(176 days)
Not Found
None
No
The 510(k) summary describes a simple silicone catheter for feeding and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device delivers nutritional media, it does not treat or cure a disease or condition.
No
The device is described as a feeding tube intended to deliver nutritional media, not to diagnose a condition.
No
The device description explicitly states it is a "silicone catheter," which is a physical hardware component.
Based on the provided information, the GuardingCatheter - Infant Feeding Tube is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- GuardingCatheter Function: The description clearly states the device is a catheter intended to deliver nutritional media directly into the stomach or intestine. It is a delivery device, not a device used for testing samples.
The information provided focuses on the physical delivery of substances into the body, which is characteristic of a therapeutic or supportive medical device, not an IVD.
N/A
Intended Use / Indications for Use
The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media. The catheter is inserted into the stomach or intestine-small bowel through the nares or mouth for delivery of liquid nutritional diets to patients with a functional GI tract.
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
stomach or intestine-small bowel
Indicated Patient Age Range
Infant
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)
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2005
Ms. Sandra Winkler Owner/President Marian Medical, Inc. P.O. Box 5193 DESTIN FL 32540
Re: K042112
K042112
Trade/Device Name: Marian Infant Feeding Tube (GuardianCatheter™-Infant Feeding Tube) Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: December 24, 2004 Received: January 6, 2005
Dear Ms. Winkler:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your bectorily be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to ttgans and ment date of the Medical Device Amendments, or to commerce prior to they 20, 2011 11:12 provisions of the Federal Food, Drug, de noos may been rout do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, maines of the Act include requirements for annual registration, listing of general volurold provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be it may of surfect to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease be actived that I termination that your device complies with other requirements of the Act that I Dr Haral statutes and regulations administered by other Federal agencies. You must of any I ederal statues and reguirements, including, but not limited to: registration and listing Comply with an the river requirement 801); good manufacturing practice requirements as set (21 CFR Part 807), as only (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 5 0 (k) I his letter will anow you to begin manceing your antial equivalence of your device to a legally premarket notification. THE PDA midnig of saostantial equice 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), please if you desire specific advice for your device of our of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, common on your responsibilities under the Act from the 807.97). Tou may obtain other gollerer mironal and Consumer Assistance at its toll-free number (800) DVNSlor of Stilan Manufacturers, internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement:
510(K) Number: K-042112
Marian Infant Feeding Tube (GuardianCatheter™-Infant Feeding Tube) Device Name: Indications For Use:
The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media. The catheter is inserted into the stomach or intestine-small bowel through the nares or mouth for delivery of liquid nutritional diets to patients with a functional GI tract.
Prescription Use Yes (Part 21 CFR 801 Subpart) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
042112
David h. Ferguson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _
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