(171 days)
The Kangaroo® Enteral Feeding Extension Set for Syringe Pumps is intended for enteral feeding, on the order of a physician, to provide a means of delivering feeding formula from a filled syringe through to any feeding tube which will accept its non-I.V. compatible connector.
The Kangaroo® Enteral Extension Set for Syringe Pumps is an Enteral Feeding Administration Set composed of a PVC material and is a class II device per 21 CFR Section 876.5980. Procode: 80FRN. The Kangaroo® Enteral Extension Set for Syringe Pumps has a non-IV compatible distal connector which when connected to a syringe allows enteral formula to be administered through an enteral feeding tube. The Kangaroo® Enteral Extension Set for Syringe Pumps is indicated for single use enteral feedings.
The provided document is a 510(k) Summary for a medical device (Kangaroo® Enteral Extension Set for Syringe Pumps). This type of document is for regulatory submission to demonstrate substantial equivalence to a predicate device, not typically a research study proving efficacy or diagnostic accuracy. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Biological Reactivity, In-Vitro, (USP XXIII ): Deemed acceptable. |
| Dermal Sensitization (ISO 10993-10.2 (draft)): Deemed acceptable. | |
| Primary Mucosal Irritation (FDA Good Laboratory Practice guidelines, 19, revision 5; GCPT-19.(5)): Deemed acceptable. | |
| Substantial Equivalence | The device is considered substantially equivalent to a family of predicate devices (Kangaroo® Enteral Extension Set for Pumps K914375, Entri-Flex® Feeding Tubes K833621, Dobbhoff ® Feeding Tubes K833188, Entri-Flex® Feeding Tubes w/flexible weight K801558, and Pediatric Feeding Tubes K822875) based on: |
| - Both proposed and predicate extensions sets are used for administering enteral feedings. | |
| - Both are made of PVC material. | |
| - Both are EtO sterilized. | |
| - Both have a non-IV compatible connector. | |
| Device Material | PVC material |
| Sterilization Method | EtO sterilized |
| Distal Connector Compatibility | Non-IV compatible distal connector |
| Packaging | Tyvek/polyethylene tray (differs from predicate's low-density polyethylene bag) |
| Length | Varies in length from the predicate device |
2. Sample size used for the test set and the data provenance
This document does not describe a "test set" in the context of an algorithm or diagnostic study. The tests performed are for biocompatibility. The sample sizes for these biological reactivity tests are not specified in the summary. The provenance is internal testing performed by the manufacturer, Sherwood-Davis & Geck.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth. The "ground truth" for the biocompatibility tests would be established through standardized laboratory procedures and measurements.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
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 is a medical device (enteral extension set), not an AI-driven diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility tests, the ground truth is based on the established standards and methodologies outlined in the referenced guidelines (USP XXIII , ISO 10993-10.2 (draft), FDA Good Laboratory Practice guidelines). "Acceptable" is determined by meeting the specified criteria within these standards.
8. The sample size for the training set
Not applicable. This is a medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an algorithm.
§ 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.