(200 days)
Mobility+ is intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over.
The Mobility+ Enteral Feeding System OTC ("Mobility+ OTC" or the "System") is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24-hour period.
The System has three primary components; food pouch, filling set and giving set.
Food Pouch: The Food Pouch serves as the Mobility+ Enteral Feeding System OTC system's combined reservoir and pump. The pouch consists of a foil container with an internal elastomeric pouch. The Food Pouch can hold up to 500 ml of feed.
Filling Set: The Filling Set is tubing that connects to the Mobility+ food pouch to deliver commercially available nutritional feed from its packaging to the Food Pouch using ENFit connectors. The Filling Set is used to transfer feed from the feed packaging into the Food Pouch, using a syringe.
Giving Set: The Giving Set is tubing that connects the Food Pouch to the implanted feeding tube's ENFit connector. The Giving Sets will be available in a variety of lengths to give a range of feed flow rates. All connectors in the Mobility+ Enteral Feeding System OTC comply with the FDA-recognized ENFit standard (ISO 80369-3 and ISO 18250-3).
The Mobility+ Enteral Feeding System OTC may be worn in a bag of choice that can fit the system without kinking the tubing and without squeezing the pouch. The instructions for use guide the user to place the spout of the pouch within 15cm (6 inches) above or below the stoma when feeding.
This is a non-AI medical device; therefore, sections 1-9 are not applicable.
The provided document describes the Mobility+ Enteral Feeding System OTC, a non-electronic, disposable enteral feeding system intended to deliver liquid nutrition formula. As a physical medical device (a pump and tubing system) rather than an AI/software device, the concepts of acceptance criteria related to AI performance, ground truth establishment by experts, training/test sets, or MRMC studies are not applicable in this context.
The document states:
- "Non-Clinical Information: The Mobility+ System OTC is the identical device as the predicate. Therefore, all technological characteristics (e.g., design, material, functionality) are identical and non-clinical performance data tests were not repeated."
- "Clinical Information: Clinical studies were not deemed necessary for The Mobility+ Enteral Feeding System OTC as bench testing was sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device."
The acceptance criteria for this device are demonstrated through design verification and validation tests, which focus on the physical and functional aspects of the system.
Here's the relevant information about the "acceptance criteria" through the lens of device testing:
1. A table of acceptance criteria and the reported device performance
The document lists "Design Verification Tests" and "Design Validation Tests". These tests represent the acceptance criteria for the device's functionality and safety. The reported device performance is that the device met these requirements.
| Acceptance Criteria (Design Verification Tests) | Reported Device Performance |
|---|---|
| System Fill | Met requirements |
| Connector dimensional and functional | Met requirements |
| Pouch valve seal pressure | Met requirements |
| On/Off Clamp functionality | Met requirements |
| Flowrate under nominal, minimum and overfill conditions | Met requirements |
| Residual Feed remaining in system | Met requirements |
| Multiple use within 24 hour period | Met requirements |
| Temperature performance | Met requirements |
| Device height relative to stoma | Met requirements |
| Shelf-life testing | Met requirements |
| Biological Evaluation | Met requirements |
| IFU requirements (maintain integrity, legible) | Met requirements |
| Tube kink resistance | Met requirements |
| Foil seal strength | Met requirements |
| Spout neck seal | Met requirements |
| Bond strength | Met requirements |
| Leak test | Met requirements |
| Drop test | Met requirements |
| Ancillary device compatibility | Met requirements |
| Packaging seal strength | Met requirements |
| Removal of product from Packaging | Met requirements |
| Labelling requirements (maintain integrity, adhesion, legible) | Met requirements |
| UDI (legible) | Met requirements |
| Acceptance Criteria (Design Validation Tests) | Reported Device Performance |
|---|---|
| Removal of Product from Packaging | Met requirements |
| Ability to fill | Met requirements |
| Ability to feed | Met requirements |
| Ability to flush | Met requirements |
| Ability to use while mobile | Met requirements |
| Labelling requirements (easy to understand, language, legible) | Met requirements |
| IFU requirements (easy to understand, language) | Met requirements |
The document states: "The test results (K222678 – Volume 0007 Bench Testing) demonstrate that the Mobility+ Enteral Feeding System OTC, being identical to the predicate device, meets the requirements in the applicable standards."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable as this is a physical device and the primary evidence is bench testing, not data from a test set. The testing was done on the predicate device (K222678) and deemed identical, meaning the provenance would be tied to the predicate's testing. Specific sample sizes for each bench test are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a physical device is established by physical measurement, performance specifications, and safety standards, not expert consensus on interpretations as would be the case for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require 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
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical, non-electronic enteral feeding system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device is established by adherence to design specifications, functional requirements, and recognized standards (e.g., ISO 10993-1 for biocompatibility, ISO 80369-3 and ISO 18250-3 for ENFit connectors), as demonstrated through bench testing.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
§ 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.