(129 days)
Not Found
No
The document describes a physical medical device (feeding tube) and its accessories, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is used to introduce fluids into the stomach for feeding, which serves a supportive or nourishing purpose rather than directly treating a disease or condition.
No
The device is intended to introduce fluids into the stomach for feeding, not to diagnose a condition or disease.
No
The device description clearly details physical components such as tubes, connectors, and syringes, indicating it is a hardware medical device. 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 is to introduce fluids into the stomach for feeding. This is a direct therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical tube designed for placement within the body. It does not involve the analysis of biological samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any other components typically associated with in vitro diagnostic devices.
In summary, this device is a medical device used for feeding, not for performing diagnostic tests outside of the body.
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 Lumited to
§ 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
Non-Confidential Summary of Safety and Effectivenes IN 2 3 2009
Page 1 of 5 15-Sep-08
| NeoChild LLC
4605 N Stiles
Oklahoma City, OK 73105 | Tel 888-887-6428
Fax 405-813-2905 |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Rhett Bolen - Operations and QA Manager |
| Proprietary or Trade Name | SafeChild Infant Feeding Tube and Accessories |
| Common/Usual Name | Feeding Tube or NG /OG Tube |
| Classification Name | Tubes, Gastrointestinal (and Accessories) |
| Predicate Devices | NeoChild - Infant Feeding Tubes - K052903
NeoChild - Infant feeding Tube with non-IV
connector - K072756
Klein Baker (Utah) – K945012 and K861090 - NutriCath Silicone
Feeding Tube and enteral feeding tube extension set
Vygon - K925854 - NutriSafe Polyurethane Feeding Tube
NeoChild - K003854 Intravascular Administration Sets |
Device Description
The proposed modification to Infant Feeding Tube and accessories is to add additional materials that the feeding tube may be made from, 1 e , silicone and polyurethane In addition, we offer accessories an enteral extension set and syringe with non-IV connector These may be sold with the Feeding tubes or separately There is an option of the connectors being standard IV luer lock or a special non-IV connector which was cleared under K072756
The feeding tubes are a small diameter tube of various diameters, 4, 5, and 8 French, and various lengths They have an integral female fitting There are 2 eyelets near the tup of the tube They have markings along the shaft of the tubing and an integral radiopaque line They are provided sterile We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of the package, which was also cleared under K072756
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 Lumited to