(102 days)
The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food contacting.
Dynarex is substantially equivalent in safety and effectiveness to the Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use in that both products have the same principles of operation, form and function and meet the same safety requirements under Class VI testing and functional Luer taper testing as required by the referenced standard.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic and Parameters | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device) |
|---|---|---|
| Product Code | KNT | KNT |
| Intended Use | "The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or spike to connect to a per-filled container." | Same |
| Luer Adapter | Slip Loc design, PVC USP Class VI Material | Standard Adapter USP Class VI Material |
| Luer Cap | Designed to fit Slip Loc, PE | Standard design fit Same Material (PE) |
| Feed Tubing (All) | PVC, USP Class VI Material | Same (PVC, USP Class VI Material) |
| Pump Tubing (Pump and Spike Set) | Silicone, USP Class VI Material | Same (Silicone, USP Class VI Material) |
| Bag Assembly (Gravity & Pump Set) | 500 ml, PVC, USP Class VI Material | 1000ml, PVC |
| Bag Assembly (Gravity & Pump Set) | 1200 ml, PVC, USP Class VI Material | 1000ml, PVC |
| Clamp (All) | ABS | Same (ABS) |
| Materials in Fluid Pathway (All) | USP Class VI Material | Same (USP Class VI Material) |
| Spike Adapter (Spike Set Only) | ABS, USP Class VI Material | Same (ABS, USP Class VI Material) |
| Spike Adapter Cap (Spike Set Only) | PE | Same (PE) |
| Performance Tests | ||
| Intracutaneous Reactivity Test | Class VI USP (Pass) | Passes |
| Systemic Injection Test | Class VI USP (Pass) | Passes |
| Muscle Implantation Test | Class VI USP (Pass) | Passes |
| Luer Taper Inspection | AAMI/ANSI ID54.1996/(R)2005 Sect. 4.1 & 4.2 (Pass) | Passes |
| Erythema and Edema Scores | Meets requirements | Meets requirements |
| Physical Specifications and Dimensions | Meets requirements | Meets requirements |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a separate "test set" in the sense of a clinical or image-based dataset. The testing described focuses on material properties and physical conformance.
- Sample Size for testing: Not explicitly stated for each test (e.g., number of devices tested for Luer taper inspection). However, it implies testing was conducted on samples of the Dynarex Enteral Feeding Sets.
- Data Provenance: The testing was conducted by Dynarex Corporation to demonstrate substantial equivalence to the predicate device. The document does not specify a country of origin for the data beyond Dynarex being a US-based company, and the nature of the tests suggests laboratory or bench testing rather than patient data. It is therefore prospective with respect to the device's design and testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a medical device clearance based on substantial equivalence to a predicate device, primarily through material and functional characteristic comparison, and safety testing (biocompatibility, physical standards). It does not involve expert interpretation of medical images or patient outcomes in the way an AI/ML device would.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
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/ML device, nor does it involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on established industry standards and validated test methods for material biocompatibility (Class VI USP) and physical performance (AAMI/ANSI ID54.1996/(R)2005). The comparison is also made against the specifications and performance of the legally marketed predicate device (Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use K012147), which serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.