GENII GI 4000 ELECTROSUGICAL GENERATOR

K113265 · Genii, Inc. · GEI · Mar 22, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113265
• Device Name: GENII GI 4000 ELECTROSUGICAL GENERATOR
• Applicant: Genii, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The gi 4000 Electrosurgical Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated lavage pump is intended to wash tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope water jet channels, or endoscope working channels. The Genii ArConnect™ Conducting Adapter is intended for use with the gi 4000 during argon assisted coagulation.

Device Story

The gi 4000 is an electrosurgical generator for flexible endoscopy; provides monopolar, bipolar, and argon-assisted coagulation outputs; includes an integrated peristaltic lavage pump for gut irrigation. Operated by physician via touch screen and dual-pedal footswitch. Inputs include user-selected power settings and argon gas from a disposable canister; outputs include RF energy and lavage fluid delivered through compatible endoscopic accessories. Argon-assisted coagulation uses 99.999% pure argon gas to create ionized RF arcs. The ArConnect adapter facilitates delivery of RF energy and argon gas to single-use probes. System requires patient return electrode for monopolar/argon modes; bipolar mode is return-electrode-free. Output power is independently controlled via LCD panel. Device assists in tissue management and visualization during endoscopic procedures.

Clinical Evidence

No clinical data. Bench testing only. In vitro tissue study compared lesions created by the gi 4000 against the Erbe ICC 200E with APC 300 system, demonstrating substantial similarity in performance. Electrical safety and EMC testing confirmed compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Biocompatibility testing (cytotoxicity, irritation, sensitization) confirmed the ArConnect cable is non-toxic.

Technological Characteristics

Electrosurgical generator with 7 monopolar, 1 monopolar argon, and 1 bipolar output. Peristaltic lavage pump. Frequency 315-550 KHz; max power 60-200W. ArConnect adapter materials: PVC, brass, ABS, HDPE, PE, Buna-U. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, CISPR 11, IEC 62304, ISO 14971. Connectivity: touch screen interface. Software: V&V performed.

Indications for Use

Indicated for patients undergoing flexible endoscopic procedures requiring electrosurgical cutting, coagulation, or argon-assisted coagulation, and gut tissue/mucosa irrigation. Contraindications not specified.

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

• Olympus AFU-100 Peristaltic Pump Unit (PPU) (K073207)
• Erbe APC 300 Argon Plasma Coagulator and Accessories (K963189)
• Erbe ICC 200 Electrosurgical Workstation for Flexible Endoscopy (K933157)
• Erbe APC Connector Hose and Probes (K013348)

Submission Summary (Full Text)

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### Section 005 - 510(k) Summary

### Submission Correspondent:

| Name: | Emergo Group, Inc.<br>www.emergogroup.com |
|----------|----------------------------------------------------------|
| Address: | 611 West Fifth Street<br>Third Floor<br>Austin, TX 78701 |
| Phone: | [phone] |
| Fax: | [phone] |

Contact: Julie Powell Email: [e-mail]

### Submission Sponsor:

Genii, Inc. 2145 Woodlane Drive Suite 101-W St. Paul, MN 55125 Tel. [phone] Fax. [phone]

| Date Prepared: | 2 November 2011; Revised 23 February 2012; Revised 14 March 2012 |
|-----------------------|------------------------------------------------------------------|
| Trade Name: | Genii gi 4000 Electrosurgical Generator |
| Regulation Number: | 878.4400 |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories. |
| Product Code: | GEI |
| Classification Panel: | General and Plastic Surgery |
| Regulatory Class: | Class II |

#### Device Description:

The gi 4000 has seven monopolar outputs, a monopolar argon assisted coagulation output, and a bipolar output. Users make selections from a touch screen that displays stored default power setting start points, convenience and safety information, as well as indications as to current selection mode and return electrode monitoring status.

The gi 4000 has an integrated peristatic lavage pump designed to provide lavage washing in the gut, either by accessories connected directly to endoscopes which have dedicated washing channels, or by accessories which introduce lavage fluid into the biopsy port of an endoscope or via dedicated washing channels incorporated into a therapeutic accessory such as a bipolar

MAR 2 2 2012

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<113265

Genii, Inc. Traditional 510(k) Premarket Submission qi 4000 Electrosurgical Generator

endostasis probe. The system is operated by a dual pedal footswitch which controls the lavage pump and power delivery.

