-surgical cable from the end of the suction tube to attach to an ESP generator. The first 8.5 feet of the suction tube incorporates the electro-surgical cable to eliminate clutter on the surgical field. The electrical-surgical cable leaves the tubing through a sealed and molded closed port and terminates in a standard 3-prong electro-surgical plug. The remaining portion of the suction tubing terminates to a flexible connector that attaches to different suction canister ports. The integrated device enables the operator to cut, coagulate, evacuate smoke and illuminate the surgical site without the need for separate tools.
The Cut-Vac® device must be used in conjunction with an electrosurgical generator and grounding pads in order to power up the device.
8. Substantial Equivalence Discussion
The following table compares the Cut-Vac® Lighted Smoke Evacuation Electrical Pencil to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Manufacturer | Precision Surgical, LLC | Megadyne Medical
Products, Inc | Device Comparison |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Trade Name | Precision Surgical | Megadyne | |
| 510(k) Number | Not assigned | K141587 | |
| Product Code | GEI | GEI | Same |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Regulation Name | Electrosurgical, Cutting
& Coagulation &
Accessories | Electrosurgical, Cutting &
Coagulation &
Accessories | Same |
| Indications for Use | The Cut-Vac® Smoke
Evacuation
Electrosurgical Pencil is
a monopolar device
designed for general
electrosurgical
applications including
cutting and coagulation
and for removing smoke
generated by
electrosurgical current | 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 | Same; No new
questions regarding
safety or
effectiveness. |
| Manufacturer | Precision Surgical, LLC | Megadyne Medical
Products, Inc | Device Comparison |
| Trade Name | Precision Surgical | Megadyne | |
| | 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. | 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. | |
| Mechanism of Action | Electrical monopolar | Electrical monopolar | Same |
| Electrode | Monopolar | Monopolar | Same |
| Handpiece
Dimensions (LxWxH) | (174mmx15mmx24mm) | (200mmx18mmx12mm) | Similar;
Dimensional
differences do
not
effect performance. |
| Nozzle construction | Polycarbonate | Polycarbonate | Same |
| Electrical Connector | US-3-pin | US-3-pin | Same |
| Smoke Evacuation | Yes | Yes | Same |
| Power Supply | Monopolar
electrosurgical
generator | Monopolar
electrosurgical generator | Same |
| Sterile | Yes | Yes | Same |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 1 year | 3 years | Similar;
Real-time
aging for Cut-Vac is in
process |
| RF Voltage Vmax | 4.0 kV peak | 5.5 kV peak | Similar;
does
not
affect performance |
| Battery Operated | LED light only | None | Similar; Battery does
not
affect
device |
| Manufacturer | Precision Surgical, LLC | Megadyne Medical
Products, Inc | Device Comparison |
| Trade Name | Precision Surgical | Megadyne | function |
| Accessories | None | Nozzle Extension, Filter, Adapter | Similar; accessories provided for marketing purposes only |
| Complies with ISO 10993-1 | Yes | Yes | Same |
| Electrical Safety Testing Passed | Yes | Yes | Same |
| Electrical Safety Testing Passed | Yes | Yes | Same |
Table 5A - Comparison of Characteristics
6
7
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of Cut-Vac® Lighted Smoke Evacuation Electrical Pencil and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Precision Surgical completed a number of non-clinical performance tests. The Cut-Vac meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The Cut-Vac® Lighted Smoke Evacuation Electrical Pencil passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility testing per ISO 10993-1
- Electrical safety testing per AAMI ANSI EC 60601-1 ●
- Electrical safety of high frequency surgical equipment testing per AAMI ANSI EC 60601-2-2
- Smoke evacuation testing per FDA Guidance document "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery"
- o Simulated smoke evacuation was performed using methane as a surrogate marker. The test sampled the amount of methane drawn through the test articles, with vacuum on, for 30 seconds with performance compared to the predicate device. Tests were performed at 3 vacuum levels. The Cut-Vac performed equivalent to the predicate.
- . Thermal Zone testing per FDA Guidance document "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery"
8
- o Thermal effects of Cut and Coag functions were evaluated in muscle, kidney, and liver at minimum, default, and maximum generator settings. The Cut-Vac performed equivalent to the predicate.
- Tubing leak test ●
- Quantitative analyses was performed using water. No leaks were detected. o
- Shelf Life Testing – 12 month Accelerated Aging was performed on the Cut-Vac devices followed by performance testing. All units passed protocol acceptance criteria.
- . Storage and Transport Testing -
- Packaging Drop Test was performed per ASTM D5276-98 and passed per the standard. O
- o Transport testing was performed and passed.
10. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).
The Cut-Vac® Lighted Smoke Evacuation Electrical Pencil, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).