(203 days)
Intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication during the time period that gastric decompression is required. The device is intended for patients with age of two-year and older.
The product is a double lumen sump tube available in 5 sizes, 10Fr – 18Fr, and lengths of 36 – 48 inches. The device is equipped with a Multi-functional port to allow alternating use for gastric decompression (via a suction connector) or delivery of fluids, including irrigation, nutritional supplements, and medication via a syringe or feeding set equipped with a female ENFit connector.
The provided text is a 510(k) Summary for a medical device (Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port). It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. This type of document typically does not include the detailed information requested in the prompt regarding acceptance criteria, study methodologies for performance evaluation, or clinical effectiveness studies in the way an AI/ML device submission would.
Therefore, for almost all categories, the answer will be that the information is not provided in this document.
However, I can extract what is present related to non-clinical testing and general acceptance.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding reported performance for a specific clinical or diagnostic metric in the way an AI/ML device would. Instead, it describes various non-clinical tests performed to ensure the device maintains safety and effectiveness equivalent to the predicate device, especially with the addition of the new ENFit connector.
Non-Clinical Tests Mentioned for the ENFit Connector (Implied Acceptance):
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Fluid leakage | Passed (tested to demonstrate performance) |
| Stress cracking | Passed (tested to demonstrate performance) |
| Resistance to separation (axial) | Passed (tested to demonstrate performance) |
| Resistance to separation (unscrewing) | Passed (tested to demonstrate performance) |
| Resistance to overriding | Passed (tested to demonstrate performance) |
| Disconnection from unscrewing | Passed (tested to demonstrate performance) |
| Dimensional analysis | Passed (tested to demonstrate performance) |
| Misconnection assessment | Demonstrated incompatibility with other medical devices (to reduce risk) |
| Durability (tensile properties) | Evaluated for durability (implies passing relevant thresholds) |
| Biocompatibility (ISO 10993-1:2009) | Demonstrated biological safety |
| Stability testing (accelerated aging) | Evaluated key performance properties in support of expiration date |
| Usability and human factors | Conducted as part of design (implies positive outcome) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to non-clinical tests on the device components, not a test set of patient data.
- Data Provenance: Not applicable, as no patient data or clinical study data is referenced for evaluation. The tests are non-clinical, likely conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth, in this context, would be established by engineering specifications and standards for device performance, not expert review of medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no expert adjudication of a test set is mentioned.
5. 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 not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the established engineering standards, regulatory requirements (e.g., ISO 10993-1:2009, AAMI/CN3:2014 (PS) Part 3), and internal design specifications for device performance and safety (e.g., for fluid leakage, tensile strength, biocompatibility).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question doesn't apply.
§ 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.