MONOFILAMENT POLYPECTOMY SNARE

K140763 · United States Endoscopy · FDI · Apr 24, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140763
• Device Name: MONOFILAMENT POLYPECTOMY SNARE
• Applicant: United States Endoscopy
• Product Code: FDI · Gastroenterology, Urology
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The US Endoscopy Monofilament polypectomy snare is an electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

Device Story

Monofilament polypectomy snare is an electrosurgical accessory used during GI endoscopy. Device consists of a wire loop (snare) passed through an endoscope to grasp, dissect, and transect tissue. Operated by a physician (gastroenterologist/endoscopist) in a clinical setting. Device connects to an electrosurgical unit to provide current for tissue cutting/coagulation. Output is mechanical tissue transection facilitated by electrosurgical energy. Benefits include minimally invasive removal of GI tissue lesions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electrosurgical accessory; monofilament wire loop design; compatible with standard endoscopic electrosurgical units; manual operation via endoscopic handle; biocompatible materials consistent with predicate device.

Indications for Use

Indicated for use in patients undergoing gastrointestinal endoscopic procedures requiring tissue grasping, dissection, and transection.

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.

Predicate Devices

• US Endoscopy Monofilament polypectomy snare (K062665)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2014

United States Endoscopy Group, Inc. Sagar Pimpalwar Regualatory Affairs Specialist 5976 Heisley Road Mentor, OH 44060

Re: K140763

> Trade/Device Name: Monofilament polypectomy snare Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: March 25, 2014 Received: March 27, 2014

Dear Sagar Pimpalwar,

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.

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### Page 2 - Sagar Pimpalwar

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.

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 at its toll-free number [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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United States Endoscopy Group, Inc.

510(k) Premarket Notification: Special Monofilament polypectomy snare

## INDICATIONS FOR USE

510(k) Number (if known):__K140763

Device Name: Monofilament polypectomy snare

Indications for Usc:

The US Endoscopy Monofilament polypectomy snare is an electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Herbert P. Lern 2014.04.24 14:12

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