FTRD System Set

K153550 · Ovesco Endoscopy AG · PKL · Oct 12, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153550
• Device Name: FTRD System Set
• Applicant: Ovesco Endoscopy AG
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Oct 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DTC Snare: The DTC Snare is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions. The clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of. - Endoscopic marking - Hemostasis for: - Mucosal/submucosal defects < 3 cm - Bleeding ulcers - Arteries < 2 mm - Polyps < 1.5 cm in diameter - Diverticula in the colon - Closure of GI tract luminal perforations < 20 mm that can be treated conservatively The snare is an instrument for flexible endoscopy for grasping tissue in the gastrointestinal tract. Marking Probe: Instrument for marking tissue using superficial HF coagulation in flexible endoscopy. Grasper: Instrument for flexible endoscopy for grasping and manipulation of tissue in the gastrointestinal tract, e.g. during interventions with the DTC Snare.

Device Story

DTC Snare system comprises snare, marking probe, and grasper for flexible endoscopy. Snare used for tissue compression, hemostasis, and lesion treatment; marking probe uses superficial HF coagulation for tissue marking; grasper used for tissue manipulation. Operated by physicians in clinical settings. System facilitates endoscopic procedures by providing mechanical grasping and coagulation capabilities to manage GI lesions, bleeding, and perforations. Output is physical tissue manipulation and coagulation effect observed by physician via endoscope. Benefits include minimally invasive management of GI defects and bleeding.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes snare, marking probe, and grasper for flexible endoscopy. Marking probe utilizes high-frequency (HF) coagulation. Mechanical design for tissue grasping and compression. No software or electronic components described.

Indications for Use

Indicated for patients requiring endoscopic GI tract intervention, including hemostasis of mucosal/submucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula, closure of GI perforations <20mm, and endoscopic marking of lesions.

Regulatory Classification

Identification

A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

Special Controls

*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

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

October 12, 2016

Ovesco Endoscopy AG % Ms. Martina Krautwald Novineon CRO & Consulting Ltd Dorfackerstrasse 26 Tuebingen, Baden-Wuerttemberg 72074 Germany

Re: K153550

Trade/Device Name: DTC Snare Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: September 9, 2016 Received: September 12, 2016

Dear Ms. Krautwald:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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,

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K153550

#### Device Name DTC Snare (Set contains DTC Snare, Marking Probe and Grasper)

Indications for Use (Describe)

DTC Snare:

The DTC Snare is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.

The clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of.

- Endoscopic marking
- Hemostasis for:
- Mucosal/submucosal defects < 3 cm
- Bleeding ulcers
- Arteries < 2 mm
- Polyps < 1.5 cm in diameter
- Diverticula in the colon

- Closure of GI tract luminal perforations < 20 mm that can be treated conservatively

The snare is an instrument for flexible endoscopy for grasping tissue in the gastrointestinal tract.

Marking Probe:

Instrument for marking tissue using superficial HF coagulation in flexible endoscopy.

Grasper:

Instrument for flexible endoscopy for grasping and manipulation of tissue in the gastrointestinal tract, e.g. during interventions with the DTC Snare.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <div> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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