(183 days)
The NeoMed Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.
The NeoMed Enteral Only Extension Set is a sterile disposable for single patient use only device designed to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. The device consists of flexible PVC tubing designed to connect existing feeding tubes (nasogastric, oralgastric, etc) to various delivery systems in including pumps and syringes. The set consists of tubing with an enteral connector (catheter tip) and an oral syringe connector not compatible with IV tubing or stopcocks. The NeoMed Enteral Only Extension Set provides an orange stripe for easy quick identification of enteral feeding lines as well as an "Enteral Only" tag and slide clamp to provide the additional safety assurance for connection errors.
The provided text describes the NeoMed Enteral Only Extension Set, a Class II medical device. However, it does not contain the information needed to fill out a table of acceptance criteria, detailed device performance, or a comprehensive study description as requested.
The document is a 510(k) summary, which focuses on establishing substantial equivalence to a predicate device rather than presenting detailed clinical study results or specific performance criteria with numerical targets.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Target) | Reported Device Performance (Result) |
|---|---|---|
| Mechanical Testing | Not specified quantitatively | Passed |
| Tensile | Not specified quantitatively | Passed |
| Strain | Not specified quantitatively | Passed |
| Elongation | Not specified quantitatively | Passed |
| Physical Properties | Not specified quantitatively | Passed |
| Dimensional Verification | Not specified quantitatively | Passed |
| Flow Rate | Not specified quantitatively | Passed |
| Hub Compatibility | Not specified quantitatively | Passed |
| Biocompatibility Testing | Passed per ISO 10993-1 | Passed |
| Cytotoxicity | Not specified quantitatively | Passed |
| Sensitization | Not specified quantitatively | Passed |
| Irritation | Not specified quantitatively | Passed |
| Packaging Challenges | Not specified quantitatively | Passed |
| Package Integrity | Not specified quantitatively | Passed |
| Product Stability | Not specified quantitatively | Passed |
Explanation of Table: The document states that "Design verification functional test results demonstrate that the NeoMed Enteral Only Extension Set performs its intended use." It then lists the types of tests conducted: "mechanical: tensile, strain, elongation and physical/properties testing comprised of dimensional verification, flow rate, and hub compatibility. Packaging challenges for package integrity and product stability were conducted with aging studies. All materials have been evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – part 1: Evaluation and Testing and the three tests conducted - cytotoxicity, sensitization, and irritation pass."
*Crucially, the specific quantitative acceptance criteria (e.g., "tensile strength > X N") and the numerical results (e.g., "tensile strength = Y N") for these tests are NOT provided in this document. The document only states that the tests were conducted and "pass" or "demonstrate that the device performs its intended use."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "functional tests conducted" but does not give the number of units tested for each type of performance test.
- Data Provenance: Not specified (e.g., country of origin of data). The testing appears to be internal validation by the manufacturer, NeoMed, Inc., or its contracted labs.
- Retrospective or Prospective: N/A for this type of bench/functional testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes bench and biocompatibility testing for a medical device (an extension set), not a diagnostic or prognostic device that requires expert-established ground truth from patient data. The "ground truth" for these tests would be the established engineering standards or regulatory requirements.
4. Adjudication method for the test set
- Not Applicable. As above, this is laboratory and bench testing, not a clinical study involving human readers or subjective interpretations requiring adjudication.
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
- No such study was done. This device is an enteral extension set, a physical medical device, not an AI-powered diagnostic or decision support system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Standards and Regulatory Guidelines. For the functional and biocompatibility tests, the "ground truth" is adherence to established industry standards (e.g., ISO 10993-1 for biocompatibility) and the device's design specifications.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this device does not involve machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set.
§ 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.