(245 days)
Not Found
Not Found
No
The summary describes a physical feeding tube and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used for introducing enteral diets, which is a nutritional support function, not a therapeutic treatment of a disease or condition.
No
Explanation: The device is described as an enteral feeding tube, used for introducing nutritional diets into the alimentary tract. Its stated purpose involves delivery of substances, not the identification or analysis of medical conditions.
No
The device description clearly describes physical components such as tubes, tips, outlets, and a stylet, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for introducing enteral diets into the patient's alimentary tract. This is a direct interaction with the patient's body for therapeutic or nutritional purposes.
- Device Description: The description details a physical tube designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly administer substances into the body. This device falls under the category of a medical device used for patient care.
N/A
Intended Use / Indications for Use
The Device is intended for introduction into the Naris (Nostril) and is is used in the introduction of various commercial or compounded enteral diets to appropriate sites along the Ailimentary tract of the patient.
Product codes (comma separated list FDA assigned to the subject device)
78 FPD
Device Description
The subject devices are weighted or unweighted, thermoplastic or elastomer tubes. The distal outlet of the tube may be closed in a spherical tip or opened and polished to facilitate passage through the mucosal tissues of the nose or esophagus. A series of side outlets may be perforated through the side wall of the tubing to allow for dispersion of the enteral diet around the distal end of the tube. A stainless steel stylet may or may not be included with the product for aid in placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
naris (nostril)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Entech Enteral Feeding Tube
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1,965+79
10f2
FI
Substantial Equivalence 510(k)Summary
Rusch Inc. Enteral Feeding Tube
To: Whom it may concern
Date: 9/16/96
Submitter/ Contact - Name and Address
Ronald J. Young Quality Manager Rusch Inc. 2450 Meadowbrook Parkway Duluth, GA 30136
Telephone: (770) 623-0816 (770) 623-1829 Fax:
Device Details:
Trade Name: Rusch Enteral Feeding Tube
Common Name: Feeding Tube
Classification Name: Tube - Feeding
Predicate Legally Marketed Device: Entech Enteral Feeding Tube
1
Description of Device
The subject devices are weighted or unweighted, thermoplastic or elastomer tubes. The distal outlet of the tube may be closed in a spherical tip or opened and polished to facilitate passage through the mucosal tissues of the nose or esophagus. A series of side outlets may be perforated through the side wall of the tubing to allow for dispersion of the enteral diet around the distal end of the tube. A stainless steel stylet may or may not be included with the product for aid in placement
F2
1(963779
2072
Device Intended Use
The device is intended for introduction into the naris (nostril) and is used in the introduction of various commercial and/or compounded enteral diets to appropriate sites along the alimentary tract of the patient.
Technological Characteristics of the Device
The device is equivalent is design and construction to the Entech Enteral Feeding Tube. It comes in a range of sizes from 6 to 20FR and from 6" to 72" in length.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 3 1997 MAY
Mr. Ronald J. Young ... . . . . . . . . Quality Manager ... . . . . Rusch, Inc. 2450 Meadowbrook Parkway Duluth, Georgia 30136
Re: K963779 Rusch Enteral Feeding Tube -Dated: February 24, 1997 Received: February 27, 1997 Regulatory class: II 21 CFR §876.5980/Product code: 78 FPD
Dear Mr. Young:
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 ensement 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 Good Manufacturing Practice for Medical (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 (301) 594-4616. Additionally, for questions on the promotion 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 internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Lillian Yin, 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
3
e p. 31. 1946
VAL61/54 13.10
FDA-ODE-DRAERD
し! レ 0003 From:QUALITY ASSURANC
Page_1_of_1
x963779 510(k) Number (if known):
Rusch Enteral Feeding Tube Device Name:
Indications For Use: The Device is intended for introduction into the
Naris (Nostril) and is is used in the introduction of various commercial or compounded enteral diets to appropriate sites along the Ailimentary tract of the patient.
signed:-----------------
Title : - 8uality Manager __ Date: -2430496_________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Ratliff/
(Division Sign-Off) Division of Reproductive, Andominal, ENT, and Radiological Devices 196.3-1 510(k) Number.
Prescription Use. (Per 21 CFR 801.109)
. 2
OR
Over-The-Counter Use.
(Optional Format 1-2-96)