(52 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and equivalence to a predicate syringe, with no mention of AI or ML capabilities.
No
The device is a syringe intended for aspiration and injection of the influenza vaccine, which is a delivery mechanism for a therapeutic agent, not a therapeutic device itself.
No
The device is described as a syringe intended for the aspiration and injection of the influenza vaccine and other fluids, not for diagnosing medical conditions.
No
The device description clearly describes a physical syringe with an integral needle, which is a hardware medical device. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "aspiration and injection of the influenza vaccine" and "general-purpose aspiration and injection of fluids from a vial or ampoule." This describes a device used to administer substances into the body, not to test samples from the body to diagnose a condition.
- Device Description: The description details a syringe and needle, which are tools for injection and aspiration, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: The document does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
The BD Flu+ Syringes are intended for the aspiration and injection of the influenza vaccine.
Product codes
FMF
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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:
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 | 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 |
|---|---|
| ---------------- | --------- |