RPI DUAL PORT IRRIGATION ADAPTER

K964920 · Ridge Products, Inc. · KNT · Jul 9, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964920
• Device Name: RPI DUAL PORT IRRIGATION ADAPTER
• Applicant: Ridge Products, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended Use

The use of this device is to gain additional access to an Enteral Gastrostomy Tube or Nasogastric Tube for the purpose of irrigation or the administration of medications without having to disconnect the Enteral Feeding Administration Set from the patients feeding tube. The consistent connection or reconnection to a feeding tube each time a patient must be medicated or irrigated can not only cause patient discomfort, but also can cause the feeding tube to leak at the connection due to wear.

Device Story

The RPI Dual Port Irrigation Adapter is a mechanical accessory designed for enteral feeding systems. It provides a secondary access point to Gastrostomy or Nasogastric tubes, allowing clinicians or caregivers to perform irrigation or administer medications without disconnecting the primary feeding administration set. By eliminating the need for frequent disconnection and reconnection, the device reduces mechanical wear on the feeding tube connection and minimizes patient discomfort. It is intended for use in clinical or home care settings where enteral nutrition is managed.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical enteral irrigation adapter; dual-port design; plastic construction; non-powered; standalone device.

Indications for Use

Indicated for patients requiring enteral feeding via Gastrostomy or Nasogastric tubes who need periodic irrigation or medication administration.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUL - 9 1997

Richard G. Voelker
Vice President/Operations
Scientific Affairs
Ridge Products, Inc.
170 Oberlin Avenue, No.
Lakewood, New Jersey 08701

Re: K964920
FPI Dual Port Enteral Irrigation Adapter
Dated: April 7, 1997
Received: April 25, 1997
Regulatory Class: II
21 CFR 876.5980/Procode: 78 KNT

Dear Mr. Voelker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsnamaiu.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive,
Abdominal, Ear, Nose and Throat,
and Radiological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number (if known): K964920

Device Name: RPI DUAL PORT IRRIGATION ADAPTER

## Indications For Use:

The use of this device is to gain additional access to an Enteral Gastrostomy Tube or Nasogastric Tube for the purpose of irrigation or the administration of medications without having to disconnect the Enteral Feeding Administration Set from the patients feeding tube.

The consistent connection or reconnection to a feeding tube each time a patient must be medicated or irrigated can not only cause patient discomfort, but also can cause the feeding tube to leak at the connection due to wear.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)