ERBE MODEL VIO 300 D WITH ACCESSORIES

K083452 · Erbe USA, Inc. · GEI · Dec 31, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K083452
• Device Name: ERBE MODEL VIO 300 D WITH ACCESSORIES
• Applicant: Erbe USA, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 31, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The ERBE ESU Model VIO 300 D with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Device Story

The ERBE ESU Model VIO 300 D is an electrosurgical generator system used in clinical settings to cut and coagulate tissue via High Frequency (HF) electrical current. The system features a color monitor displaying settings, operational information, and an on-screen tutorial. Physicians operate the device using footswitches or hand instruments to deliver energy; the system includes automatic start/stop functionality and programmable modes. It provides audio and visual alerts for malfunctions or user errors. The device can be used with an Argon Plasma Coagulator (APC) accessory. Modifications include improved hardware (PCBs, display durability, monopolar/bipolar receptacles) and software updates (optimized power/resistance associations, crest factor changes, increased power for specific modes, and enhanced safety features like NESSY neonatal monitoring). The device benefits patients by providing precise, programmable electrosurgical energy for interventional procedures, with safety monitoring to prevent thermal damage and user error.

Clinical Evidence

Bench testing only. All modifications were verified and validated through design control processes.

Technological Characteristics

Electrosurgical generator system; HF electrical current output. Features color display, programmable modes, and footswitch/hand instrument connectivity. Hardware includes upgraded PCBs, improved anti-reflective display, and specialized monopolar/bipolar receptacles. Software-controlled energy delivery with NESSY (Neutral Electrode Safety System) monitoring. Non-sterile, reusable device.

Indications for Use

Indicated for the cutting and/or coagulation of tissue using High Frequency (HF) electrical current. Intended for prescription use.

Regulatory Classification

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.

Predicate Devices

• ERBE VIO ESU (Model VIO 300 D) (K023886)
• ERBE VIO ESU (Model VIO 300 D) (K060484)

Submission Summary (Full Text)

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ERBE USA Incorporated

K083452

DEC 31 200NFIDENTIAL

Special 510(k): ERBE ESU Model VIO 300 D with Accessories

# 510(k) SUMMARY

- Submitted By: ERBE USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 Tel: [phone] Fax: [phone]
Contact Person: Julie Stephens, President/Consultant Regulatory Resources Group, Inc.

GEI

Date Prepared:

Common Name: ElectroSurgical Unit (ESU/Generator) System

November 20, 2008

ERBE ESU Model VIO 300 D with Accessories Trade/Proprietary Name:

Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400)

Product Code:

Legally Marketed Predicate Device:

ERBE VIO ESU (Model VIO 300 D) with Accessories 510(k) Numbers: K023886 and K060484

## Device Description:

The ERBE ESU Model VIO 300 D with Accessories is an electrosurgical system that uses High Frequency (HF) electrical current waveforms to cut and/or coagulate tissue. There are modifications made to only a few of the Accessories from the previously cleared 510(k) Number K023886 and they are included within this submission.

## ESU Model VIO 300 D

The ESU has a color monitor display that provides the user with an on-screen tutorial as well as settings and operational information. The unit has various cutting and coagulation modes with defined effect levels to provide the physician flexibility in interventional applications (i.e. its ability to generate HF current). The system has automatic start and stop features. The equipment is programmable and various accessories (e.g. footswitches, hand instruments, etc.) as well as modes may be assigned to perform specific functions. When activated, the device has an audio and visual error system (i.e., malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered). Upon activation, the energy delivered (in watts) from the ESU to the tissue is displayed on the display screen.

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083452

Special 510(k): ERBE ESU Model VIO 300 D with Accessories

Also, the Unit can be used in association with an ERBE compatible Argon Plasma Coagulator (APC). The ESU is supplied non-sterile and is reusable.

#### Accessories (Modified VIO Footswitches)

Various types of single and double pedal Footswitches have been designed for ESU VIO Models. The Footswitches are used to activate the Generator. Some of the Footswitches have a ReMode button so that the physician can toggle between preset programs. Also, some Footswitches are equipped with a bracket (i.e. bar) so that the operator can position their foot.

Note: VIO stands for Variable Cut and Coaqulation.

Indications for Use:

ERBE USA Incorporated

The ERBE ESU Model VIO 300 D with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence):

Similarities

ESU Model VIO 300 D

The modified ESU has the same intended use, protective circuits, and uses the same basic accessories (i.e. A/C Cord, Adapters, etc.) as the predicate. Also, the Modes with and without Auto Stop in the modified device are the same Modes that are in the predicate. Both Generators have an on-screen tutorial as well as the same user interface display to select modes, power settings, etc. The modified and predicate devices are programmable and have ReMode capabilities. Both devices have Auto Start and Auto Stop functions. Also, each Unit has audio and visual error monitoring. The modified and predicate devices both can be used with a compatible Argon Plasma Coagulator (APC) with the respective APC being controlled through the ESU. Both Units have the actual software for the APC within the ESU. The APC related Modes for the modified device are the same as the predicate device. The modified ESU is also manufactured by ERBE Elektromedizin GmbH in Germany and like the predicate Generator will be supplied as non-sterile and is reusable. The packaging is also the same for each device with similar labeling (e.g. Outer Package Label, User Manual, etc.).

