(212 days)
None
Not Found
No
The summary describes a simple mechanical adapter for feeding tubes and contains no mention of AI, ML, or related concepts.
No.
The device is used for access to existing feeding tubes for irrigation or medication administration, not for treating a disease or condition itself.
No
Explanation: The device is described as an "irrigation adapter" used for administering medications or irrigation without disconnecting feeding tubes. Its purpose is to provide additional access for treatment, not to diagnose a condition.
No
The device description "RPI DUAL PORT IRRIGATION ADAPTER" clearly indicates a physical hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide additional access to enteral feeding tubes for irrigation and medication administration. This is a direct interaction with the patient's feeding system, not the analysis of biological samples in vitro (outside the body).
- Device Description: The description "RPI DUAL PORT IRRIGATION ADAPTER" further supports its function as a physical adapter for tubes.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device (e.g., reagents, assays, measurement of biomarkers).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely for facilitating the delivery of substances into the body via existing feeding tubes.
N/A
Intended Use / 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.
Product codes
78 KNT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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:
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)
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)
OR
.:
Over-The-Counter Use
(Optional Format 1-2-96)