TRACTION POLYPECTOMY SNARE

K140923 · Ovesco Endoscopy AG · FDI · Nov 18, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140923
• Device Name: TRACTION POLYPECTOMY SNARE
• Applicant: Ovesco Endoscopy AG
• Product Code: FDI · Gastroenterology, Urology
• Decision Date: Nov 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Instrument for flexible endoscopy for grasping and removing tissue in the gastrointestinal tract.

Device Story

The Traction Polypectomy Snare is an endoscopic instrument designed for grasping and removing tissue during gastrointestinal procedures. It is used by physicians during flexible endoscopy. The device functions as a mechanical accessory to an electrosurgical unit, allowing the clinician to capture and excise polyps or other tissue. By providing traction, it facilitates the removal process, potentially improving procedural efficiency and patient outcomes during endoscopic interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endoscopic electrosurgical accessory; mechanical snare mechanism for tissue capture and excision. Designed for use with standard electrosurgical units. Materials and dimensions consistent with established endoscopic snare technology.

Indications for Use

Indicated for use in patients undergoing flexible endoscopy for the grasping and removal of tissue within the gastrointestinal tract.

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 Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2014

Ovesco Endoscopy AG Tanja Linzer Head of Quality Management & Regulatory Affairs Dorfackerst. 26 D-72074 Tuebingen Germany

K140923 Re: Trade/Device Name: Traction Polypectomy Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories. Regulatory Class: Class II Product Codes: FDI Dated: October 2, 2014 Received: October 8, 2014

Dear Tanja Linzer,

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801 and Part 809); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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" (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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Benjamin R. Fisher -A

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) 140923

Device Name Traction Polypectomy Snare

Indications for Use (Describe)

Instrument for flexible endoscopy for grasping and removing tissue in the gastrointestinal tract.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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