(157 days)
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.
A Nasojejunal Feeding Tube with or without Gastric Drainage.
This document, K961664, is a 510(k) premarket notification for a medical device: a nasojejunal feeding tube. The purpose of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Premarket Approval).
Therefore, the submission does not contain the typical "acceptance criteria" and a detailed "study" as you might expect for a new diagnostic or AI-powered device. Instead, it focuses on demonstrating equivalence to a predicate device.
Here's an analysis based on the provided text, addressing your points where applicable:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Logic)
Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be at least equivalent performance regarding safety and effectiveness as the predicate device. The "reported device performance" is essentially the claim that the modified device performs similarly to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: No negative impact on patient safety. | "Sandoz Nutrition believes that the changes described in this submission do not negatively affect the safety..." Material and bonding for new features (grasping rings, bolus tip) are identical to SE device. No complaints on materials of SE device in 5 years. |
| Effectiveness: Ability to deliver enteral formula post-pylorically. | The tubes are intended to "provide means for delivering enteral formula to the intestine (i.e., post pylorically)." |
| Effectiveness: Ability to perform gastric evacuation (for one model). | The #082302 tube "also provide the means for gastric evacuation or drainage which is the same intended use of the predicate device #082301." |
| Functional Equivalence: Similar materials, lengths, diameters, connections. | "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." |
| Radiographic Visibility: Certain features are radiopaque for placement confirmation. | "Confirmation of placement position... 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)." This implies equivalence to the predicate in this aspect. |
Addressing Your Specific Points:
-
A table of acceptance criteria and the reported device performance
See table above. The "acceptance criteria" are not explicitly stated in a quantitative manner as this is a medical device and not a diagnostic/AI product. The criteria are implicitly tied to the safety and performance of the predicate device. -
Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable / Not provided. This submission does not describe a test set or clinical study in the traditional sense for evaluating performance. The argument for substantial equivalence relies on material equivalence, design similarity, and the existing safety record of the predicate device. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable / Not provided. No ground truth establishment is described as there is no specific performance test set. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable / Not provided. No test set or expert adjudication is described. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (feeding tube), not a diagnostic or AI product. Therefore, an MRMC study is not relevant or described. -
If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No specific "ground truth" or clinical outcomes data is presented to prove performance of this specific modification. The "ground truth" for the predicate device's safety and effectiveness is assumed to be established through its 5 years of marketing without complaints regarding materials. -
The sample size for the training set
Not applicable / Not provided. There is no training set mentioned, as this is not an AI or machine learning device. -
How the ground truth for the training set was established
Not applicable / Not provided. No training set is mentioned.
In summary: This 510(k) submission for a nasojejunal feeding tube demonstrates substantial equivalence to a predicate device by highlighting:
- Identical intended use (delivering enteral formula post-pylorically, and gastric drainage for one model).
- Identical materials for new and existing components.
- Identical lengths, diameters, and connectors to the predicate.
- The minor changes (grasping rings, bolus tip) are designed to "assist in surgical palpation on manipulation of the tube tip during placement" and don't negatively affect safety or effectiveness, especially since their materials and bonding are the same as the predicate device which has a 5-year complaint-free history regarding materials.
- Placement confirmation can still be achieved via radiography due to radiopaque features.
The "study" in this context is the comparison between the proposed device and the predicate device, emphasizing their similarities and arguing that the minor differences do not introduce new risks or alter fundamental performance, thus meeting the criteria for substantial equivalence. No clinical trials or performance studies are detailed in this summary.
{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 andAccessories (21 CFR 876.5980) |
|---|---|
| Common/Usual Name: | Nasojeunal Feeding Tube with orwithout Gastric Drainage. |
| Trade Name: | Sandoz Nutrition COMPAT NasojejunalFeeding 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.
§ 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.