CORGRIP

K133599 · Corpak Medsystems · KNT · Mar 26, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133599
• Device Name: CORGRIP
• Applicant: Corpak Medsystems
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Mar 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for Use

The CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is indicated for use with CORPAK MedSystems enteral feeding tubes of 8 Fr and greater to prevent inadvertent removal or displacement of the tubes for adult patients.

Device Story

CORGRIP is a retention system designed to secure enteral feeding tubes (nasogastric/nasointestinal) in adult patients. The device functions as a mechanical accessory to prevent accidental tube dislodgement or displacement. It is intended for use with CORPAK MedSystems enteral feeding tubes sized 8 Fr and greater. The device is applied by healthcare providers in clinical settings to maintain tube placement, thereby ensuring consistent delivery of enteral nutrition and reducing the risks associated with tube re-insertion.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical retention system for enteral feeding tubes. Compatible with tubes 8 Fr and greater. Class II device under 21 CFR 876.5980.

Indications for Use

Indicated for adult patients requiring enteral feeding tubes (8 Fr or greater) to prevent inadvertent tube removal or displacement.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Submission Summary (Full Text)

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Public Health Service

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

## March 26, 2014

CORPAK MedSystems, Inc. Stephanie Wasielewski VP, RA/QA 1001 Asbury Drive Buffalo Grove, IL 60089

K133599 Re:

> Trade/Device Name: CORGRIP Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: February 24, 2014 Received: February 25, 2014

Dear Stephanie Wasielewski,

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 I ou may a 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 r lease oc advised that i Driv issual.co evour device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies.

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Page 2 – Stephanie Wasielewski

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/6 description: The image shows the name "Benjamin Asher-S" in a bold, sans-serif font. The letters are black against a white background, and the name is written in a single line. The letters "DA" are stylized and appear to be part of a logo.

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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## INDICATIONS FOR USE

510(k): K133599

Device Name: CORGRIP

Indications for use:

The CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is indicated for use with CORPAK MedSystems enteral feeding tubes of 8 Fr and greater to prevent inadvertent removal or displacement of the tubes for adult patients.

× Prescription Use __ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801.109)

or Over-the-counter use ______________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

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