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510(k) Data Aggregation
(212 days)
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids and medication. The device is intended for patients with age of two and older.
The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is a double-lumen tube made of PVC used for naso/orogastric drainage and feeding. The larger (main) lumen is for feeding and drainage, while the smaller lumen draws in outside air to moderate the amount of suction at the drainage eyes. The device contains an ISO 80369-3 compliant ENFit connector which is inserted into the main lumen after decompression is no longer required to administer enteral fluids, including enteral nutrition, hydration and medication. It is a single use device which is provided sterilized via EO sterilization.
The provided document is a 510(k) premarket notification for a medical device: the Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets novel clinical acceptance criteria for an AI/CAD system or a diagnostic tool that requires robust clinical performance studies.
Therefore, the information requested in your prompt regarding acceptance criteria for an AI study, sample sizes, expert ground truth adjudication, MRMC studies, standalone algorithm performance, or training set details cannot be found in this document. The requirements you listed are typically applicable to software as a medical device (SaMD) or devices that rely heavily on algorithmic or diagnostic performance for their intended use.
This 510(k) summary focuses on the physical and functional characteristics of a physical device (a stomach tube) and its safety and efficacy as compared to a previously cleared device. The "acceptance criteria" here would be largely non-clinical performance benchmarks and adherence to established standards for medical tubing and connectors.
Here's how to interpret the document in the context of what is provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of acceptance criteria with quantitative results in the way you might expect for an AI study. Instead, it lists the non-clinical performance data (testing) performed and broadly states that the results "show that the modified device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence."
The "acceptance criteria" are implied by the standards and the successful completion of the listed tests:
| Acceptance Criteria (Implied by Standards/Tests) | Reported Device Performance (Summary) |
|---|---|
| Compliance with EN 1615:2000 (Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing) | Device complies with this standard. |
| Compliance with EN 1618:1997 (Catheters other than intravascular catheters. Test methods for common properties) | Device complies with this standard. |
| Compliance with ISO 80369-1:2010 (Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements) | Device complies with this standard. |
| Compliance with ISO 80369-3:2016 (Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications) | Device complies with this standard. |
| Compliance with ISO 80369-20:2015 (Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods) | Device complies with this standard. |
| Compliance with ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) | Device complies with this standard (related to biocompatibility). |
| Functional Verification (e.g., proper operation for intended use) | Testing showed functional performance. |
| Occlusion Verification (e.g., tube does not easily occlude) | Testing showed acceptable performance. |
| Liquid/Fluid Leakage (e.g., no leaks) | Testing showed no unacceptable leakage. |
| Patency Verification (e.g., remains open for fluid flow) | Testing showed patency. |
| Tensile Strength (e.g., resistance to breaking under tension) | Testing showed acceptable tensile strength. |
| Resistance to separation from axial load | Testing showed acceptable resistance to separation. |
| Resistance to separation from unscrewing | Testing showed acceptable resistance to separation. |
| Resistance to overriding | Testing showed acceptable resistance to overriding. |
| Disconnection by unscrewing | Testing showed acceptable performance. |
| Stress Cracking (e.g., resistance to cracking under stress) | Testing showed resistance to stress cracking. |
| Dimension verification (e.g., correct sizes, given configurations) | Dimensions verified to be within specification. |
| Flow Rate (e.g., fluids pass through at expected rates) | Testing showed acceptable flow rates. |
| Simulated Gastric Indwell (e.g., maintains integrity in gastric environment) | Testing showed stability during simulated indwell. |
| Biocompatibility Evaluation (e.g., non-toxic, non-irritating) | Device is biocompatible. |
| Shelf Life (2 years) (e.g., maintains integrity and function over 2 years) | Device maintains function and integrity for 2 years. |
The "reported device performance" for each of these is broadly summarized as "met requirements" or "complies," demonstrating "substantial equivalence."
Regarding points 2-9 of your prompt:
These points are not applicable to this 510(k) submission because it is for a physical medical device (Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection), not an AI/CAD system or a diagnostic device.
- 2. Sample sized used for the test set and the data provenance: Not applicable. Testing was likely done on a sample of manufactured devices, but not on "data" in the sense of patient images or clinical records.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical tube involves manufacturing specifications and physical testing, not expert clinical interpretation.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is for an AI/CAD system.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is based on engineering specifications, material properties, and performance standards for medical tubing and connectors (e.g., ISO, EN standards).
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission for a physical medical device, not a software or AI-based diagnostic tool. The "acceptance criteria" and "study" described align with the physical and functional performance testing required for a Class II device like a stomach tube.
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