(84 days)
The GUARDIAN CONNECTION™ is designed to be used with standard adult tapered feeding tube connectors to secure the connection.
The Guardian Connection is a non-sterile, reusable, plastic "Ushaped" clip designed to hold the connectors of an enteric feeding tube and an enteric feeding set together to help prevent inadvertent disconnection. The product is specifically designed to accommodate the non-IV tapered male conical stepped connectors and mating non-IV tapered female connectors commonly found on standard adult enteric feeding tubes and sets. The Guardian Connection clips around the outside of these connectors, and helps to prevent them from being pulled apart by tensile force.
The provided FDA 510(k) summary for the Guardian Connection™ device focuses on its substantial equivalence to a predicate device based on technological characteristics and bench testing. It does not contain information about acceptance criteria and a study in the context of diagnostic performance metrics like sensitivity, specificity, or AUC, as it is a physical medical device (a clip for feeding tubes), not a diagnostic algorithm.
Therefore, many of the requested categories are not applicable to this particular device submission.
Here's a breakdown of the relevant information from the document in relation to your request, and where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implicit from testing description):
- The device should secure the connection between an enteric feeding tube and a nutrient delivery set.
- The device should "break away" at a tensile force of approximately two pounds.
Reported Device Performance:
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Connection Security | Device should secure the connection between an enteric feeding tube and a nutrient delivery set, preventing inadvertent disconnection due to low-level forces. | "helps to prevent them [connectors] from being pulled apart by tensile force." |
| Breakaway Force | The device should break away at a tensile force of approximately two pounds. | "The Guardian Connection will break away at a tensile force of approximately two pounds." |
Regarding the study proving the device meets the acceptance criteria:
The document states: "Bench testing was performed on the Guardian Connector to show that the device performs as intended. No clinical testing was performed on this device."
The following questions are not applicable to this 510(k) submission as it is for a physical medical device (a clip) and not an AI/diagnostic algorithm:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.