(139 days)
Not Found
No
The document describes a standard electrosurgical generator with a lavage pump and argon gas delivery. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to deliver electrosurgical outputs to perform cutting and/or coagulation in flexible endoscopic applications, and also has an integrated lavage pump to wash tissue or mucosa, which are direct therapeutic actions.
No
The device is an electrosurgery generator and lavage pump, intended to deliver electrosurgical outputs for cutting and coagulation and to wash tissue. It performs therapeutic procedures, not diagnostic ones.
No
The device description clearly details hardware components such as an electrosurgery generator, lavage pump, touch screen, footswitch, and connections for accessories and patient return electrodes. While it mentions software verification and validation, the core functionality and description are centered around physical hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes performing electrosurgical procedures (cutting and coagulation) and lavage within the gut. These are direct interventions on the patient's body, not tests performed on samples taken from the body.
- Device Description: The description details the electrosurgical generator, lavage pump, and accessories used for delivering energy and fluid directly to tissue. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is an electrosurgical generator and lavage pump intended for therapeutic and procedural use within the body, not for in vitro diagnostic testing.
N/A
Intended Use / 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 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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gut
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)
Non-clinical Data - Bench Testing:
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.
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.
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.
K073207, K963189, K933157, K013348
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
Section 005 - 510(k) Summary
Submission Correspondent:
| Name: | Emergo Group, Inc.
www.emergogroup.com |
|----------|----------------------------------------------------------|
| Address: | 611 West Fifth Street
Third Floor
Austin, 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:
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
1
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.
6
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.
7
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
8
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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