RPI DUAL PORT IRRIGATION ADAPTER by RIDGE PRODUCTS, INC.

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 Description

RPI DUAL PORT IRRIGATION ADAPTER

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "PiPI Dual Port Enteral Irrigation Adapter" (K964920). This document grants market clearance based on substantial equivalence to a predicate device, which is a regulatory pathway for low-to-moderate risk medical devices.

Crucially, a 510(k) clearance does not typically require the comprehensive clinical studies with detailed acceptance criteria, ground truth establishment, sample sizes, and expert reviews that are characteristic of premarket approval (PMA) applications or more complex AI/CAD device submissions. The information requested in your prompt (especially regarding acceptance criteria tables, sample sizes for test sets, expert consensus, MRMC studies, standalone performance, and training set details) is largely irrelevant to a 510(k) clearance of this type of device.

Therefore, based on the provided document, I cannot fulfill your request for the following reasons:

No Acceptance Criteria or Performance Data: The document does not contain acceptance criteria for device performance or any reported performance data. The device is a "Dual Port Enteral Irrigation Adapter," a mechanical device for medical tubing. Its "performance" would likely be assessed through bench testing for leak resistance, material compatibility, and proper connection, rather than diagnostic accuracy metrics.
No "Study" in the requested sense: A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, energy used, and performance characteristics (often through bench testing or minor animal/clinical studies if needed to support equivalence, but not a full-scale clinical trial as implied by your questions).
No AI/CAD Component: The device is a simple mechanical adapter. It does not involve any artificial intelligence, machine learning, or computer-aided detection (CAD) algorithms. Therefore, questions about training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable.
No Ground Truth Establishment: For a mechanical adapter, "ground truth" as it pertains to diagnostic accuracy (e.g., presence or absence of a disease) is not relevant.

However, I can extract the following relevant information from the document:

1. Device Name and Purpose:

Device Name: PiPI Dual Port Enteral Irrigation Adapter (also referred to as "RPI DUAL PORT IRRIGATION ADAPTER" in the Indications for Use page).
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."
Problem Addressed: "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."

2. Regulatory Information:

510(k) Number: K964920
Regulatory Class: II
Procode: 78 KNT
CFR: 21 CFR 876.5980 (Gastroenterology-Urology Endoscopes and Accessories)
Date Cleared: July 9, 1997
Regulatory Pathway: Substantial Equivalence (510(k))

In summary, the provided document is a notification of substantial equivalence for a non-diagnostic, non-AI medical device. The detailed questions about acceptance criteria, study design, expert review, and AI performance are not applicable to this type of regulatory submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

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

PiPI 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 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 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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its fullernet address hitts //www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

h7iliau Yu
Lillian Yiu, Ph.D.

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

{1}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K964920

Device Name:RPI DUAL PORT IRRIGATION ADAPTER

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dorey J. B. H.

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiclogical Devices

K964920 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
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).(b)
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.