(190 days)
The Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter is intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication.
The Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter is a dual lumen device used for gastric decompression (removal of gastric secretions and gases), gastric lavage, and administration of nutritional supplements and medication. Nasogastric sump tubes are generally used with a suction source to facilitate gastric drainage. The primary suction lumen of the tube is used for drainage, the second lumen, the vent lumen, provides an air inlet as a mechanism to break suction minimizing the potential for tube blockage secondary to mucosal tissue invagination into the side holes of the primary suction lumen. With the dual lumen nasogastric sump tube, if the primary lumen becomes obstric contents can back up into the vent lumen causing spillage onto the patient and possible clinical staff exposure to the gastric contents. The PreVent Anti-Reflux Filter provided with the Davol Nasogastric Sump Tube prevents reflux from exiting the vent lumen and spilling from the vent tube. The anti-reflux filter was incorporated for convenience, so that the clinical staff would not have to contend with and be exposed to spilled gastric contents and subsequent patient gown and linen changes. Although spillage from the vent tube is prevented, the user is still able to visualize reflux in the vent tube and therefore, the ability to diagnose a blocked primary lumen is maintained.
The provided text is a 510(k) summary for a medical device (Nasogastric Sump Tube) and does not describe an AI/ML powered device or a study involving acceptance criteria for an AI/ML model's performance. Therefore, most of the requested information (sample sizes, ground truth, experts, MRMC, standalone performance, training set) is not applicable to this document.
However, I can extract the acceptance criteria and the performed studies related to the physical medical device Davol8 Nasogastric Sump Tube with PreVent™ Anti-Reflux Filter.
Here's the information based on the provided text, recognizing its limitations regarding AI/ML:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Similar Indication Statements The device must have the same intended use as the predicate device (gastric decompression, gastric lavage, and administration of nutritional supplements and medication). | Met: Both the Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter and the Predicate Salem are intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication. |
| Technological Characteristics - Materials, Sizes, Features (excluding anti-reflux device) The device should be manufactured from identical material (PVC), offered in same sizes (10, 12, 14, 16, 18 French; 36 and 48 inches length), have a radiopaque stripe, five sets of drainage eyes, and one eye on the radiopaque stripe, and be sold sterile for single patient use. | Met: Both devices are manufactured from identical material (PVC), offered in the same sizes, have a radiopaque stripe, five sets of drainage eyes, and one eye on the radiopaque stripe. Both are sold sterile for single patient use. |
| Anti-Reflux Device Function - Prevent Reflux Spillage Both the subject device's PreVent Anti-Reflux Filter and the predicate's anti-reflux valve must prevent stomach reflux from exiting the vent tube. | Met: The Davol Nasogastric Sump Tube's PreVent Anti-Reflux Filter is described as preventing reflux from exiting the vent lumen and spilling. The predicate's anti-reflux valve is also intended to contain reflux. |
| Anti-Reflux Device Function - Not Significantly Affect Decompression Flow Rates The anti-reflux device should not significantly impede the flow of gastric contents/air. | Met: Laboratory testing performed to demonstrate substantial equivalence for specific performance criteria (i.e., flow rates) between the Davol Nasogastric Sump Tube with and without the PreVent Anti-Reflux Filter and the Predicate Salem under simulated clinical conditions showed comparable performance. |
| Biocompatibility The materials used must be suitable for the device's intended use as a mucosal contacting device of prolonged duration. | Met: Biocompatibility testing, performed in accordance with ODE memorandum #G95-1 (International Standard ISO-10993, Part 1), has shown that the materials used are suitable. |
| Maintain Ability to Diagnose Blocked Primary Lumen (for Davol device specifically) The user should still be able to visualize reflux in the vent tube to diagnose an obstructed primary lumen. | Met: The Davol device's filter allows two-way air flow, meaning reflux may enter the vent tube, allowing for visualization and diagnosis of an obstructed primary lumen. |
Regarding AI/ML-specific questions (not applicable to this document):
- Sample size used for the test set and the data provenance: Not applicable. This document describes a physical medical device, not an AI/ML model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here refers to the physical properties and performance of the device itself (e.g., flow rates, material composition, biocompatibility).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.