The argon output is designed for an argon assisted coagulation method. This method uses 99.99% pure argon gas to provide ionized RF arcs to the targeted tissue. The monopolar outputs are designed for cutting and coagulation methods. The unit is designed with a standard monopolar active cord receptacle (foot switch activated).

Endoscopic accessories connect to the monopolar receptacle via a widely available detachable active cord accessory. Both the monopolar and argon outputs require the use of a patient return electrode (grounding pad) to return the RF energy from the patient back to the generator. The unit is designed with a standard GI bipolar single jack receptacle. No patient return electrode (grounding pad) is needed for bipolar methods. The output power of the argon, monopolar and bipolar methods are independently controlled through a touch panel LCD display located on the front panel of the generator.

The argon gas for the argon output is exclusively supplied by the disposable Genii Argon Gas Canister. Each canister contains 49 liters of ultra-high purity (99.999% pure) argon gas (certified). When using the Argon Coagulation Method, the ArConnect is intended for single-use only and will be supplied as a non-sterile, disposable item. The ArConnect has been designed to allow the delivery of monopolar high frequency electrosurgical energy and argon gas to a single use argon coagulation probe sold separately. The ArConnect is supplied individually packaged in disposable packaging and is not to be reprocessed or re-used.

### Indications for Use:

The gi 4000 Electrosurgery Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated lavage purnp is intended to wash tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope water jet channels, or endoscope working channels. The Genii ArConnect™ Conducting Adapter is intended for use with the gi 4000 during argon assisted coagulation.

#### Predicate Devices:

- 1. Olympus AFU-100 Peristaltic Pump Unit (PPU); K073207
- 2. Erbe APC 300 Argon Plasma Coagulator and Accessories; K963189
- 3. Erbe ICC 200 Electrosurgical Workstation for Flexible Endoscopy; K933157
- Erbe APC Connector Hose and Probes; K013348 বে

### Summary of Technical Comparisons:

The following table compares gi 4000 Electrosurgery Generator to the predicate devices with respect to intended use, target population, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

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| Manufacturer | Genii | Olympus | Erbe APC 300 | Erbe ICC 200 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Gi 4000 | Olympus AFU-100 | Erbe APC 300 | Erbe ICC 200 |
| 510(k) Number | NA | K073207 | K963189 | K933157 |
| Product Code | GEI | FEQ (with GEI) | GEI | GEI |
| Regulation Number | 878.4400 | 876.1500 (with<br>878.4400) | 878.4400 | 878.4400 |
| Regulation Name | Electrosurgical cutting and<br>coagulation device and<br>accessories | Pump, air non<br>manual, for<br>endoscope (with<br>Electrosurgical<br>cutting and<br>coagulation device<br>and accessories) | Electrosurgical<br>cutting and<br>coagulation device<br>and accessories | Electrosurgical cutting<br>and coagulation device<br>and accessories |
| Intended Use | The gi 4000 Electrosurgery<br>Generator is intended to deliver<br>electrosurgical outputs to<br>perform cutting and/or<br>coagulation and coagulation with<br>or without delivery of argon gas<br>in flexible endoscopic<br>applications. The integrated<br>lavage pump is intended to wash<br>tissue or mucosa within the gut<br>when used in conjunction with<br>washing catheters or bipolar<br>endoscopic probes, endoscope<br>water jet channels, or endoscope<br>working channels. | The Olympus AFU-<br>100 peristaltic<br>flushing pump is<br>intended for<br>irrigation of<br>instruments or<br>irrigation/flushing/<br>cleansing of tissue<br>surfaces and<br>wounds<br>supporting<br>endoscopic<br>diagnosis or<br>therapy. | The Erbe APC 300<br>Argon Plasma<br>Coagulator is an<br>argon gas delivery<br>system that is<br>designed for<br>coagulation when<br>used in<br>combination with<br>Erbe ICC<br>electrosurgery<br>Generators and<br>Erbe APC Probes. | The ICC 200 is intended<br>to deliver high frequency<br>electrical current for the<br>cutting/or coagulation of<br>tissue. |
| Pump Type | Peristaltic | Peristaltic | n/a | n/a |
| Flow Rate | 0-735 ml/minute(tubing<br>dependent)200 ml max through<br>leur valves | 0-600ml/minute<br>(tubing<br>dependent) 200 ml<br>max through leur<br>valves | n/a | n/a |
| Dimensions<br>(Width x Height x<br>Depth) | 16" x 6.5" x 16" (19.5 X 7 X 19<br>max overall including pump head,<br>water bottle holder and feet) | 295 X 430 X115<br>mm (note<br>millimeters not<br>inches) | APC 16" x 4" x<br>14.5" (needs cart<br>for gas tanks) | 11" x 6" x 14.5" |
| Max Voltage Peak | 4200 Vp. | n/a | n/a | 4000 Vp |
| Frequency | 315-550 KHz. | n/a | n/a | 330-1,000 KHz (1 MHz). |
| Output Power Limit | 60-200 watts. | n/a | n/a | 120-200 watts |
| Gas Flow Rate | 0.1-2.0 mL/minute. | n/a | 0.1-9.0<br>mL/minute. | n/a |
| Gas Purity | 99.999%. | n/a | 99.998%. | n/a |
| Tank Size | 49 liters. | n/a | 2 X 934 liters. | n/a |
| Electrical Safety/other<br>standards | IEC 60601-1<br>IEC 60601-1-2,<br>IEC 60601-2-2,<br>CISPR 11,<br>IEC 62304,<br>ISO 14971 | IEC 60601-1,<br>UL 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-4 | ANSI/AAMI HF-<br>18/1993, IEC<br>60601-1-2 | Not known |
| Wave Form | | n/a | n/a | |
| •Mono Soft Coag | Continuous Sine | | | Continuous Sine |
| •Mono Coag | Modulated | | | Modulated |
| •Mono Blend Cut | Alternating 50%DC | | | n/a |

