(97 days)
The MPS Acacia Enteral Feeding Tube is intended to be placed into the stomach, nasogastrically or orogastrically, for the introduction of fluids and/or oral medication. The Enteral Feeding Tube is disposable and single use only. Not intended for intravascular or intravenous use.
The MPS Acacia Enteral Feeding Tube is a polyurethane or polyvinyl chloride (PVC) tube of various French sizes and lengths. A rigid female oral connector is attached to the proximal end of the Enteral Feeding Tube and accepts all male oral connectors such as those found on oral syringes.
The provided 510(k) summary for the MPS Acacia Enteral Feeding Tube (K080328) indicates that the device's acceptance criteria are met through non-clinical testing and substantial equivalence to predicate devices, rather than a clinical study with detailed performance metrics.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Substantial Equivalence: | MPS Acacia Enteral Feeding Tube utilizes the Kendall Feeding Tube and MPS Acacia's rigid female oral connector. The only change is the replacement of Kendall's soft boot female connector with MPS Acacia's rigid female oral connector. |
| The attachment of MPS Acacia's oral female connector does not require additional clinical testing since no changes in the common clinical use or intended use of the device is being made. | MPS Acacia's oral female connector can only accept an oral male connector (e.g., from oral syringes), ensuring intended interface compatibility. There are no other technological differences with the predicate devices. |
| Intended Use Equivalence: | Intended use remains the same as the predicate devices: placement into the stomach, nasogastrically or orogastrically, for introduction of fluids and/or oral medication. Disposable and single-use only. Not for intravascular or intravenous use. |
| Safety and Effectiveness: | Implied through substantial equivalence to legally marketed predicate devices (Argyle Indwell Polyurethane Feeding Tube K820442 and Argyle PVC Feeding Tube K820441), which have established safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No specific "test set" of patient data was used in a clinical study for this 510(k). The evaluation relied on non-clinical assessment of the design and comparison to predicate devices.
- Data Provenance: Not applicable. No clinical data was collected or analyzed for this 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No ground truth was established by experts for a test set in the context of this 510(k), as no clinical study was performed. The evaluation was based on the manufacturer's engineering assessment and regulatory comparison.
4. Adjudication Method for the Test Set
- Not applicable. As no clinical study or test set requiring expert adjudication was conducted, there was no adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This 510(k) is for an enteral feeding tube, which is a physical medical device, not an AI software or imaging interpretation tool that would typically undergo such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study was not done. This device is a physical medical device and does not involve an algorithm.
7. The Type of Ground Truth Used
- Ground Truth: For this 510(k), the "ground truth" essentially refers to the established safety and effectiveness of the legally marketed predicate devices (Kendall's Argyle Indwell Polyurethane Feeding Tube K820442 and Argyle PVC Feeding Tube K820441). The MPS Acacia Enteral Feeding Tube's performance is deemed acceptable because it is substantially equivalent in design, materials, and intended use to these already-approved devices, with a minor modification (the connector) that does not alter its fundamental function or safety profile.
8. The Sample Size for the Training Set
- Not applicable. As no artificial intelligence or machine learning component is involved, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no artificial intelligence or machine learning component is involved, there is no "training set" or ground truth establishment relevant to one.
§ 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.