(195 days)
Not Found
No
The device description and intended use describe a simple mechanical feeding tube with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as an infant feeding tube intended for the introduction of fluids into the stomach, which is primarily a supportive function, not a therapeutic treatment of a disease or condition.
No
This device is a feeding tube, designed for introducing fluids into the stomach, not for diagnosing medical conditions.
No
The device description clearly describes a physical tube with specific dimensions, materials (implied by radiopaque line), and features (eyelets, luer fitting, markings). This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Infant Feeding Tube is a device that is physically inserted into the body (stomach) to deliver fluids. It does not analyze or test any biological specimens.
- Intended Use: The intended use clearly states its purpose is for the "introduction of fluids," not for diagnostic testing.
The information provided describes a medical device used for therapeutic purposes (feeding), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to less than 30-day placement. Not intended for transpyloric placement.
Product codes
78 KNT
Device Description
The Infant Feeding Tube is a small diameter tube of various sizes - 5,6, and 8 French, and lengths of 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
Indicated Patient Age Range
infants
Intended User / Care Setting
Hospital or environment where placement of a feeding tube is required.
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
'JUL 1 6 2002
Non-Confidential Summary of Safety and Effectiveness
| | Page 1 of 2
April 16, 2002 |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| ProMedic, Inc.
6329 W. Waterview Ct.
McCordsville, IN 46055 | Tel (317) 335-3780
Fax (317) 335-9270 |
| Official Contact: | Paul Dryden - President |
| Proprietary or Trade Name: | Infant Feeding Tube |
| Common/Usual Name: | Feeding Tube |
| Classification Name: | Tubes, Gastrointestinal (and Accessories) |
| Predicate Devices: | Vygon - Infant Feeding Tubes - K925854
Klein-Baker - Neo-Care Feeding Tube - K861090
Knott Gastric tube - K971354 |
Device Description: ----------------------------------------------------------------------------------------------------------------------------------------------------------
The Infant Feeding Tube is a small diameter tube of various sizes - 5,6, and 8 French, and lengths of 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.
| Intended Use: | |
|---|---|
| Indicated Use -- | The Infant Feeding tube is intended to be placed into the stomach |
| to permit the introduction of fluids as directed by the physician. | |
| Intended for nasogastric or orogastric placement. Limited to less | |
| than 30 day placement. Not intended for transpyloric placement. | |
| Environment of Use -- | Hospital or environment where placement of a feeding tube is |
| required. |
rate of the comments of
02005
1
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2 April 16, 2002
Comparison to Predicate Devices: Devices: 10 Comparison 1
| Attribute | Proposed device | Predicate Vygon Infant
Feeding Tube - K925854 |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------|
| Intended use | | |
| To be placed into the stomach to
permit the introduction of fluids
as directed by the physician.
Nasogastric or orogastic
placement. | Yes | Yes |
| Intended for single patient use for
a duration of