FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS

K142012 · Corpak Medsystems · PIF · Nov 20, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K142012
• Device Name: FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
• Applicant: Corpak Medsystems
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Nov 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is a closed reservoir system intended to allow the evacuation of excess gas (gastric distention/bloating) and drainage/collection of enteral feeding formula and gastrointestinal tract contents from patients utilizing an enteral device. The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is for use with neonates, pediatric, and adult patients.

Device Story

The FARRELL® Valve System is a closed reservoir device designed to manage gastric pressure and drainage in patients with enteral feeding tubes. It functions by allowing the evacuation of excess gas and the collection of gastric contents, preventing distention and bloating. The system incorporates EQUILIBRIUM TECHNOLOGY™ to maintain pressure balance and features ENFit™ enteral connectors to ensure secure, standardized connections to feeding tubes. It is used in clinical settings by healthcare providers to manage enteral nutrition and gastrointestinal decompression. By providing a controlled path for gas and fluid exit, the device helps reduce patient discomfort associated with gastric distention and facilitates safe enteral feeding management.

Clinical Evidence

Bench testing only.

Technological Characteristics

Closed reservoir system for enteral drainage and gas evacuation. Features EQUILIBRIUM TECHNOLOGY™ for pressure management and ENFit™ connectors for standardized enteral interface. Non-powered, mechanical device.

Indications for Use

Indicated for neonates, pediatric, and adult patients requiring evacuation of excess gas (gastric distention/bloating) and drainage/collection of enteral feeding formula and gastrointestinal tract contents via an enteral device.

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.

Predicate Devices

• FARRELL® Valve System (K033665)

Submission Summary (Full Text)

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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 a stylized symbol of three human profiles facing to the right, arranged in a cascading manner.

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

November 20, 2014

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

Re: K142012

> Trade/Device Name: FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: November 12, 2014 Received: November 13, 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 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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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" (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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## INDICATIONS FOR USE

510(k):

## Device Name: FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors

## Indications for use:

The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is a closed reservoir system intended to allow the evacuation of excess gas (gastric distention/bloating) and drainage/collection of enteral feeding formula and gastrointestinal tract contents from patients utilizing an enteral device. The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is for use with neonates, pediatric, and adult patients.

Prescription Use X (Per 21 CFR 801.109) or Over-the-counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)