MODERN MEDICAL RESECTOSCOPE ELECTRODES

K091511 · Modern Medical Equipment Mfg., Ltd. · FAS · Jan 15, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K091511
• Device Name: MODERN MEDICAL RESECTOSCOPE ELECTRODES
• Applicant: Modern Medical Equipment Mfg., Ltd.
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: Jan 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 .

Device Story

Monopolar electrode; used for soft tissue ablation and coagulation. Input: electrical energy from compatible electrosurgical generator. Operation: device delivers high-frequency current to target tissue via resectoscope interface. Used in clinical settings (e.g., OR) by physicians. Output: thermal effect on tissue for cutting or hemostasis. Benefits: enables precise tissue management during endoscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monopolar electrode; compatible with standard resectoscopes; energy source: external electrosurgical generator; materials: medical-grade conductive metals and insulation; sterilization: provided sterile.

Indications for Use

Indicated for ablation and coagulation of soft tissues during procedures using compatible resectoscopes. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full 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 [phone] or [phone] 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)

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Hales Heins

(Division Sign-Off)

uctive, Abdominal.