(35 days)
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Not Found
No
The summary describes an electrosurgical generator and lavage pump, with no mention of AI or ML capabilities.
Yes
The device is used to perform cutting and/or coagulation which directly treats tissue, making it a therapeutic device.
No
The device is described as an electrosurgical generator intended to deliver electrosurgical outputs for cutting and/or coagulation, and an integrated lavage pump for washing tissue. These are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly indicates a hardware device (Electrosurgical Generator, layage pump, Conducting Adapter) with electrosurgical outputs and a pump, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that performs electrosurgical procedures (cutting and coagulation) and tissue washing within the body (flexible endoscopic applications, within the gut). This is an in vivo procedure, meaning it's performed on a living organism.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
The gi 4000 Electrosurgical Generator and its components are used directly on the patient's tissue during a medical procedure, not for analyzing samples outside the body.
N/A
Intended Use / 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 layage pump is intended to was 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
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
gut
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
October 23, 2017 United States Endoscopy Group, Inc. Carroll Martin Director, Regulatory Affairs 5976 Heisley Road Mentor, Ohio 44060
Re: K172805
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: September 13, 2017 Received: September 18, 2017
Dear Carroll Martin:
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, 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 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical 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 (Describe)
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 layage pump is intended to was 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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