(301 days)
The Enteral Feeding Sets are intended to dispense liguid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the passess feeding tube and may asse gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a hag to contain the feeding solution and/or spike to a pre-filled container.
The Generica Medical International's line of Enteral Feeding Sets consists of the following:
- Generica Medical Enteral Delivery Pump Bag Set, 1.
- Generica Medical Enteral Delivery Pump Spike Set, 2.
- ે. Generica Medical Enteral Delivery Gravity Bag Set
The Generica Medical Enteral Delivery Pump Spike Set with the Cross Spike Connector is compatible with SpikeRight® and SpikeRight® enteral feeding systems.
The Generica Medical Enteral Delivery Pump Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easv and helps prevent spills and waste. The 1000 mL formula vinvi bag has 50 mL graduations to make it easier for reading and better accuracy when filling.
The Generica Medical Enteral Delivery Gravity Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easy and helps prevent spills and waste. Bag graduations are in 50 mL increments for easier readings and allow for better accuracy when filling
Here's a breakdown of the requested information based on the provided document:
This document describes a 510(k) submission for Enteral Feeding Sets, which are devices intended to dispense liquid nutrients. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than undergoing extensive clinical trials for de novo approval. Therefore, the "study" proving the device meets acceptance criteria is primarily non-clinical performance testing to demonstrate equivalence to the predicate, not a clinical study involving human patients or complex AI model evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating substantial equivalence to the predicate device (Dynarex Enteral Feeding Sets) through similar technological characteristics and comparable performance in specific tests.
| Parameter Description | Predicate Device Acceptance Criteria | Subject Device (Generica Medical Enteral Feeding Set) Reported Performance | Comparison Result |
|---|---|---|---|
| Description | Similar to Dynarex Enteral Delivery Pump Spike Set & Gravity Bag Set | Generica Medical Enteral Delivery Pump Bag Set, Pump Spike Set, and Gravity Bag Set descriptions provided. | Similar and Slightly Different (due to bag volume, but overall function similar) |
| Port: Bag Volume | 1200 mL | 1000 mL | Substantially Equivalent (SE) - While different, implies it's acceptable for similar use. |
| Port: Spike | Spike Right | Spike Right | Same |
| Port: Drip Chamber | Clear | Clear | Same |
| Port: Distal Tip Connector | 4 Step Adapter | 4 Step Adapter | Same |
| Style: Pump Bag Set | Yes | Yes | Same |
| Style: Spike Set | Yes | Yes | Same |
| Style: Gravity Bag Set | Yes | Yes | Same |
| Flow Rate Variance |
§ 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.