(152 days)
The Oral/Enteral Syringes is intended for the delivery of liquid medication, formula, and breast milk.
The Oral/Enteral Syringes are intended for the delivery of liquid medication, formula, and breast milk. The syringes incorporate safety connectors that mate with the Respironics Enteral Only Extension Set, but will not mate with Luer lock or Luer slip fittings. The safety connectors prevent inadvertent connection of the enteral system to an IV system or an IV system to the enteral system. The Oral/Enteral Syringe barrels, plungers and end caps are comprised of Polypropylene, and the pistons are comprised of Silicone.
The provided text describes a 510(k) premarket notification for "Oral/Enteral Syringes." However, it is a submission for a medical device (syringes), not an AI/ML powered device. As such, the information you requested regarding acceptance criteria and studies that apply to AI/ML powered devices, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices through design verification tests related to the physical and functional properties of the syringes.
Here's the information that is available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Volume Measurement Accuracy Testing | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
| Enteral Feeding Extension Set Interface Testing | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
| Size and Material Inspection | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
| Biocompatibility Testing | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
| Sterility Testing | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
| Reliability Inspection | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
| Labeling Inspection | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
| Environmental Operating Testing | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
| Storage Testing | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
| ISTA Testing | Not explicitly stated, implied to meet product requirements | Testing Results demonstrated that the Oral/Enteral Syringes meet the required acceptance criteria. |
2. Sample size used for the test set and the data provenance: Not applicable (this is a physical device, not an AI/ML model evaluated on a test set of data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
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.): Not applicable. The "ground truth" for this device would be its physical properties and functional performance as described by engineering and regulatory standards, not expert consensus on data interpretation.
8. The sample size for the training set: Not applicable.
9. 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.