(238 days)
It is a monopolar electrode intended for ablation and coagulation of soft tissues by means of electrical energy delivered by an electrical generator. It is used with compatible resectoscopes .
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding "Modern Medical Resectoscope Electrodes." It confirms the device's substantial equivalence to legally marketed predicate devices.
The letter explicitly states that "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..."
This type of FDA letter (a 510(k) clearance) indicates that the device has been found substantially equivalent to a predicate device already on the market. A 510(k) clearance typically does NOT involve a comprehensive study with specific acceptance criteria and detailed performance data as would be required for a novel device or a PMA.
Therefore, based on the provided text, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/testing.
The document primarily focuses on regulatory clearance based on substantial equivalence, rather than a detailed performance study report.
In summary, none of the requested information regarding acceptance criteria and a study proving device performance can be extracted from the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Eugene Yeung Modern Medical Equipment Mfg., Ltd. Unit F, 5th Floor, Gold King Ind. Bldg. 35-41 Tai Lin Pai Rd. Kwai Chung, N.T.,Hong Kong CHINA
JAN 1 5 2010
Re: K091511
Trade/Device Name: Modern Medical Resectoscope Electrodes Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscope electrosurgical unit and accessories Product Code: FAS Dated: November 30, 2009 Received: December 8, 2009
Dear Mr. Yeung:
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.
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
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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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
Applicant: Modern Medical Equipment Mfg. Ltd.
510(k) Number Not assigned yet K091511
Device Name: Modern Medical Resectoscope Electrodes
Indications For Use:
It is a monopolar electrode intended for ablation and coagulation of soft tissues by means of electrical energy delivered by an electrical generator. It is used with compatible resectoscopes .
Prescription Use Use AND/OR (Part 21 CFR 801 sub-part D)
Over-The-Counter Use (Part 21 CFR 807 sub-part C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sec II - 2
Hales Heins
(Division Sign-Off)
uctive, Abdominal.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).