The ERBE ESU Model VIO 200 S is an ESU that uses High Frequency (HF) electrical current waveforms to cut and/or coagulate tissue. It has a display as well as various cutting and coagulation modes with defined effect levels to provide the physician flexibility in interventional applications (i.e. its ability to generate the 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 as well as a visual erroring 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.). Also, the ESU can be used in association with an ERBE compatible Argon Plasma Coagulator (APC). The unit is supplied non-sterile and is reusable.

AI/ML Overview

The provided text is a 510(k) summary for an electrosurgical unit (ESU). This type of device is an electrical instrument used in surgery for cutting and coagulating tissue. The review process for such devices, especially special 510(k)s, focuses on demonstrating substantial equivalence to a predicate device. This typically involves comparing technical specifications and performance data, often through bench testing and electrical safety/EMC testing, rather than clinical studies with human subjects or AI performance metrics.

Therefore, many of the requested categories for AI-based medical devices are not applicable to this submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use: Deliver HF electrical current for cutting/coagulation.	"The ERBE ESU Model VIO 200 S is intended to deliver high frequency electrical current for the cutting and/or coagulation of tissue." (Identical to predicate)
Protective Circuits: Same as predicate.	"The modified ESU... has the same... protective circuits."
Basic Accessories: Uses same basic accessories as predicate.	"The modified ESU... uses the same basic accessories."
Modes of Operation: Presence and functionality of specified modes.	Common modes (Auto Cut, Endo Cut Q, Endo Cut I, Soft Coag, Forced Coag, Bipolar Soft Coag with/without Auto Stop, APC modes) are present, but some have power limitations compared to the predicate.
User Interface: Functional display for mode/power selection.	Has a display with LEDs for effect/wattage settings. User-friendly interface, though no on-screen tutorial.
Programmability: Adequate programming capabilities.	9 program possibilities (less than predicate's 99), deemed "adequate" and less confusing.
Error Monitoring: Audio and visual error system.	Has "audio and visual error monitoring."
Compatibility with APCs: Functions with ERBE compatible APCs.	"Can be used in association with an ERBE compatible Argon Plasma Coagulator (APC)."
Max Wattage: Adequate for intended use.	Maximum 200 watts (less than predicate's 300 watts), deemed "more than adequate."
Power Delivery: Delivers only necessary power in Cut/Coag modes.	"Still only delivers the amount of power needed" in Cut and Coag Modes.
Safety and Efficacy: No adverse effect from modifications.	"The changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness."
Effectiveness: Efficient unit.	"The modified ESU is an efficient unit."

Study Proving Acceptance Criteria:

The document describes a "Special 510(k)" submission. This type of submission relies heavily on demonstrating substantial equivalence to a legally marketed predicate device (ERBE VIO ESU Model VIO 300 D, K060484). The "study" proving the device meets acceptance criteria is primarily a comparative analysis of technical specifications and performance data against the predicate device, supported by verification and validation activities.

The statement "all the changes were verified or validated" implies that internal testing was conducted to ensure the modified device performs as expected and meets its design specifications, consistent with established quality system procedures for medical device manufacturing. This would include testing related to electrical safety, electromagnetic compatibility (EMC), general performance (e.g., power output accuracy, current waveform characteristics), and the functionality of various modes.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of human data. For bench testing and engineering verification, the "sample size" would relate to the number of units tested, the number of test runs, or the range of parameters evaluated. This information is not detailed in the 510(k) summary.
Data Provenance: The device is manufactured by ERBE Elektromedizin GmbH in Germany. The verification and validation activities would likely have been conducted internally by the manufacturer. This is an engineering/bench testing assessment, not a clinical study involving patients or human data in the traditional sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. For a device like an electrosurgical unit, "ground truth" is typically defined by engineering specifications, safety standards (e.g., IEC 60601 series for medical electrical equipment), and established performance metrics for HF energy delivery. Experts involved would be engineers, electrical safety specialists, and possibly medical professionals advising on clinical requirements, but not establishing a "ground truth" for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes where discrepancies need resolution. This submission focuses on technical equivalence and safety/performance characteristics verified through engineering testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is used to assess the diagnostic accuracy or effectiveness of a system (often an imaging system or AI algorithm) by comparing independent interpretations from multiple readers across multiple cases. This is not relevant for an electrosurgical unit.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. The ERBE ESU Model VIO 200 S is an electromechanical device, not an AI algorithm. Its performance is inherent in its hardware and software design for delivering HF current, not derived from an AI model.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance is based on engineering specifications, international safety standards (e.g., IEC), and the documented performance of the predicate device. Verification and validation activities would confirm that the device meets these pre-defined technical criteria (e.g., output power within tolerance, impedance recognition, safety features functioning).

8. The Sample Size for the Training Set

Not applicable. This device does not employ an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no AI algorithm or training set, this question is irrelevant to the device described.

