gastroduodenal FTRD Set

K200684 · Ovesco Endoscopy AG · PKL · Jun 2, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K200684
• Device Name: gastroduodenal FTRD Set
• Applicant: Ovesco Endoscopy AG
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Jun 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Instrument for flexible endoscopy, for full-thickness resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum. The gastroduodenal FTRD is indicated for the resection of lesions < 2.5 cm in the stomach and duodenum. Resection sizes may be less than 2.5 cm due to target tissue thickness and degree of fibrosis. For the resection of subepithelial tumors (SETs) the resection size is limited by the inner cap diameter.

Device Story

The gastroduodenal FTRD Set is an endoscopic instrument designed for full-thickness resection of gastric and duodenal lesions. It is used during flexible endoscopy procedures by trained clinicians. The device facilitates the removal of tissue for diagnostic purposes or lesion excision. It functions by capturing target tissue within an applicator cap, followed by mechanical resection. The device is intended for use in clinical settings where endoscopic procedures are performed. By enabling full-thickness resection, it allows for the complete removal of lesions, including subepithelial tumors, which can assist in definitive diagnosis and therapeutic management of gastrointestinal conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endoscopic instrument for full-thickness resection; consists of an applicator cap, integrated snare, and deployment mechanism. Designed for use with flexible endoscopes. Mechanical operation for tissue capture and resection.

Indications for Use

Indicated for patients requiring full-thickness resection and diagnostic tissue acquisition of lesions < 2.5 cm in the stomach and duodenum, including subepithelial tumors (SETs).

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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June 2, 2020

Ovesco Endoscopy AG % Julia Ehmann Consultant novineon CRO GmbH Friedrich-Miescher-StraBe 9 Tuebingen, Baden-Wuerttemberg 72076 GERMANY

Re: K200684

Trade/Device Name: gastroduodenal FTRD Set Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL, FDI, KNS Dated: March 11, 2020 Received: March 16, 2020

Dear Julia Ehmann:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K200684

Device Name gastroduodenal FTRD Set

## Indications for Use (Describe)

Instrument for flexible endoscopy, for full-thickness resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum.

The gastroduodenal FTRD is indicated for the resection of lesions < 2.5 cm in the stomach and duodenum. Resection sizes may be less than 2.5 cm due to target tissue thickness and degree of fibrosis.

For the resection of subepithelial tumors (SETs) the resection size is limited by the inner cap diameter.

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

| | <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|----------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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