(115 days)
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include an interesting point on a spike to connect to a pre-filled container.
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a use gravity of an interesting point on a spike to connect to a pre-filled container.
The provided document is a 510(K) summary for ZEVEX, Inc.'s Enteral Feeding Sets for Gravity and Pump Use. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study showing device performance against specific acceptance criteria.
The document discusses various modifications to the enteral feeding sets, including a new "Slip Loc" enteral adapter design, a modified cap, an Anti Free Flow Fitting for pump models, and smaller surface area bags for some models. The "study" mentioned isn't a complex clinical trial but rather a series of engineering tests to confirm the modifications do not reduce safety or effectiveness.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like a typical clinical study. However, it lists tests performed and a general conclusion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: USP Class VI for new materials and colorants approved by FDA for food grade applications. | New materials ('Slip Loc' enteral adapter and anti free flow fitting) are USP Class VI. Colorants are approved by FDA for food grade applications. Cytotoxicity test results indicated biocompatibility met requirements. |
| Volumetric Accuracy: (for pump sets, implied to be within acceptable limits for nutrient delivery) | Testing included a volumetric accuracy test. Results "indicated that the modifications have not reduced the safety or effectiveness of the product." (No specific quantitative results provided) |
| Blow-by Pressure: (for anti free flow fitting, implied to be sufficient to prevent flow) | Testing included a test to check the blow-by pressure of the anti free flow fitting. Results "indicated that the modifications have not reduced the safety or effectiveness of the product." (No specific quantitative results provided) |
| Bond Strength: (between components, implied to be sufficient for structural integrity) | Testing included a bond test to check the bond strength between components. Results "indicated that the modifications have not reduced the safety or effectiveness of the product." (No specific quantitative results provided) |
| Safety and Effectiveness: (Overall, modifications should not reduce these) | "The test results indicated that the modifications have not reduced the safety or effectiveness of the product or created new issues regarding safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The tests mentioned (volumetric accuracy, blow-by pressure, bond test, cytotoxicity) likely involved a representative number of samples of the modified components and complete sets, but the exact count is not provided.
- Data Provenance: Not specified, but given it's a 510(k) submission, the testing would have been conducted by the manufacturer (ZEVEX, Inc.) in a controlled environment. The data is prospective for the modified devices. There is no mention of country of origin for the data, but it can be assumed to be from the US, where ZEVEX is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in the context of this device and testing. The "ground truth" for these engineering tests is established through objective measurement against engineering specifications and regulatory standards (e.g., USP Class VI, FDA food-grade approval).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This type of testing does not involve expert adjudication in the way a clinical study with subjective assessments would. The results are based on objective measurements against predefined criteria or established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices where human interpretation is involved. The ZEVEX enteral feeding sets are medical devices concerned with physical performance and material safety, not diagnostic interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This document describes physical medical devices, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for this submission are objective engineering specifications, material standards (e.g., USP Class VI), and regulatory requirements (e.g., FDA approval for food-grade colorants). For example, a material either is USP Class VI or it isn't.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. There is no "training set" in the context of physical device testing as described. Machine learning models use training sets, not directly manufactured products undergoing physical performance tests.
9. How the Ground Truth for the Training Set Was Established
- Establishment of Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.
§ 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.