(89 days)
K853351/A
No
The device description focuses on the mechanical components and surgical placement of a feeding tube, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended to deliver enteral feeding formulas for patients with various medical conditions, providing nutrition to enhance absorption and minimize risks like gastric reflux and aspiration, thus treating or managing a medical condition.
No
The device is a feeding tube designed to deliver enteral feeding formulas and evacuate gastric contents, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components like tubes, stylets, connectors, and an inflatable cuff/balloon, indicating it is a hardware medical device.
Based on the provided text, this device 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, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Sandoz Nutrition #0888000 Gastrostomy/Jejunostomy Feeding Tube is a device used for the delivery of enteral feeding formulas directly into the small bowel and for the evacuation of gastric contents. It is a tube placed surgically within the body.
- No Testing of Samples: The description does not mention any function related to analyzing samples taken from the body. Its purpose is to facilitate feeding and drainage, not to diagnose or monitor conditions through laboratory testing.
Therefore, this device falls under the category of a surgically implanted or placed medical device for therapeutic and supportive purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Sandoz Nutrition #0888000 Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require delivery of enteral feeding formulas directly into the small bowl (jejunum). The Sandoz Nutrition #088000 Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require 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 is accomplished surgically using standard surgical techniques.
The Sandoz Nutrition #0888000 Gastrostomy/Jejunostomy Feeding Tube also provides for the evacuation of gastric contents through the gastrostomy tube while simultaneously feeding directly into the small bowl with the jejunal feeding tube.
The Sandoz Nutrition Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding tube. Jejunal feeding us used when patients require feeding past the stomach directly into the jejunum. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration.
Product codes
Not Found
Device Description
A Surgical Gastrostomy/Jejunostomy Feeding Tube Kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray or fluoroscopic techniques.
Anatomical Site
small bowl (jejunum), stomach
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K853351/A
Reference Device(s)
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/0 description: The image shows the text "K965087 1 of 3" in a handwritten style, followed by the logo of Sandoz. The Sandoz logo consists of a triangle with the letter "S" inside, followed by the word "SANDOZ" in bold, sans-serif font. The text and logo are arranged vertically, with the handwritten text at the top and the Sandoz logo at the bottom.
Z NUTRITION CORPORATION INNEAPOLIS MINNESOTA 55440
APPENDIX E 510(K) SUMMARY
MAR 1 8 1997
TEL. 612 925 2100 FAX 612 593 2087 SAN NUT MPS TWX 9109973809
Submitter Name:
Sandoz Nutrition Corporation P.O. Box 370 Minneapolis, MN 55440
Robert J. Lang Director of Quality Operations 612-591-2950
December 9, 1996
Device Name :
Classification Name: Common/Usual Name: Trade Name:
Gastrointestinal Tube and Accessories (21 CFR 876.5980) Surgical Gastrostomy/Jejunostomy Feeding tube Kit. Nutrition COMPAT Surgical Sandoz Gastrostomy/Jejunostomy Feeding Tube Kit.
Identification of the Legally Marketed Device
#088000 MODIFIED SURGICAL GASTROSTOMY/JEJUNOSTOMY The FEEDING TUBE KIT is Substantially Equivalent (SE) to the currently marketed Sandoz Nutrition #088000 Surgical Gastrostomy/Jejunostomy Feeding Tube Kit currently marketed under K853351/A
Description of the device that is the subject of this 510(K).
A Surgical Gastrostomy/Jejunostomy Feeding Tube Kit.
Image /page/0/Picture/17 description: The image shows a circular logo with the text "QUALITY ASSURED FIRM" around the top half of the circle. Inside the circle is the text "ISO 9001" in a bold, sans-serif font. Below the text is a check mark and the letters "SGS".
1
Image /page/1/Picture/0 description: The image shows the number 476-637 at the top, followed by the text "2 of 3". Below that is the Sandoz logo, which includes a triangle with the letter S inside, followed by the word "SANDOZ" in bold, sans-serif font. The image appears to be a page number or identifier from a document.