## Accessories (Modified VIO Footswitches)

The modified Footswitches are manufactured with the same type of materials and have the same functions as well as features as the predicate Footswitches. The packaging is also the same for each device with similar labeling (e.g. Outer Package Labels and Notes On Use, etc.).

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KO83452

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CONFIDENTIAL

ERBE USA Incorporated Special 510(k): ERBE ESU Model VIO 300 D with Accessories

Differences

ESU Model VIO 300 D

The modified ESU has the following changes or additions: Hardware

- The method for installing an optional software mode utilizes a communications . cable with a "serialized" dongle which requires changes to the internal communications Printed Circuit Boards (PCBs).
- . Several internal PCBs are upgraded with more robust components to prevent field issues and errors.
- The display is more durable and the anti-reflective coating on the display screen . is improved.
- The monopolar receptacle was improved to prevent the connection of instrument ● cables being inserted into the wrong holes of the module.
- An additional type of bipolar receptacle was created to further meet customer's ● needs.

Software

- Software changes are made to correct field issues and incorrect error situations. .
- With some of the modes, the association of effects with power (outputs) and . resistance were optimized and crest factors changed.
- Some visual cues and audio cues were improved (e.g. lighting of specific icons, . change in tone or increased sound for a mode or feature, added power display for specific bipolar modes).
- . The Endo Cut "I" and BiClamp modes have higher maximum output powers for the availability of more power if needed.
- The Auto Start and Auto Stop features are now available with additional modes. .
- An additional feature was created for the Neutral Electrode Safety SYstem . (NESSY) involving the use of a Neonatal Neutral Electrode (NE) (also referred to as Return Electrode, Patient Pad, Patient Plate, Grounding Pad, etc.). With the feature being turned "On", the Unit will display the message: "NE Neonatal Monitoring - reduce the effect or power setting" if a current of 300mA is reached.
- Upon connecting a recognized reusable instrument into the Unit, the following . additional message displays: "the instrument has already been sterilized around xx times" to provide usage information.
- An additional method for toggling between preset programs (i.e. the ReMode . feature) was added. That is, toggling between preset programs can be done by simultaneously pushing the Cut (Yellow) and Coag (Blue) buttons of a handswitch device.
- A "Maximum application time" setting is added to the Precise APC mode to . reduce the possibility of thermal damage with the mode.
- Added identification field so that its identity can be displayed when the Unit is . turned "On"

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K083452

Special 510(k): ERBE ESU Model VIO 300 D with Accessories

- The maximum voltage for High Cut and Argon-Assisted High Cut modes has . been changed in the User Manual from being the average value to the maximum number with the tolerance added.
### Accessories (Modified VIO Footswitches)

Footswitches with different configurations (i.e. single or double pedals, with or without ReMode, and with or without a bar) have been developed. Also, the Footswitches will be manufactured in house at ERBE Elektromedizin GmbH.

All of the modifications (i.e., additions and changes) for the ERBE ESU Model VIO 300 D with Accessories have been verified or validated in design control. All of the changes and additions as necessary are reflected in the labeling.

#### Conclusion:

ERBE USA Incorporated

The ERBE ESU Model VIO 300 D with Accessories has the same intended use, principles of operation, and technological characteristics as the predicate devices in the previously cleared 510(k)s. All of the modifications have been verified or validated in design control. In conclusion, there are no issues with the ERBE ESU Model VIO 300 D with Accessories that would raise additional safety or efficacy issues when compared to the predicate devices.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract design of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.

DEC 3 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ERBE, USA Inc. % Regulatory Resources Group Inc Ms. Julie Stephens 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K083452

Trade/Device Name: ERBE USA, Inc.'s ERBE ESU Model VIO 300 D with Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 20, 2008 Received: December 1, 2008

Dear Ms. Stephens:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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#### Page 2 -- Ms. Julie Stephens

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sinccrely yours,

Mark N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

083452 510(k) Number (if known):

Device Name: ERBE USA, Inc.'s ERBE ESU Model VIO 300 D with Accessories

Indications For Use:

The ERBE ESU Model VIO 300 D with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MKM

(Division Sign-O (Division Sign of General, Restorative, Division of Neurological Devices

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**510(k) Number** K083452