(52 days)
The BD Flu+ Syringes are intended for the aspiration and injection of the influenza vaccine.
The BD Flu+ is a two-piece single use, sterile syringe with an integral needle. It allows for a variable dose up to 1 ml to be aspirated and injected. It is intended for generalpurpose aspiration and injection of fluids from a vial or ampoule. The BD Flu+ syringe has been designed for low dead space to reduce medication waste.
The BD Flu+ Syringe is a 1.0mL maximum dosage with 0.5mL and 1.0mL barrel marking and 0.25mL incremental markings. The Flu+ syringe is assembled with a pre attached needle in the following gauges and sizes
Needle Gauge: 23G (0.6mm) x 1 inch (25mm), 25G (0.5mm) x 5/8 inch (16mm), 25G (0.5mm) x 1inch (25mm)
Color Coding (ISO-6009) Plunger Rod Color: Blue, Orange, Orange
Plunger Rod is color coded to comply with the ISO 6009 for needle gauge sizes.
The provided document is a 510(k) summary for a medical device called the "BD Flu+ Syringe." This type of document is for regulatory submission and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results and acceptance criteria in the format typically seen for novel therapeutic or diagnostic devices.
Therefore, many of the requested elements (acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth methodology, expert qualifications, MRMC studies) are not applicable or not provided in this type of regulatory submission for a piston syringe.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in a structured table as would be expected for a diagnostic or therapeutic device. Instead, the criterion for device performance is "performed in an equivalent manner to the predicate device and is safe and effective when used as intended."
- Reported Device Performance:
- "Design Verification tests were performed based on the risk analysis performed, and the results of these tests demonstrate that the BD Flu + Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended."
- The modifications (removal of stainless steel clip, modification of barrel scale markings) did not negatively impact performance.
- The device maintains a Sterility Assurance Level (SAL) of 10^-6.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. Design verification tests generally involve testing a representative sample, but the size of this sample is not disclosed in the summary.
- Data Provenance: Not applicable. Design verification tests are typically conducted in a laboratory setting by the manufacturer, not on human patients, as this is a medical device for aspirations/injections, not a diagnostic or therapeutic agent itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. "Ground truth" as understood in the context of clinical studies (e.g., for diagnostic accuracy) does not apply to the regulatory approval of a syringe, which is a physical medical device. Performance is assessed through engineering and design verification tests (e.g., force to depress plunger, leakage, fluid aspiration/injection accuracy), not expert review of clinical data.
4. Adjudication Method for the Test Set
- Not applicable for a physical device like a syringe. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for ambiguous cases.
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 a syringe, not an AI-powered diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. There is no algorithm associated with this physical medical device.
7. The Type of Ground Truth Used
- Not applicable. For a syringe, performance is measured against engineering specifications, standards (e.g., ISO, national standards for syringes), and an established risk analysis. There isn't a "ground truth" in the clinical sense (e.g., pathology, outcomes data) for the device's functional performance.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a syringe.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).