Statement of intended use of the device.
The Sandoz Nutrition #0888000 Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require delivery of enteral feeding formulas directly into the small bowl (jejunum). The Sandoz Nutrition #088000 Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require 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 is accomplished surgically using standard surgical techniques.
The Sandoz Nutrition #0888000 Gastrostomy/Jejunostomy Feeding Tube also provides for the evacuation of gastric contents through the gastrostomy tube while simultaneously feeding directly into the small bowl with the jejunal feeding tube.
Summary of technological characteristics in comparison to those of the predicate device.
Intestinal feeding and gastric drainage. 1.
The Sandoz #088000 Surgical Gastrostomy and Jejunostomy Feeding Tube Kit provides the same ability as the comparative substantially equivalent (SE) device for delivery of formula and medications to the small intestine (through "FEED" port) while allowing simultaneous gastric drainage (through "DRAIN" port) via the gastrostomy tube.
2. Placement techniques and confirmation methods.
Initial placement of the #088000 Kit tubes may be accomplished surgically, as with the predicate SE device through a laparotomy midline incision and Stamm (gastrostomy) technique. The jejunal feeding tube can be placed in a similar fashion to that of the SE device in that the tube is led through the lumen of the gastrostomy tube into the stomach, then grasped at its tip and manipulated through the gastric pylorus into the small intestine.
This manual manipulation into the bowel is assisted by the presence of the bolus tip on the jejunal tube and by a removable stylet. In the SE device, the stylet is a twisted wire stiffener; however, in the device of this submission, the stylet is made of a plastic material with an inflatable cuff/balloon at its distal end. The inflation of the cuff provides an additional (temporary) feature for grasping and directing the jejunal tube tip.
Both the SE and modified (submission) devices contain a Y-port at the connector end of the Jejunal Feeding tube which may be pressed into the lumen of the Gastrostomy tube to complete the placement and allow for gastric drainage through the gastrostomy tube. The Gastrostomy/Jejunostomy tube combination may be immobilized using the external retainer and the abdomen may be closed in the standard fashion.
Image /page/1/Picture/11 description: The image is a circular logo for ISO 9001 certification. The words "QUALITY ASSURED FIRM" are arranged around the top half of the circle. The text "ISO 9001" is in bold, large font in the center of the circle. A check mark is below the text, and the letters "SGS" are at the bottom of the circle.
2
Image /page/2/Picture/0 description: The image shows the number 1 16-5-37 at the top. Below that is the text "3 of 3". The image also contains the Sandoz logo, which includes a triangle with the letter A inside and the word SANDOZ in bold letters.
Confirmation of placement of both tubes may be accomplished using x-ray or fluoroscopic techniques.
-
Tube and Stylet Construction. 3.
· The construction of the Gastrostomy and Jejunostomy tubes is almost identical to that of the SE device for the #088000 Kit. The only difference occurs in the Jejunal feeding tube where the Y-Connector has been modified to a 3 part assembly from what was previously an 8 part assembly. This revised Y-Connector assembly was included in a previous 510(k) notification, K961664. Also, the bolus tip is shortened. -
· The two stylets of the SE device and the submission device differ in that:
- a) The SE device stylet is a twisted wire construction with an end button.
- b) The submission device stylet is a semi-rigid plastic tube with and inflatable cuff/balloon at one end and an inflation port/valve at the opposite end.
The applied standard for strength of bonding joints on portions of devices which will reside internally to a patient is the same as in the SE product.
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 gastrostomy and the jejunal feeding tubes are identical to those used in the SE device.
Indications for Use:
The Sandoz Nutrition Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding tube. Jejunal feeding us used when patients require feeding past the stomach directly into the jejunum. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration.
Image /page/2/Picture/12 description: The image is a circular logo with the text "QUALITY ASSURED FIRM" around the top half of the circle. Inside the circle is the text "ISO 9001" in large, bold letters. Below the text is a check mark and the letters "SGS".