(448 days)
Not Found
No
The description focuses on standard electrosurgical unit functionality, pre-programmed modes, and remote control capabilities, with no mention of AI or ML.
Yes
The device is intended to deliver High Frequency (HF) current for the cutting and/or coagulation of tissue, which are therapeutic medical procedures.
No
This device is an ElectroSurgical Unit (ESU) intended to deliver High Frequency (HF) current for cutting and/or coagulating tissue. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly states it is an ElectroSurgical Unit that generates High Frequency (HF) electrical current and has physical controls, connection points for instruments, and accessories, indicating it is a hardware device with integrated software.
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 High Frequency (HF) current for the cutting and/ or coagulation of tissue." This is a direct surgical intervention on the patient's body.
- Device Description: The device is an ElectroSurgical Unit that generates electrical current for surgical procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly intended for surgical use directly on the patient.
N/A
Intended Use / Indications for Use
The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) current for the cutting and/ or coagulation of tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ERBE ESU Model VIO dV with Accessories is an ElectroSurgical Unit that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. The ESU has clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. The available Modes are Auto Cut, Dry Cut, Swift Coag, Forced Coag, and Bipolar Soft Coag with and without Auto Stop and BiClamp. Each Effect level corresponds to a specific voltage. The Modes provide the physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications.
The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible.
Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables
The VIO dV has a RCB (Remote Communication Bus) for remote control operation by the da da Vinci Xi Surgical System by Intuitive Surgical Inc. To have the unit installed as part of the da Vinci Xi Surgical System, contact Intuitive Surgical
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 release of the software version 3.1 for the RCB remote control of the ERBE ESU Model VIO dV has been verified and validated as part of the design control. Software validation for remote control functions has been carried out for the VIO dV Software 3.1 as well as for the integrated system (VIO dV and da Vinci system). Testing/measurement of the output parameters of the BiClamp-Mode was carried out to show that the ESU's BiClamp-Mode performs as specified and in accordance with the specifications of the predicate device ERBE ESU Model VIO 300 D.
Animal or clinical performance testing was not considered necessary.
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.
ERBE ESU Model VIO dV with Accessories, 510(k) Number K133180, ERBE ESU Model 300 D with Accessories, 510(k) Number K083452
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.
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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 design of an eagle or bird-like figure with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
ERBE Elektromedizin GmbH Mr. Axel Retzlaff Director of Regulatory Affairs Waldhoernlestr. 17 Tuebingen, Germany 72072
Re: K150364
Trade/Device Name: ERBE ESU Model VIO dV with Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device Regulatory Class: Class II Product Code: GEI Dated: May 2, 2016 Received: May 4, 2016
Dear Mr. Retzlaff:
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 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" (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 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 yours.
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
510(k) Number (if known) K150364
Device Name
ERBE ESU Model VIO dV with Accessories
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) current for the cutting and/ or coagulation of tissue.
| | X Prescription Use (Part 21 CFR 801 Subpart D)
Over=The=Counter Use (21 CFR 801 Subpart C) | | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
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510(k) SUMMARY
As Required by 21 CFR 807.92(c)
| Owner/Operator: | ERBE Elektromedizin GmbH
Waldhoernlestr. 17
72072 Tuebingen
Germany
Phone +49-7071-755-0
Fax +49-7071-755-179
Contact: Axel Retzlaff, Director RA |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 20/01/2015 |
| Trade (Proprietary) Name: | ERBE ESU Model VIO dV with Accessories |
| Common Name: | Electrosurgical Unit (ESU/Generator) System |
| Classification Name: | Electrosurgical Cutting and Coagulation Device
and Accessories (21 CFR 878.4400) |
| Product Code: | GEI |
| Legally Marketed Predicate Device: | ERBE ESU Model VIO dV with Accessories,
510(k) Number K133180
ERBE ESU Model 300 D with Accessories, 510(k)
Number K083452 |
Description of the Device:
The ERBE ESU Model VIO dV with Accessories is an ElectroSurgical Unit that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. The ESU has clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. The available Modes are Auto Cut, Dry Cut, Swift Coag, Forced Coag, and Bipolar Soft Coag with and without Auto Stop and BiClamp. Each Effect level corresponds to a specific voltage. The Modes provide the
4
physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications.
The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible.
Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables
The VIO dV has a RCB (Remote Communication Bus) for remote control operation by the da da Vinci Xi Surgical System by Intuitive Surgical Inc. To have the unit installed as part of the da Vinci Xi Surgical System, contact Intuitive Surgical
Intended Use:
The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) current for the cutting and/or coagulation of tissue.
Summary of the Technological Characteristics:
Similarities between modified and predicate devices:
Unit:
The proposed device ERBE ESU Model VIO dV (remote) compares to the predicate device ERBE ESU Model VIO dV (standalone) as follows:
Both devices have the same intended use, the same basic technology, protective circuits, and use the same basic accessories. Both devices are identical in hardware design including all materials and are using the same energy source. Both generators have the same user interface displays to select modes, power settings, etc. and both have the same Modes Auto Cut, Dry Cut, Swift Coag, Forced Coag, Bipolar Soft Coag with and without AutoStop function. Also, both units have audio and visual error monitoring.
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The subject ESU and the predicate devices are manufactured by ERBE Elektromedizin GmbH in Germany and are supplied as non-sterile and are reusable. The packaging is also the same for both devices with similar labeling (e.g. Outer Package Label, User Manual, etc.). The proposed device ERBE ESU Model VIO dV (remote) compares to the predicate device ERBE ESU Model VIO 300 D as follows:
Both devices have the same BiClamp Mode.
Accessories:
The one pedal and two pedal footswitches are the same for both the subject and the predicate devices. The packaging is also the same with equal labeling.
Differences between modified and predicate devices:
The proposed device ERBE ESU Model VIO dV (remote) differs from the predicate device ERBE ESU Model VIO dV (standalone) as follows:
The proposed device has an updated Software Version 3.1 (predicate: 3.0) as the device is intended for remote control including HF-activation and change of settings via Intuitive Surgical, Inc.'s Da Vinci Surgical System. The BiClamp Mode which was disabled in the predicate ERBE ESU Model VIO dV is enabled in the proposed device. The User Manual was modified to appropriately address both changes.
Performance Data to determine Substantial Equivalence
The release of the software version 3.1 for the RCB remote control of the ERBE ESU Model VIO dV has been verified and validated as part of the design control. Software validation for remote control functions has been carried out for the VIO dV Software 3.1 as well as for the integrated system (VIO dV and da Vinci system). Testing/measurement of the output parameters of the BiClamp-Mode was carried out to show that the ESU's BiClamp-Mode performs as specified and in accordance with the specifications of the predicate device ERBE ESU Model VIO 300 D.
ERBE Elektromedizin GmbH, in accordance with established procedures, directs and controls design activities. These procedures involve design and development planning,
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design input, design review, design verification/design validation, design transfer, as well as design change control. The activities provide the oversight and forum for project approval, formal management/design review, evaluation, and final project approval. This work is documented within design review and the approvals are documented as part of the current change control system.
The ERBE ESU Model VIO dV, software version 3.1 for the RCB remote control complies to FDA's "Recognized Consensus Standards". Animal or clinical performance testing was not considered necessary.
Conclusion:
The software release version 3.1 and modification of the ERBE ESU Model VIO dV has the same intended use, principles of operation and technological characteristics as the predicate devices in the previously cleared 510(k)s. The subject device has been verified and validated in design control. There are no issues with the subject device that would raise additional safety or efficacy issues, when compared to the predicate devices.