(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.
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Davol8 Nasogastric Sump Tube with PreVent™ Anti-Reflux Filter 510(k) Summary
Jul 2 4 1996
Predicate Device: Salem Sump Tube with Anti-Reflux Valve
Intended Use of the Device:
The Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter is intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication.
Device Description:
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.
Summary of Similarities and Differences:
The 510(k) Substantial Equivalence Decision-Making Process (Detailed) decision tree (ODE Guidance Memo #K86-3) was utilized to make a determination of substantial equivalence (see Exhibit VII-2). The answers to the following questions from this decision tree lead to a determination of substantial equivalence.
1. Does the Device Have Same Indication Statements?
Yes. 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.
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Does New Device Have the Same Technological Characteristics, e.g., Design, Materials, etc.? 2.
No. Both the Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter and the Predicate Salem consists of a dual lumen tube (with primary suction lumen and vent lumen) and "side-arm" vent tube connected to the vent lumen. Both nasogastric tubes are provided with an anti-reflux device on the vent Although the nasogastric sump tube components of the two devices are very similar, the tube. technological characteristics of the anti-reflux devices are different.
The Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter and the Predicate Salem are manufactured from identical material, PVC; are offered in 10, 12 14, 16 and 18 French sizes and in 36 and 48 inches in length; and have a radiopaque stripe. Both devices have five sets of drainage eyes for vacuum sump action; and one eve on the radiopaque stripe. The distal end of the tubes are configured with a tapered funnel for connection to suction systems or standard syringes. Additionally, both devices are sold sterile, for single patient use.
The Davol Nasogastric Sump Tube's PreVent Anti-Reflux Filter is a bidirectional hydrophobic filter with a pore size of 1 micron. The filter housing is manufactured from acrylic plastic while the filter media is manufactured from PTFE. The Predicate Salem's Anti-Reflux valve is a one-way mechanical valve manufactured from plastic material. Both the filter and the valve are intended to contain reflux within the nasogastric tube. Since the Davol Nasogastric Sump Tube's anti-reflux filter allows two-way air flow, reflux may enter the vent tube allowing for visualization of the reflux thus allowing diagnosis of an obstructed primary lumen. The Predicate Salem's anti-reflux valve only allows for one-way air flow into the vent lumen. Air trapped in the vent lumen (between the surface of stomach content and valve base) prevents the rise of gastric content in the vent lumen beyond the point at which trapped air has been compressed.
Both devices require diligent monitoring by the clinical staff to assure proper nasogastric tube function (i.e., adequate gastric fluid/air removal) to help minimize the potential of patient aspiration which may result if the primary suction lumen is obstructed and not cleared. The proposed labeling for the Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter includes a warning in the Instructions for Use and on the vent tube which reiterates the importance of routine monitoring for gastric reflux.
3. Could the New Characteristics Affect Safety or Effectiveness?
Yes. The differences in the configurations of the anti-reflux devices provided with the Davol Nasogastric Sump Tube and the Predicate Salem could affect the ability of the anti-reflux device to contain gastric reflux and allow proper tube function.
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Do the New Characteristics Raise New Types of Safety or Effectiveness Questions? 4.
No. It is generally acknowledged that all nasogastric tubes, whether provided with or without an antireflux component, require routine monitoring to assure proper tube function in order to minimize potential complications such as reflux aspiration, Both the Davol Nasogastric Sump Tube PreVent Anti-Reflux Filter and the Predicate Salem Anti-Reflux Valve must prevent stomach reflux from exiting the vent tube without significantly affecting decompression flow rates.
Do Accepted Scientific Methods Exist for Assessing Effect of the New Characteristics? ડ.
Yes. Relatively simple tests methods can be employed to assess the effects of the differences in design between the Davol Nasogastric Sump Tube and the Predicate Salem.
Are Performance Data Available to Assess Effects of New Characteristics? 6.
Laboratory testing has been performed to demonstrate substantial equivalence for specific Yes. 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. In addition, biocompatibility testing, performed in accordance with ODE memorandum #G95-1 (International Standard ISO-10993, Part 1), has been conducted on the Davol Nasogastric Sump Tube with PreVent Anti-Reflux device.
Does Performance Data Demonstrate Equivalence? 7.
Yes. Based on the results of the laboratory testing provided in Section V of this submission, the performance characteristics of the Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter are comparable to that of the currently marketed Predicate Salem. Results from the biocompatibility tests have shown that the materials used to manufacture the Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter are suitable for the devices intended use as a mucosal contacting device of prolonged duration.
Conclusion:
Based on the FDA's decision tree, the subject device, the Davol Nasogastric Sump Tube with Anti-Reflux Filter, is substantially equivalent to the Predicate Salem.
Contact Person: Robin M. Drago
Robin M. Drago
Dated: January 5, 1996
§ 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.