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The BD Flu+ Syringe is a sterile 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 general-purpose 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: 23G (0.6mm) x 1 inch (25mm), 25G (0.5mm) x 5/8 inch (16mm.), 25G (0.5mm) x 1 inch (25mm).

AI/ML Overview

The device in question is the BD™ Flu+ Syringe. This submission is a 510(k) for an updated indication for use, stating it is "intended for aspiration and injection of fluids." The acceptance criteria and the studies that prove the device meets these criteria are outlined below:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Standard / Requirement)	Reported Device Performance
Bench Performance
Leakage	ISO 7886-1:2017 (Syringes for medical use - Part 1: Syringes for manual use)	Met acceptance criteria. (Implied to be same as predicate device, which also met ISO 7886-1)
Dose Accuracy	ISO 7886-1:2017	Met acceptance criteria. (Implied to be same as predicate device, which also met ISO 7886-1)
Dead Space	ISO 7886-1:2017	Met acceptance criteria. (Implied to be same as predicate device, which also met ISO 7886-1)
Activation Forces	ISO 7886-1:2017	Met acceptance criteria. (Implied to be same as predicate device, which also met ISO 7886-1)
Cannula Pull Force	ISO 7864:2016 (Sterile hypodermic needles for single use)	Met acceptance criteria. (Implied to be same as predicate device, which also met ISO 7864)
Shield Pull Force	BD Internal Requirement	Met acceptance criteria. (Implied to be same as predicate device, which also met BD Internal Requirement)
Scale Mark Permanency	BD Internal Requirement	Met acceptance criteria. (Implied to be same as predicate device, which also met BD Internal Requirement)
Package Integrity	ISO 11607-1:2010 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)	Met acceptance criteria during testing after environmental conditioning and simulated transportation.
Particulate Matter	USP Particulate Matter in Injections	Met USP acceptance criteria.
Biocompatibility
Cytotoxicity	ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) & USP (Biological Reactivity Tests, In Vitro)	Non-cytotoxic. (Implied to be same as predicate device, which also met these standards).
Sensitization	ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) & ASTM F2148 (Method for Assessment of Local Lymph Node Assay for Allergic Reaction) / Maximization: ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)	Non-sensitizer. (Implied to be same as predicate device, which also met these standards).
Intracutaneous Reactivity/Irritation	ISO 10993-10 & USP (Biological Reactivity Tests, In Vivo - Intracutaneous Reactivity)	Non-irritant. (Implied to be same as predicate device, which also met these standards).
Primary Dermal Irritation	ISO 10993-10	Met acceptance criteria. (Implied to be same as predicate device, which also met this standard).
Acute Systemic Toxicity	ISO 10993-11 & USP	Non-toxic. (Implied to be same as predicate device, which also met these standards).
Material-Mediated Pyrogenicity	ISO 10993-11:2017 & USP (Pyrogen Test)	Non-pyrogenic. (Implied to be same as predicate device, which also met these standards).
Extractables/Leachables	ISO 10993-18:2005 (Biological evaluation of medical devices - Part 18: Chemical characterization of materials)	Acceptable. (Implied to be same as predicate device, which also met this standard).
Hemolysis	ISO 10993-4 (Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood)	Non-hemolytic. (Implied to be same as predicate device, which also met this standard).
Sterility
Sterilization Method	Ethylene Oxide (ETO) Sterilization per Standard EN ISO 11135-1 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices). Product meets EN 556 (Sterilization of Medical Devices - Requirements for Medical Devices to be Labelled Sterile) requirements.	Validation conducted in accordance with EN ISO 11135-1. The sterilized product meets EN 556.
Sterilization Residuals	Maximum EO mg/device limit: 4mg/device. Maximum ECH mg/device Limit: 9mg/device. Acceptable per ISO 10993-7:2008 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals).	Residuals are within acceptable limits per ISO 10993-7:2008.
Pyrogenicity / Endotoxin Testing	USP 40-NF 35 monographs 85 (Bacterial Endotoxins Test) and 161 (Medical Devices Bacterial Endotoxin and Pyrogen Test)	Test methods per USP 40-NF 35 monographs 85 and 161 were conducted, implying results met acceptance criteria.
Shelf-Life	ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices for a 5-year shelf life.	5-year shelf life validated using ASTM F1980-16. Device continues to meet all predetermined acceptance criteria for performance tests over this period.

Study Details:

The primary study type reported is bench testing and biocompatibility testing. The submission emphasizes that modifications of the subject device's intended use does not affect the results of this analysis, suggesting that the underlying performance characteristics tested are largely identical to the predicate device.

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size: The document does not explicitly state the specific sample sizes used for each individual bench or biocompatibility test. However, it indicates these tests were performed by BD on the BD™ Flu+ Syringe.
Data Provenance: The data is generated from bench testing and biocompatibility testing conducted by the manufacturer, Becton, Dickinson and Company (BD). It does not involve patient data. The context implies these tests were performed internally by BD, likely in the US, given the submission to the FDA. The nature of these tests (bench and biocompatibility) means they are prospective in the sense that they are conducted specifically for this device and submission.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: This information is not applicable. The device's performance is evaluated against recognized international standards (ISO, ASTM) and USP monographs, as well as internal BD requirements, not against expert consensus on a test set.
Qualifications of Experts: Not applicable for establishing ground truth in this context. The "ground truth" is defined by the objective performance criteria outlined in the referenced standards and internal requirements.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The tests performed are objective, measurable performance characteristics evaluated against predetermined pass/fail criteria from established standards. There is no subjective interpretation requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, where the AI assists human readers. The BD™ Flu+ Syringe is a physical medical device (syringe) and does not involve human readers in its operational use that could be augmented by AI.

6. Standalone Performance Study (Algorithm Only)

Standalone Performance: Not applicable. This device is a physical product and does not incorporate an algorithm or AI component. Therefore, no standalone algorithm-only performance study was conducted.

7. Type of Ground Truth Used

Ground Truth Type:
- Objective Performance Standards: The ground truth for the device's performance is established by objective, quantitative performance standards defined by international organizations (ISO, ASTM) and national pharmacopeias (USP), as well as internal engineering specifications (BD Internal Requirement). Examples include specific limits for leakage, dose accuracy, particulate matter concentration, and biological responses in biocompatibility tests.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not use machine learning or AI, and therefore no "training set" is required or used in its development or validation.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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