(181 days)
To deliver liquid nutrition formula from storage container to an enteral access device (feeding tube)
Acta Enteral Sets are constructed from flexible, medical grade, Non-DEHP tubing and have various different connectors at each end of the tubing. One configuration may include an Enteral solution container constructed from same PVC material as the tubing with a Christmas tree connector to connect to a gastric tube (or an extension set) or another configuration may simply be an extension set which connects to patient gastric tube to the nutrition liquid delivery system. The following three configurations are most common, however, other configurations may be manufactured based on customer demand. (Further details, photos, drawings provided in Device Description, Section XI)
- A complete solution delivery system: This consists of, a solution container, integrated delivery set and a Christmas tree connector to connect to the gastric tube or to an extension set
- Enteral Administration Set: This consists of a delivery set with a spike to connect to a nutrition solution storage container and a Christmas tree connector to connect to gastric tube or an extension set
- Enteral Extension Set: This consists of flexible PVC tubing set with proximal connector which can accept a standard Christmas tree connector and a distal connector designed to fit a custom gastric tube
The provided text describes a medical device submission (K112863) for an "Enteral Set." This document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance results in the way a clinical trial or algorithm performance study would.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The document primarily details the device's design, intended use, and material testing to demonstrate equivalence.
Here's a breakdown of the information that can be extracted, and where the information is not present:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Meets all the requirements for biocompatibility (ISO 10993-1) |
| Performance | Meets applicable performance criteria (ISO 8536-4) for leak test and tensile strength. |
| DEHP Content | Tested for DEHP content. (Result not quantitatively specified, but implied to meet requirements for "Non-DEHP tubing" as stated in Device Description) |
| Extractables | Tested for extractables. (Result not quantitatively specified, but implied to meet requirements) |
| Leachables | Tested for leachables. (Result not quantitatively specified, but implied to meet requirements) |
| Physico-chemical | Tested for physico-chemical properties for plastics. (Result not quantitatively specified, but implied to meet requirements) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to general testing of construction materials and manufactured sets, not a specific clinical or performance test set size.
- Data Provenance: Not specified for the performance tests. The manufacturing location is listed as Yangzhou City, Jiangsu Province, China.
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. This document does not describe a study involving expert-established ground truth for a diagnostic or AI-based device. It concerns a physical medical device (enteral set).
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. This is not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance appears to be based on compliance with established international standards for medical devices and materials:
- ISO 10993-1 for biocompatibility.
- ISO 8536-4 for specific performance criteria (leak test, tensile strength).
- Chemical testing for DEHP, extractables, leachables, and physico-chemical properties.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
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.