.

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K113265

| Manufacturer | Genii | Olympus | Erbe APC 300 | Erbe ICC 200 |
|------------------------|-----------------------------------------|-----------------|--------------|-------------------|
| Trade Name | Gi 4000 | Olympus AFU-100 | | |
| • Mono Cut | Continuous sine | | | Continuous sine |
| • Bipolar | Continuous sine | | | Continuous sine |
| • Argon | Modulated | | | Modulated |
| Max Voltage Peak | | n/a | n/a | |
| • Mono Soft Coag | 300 | | | 190 |
| • Mono Coag | 2200 | | | 2300-2500 |
| • Mono Blend Cut /PBC | 1625/1050 | | | n/a (EC) |
| • Mono Pulse Cut | 1000 | | | 380-600/190 (EC) |
| • Mono Cut | 780 | | | 600 |
| • Bipolar | 104 | | | 190 |
| • Argon | 4200 | | | 4000 |
| Frequency (KHz) | | n/a | n/a | |
| • Mono Soft Coag | 350KHz | | | 330KHz |
| • Mono Coag | 460-500KHz | | | 1,000KHz |
| • Mono Blend Cut/PBC | 350/350 | | | n/a |
| • Mono Pulse Cut | 350 | | | 330 |
| • Mono Cut | 350 | | | 330 |
| • Bipolar | 350 | | | 350 |
| • Argon | 460-500 | | | 1,000KHz |
| Max Power | | n/a | n/a | |
| • Mono Soft Coag | 120 Watts @ 100 Ω | | | 120 Watts @ 125 Ω |
| • Mono Coag | 120 Watts @ 500 Ω | | | 120 Watts @ 350 Ω |
| • Mono Blend Cut/ PBC | 120 Watts @ 500 Ω/<br>120 Watts @ 500 Ω | | | n/a |
| • Mono Pulse Cut | 120 Watts @ 500 Ω | | | 200 Watts @ 500 Ω |
| • Mono Cut | 200 Watts @ 500 Ω | | | 200 Watts @ 500 Ω |
| • Bipolar | 60 Watts @ 400 Ω | | | 120 Watts @ 125 Ω |
| • Argon | 120 Watts @ 500 Ω | | | 99 Watts @ 350 Ω |
| Duty Cycle | | n/a | n/a | |
| • Mono Soft Coag | 100% | | | 100% |
| • Mono Coag | 6% | | | 4%-6% |
| • Mono Cut | 100% | | | 100% |
| • Bipolar | 100% | | | 100% |
| Crest Factor | | n/a | n/a | |
| • Mono Soft Coag | 1.4 | | | 1.4 |
| • Mono Cut | 1.4 | | | 1.4 |
| • Bipolar | 1.4 | | | 1.4 |
| Power Curve | | n/a | n/a | |
| • Mono Soft Coag | Narrow | | | Narrow |
| • Mono Coag | Wide | | | Wide |
| • Bipolar | Narrow | | | Narrow |
| Pulse Speed | | n/a | n/a | |
| • Mono Pulse Blend Cut | 700ms ON/50ms OFF | | | 750ms ON/50ms OFF |

