(55 days)
Not Found
No
The description focuses on standard electrosurgical unit functionality, waveforms, and modes, with no mention of AI or ML terms or capabilities.
Yes
The device is an ElectroSurgical Unit that delivers electrical current to cut and/or coagulate tissue, which are therapeutic actions.
No
The device is an electrosurgical unit intended to deliver high-frequency electrical current for cutting and/or coagulating tissue. It does not perform any diagnostic functions.
No
The device description clearly states it is an "ElectroSurgical Unit" and a "stand-alone generator" with physical controls, connection points for instruments, and accessories like footswitches and cables. This indicates it is a hardware device, not software-only.
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) electrical current for the cutting and/or coagulation of tissue." This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from a patient outside the body.
- Device Description: The description details an "ElectroSurgical Unit" that generates electrical current for surgical purposes. This aligns 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.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to surgically alter tissue using electrical current.
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. It is a stand-alone generator. The ESU has five clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. 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
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 ERBE ESU Model VIO dV with Accessories has been verified or validated in design control.
Animal or clinical performance testing was not considered necessarv.
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.
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
ERBE USA Incorporated Special 510(k) for ERBE ESU Model VIO dV with Accessories
Page 1 of 3 October 2013
| Owner/Operator: | ERBE USA Incorporated
2225 Northwest Parkway
Marietta, GA 30067 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Trade (Proprietary) Name: | ERBE ESU Model VIO dV with Accessories |
| Common Name: | Electrosurgical Unit (ESU/Generator) |
| Classification Name, Number, and
Product Code: | Electrosurgical, Cutting & Coagulation &
Accessories; 21 CFR 878.4400; GEI |
| Legally Marketed Predicate Device: | ERBE ESU Model VIO 300 D with Accessories,
510(k) Number K083452
Note: VIO stands for Variable Cut and
Coagulation. |
510(k) SUMMARY [As Required by 21 CFR 807.92(c)]
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. It is a stand-alone generator. The ESU has five clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. 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
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.
1
ERBE USA Incorporated Special 510(k) for ERBE ESU Model VIO dV with Accessories
Page 2 of 3 October 2013
Summary of the Technological Characteristics:
Similarities between modified and predicate devices:
Unit
The ERBE ESU Model VIO dV has the same intended use, the same basic technology, protective circuits, and uses the same basic accessories as the predicate ESU (ERBE Model VIO 300 D). Also, the Modes available in the ERBE ESU Model VIO dV ESU [i.e. Auto Cut, Dry Cut, Swift Coag, Forced Coag, and Bipolar Soft Coag with and without Auto Stop] are the same in the predicate. Both generators have user interface displays to select modes, power settings, etc. and have the AutoStop function. Also, both units have audio and visual error monitoring.
The subject ESU and the predicate device both 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.).
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 similar labeling.
Differences between modified and predicate devices:
The ERBE ESU Model VIO dV differs from the predicate ERBE ESU Model VIO 300 D as follows:
| Subject device | Predicate device |
|---|---|
| - the unit has a square shape | |
| (408 x 163 x 380 mm) | |
| with rounded front panel | - the unit is of 'cake slice' shape |
| (425 x 211 x 462 mm) | |
| with square front panel | |
| - the ESU has a 10" Touchscreen color monitor display | - it has 6" button and LED color monitor display |
| - it has 4 HF receptacles in the front panel | |
| (2 monopolar and 2 bipolar) with | |
| instrument recognition on both the | |
| monopolar and bipolar receptacles. | - it has 3 HF receptacles in the front panel |
| (monopolar, bipolar, multifunction) | |
| - it has a receptacle for a CAN-bus for a remote controller | - it has no receptacle for a CAN-bus for a remote controller |
| - it has no receptacle for an APC unit | - it has a receptacle for an APC unit |
| - it has a firewall function | - it has no firewall function |
2
Page 3 of 3
ERBE USA Incorporated Special 510(k) for ERBE ESU Model VIO dV with Accessories
October 2013
| - it has no programming capabilities
- it ha a recall function
- the modes that are present are the
principal ones to perform essential
cutting and coagulating activities.
Auto Cut, Dry Cut, Swift Coag, Forced
Coag., Soft Coag, Soft Coag with
AutoStop,,
No new modes are added. | - it has 99 program possibilities - it has no recall function
- the predicate has a wide range of modes
such as Auto Cut, High Cut, Dry Cut, Dry
Cut °, Precise Cut, Soft Coag, Soft Coag
with AutoStop, Swift Coag, Swift Coag °,
Classic Coag, Forced Coag, Spray
Coag, Precise Coag, Twin Coag, Bipolar
Cut, Bipolar Cut +, Bipolar Precise Cut,
Endo Cut Q, Endo Cut I, Bipolar Soft
Coag +, Bipolar Forced Coag, BiClamp,
Bipolar Precise Coag, Precise APC,
Forced APC, Pulsed APC, Argon-
assisted High Cut, Argon-assisted AUTO
Cut, Argon-assisted Dry Cut, Argon-
assisted Dry Cut °, Argon-assisted Swift
Coag, Argon-assisted Swift Coag °,
Argon-assisted Soft Coag, Argon-
assisted Forced Coag and Argon-
assisted Twin Coag (Note: Only some of
these Modes are standard with the
predicate device.). |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
The ERBE ESU Model VIO dV with Accessories has been verified or validated in design control.
ERBE Elektromedizin GmbH, in accordance with established procedures, directs and controls design activities. These procedures involve design and development planning, design input, design review, design verification/design output, 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 with Accessories was tested to FDA's "Recognized Consensus Standards". Animal or clinical performance testing was not considered necessarv.
Conclusion:
The ERBE ESU Model VIO dV with Accessories has the same intended use, principles of operation and technological characteristics as the predicate device in the previously cleared 510(k)s. The subject device has been verified or validated in design control. In conclusion, there are no issues with the subject device that would raise additional safety or efficacy issues, when compared to the predicate devices.
E 3
3
Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized emblem with three curved shapes, resembling a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ERBE USA Incorporated Mr. John Tartal Ouality Assurance/Regulatory Affairs Director 2225 Northwest Parkway Marietta, Georgia 30067
December 11, 2013
Re: K133180
Trade/Device Name: ERBE ESU Model VIO dV with Accessories 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, 2013 Received: November 12, 2013
Dear Mr. Tartal:
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
4
Page 2 - Mr. John Tartal
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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.goy/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 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,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K133180 510(k) Number (if known):
Device Name: ERBE ESU Model VIO dV with Accessories
Indications For Use:
ﺍﻟﻤﺴﻴﺴﻴﺔ ﺍﻟﺘﺤﺘﻮﻱ ﺍﻟﻤﻮﺗﻮﻓﻴﺎ
The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Prescription Use 2 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Figure/10 description: The image shows a document sign-off for the Division of Surgical Devices. The 510(k) number is K133180. The document is signed by Long H. Chen-A on December 10, 2013. The document is for BSA.
001_4 Indications for Use Statement
004 - 1