(48 days)
Not Found
No
The description focuses on standard electrosurgical generator functions and features like power output, modes, and safety mechanisms. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used to "cut and coagulate different kinds of tissue," which directly addresses and treats a medical condition.
No
Explanation: The ESU-1 Electrosurgical Generator is used to deliver RF energy for cutting and coagulating tissue during surgery, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a generator, power cord, and internal components like printed circuit boards, speakers, and cabling, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue." This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details a generator that provides electrical current for surgical cutting and coagulation. This is consistent with a surgical device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is to perform surgical procedures, not to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ESU-1 Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ESU-1 Electrosurgical Generator is a high frequency isolated generator that utilizes electrical current via an assortment of surgical devices to cut and coagulate different types of tissue. The ESU-1 Electrosurgical Generator features cutting up to 300 watts with 2 cut modes, including "Cut T", a blend mode with 4 levels, 3 coagulation modes and 4 bipolar modes with Auto Bipolar option. "Cut T" mode is a new feature that includes a timing feature which automatically ceases RF activation after a user selectable period of time that can be altered between 0.1 and 3.0 seconds. The RF activation for Cut T mode is initially pre-set at 2 seconds (Note: if the operator changed these settings, the generator will powerup with the mode and setting in which the operator last activated the generator). The generator offers 2 monopolar headpiece outputs, monopolar foot controlled output, bipolar handpiece output, and bipolar foot controlled output. The generator has a return electrode sensing feature allows the user to use either a split or solid return electrode site. The padsensing feature allows the user to use either a split or solid return electrode.
The device consists of a generator and power cord and is packaged with a User's Guide in a cardboard shipping box with protective foam inserts. The main device components are a front panel containing the power button, wattage selection buttons, LED numeric display, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of footswitch ports, volume controls, a power cord outlet and fuse, and internal components (printed circuit boards, speakers, cabling).
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)
Bench testing was performed to demonstrate that the generator met its design specifications. The testing consisted of Mechanical Verification Testing, Inspection Verification Testing, Electrical Verification Testing, Shipping Study, FPGA Validation for Main Board, FPGA Validation for Display Board and was conducted on the ESU-1 or devices representative of its design. The results from these tests demonstrate that the technological characteristics and performance criteria of the ESU-1 are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use.
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.
Bovie® IDS-310 Electrosurgical Generator [Bovie Medical Corporation; K134054]
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2016
TVA Medical, Inc. Ms. Katherine Kumar VP of Regulatory & Clinical Affairs 7000 Bee Caves Rd., Suite 250 Austin, Texas 78746
Re: K162656
Trade/Device Name: ESU-1 Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 21, 2016 Received: September 23, 2016
Dear Ms. Kumar:
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 of medical devicerelated 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.
1
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 -A
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162656
Device Name ESU-1 Electrosurgical Generator
Indications for Use (Describe)
The ESU-1 Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY (K162656)
ESU-1 Electrosurgical Generator
510(k) Owner
TVA Medical, Inc. 7000 Bee Caves Rd., Suite 250 Austin, TX 78746
Official Correspondent
Katherine Kumar, PhD, RAC TVA Medical, Inc. VP of Regulatory & Clinical Affairs 7000 Bee Caves Rd., Suite 250 Austin, TX 78746
Email: kkumar@tvamedical.com Phone: 612-716-5578 (cell) Fax: 612-435-0292
Date Prepared: September 8, 2016
Subject Device Name
| Trade Name | ESU-1 Electrosurgical Generator |
|---|---|
| Common or usual name | Electrosurgical Generator |
| Classification name | Electrosurgical Cutting and Coagulation |
| Device and Accessories [21 CFR 878.4400 | |
| product code GEI] | |
| Class | II |
| Classification Panel | General and Plastic Surgery (79) |
Predicate Device
Bovie® IDS-310 Electrosurgical Generator [Bovie Medical Corporation; K134054]
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Device Description
The ESU-1 Electrosurgical Generator is a high frequency isolated generator that utilizes electrical current via an assortment of surgical devices to cut and coagulate different types of tissue. The ESU-1 Electrosurgical Generator features cutting up to 300 watts with 2 cut modes, including "Cut T", a blend mode with 4 levels, 3 coagulation modes and 4 bipolar modes with Auto Bipolar option. "Cut T" mode is a new feature that includes a timing feature which automatically ceases RF activation after a user selectable period of time that can be altered between 0.1 and 3.0 seconds. The RF activation for Cut T mode is initially pre-set at 2 seconds (Note: if the operator changed these settings, the generator will powerup with the mode and setting in which the operator last activated the generator). The generator offers 2 monopolar headpiece outputs, monopolar foot controlled output, bipolar handpiece output, and bipolar foot controlled output. The generator has a return electrode sensing feature allows the user to use either a split or solid return electrode site. The padsensing feature allows the user to use either a split or solid return electrode.
The device consists of a generator and power cord and is packaged with a User's Guide in a cardboard shipping box with protective foam inserts. The main device components are a front panel containing the power button, wattage selection buttons, LED numeric display, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of footswitch ports, volume controls, a power cord outlet and fuse, and internal components (printed circuit boards, speakers, cabling).
Indications for Use
The ESU-1 Electrosurgical Generator [ESU-1] is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
Comparison of Indications for Use to Predicate Device
The ESU-1 has the same indications for use as the Bovie IDS-310.
Comparison of Technological Characteristics to Predicate Device
The ESU-1 has the following similarities to the Bovie IDS-310:
- Both devices have the same intended use/indications for use
- . Each device is identical in size, weight and construction.
- Each device uses high frequency RF current to deliver a desired clinical effect.
- Each device offers monopolar and bipolar output modes.
- Each device offers the same waveforms, output frequencies and maximum output . power for all monopolar modes.
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- . Each device offers the same waveforms, output frequencies and maximum output power for Micro. Standard and Bovie Bipolar modes.
- Each device offers the AutoBipolar Feature.
- Each device offers the same Return Electrode Monitoring System.
- . Each device has the same chassis.
- Each device has the same interconnections, internal printed circuit boards and electrical components.
- . Each device has the same rated duty cycle.
The RF output for both generators is identical and both generators have identical modes with the exception that the ESU-1 has a "Cut T" mode, which includes a timing feature which automatically ceases RF activation after a user selectable period of time that can be altered between 0.1 and 3.0 seconds. The RF activation for Cut T mode is initially pre-set at 2 seconds. The Cut T mode replaces the Cut II function on the IDS-310. The RF output for both generators is identical.
Performance testing
The software for the ESU-1 has been verified and validated based on its moderate level of concern. The ESU-1 complies with IEC60601-1 (third edition), IEC60601-2 (electromagnetic compatibility), and IEC60601-2-2 standard for the safety of electrosurgical equipment. Bench testing was performed to demonstrate that the generator met its design specifications. The testing consisted of Mechanical Verification Testing, Inspection Verification Testing, Electrical Verification Testing, Shipping Study, FPGA Validation for Main Board, FPGA Validation for Display Board and was conducted on the ESU-1 or devices representative of its design.
The results from these tests demonstrate that the technological characteristics and performance criteria of the ESU-1 are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use.
Sterilization
The ESU-1 Electrosurgical Generator is a non-sterile device.
Biocompatibility
The ESU-1 Electrosurgical Generator is not a patient contacting device.
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Conclusion
The ESU-1 met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The ESU-1 is substantially equivalent to legally marketed predicate devices.