(36 days)
The BD Oral/Enteral Syringe with BD UniVia Connection are intended to be used by healthcare professionals to measure and administer oral medication and enteral nutrition.
The BD Oral/Enteral Syringe with BD UniVia Connection is a standard piston, syringe which incorporates a safety connector that is incompatible with luer (6%) connectors and intravenous devices. The BD Oral/Enteral Syringe with BD UniVia Connection is designed to mate with a range of enteral feeding extension sets. The 3-piece design syringe consists of a polypropylene barrel and plunger rod and a synthetic rubber stopper. In addition, the plunger rod of the BD Oral/Enteral Syringe with BD UniVia Connection incorporates an orange colorant to further distinguish the device from a standard piston, syringe. The performance of the BD Oral/Enteral Syringe with BD UniVia Connection is equivalent to the predicate device.
The provided text describes a 510(k) premarket notification for a medical device, the "BD Oral/Enteral Syringe with BD UniVia Connection." This submission focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML driven device, therefore many of the typical acceptance criteria and study design elements for AI/ML devices are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item # | Performance Specification (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| 1 | Tip Cap Leakage | Equivalent performance to predicates |
| 2 | Connection w/ Mating Devices | Equivalent performance to predicates |
| 3 | Luer Incompatibility | Equivalent performance to predicates |
| N/A | Operating principle | Same as predicate device |
| N/A | Barrel, plunger rod, stopper materials | Same as Becton, Dickinson Single Use Hypodermic Syringe predicate device |
| N/A | Barrel, plunger rod, stopper design | Same as Becton, Dickinson Single Use Hypodermic Syringe predicate device (with exception of safety connector) |
| N/A | Non-luer connector | Similar to Children's Medical Ventures Oral/Enteral Syringe, with same design intent |
| N/A | ISO 7886-1 and ISO 7886-2 compliance | Meets requirements (with exception of safety connector feature) |
| N/A | ISO 10993 compliance | Meets requirements as applicable |
| N/A | Sterilization assurance level (SAL) | Same as predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Design Verification tests were performed." However, it does not provide any specific sample sizes for these tests for each performance element. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) as this is a physical medical device and not an AI/ML model being trained on data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device submission. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on training or test data. For a physical device, performance is evaluated against engineering specifications and predicate device performance, not expert-established "ground truth" on data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human readers or labelers for AI/ML model ground truth establishment. For a physical device, performance is measured objectively against predefined engineering and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable. MRMC studies are typically done for AI/ML-assisted diagnostic devices to assess the impact of AI on human reader performance. This device is a physical syringe, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human interaction. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications, risk analysis, product requirements, and comparison to the performance of predicate devices. It is not expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML. The "equivalence" claimed is based on physical and functional properties, as well as adherence to relevant ISO standards.
8. The Sample Size for the Training Set
This information is not applicable. This device is not an AI/ML model, and therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
Summary of the Study:
The study described is a Design Verification Test for a physical medical device (BD Oral/Enteral Syringe with BD UniVia Connection). The primary goal of the study was to demonstrate substantial equivalence to existing predicate devices (Children's Medical Ventures Oral/Enteral Syringe, Becton, Dickinson Single Use, Hypodermic Syringe, and BD Oral Syringe).
The study involved testing various performance elements of the new syringe, including:
- Tip Cap Leakage
- Connection with Mating Devices
- Luer Incompatibility
The "acceptance criteria" were that the device's performance for these elements would be equivalent to the predicate devices. The results reported confirm that the BD Oral/Enteral Syringe with BD UniVia connection "performed in an equivalent manner to the predicate devices." Additionally, the device demonstrated compliance with various ISO standards (ISO 7886-1, ISO 7886-2, ISO 10993) and maintained the same materials, design principles, and sterilization levels as its predicates.
This type of submission largely relies on proving that the new device does not introduce new questions of safety or effectiveness compared to legally marketed devices, which is typical for 510(k) clearances of non-software or non-AI medical devices.
§ 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.