(161 days)
Not Found
No
The summary describes a standard enteral feeding bag and makes no mention of AI or ML capabilities.
Yes
The device is used for medical situations where a patient is nourished by an appropriate formula into the stomach, indicating a therapeutic purpose.
No
Explanation: The device is described as an "enteral feeding bag" used for "nourishment" and passing "formula" into the stomach. This indicates a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly states it is an "enteral feeding bag," which is a physical hardware component. The predicate device is also an enteral feeding bag. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for delivering nutrition directly into the stomach via a tube. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an "enteral feeding bag," which is a common medical device used for delivering liquid nutrition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to deliver nutrition, which is a treatment, not a diagnostic activity.
N/A
Intended Use / Indications for Use
This product must be used only under a doctor's prescription. Its indications for use are medical situations wherein the patient is nourished by an appropriate formula by various means passed into the stomach from the nasal passage. It is used for patients unable to masticate or swallow food. The product is not for intravenous feeding.
Product codes
78 KNT
Device Description
The Enteral Nutrition device is a common enteral feeding bag. The device will be used for dispensing liquid nutrients and medication under a doctors prescription.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach from the nasal passage
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)
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/1 description: The image shows the letters "MIT" in a bold, sans-serif font. The letters are arranged diagonally, slanting upwards from left to right. The text is black and the background is white.
Medical Infusion Technologies, Inc 6576 East Quaker Stree Orchard Park, NY 14127-259 Fax: 716-667-007 Phone: 716-667-006
AUG 1 5 1997
Premarket Notification [510(k)] Summary
as required by section 807.92(c)
Preparation Date: March 4, 1997
Per requirements of this section, the letter head contains address, phone, and fax numbers of the submitter, Mr John McNeirney, Vice President.
Trade name - "Enteral Nutrition" Common name - is Enteral Feeding Bag and accessories Classification name - Gastrointestinal tube and accessories (per CFR 876.5980(a))
The Enteral Nutrition device is equivalent to the RPI Enteral Feeding Bag, manufactured by Ridge Products, Inc., carrying 510(k) number K902641.
The device is a common enteral feeding bag.
The device will be used for dispensing liquid nutrients and medication under a doctors prescription.
The device will be identical to units on the market with the exception of our private label and per HHS Publication FDA 95-4158 "Premarket Notification 510(k), Regulatory Requirements for Medical Devices", page 3-7 "Clinical data is not needed for most devices cleared by the 510(k) process."
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 997
Mr. John MeNeirney Vice President Medical Infusion Technology, Inc. 6576 East Quaker Street Orchard Park, New York 14127-2593 Re: K970849 Enact™ Enteral Feeding Bag Dated: June 13, 1997 Received: June 17, 1997 Regulatory Class: II 21 CFR §876.5980/Product Code: 78 KNT
Dear Mr. McNeirney:
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, 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 (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 yitro 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 Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h.J. liau
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
2
"Indication For Use"
K970849 510(k) Number :
This product must be used only under a doctor's prescription. Its indications for use are r nis product medical situations wherein the patient is nourished by an appropriate formula by varrous moundal passed into the stomach from the nasal passage. It is used for patients means of a taoo passod into the steman and to masticate or swallow food. The product is not for intravenous feeding.
Robert R. Satling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K970849 510(k) Number
Prescription Use _ (Per 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________