(266 days)
No
The document describes a physical medical device (feeding tubes and accessories) and its materials and dimensions. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an enteral feeding tube, which is used for introducing fluids into the stomach, not for treating or curing a disease.
No
Explanation: The device described is a Pediatric Enteral Feeding Tube, intended for introducing fluids into the stomach. Its purpose is to facilitate feeding, not to diagnose a condition, disease, or injury.
No
The device description clearly outlines physical components such as tubes, extension sets, and syringes made from materials like PVC, silicone, and polyurethane. It also mentions physical characteristics like diameters, lengths, eyelets, markings, and radiopaque lines. 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 therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical tube and accessories used for delivering substances directly into the body. It does not involve analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical characteristics and adherence to industry standards for feeding tubes, not on diagnostic accuracy metrics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Pediation Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric or orogastric placement, limited 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.
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K092628
Page 1 of 3
510(k) Summary Page 1 of 3 12-May-10
MAY 2 0 2010
| Alan Reid | |
|---|---|
| PO Box 660 | |
| 2 South Winchester Street | Tel - 603-357-8733 |
| West Swanzey, NH 03459 | Fax - 603-357-0732 |
| Official Contact: | Alan Reid |
| Proprietary or Trade Name: | Pediatric Enteral Feeding Tube and Accessories |
| Pediatric Enteral Feeding Tube Extension sets | |
| Common/Usual Name: | Feeding Tube or NG /OG Tube |
| Classification Name: | Tubes. Gastrointestinal (and Accessories) |
| Predicate Devices: | NeoDevices - K020005 - Infant Feeding Tubes |
| NeoChild -- K082710 - Infant Feeding Tube | |
| Argyle / Kendall - K820442 Feeding Tube |
Device Description:
The proposed modification to the Pediatric Enteral Feeding Tubes and accessories is to add additional materials that the feeding tube may be made from, i.e., PVC, silicone, and polyurethane. In addition, we offer accessories: an enteral feeding extension set and syringe with non-IV connector. These may be sold with the Enteral Feeding tubes or separately. There is an option of the connectors to be provided as standard IV luer lock or a non-IV connector. In all cases the feeding tube and accessories are marked "For enteral feeding only".
The enteral feeding tubes are provided in various diameters (4, 5, 6.5, 8, 10 Fr) and various lengths. They have an integral female fitting. There are 2 eyelets near the tip of the tube. They have markings along the shaft of the tubing and an integral radiopaque line. They are provided sterile.
The Enteral extension sets are provided in various lengths and various configurations of components.
Indications for Use:
The Pediatric Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric placement, limited to