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 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 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 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.

AI/ML Overview

The provided text describes the Genii gi 4000 Electrosurgical Generator and its comparison to predicate devices, focusing on technical characteristics and safety/effectiveness testing. However, it does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in the manner one might see for novel technologies.

Here's a breakdown of what is and is not in the provided text, related to your request:

1. A table of acceptance criteria and the reported device performance

Not present. The document includes a comparison table (Section 2 and 3) that lists technical specifications of the gi 4000 and its predicate devices (Olympus AFU-100, Erbe APC 300, Erbe ICC 200). This table outlines characteristics like flow rate, dimensions, max voltage peak, frequency, output power limit, gas flow rate, and gas purity. While these are performance specifications, they are not presented as acceptance criteria with corresponding explicit "reported device performance" results against those criteria. Instead, they are presented as comparative data points to establish substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not present. The document mentions an "In vitro tissue study" but provides no details on sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not present. The study mentioned is an in vitro tissue study comparing lesion creation, not a clinical study involving experts establishing ground truth for diagnostic or prognostic purposes. Therefore, there's no mention of experts or their qualifications for ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not present. As this was an in vitro tissue study, there would not be an adjudication method for a "test set" in the sense of clinical image interpretation or similar expert-driven assessment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not present. This device is an electrosurgical generator, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance effect sizes are not relevant and are not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not present. This is an electrosurgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implied, but not explicitly stated or detailed. For the "in vitro tissue study," the ground truth for comparison would be the characteristics of the lesions created by both the subject device and the predicate device. This would likely involve visual assessment or measurement of the lesions, but the method (e.g., expert assessment of tissue damage, histological analysis) is not specified. The document simply states the study "demonstrated substantial similarity between lesions created."

8. The sample size for the training set

Not applicable/Not present. As this is not an AI/machine learning device, there is no "training set."

9. How the ground truth for the training set was established

Not applicable/Not present. Again, no training set for this type of device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through technical comparison and specific non-clinical bench testing (electrical safety, EMC, biocompatibility, software verification/validation, and an in vitro tissue study). It does not present detailed acceptance criteria with corresponding device performance results in the format requested, nor does it describe studies involving expert ground truth, sample sizes for test/training sets, or MRMC studies, as those are typically relevant for different types of medical devices (e.g., diagnostic software, AI algorithms).

Summary

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Section 005 - 510(k) Summary

Submission Correspondent:

Name:	Emergo Group, Inc.www.emergogroup.com
Address:	611 West Fifth StreetThird FloorAustin, TX 78701
Phone:	(512) 327-9997
Fax:	(512) 327-9998

Contact: Julie Powell Email: jpowell@emergogroup.com

Submission Sponsor:

Genii, Inc. 2145 Woodlane Drive Suite 101-W St. Paul, MN 55125 Tel. 651-501-4810 Fax. 651-501-4819

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:

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.

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
1. Erbe APC 300 Argon Plasma Coagulator and Accessories; K963189
1. 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 (with878.4400)	878.4400	878.4400
Regulation Name	Electrosurgical cutting andcoagulation device andaccessories	Pump, air nonmanual, forendoscope (withElectrosurgicalcutting andcoagulation deviceand accessories)	Electrosurgicalcutting andcoagulation deviceand accessories	Electrosurgical cuttingand coagulation deviceand accessories
Intended Use	The gi 4000 ElectrosurgeryGenerator is intended to deliverelectrosurgical outputs toperform cutting and/orcoagulation and coagulation withor without delivery of argon gasin flexible endoscopicapplications. The integratedlavage pump is intended to washtissue or mucosa within the gutwhen used in conjunction withwashing catheters or bipolarendoscopic probes, endoscopewater jet channels, or endoscopeworking channels.	The Olympus AFU-100 peristalticflushing pump isintended forirrigation ofinstruments orirrigation/flushing/cleansing of tissuesurfaces andwoundssupportingendoscopicdiagnosis ortherapy.	The Erbe APC 300Argon PlasmaCoagulator is anargon gas deliverysystem that isdesigned forcoagulation whenused incombination withErbe ICCelectrosurgeryGenerators andErbe APC Probes.	The ICC 200 is intendedto deliver high frequencyelectrical current for thecutting/or coagulation oftissue.
Pump Type	Peristaltic	Peristaltic	n/a	n/a
Flow Rate	0-735 ml/minute(tubingdependent)200 ml max throughleur valves	0-600ml/minute(tubingdependent) 200 mlmax through leurvalves	n/a	n/a
Dimensions(Width x Height xDepth)	16" x 6.5" x 16" (19.5 X 7 X 19max overall including pump head,water bottle holder and feet)	295 X 430 X115mm (notemillimeters notinches)	APC 16" x 4" x14.5" (needs cartfor 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	0.1-9.0mL/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/otherstandards	IEC 60601-1IEC 60601-1-2,IEC 60601-2-2,CISPR 11,IEC 62304,ISO 14971	IEC 60601-1,UL 60601-1,IEC 60601-1-2,IEC 60601-1-4	ANSI/AAMI HF-18/1993, IEC60601-1-2	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/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 andaccessories	Electrosurgical cutting and coagulationdevice and accessories
Intended Use	The Genii ArConnect conducting adapter is intended foruse with the Genii GI4000 during argon assistedcoagulation.	The APC Connector Hose and Probes areintended for use in argon plasmacoagulation. The device is used to treatmany conditions in endoscopy for varioussurgical procedures.
Material	PVC tubing Shore A75+3Clear,Cable 24AWGTerminal: brass with nickel and Gold plating;Insert: ABS PA707 with EX-33084 white;Overmold HDPE LH523, nature; PE white, #PEM864;Gas Tube: ABS PA707, with EX-33084 White;O ring: AS 568-008, Katon P/N: OR-NB50NL-008-BK,ShoreA: 50, BUNA-U;Heat shrink sleeve band: 8298.5	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 soldseparately 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 (800) 638-2041 or (301) 796-7100 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

Page 1 of 1

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.