Summary

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K080715

ERBE USA Incorporated Special 510(k): ERBE ESU Model VIO 200 S

510(k) SUMMARY

Submitted By:

ERBE USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 Tel: 770-955-4400 Fax: 770-955-2577

Contact Person: John Tartal QA/RA Manager

Date Prepared: March 10, 2008

Common Name: ElectroSurgical Unit (ESU/Generator)

Trade/Proprietary Name: ERBE ESU Model VIO 200 S

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

79GEI Product Code:

Legally Marketed Predicate Device:

ERBE VIO ESU (Model VIO 300 D), 510(k) Number: K060484

Device Description:

Note: VIO stands for Variable Cut and Coagulation.

Page 1 of 3

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K080715

ERBE USA Incorporated Special 510(k): ERBE ESU Model VIO 200 S

CONFIDENTIAL

Page 2 of 3

Intended Use:

The ERBE ESU Model VIO 200 S is intended to deliver high frequency 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

The modified ESU (ERBE Model VIO 200 S) has the same intended use, protective circuits, and uses the same basic accessories (i.e. A/C Cord, Footswitches, Adapters, etc.) as the predicate ESU (ERBE Model VIO 300 D). Also, the available Modes [i.e. Auto Cut, Endo Cut Q, Endo Cut I, Soft Coag, Forced Coag, Bipolar Soft Coag with and without (Auto Stop) in the modified device are the same Modes that are in the predicate (Note: Some Modes have power limitations with the modified device as compared to the predicate.). Both Generators have user interface displays to select modes, power settings, etc. The modified and predicate devices are programmable and 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 compatible APCs with the respective APC being controlled through the Both models have the actual software for the APC within the ESU. The ESU. available APC related Modes (i.e., Forced APC as well as Argon-assisted Auto Cut, Forced Coag, and Soft Coag), for the modified device are the same as the predicate device (Note: Some Modes have power limitations with the modified device as compared to the predicate.). 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.).

Differences

The ERBE ESU Model VIO 200 S is different than the predicate VIO 300 D Model in that the modified ESU's display has Light Emitting Diodes (LEDs) for effect and wattage settings and it does not have an onscreen tutorial. However, it is easy for the user to interface with the display screen of the modified ESU. Also, there is a "Tutorial" section in its User Manual. There are less programming capabilities for the proposed device [nine (9) program possibilities] compared with 99 for the predicate ESU. However, only having 9 or less programs is adequate and there is less confusion with the smaller number. In regards to hardware features of the modified ESU, the unit was not designed with a Multi-Function (MF) module/receptacle and the associated specialty Mode (BiClamp) will not be offered with the modified device.

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ERBE USA Incorporated Special 510(k): ERBE ESU Model VIO 200 S

CONFIDENTIAL

Page 3 of (3)

The ERBE ESU Model VIO 200 S also is different than the ERBE VIO 300 D ESU in that the available wattage is less (i.e. 200 watts compared to 300 watts). However, maximum 200 watt Generator has been found to be more than adequate (Note: a The many ESUs on the U.S. market with maximum wattage being less than 200 watts.). With the limitation in power, the modified device doesn't have the capability of displaying the actual power delivered. Nonetheless, like the predicate device in the Cut and Coag Modes, the modified device still only delivers the amount of power needed.

Finally, there is no ReMode feature and less Modes with the modified device as compared to the predicate. Modes that are in the predicate and not in the modified device are High Cut, Dry Cut, Dry Cut °, Precise Cut, Swift Coaq, Swift Coaq °, Spray Coag, Precise Coag, Twin Coag, Bipolar Cut, Bipolar Cut +, Bipolar Precise Cut, Bipolar Soft Coag +, Bipolar Forced Coag, BiClamp, Bipolar Precise Coag, Precise APC, Pulsed APC, Argon-assisted High Cut, Argon-assisted Dry Cut, Argonassisted Dry Cut °, Argon-assisted Swift Coag, Argon-assisted Swift Coaq °, and Argon-assisted Twin Coag (Note: Only some of these Modes were standard with the predicate device.). Even though there are fewer modes within the ERBE Model VIO 200 S, the modes that are present are the principal ones to perform essential cutting and coagulating activities.

Conclusion:

The ERBE ESU Model VIO 200 S has the same intended use, principles of operation, and technological characteristics as the predicate ESU in the previously cleared 510(k). The modifications involve having a Generator that is more basic (i.e. less complicated with fundamental Modes thus having a more cost effective unit). Nonetheless, the modified ESU is an efficient unit. In conclusion, all the changes were verified or validated. As a result, the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, rendered in black. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", arranged in a circular fashion around the bird. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ERBE USA, Inc. % Mr. John Tartal QA/RA Manager 2225 Northwest Parkway Marietta, Georgia 30067

APR - 2 2008

Re: K080715

Trade/Device Name: ERBE ESU Model VIO 200 S Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 11, 2008 Received: March 13, 2008

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.

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 - Mr. John Tartal

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 (240) 276-0115. Also, plcase 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 Postmarles, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N Millerson

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

080 415

510(k) Number (if known):

Device Name: ERBE USA, Inc.'s ERBE ESU Model VIO 200 S

Indications For Use:

The ERBE ESU Model VIO 200 S 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)

Neifre Ogl for mkm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K080715

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Regulation Number and Section

§ 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.