MEDLINE ANTI-REFLUX VALVE

K132314 · Medline Industries, Inc. · FEG · Sep 18, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K132314
• Device Name: MEDLINE ANTI-REFLUX VALVE
• Applicant: Medline Industries, Inc.
• Product Code: FEG · Gastroenterology, Urology
• Decision Date: Sep 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for Use

The Medline Anti-Reflux Valve allows the vent lumen of the gastric sump tube to neutralize the vacuum pressure in the stomach when the contents are fully evacuated, but prevents stomach contents from exiting the vent lumen. This reduces the risk that healthcare workers will be exposed to potentially infectious gastric fluids and also prevents unnecessary patient bedding and gown changes.

Device Story

Medline Anti-Reflux Valve is an accessory for gastric sump tubes. Device functions as a one-way valve attached to the vent lumen of a gastric sump tube. Principle of operation involves allowing air to enter to neutralize vacuum pressure while preventing gastric contents from exiting the vent lumen. Used in clinical settings by healthcare workers. Output is the prevention of gastric fluid leakage from the vent lumen. Benefits include reduced risk of healthcare worker exposure to infectious gastric fluids and prevention of patient bedding/gown contamination.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical anti-reflux valve accessory for gastric sump tubes. Designed to interface with the vent lumen to regulate pressure and prevent fluid egress.

Indications for Use

Indicated for use with gastric sump tubes to neutralize vacuum pressure in the stomach during evacuation and prevent gastric fluid leakage from the vent lumen.

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

September 18, 2013

Medline Industries, Inc. % Matt Clausen Sr. Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060

Re: K132314

Trade/Device Name: Medline Anti-Reflux Valve Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FEG Dated: July 22, 2013 Received: July 25, 2013

Dear Matt Clausen,

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. Iisting 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

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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/ReportalProblem/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/Figure/6 description: The image shows the name "Herbert P. Lerner-S" in a stylized font. The name is written in black ink on a white background. The letters "P" and "L" are stylized with a decorative pattern.

for

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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Image /page/2/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in bold, italicized letters. Above the word is a symbol that resembles a compass rose or a stylized star. The symbol has four points, with the bottom point extending further down than the others.

Medine Industries Inc. Medline Place ndelein, II 60060

## Indications for Use

510(k) Number (if known):

Device Name: Medline Anti-Reflux Valve

Indications for Use:

The Medline Anti-Reflux Valve allows the vent lumen of the gastric sump tube to neutralize the vacuum pressure in the stomach when the contents are fully evacuated, but prevents stomach contents from exiting the vent lumen. This reduces the risk that healthcare workers will be exposed to potentially infectious gastric fluids and also prevents unnecessary patient bedding and gown changes.

Prescription Use X - -(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Lerner -S