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| Manufacturer | Genii | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Genii ArConnect | Erbe APC Connector Hose |
| 510(k) Number | NA | K013348 |
| Product Code | GEI | GEI |
| Regulation Number | 878.4400 | 878.4400 |
| Regulation Name | Electrosurgical cutting and coagulation device and<br>accessories | Electrosurgical cutting and coagulation<br>device and accessories |
| Intended Use | The Genii ArConnect conducting adapter is intended for<br>use with the Genii GI4000 during argon assisted<br>coagulation. | The APC Connector Hose and Probes are<br>intended for use in argon plasma<br>coagulation. The device is used to treat<br>many conditions in endoscopy for various<br>surgical procedures. |
| Material | PVC tubing Shore A75+3Clear,<br>Cable 24AWG<br>Terminal: brass with nickel and Gold plating;<br>Insert: ABS PA707 with EX-33084 white;<br>Overmold HDPE LH523, nature; PE white, #PEM864;<br>Gas Tube: ABS PA707, with EX-33084 White;<br>O ring: AS 568-008, Katon P/N: OR-NB50NL-008-BK,<br>ShoreA: 50, BUNA-U;<br>Heat shrink sleeve band: 82*98.5* | Polyamide, PEEK, Thermoflex, silicone. |
| Length | 5 feet. | 6.5 feet. |
| Back Flow | Integrated in the generator gas flow design | A separate back flow filter/valve is sold<br>separately to be used with the hose. |
| How Supplied | Single use; disposable. | Re-useable. |

The following table compares Genii ArConnect accessory to the predicate accessory device.

### Non-clinical Data - Bench Testing:

As part of demonstrating safety and effectiveness of the Genii gi 4000 Electrosurgical Generator and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, the following testing has been performed:

In vitro testing Electrical Safety EMC Biocompatibility Software Testing

In Vitro Testing: An in vitro tissue study was conducted to compare the lesions created by the subject gi 4000 electrosurgical generator and the predicate Erbe ICC 200E with APC 300 system when using equivalent outputs. This in vitro study demonstrated substantial similarity between lesions created by the subject gi 4000 device and the predicate Erbe ICC 200E with APC 300 system. The data demonstrate that the performance of the subject device is equivalent to the predicate devices.

Electrical Safety and EMC: The gi 4000 Electrosurgical Generator has been tested and met the requirements of the Electrical Safety and EMC standards used.

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K113265

> Biocompatibility Testing: Cytotoxicity, Irritation and Sensitization testing have been completed on the ArConnect Conducting Cable. The test results demonstrate that the ArConnect Conducting Cable is non-toxic.

Software Verification and Validation: Software verification and validation testing has been performed on the gi 4000 Electrosurgical Generator.

### Safety and Effectiveness:

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the Genii gi 4000 Electrosurgical Generator and the predicate devices do not raise any questions regarding its safety and effectiveness. The Genii gi 4000 Electrosurgical Generator, as designed and manufactured, therefore is determined to be substantially equivalent to the referenced predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Genii, Incorporated % Emergo Group, Incorporated Ms. Julie Powell 611 West 5th Street, Third Floor Austin, Texas 78701

MAR 2 2 2012

Re: K113265

Trade/Device Name: gi 4000 Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 14, 2012 Received: March 15, 2012

Dear Ms. Powell:

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 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 Powell

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known):

Device Name: gi 4000 Electrosurgical Generator

Indications for Use:

The gi 4000 Electrosurgical Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated lavage pump is intended to wash tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope water jet channels, or endoscope working channels. The Genii ArConnect™ Conducting Adapter is intended for use with the gi 4000 during argon assisted coagulation.

Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Office of Device Evaluation

210(k)

(ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113265

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