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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

510(K) Summary of Safety and Effectiveness

JUL = 2 2009

1. Submitted By:

Eileen Hiller Manager, Regulatory Affairs BD Medical Surgical 1 Becton Drive Franklin Lakes, NJ 07417 Tel: 201 847 4570 201 847 5307 Fax:

Device Name: 2.

Trade Name: BD Flu+ Syringe

Common Name: Piston Syringe

Classification Name: Syringe, Piston

Predicate Device: 3.

Trade Name:	BD SoloShot IX Syringe
Manufacturer:	Becton, Dickinson and Company
510(k) Number:	K042934

4. Device Description:

Needle Gauge	Color Coding (ISO-6009) Plunger Rod Color
23G (0.6mm) x 1 inch (25mm)	Blue
25G (0.5mm) x 5/8 inch (16mm)	Orange
25G (0.5mm) x 1inch (25mm)	Orange

Plunger Rod is color coded to comply with the ISO 6009 for needle gauge sizes.

{1}------------------------------------------------

న్. Intended Use:

The BD Flu+ Syringe is intended for the aspiration of the influenza vaccine.

6. Technological Characteristics:

The Modified Device, the subject of this 510(k), The BD Flu+ Syringe was modified by removing the stainless steel clip and modifying the barrel scale markings (variable dose). The Modified Device is manufactured of the same materials, has the same intended use and SAL of 106 as the Predicate Device.

6. 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 Modified Device is manufactured of identical materials and has the same intended use as the Predicate Devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2009

Ms. Eileen Hiller Manager of Regulatory Affairs Becton Dickinson and Company BD Medical Surgical 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K091377

Trade/Device Name: BD Flu + Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 26, 2009 Received: June 30, 2009

Dear Ms. Hiller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

{3}------------------------------------------------

Page 2 - Ms. Hiller

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Antrony V. amster for
B.B.B.M.

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): KOQL377

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Device Name: BD Flu+ Syringe

Indications for Use:

The BD Flu+ Syringes are intended for the aspiration and injection of the influenza vaccine. 、

Prescription Use(Part 21 CFR 801 Subpart D)	X
AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

Page 1 of 1	(Division Sign-Off)
	Division of Anesthesiology, General Hospital
	Infection Control, Dental Devices

510(k) Number:	K091377
----------------	---------

Regulation Number and Section

§ 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).