(157 days)
K913407/B
Not Found
No
The summary describes a physical medical device (feeding tube) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a feeding tube used for nutritional support and gastric suction, not for treating a disease or condition itself.
No
Explanation: The device is described as a nasojejunal feeding tube intended for providing enteral feeding and/or gastric suction. Its purpose is for treatment (feeding, drainage), not for diagnosing medical conditions.
No
The device description clearly states it is a "Nasojejunal Feeding Tube," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for enteral feeding and gastric suction, which are procedures performed on the patient's body.
- Device Description: The device is described as a Nasojejunal Feeding Tube, which is a physical device inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not devices inserted into the body for treatment or support.
N/A
Intended Use / Indications for Use
The Sandoz Nutrition #082302 NFG Tube is intended for use with patients who require both enteral feeding and gastric suction simultaneously. The Sandoz Nutrition #082304 NF Tube is intended for use with patients who require only enteral feeding. Indications for such medical and post-surgical treatments may include surgical problems, prolonged artificial ventilation, central nervous system trauma, and others. The placement of the device in patients can be accomplished intraoperatively at laparotomy using standard surgical techniques.
Product codes
Not Found
Device Description
A Nasojejunal Feeding Tube with or without Gastric Drainage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K913407/B
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
OCT 4 1996
510(K) SUMMARY
Submitter Name:
Sandoz Nutrition Corporation P.O. Box 370 Minneapolis, MN 55440
Robert J. Lanq Director of Quality Operations 612-591-2950 April 22, 1996
Device Name :
| Classification Name: | Gastrointestinal Tube and
Accessories (21 CFR 876.5980) |
|----------------------|--------------------------------------------------------------|
| Common/Usual Name: | Nasojeunal Feeding Tube with or
without Gastric Drainage. |
| Trade Name: | Sandoz Nutrition COMPAT Nasojejunal
Feeding Tube. |
Identification of the Legally Marketed Device
The #082302 NASOJEJUNAL FEEDING TUBE WITH GASTRIC DRAINAGE AND the #082304 NASOJEJUNAL FEEDING TUBE FOR SURGICAL PLACEMENT Substantially Equivalent (SE) to the Sandoz Nutrition are #082301 Nasojejunal Feeding Tube With Gastric Drainage and the Sandoz Nutrition #082303 Nasojejunal Feeding Tube legally marketed under 510 (k) : K913407/B
Description of the device that is the subject of this 510(K).
A Nasojejunal Feeding Tube with or without Gastric Drainage.
Statement of intended use of the device.
The Sandoz Nutrition #082302 NFG Tube is intended for use with patients who require both enteral feeding and gastric suction simultaneously. The Sandoz Nutrition #082304 NF Tube is intended for use with patients who require only enteral feeding. Indications for such medical and post-surgical treatments may include surgical problems, prolonged artificial ventilation, central nervous system trauma, and others. The placement of the device in patients can be accomplished intraoperatively at laparotomy using standard surgical techniques.
1
Summary of technological characteristics in comparison to those of the predicate device.
The tubes of this submission and the predicate device are both intended to provide means for delivering enteral formula to the intestine (i.e., post pylorically). The #082302 tube, also provide the means for gastric evacuation or drainage which is the same intended use of the predicate device #082301
differ Placement technique and confirmation methods The slightly from the predicate device. The devices in this submission are designed to facilitate placement into a patient intraoperatively using standard surgical techniques at The predicate devices may be placed using laparotomy. fluoroscopic and endoscopic guidewire techniques; however, these tubes can also be placed surgically, depending on physician preference.
Confirmation of placement position for all of the tubes above may be performed using radiographic techniques since certain location features are radiopaque (i.e., Bolus Tip, Grasping Rings, 9/18 FR Gastric Bushing, and tubing stripe).
The feeding tubes of this submission are nearly identical to the currently marketed tubes with the exception that grasping rings and bolus tips are added to the 9 French feeding portion of the tubes. The grasping rings located at the distal end of the tube are designed to assist in surgical palpation on manipulation of the tube tip during placement of the tube.
The feeding tubes and the stylets/stiffener of this submission are made of identical materials to those used in the currently marketed SE devices. The lengths, diameters, gastric suction holes and Y connectors of the devices of this submission are identical to those of the currently marketed SE devices.
Conclusions Drawn that demonstrate that the device is safe, as effective and performs as well as the legally marketed device.
Sandoz Nutrition believes that the changes described in this submission do not negatively affect the safety or effectiveness of the product. The material and bonding method for the grasping rings and bolus tip are identical to those used in the SE device. Furthermore, there have been no complaints with respect to the materials in the 5 years that the SE device has been marketed.