(35 days)
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.
Not Found
This document is an FDA 510(k) clearance letter for the gi-4000 Electrosurgical Generator. It confirms that the device has been found substantially equivalent to existing legally marketed predicate devices.
However, this document does not contain the acceptance criteria or a study demonstrating that the device meets acceptance criteria.
The 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, focusing on safety and effectiveness. While testing is certainly conducted by the manufacturer, the detailed results and acceptance criteria are typically part of the manufacturer's submission to the FDA, which is not publicly available in this clearance letter.
Therefore, I cannot provide the requested information based on the given text.
To give you an idea of what that typically looks like for a medical device cleared via 510(k), here's a general outline of the information you've requested, and why it's not present in this specific document:
- A table of acceptance criteria and the reported device performance: This would typically involve specific quantifiable metrics for the device's performance (e.g., power output accuracy, coagulation time, safety parameters) and the pre-defined thresholds for acceptable performance. This is part of the manufacturer's test report.
- Sample size used for the test set and the data provenance: This refers to the number of units tested, conditions, and origin of the data. Again, internal testing by the manufacturer.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Less applicable to an electrosurgical generator in terms of "ground truth" like in AI/imaging; more relevant to clinical evaluation if human assessment was part of performance testing (e.g., assessment of tissue effects).
- Adjudication method: Not directly applicable to the type of device or information found in this letter.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is primarily relevant for diagnostic imaging devices or AI algorithms that assist human interpretation, not electrosurgical generators.
- Standalone performance (algorithm only without human-in-the-loop performance): This is specific to AI algorithms. The gi-4000 is a physical electrosurgical generator, so this concept doesn't apply.
- Type of ground truth used: For an electrosurgical device, "ground truth" would relate to objective measurements of its physical output and effects, often against a gold standard instrument or validated test methods, not expert consensus or pathology in the same way as an imaging diagnostic.
- Sample size for the training set: Not applicable for this type of device, as it's not an AI/machine learning product that requires training data.
- How the ground truth for the training set was established: Not applicable for this type of device.
In summary, the provided FDA clearance letter confirms the regulatory status of the gi-4000 Electrosurgical Generator but does not contain the detailed technical performance data, acceptance criteria, or study results that would typically be part of the manufacturer's 510(k) submission.
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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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§ 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.