BD Flu+ Syringe

K203359 · Becton, Dickinson and Company · FMF · Jul 28, 2021 · General Hospital

Device Facts

• Record ID: K203359
• Device Name: BD Flu+ Syringe
• Applicant: Becton, Dickinson and Company
• Product Code: FMF · General Hospital
• Decision Date: Jul 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD™ Flu+ Syringe is intended for aspiration and injection of fluids.

Device Story

BD Flu+ Syringe is a sterile, two-piece, single-use piston syringe with an integrated needle; designed for variable dose delivery up to 1 mL. Features low dead space to minimize medication waste. Used in clinical settings for general-purpose aspiration and injection of fluids from vials or ampoules. Operated by healthcare professionals. Device provides visual dose markings (0.5 mL, 1.0 mL, and 0.25 mL increments) to assist clinicians in accurate dosing. Benefits include reduced medication waste and simplified fluid delivery.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench performance testing (leakage, dose accuracy, dead space, activation forces, cannula/shield pull force, scale mark permanency) and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility) per ISO 10993 and USP standards.

Technological Characteristics

Two-piece piston syringe (plastic barrel/plunger) with integrated stainless steel needle. Low dead space design. Sterilized via Ethylene Oxide (SAL 10^-6). Materials: plastic barrel, plastic/colorant plunger, stainless steel cannula, silicone lubricant, epoxy adhesive. Dimensions: 1.0 mL max capacity. Standards: ISO 7886-1 (performance), ISO 7864 (cannula), ISO 10993 (biocompatibility), ASTM F1980-16 (shelf life).

Indications for Use

Indicated for aspiration and injection of fluids in patients requiring medication delivery via syringe.

Regulatory Classification

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.

Predicate Devices

• BD™ FLU+ Syringe (K091377)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text.

July 28, 2021 Becton, Dickinson and Company Nikita Kumar Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

### Re: K203359

Trade/Device Name: BD Flu+ Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: June 26, 2021 Received: June 30, 2021

### Dear Nikita Kumar:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 Federal Register.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K203359

Device Name BD™ Flu+ Syringe

| Indications for Use (Describe) |
|---------------------------------------------------------------------------------------|
| The BD ^TM Flu+ Syringe is intended for aspiration and injection of fluids. |

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular symbol on the left and the letters "BD" on the right. The circular symbol is orange and features a stylized image of a person with outstretched arms inside of a circle. The letters "BD" are in blue and are written in a bold, sans-serif font.

## K203359 510(k) Summary

# BD™ Flu+ Syringe

| Submitter<br>Information | Submitter Name: | Becton, Dickinson and Company |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | Submitter Address: | 1 Becton Drive<br>Franklin Lakes, NJ 07417 |
| | Contact Person: | Nikita Abirami Mahendra Kumar<br>Senior Regulatory Affairs Specialist |
| | Email Address: | [e-mail] |
| | Phone Number: | [phone] |
| | Date of Preparation: | July 28, 2021 |
| Subject Device | Trade Name: | BD™ Flu+ Syringe |
| | Common Name: | Piston Syringe |
| | Regulation Number: | 21 CFG 880.5860 |
| | Regulation Name: | Piston Syringe |
| | Regulatory Class: | Class II device |
| | Product Code: | FMF |
| | Classification Panel: | General Hospital |
| Predicate Device | Trade Name: | BD™ FLU+ Syringe |
| | 510(k) Reference: | K091377 |
| | Common Name: | Piston Syringe |
| | Regulation Number: | 21 CFR 880.580 |
| | Regulation Name: | Piston Syringe |
| | Regulatory Class: | Class II Device |
| | Product Code: | FMF |
| | Classification Panel: | General Hospital |
| Reason for<br>Submission | The basis of this submission is to modify the indications for use<br>of the BD™ Flu+ Syringe. | |
| Device Description | The BD Flu+ Syringe is a sterile two-piece single use, sterile<br>syringe with an integral needle. It allows for a variable dose up<br>to 1 ml to be aspirated and injected. It is intended for general-<br>purpose aspiration and injection of fluids from a vial or ampoule.<br>The BD Flu+ syringe has been designed for low dead space to<br>reduce medication waste. | |
| | The BD Flu+ Syringe is a 1.0mL maximum dosage with 0.5mL<br>and 1.0mL barrel marking and 0.25mL incremental markings.<br>The Flu+ syringe is assembled with a pre attached needle in the<br>following gauges and sizes: | |
| | 23G (0.6mm) x 1 inch (25mm) | |
| | 25G (0.5mm) x 5/8 inch (16mm.) | |
| Indications for Use | The BD™ Flu+ Syringe is intended for aspiration and injection of fluids. | |
| Technological<br>Characteristics | The subject devices are equivalent to the predicate devices in intended use, materials and performance characteristics. | |

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# 25G (0.5mm) x 1 inch (25mm)

| Element of<br>Comparison | Subject Device:<br>BD™ Flu+ Syringe | Predicate Device<br>BD™ Flu+ Syringe | Comparison |
|----------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------|
| 510(k) Number | K203359 | K091377 | N/A |
| Intended Use | Intended for<br>aspiration and<br>injection of fluids | Intended for<br>aspiration and<br>injection of the<br>influenza vaccine | Different; Subject<br>device is intended<br>for general use |
| Syringe Type | 2 Piece (barrel and<br>plunger) | 2 Piece (barrel and<br>plunger) | Same |
| Dose Saving<br>Feature | Low Dead<br>Space/Volume | Low Dead<br>Space/Volume | Same |
| Integrated<br>Needle | Yes | Yes | Same |
| Dose<br>Setting/Volumes | Variable dose scale<br>markings with<br>1.0mL max delivery | Variable dose scale<br>markings with<br>1.0mL max delivery | Same |
| Needle Size<br>(Gauge x Length) | 23G x 1"<br>25G x 1"<br>25G x 5/8" | 23G x 1"<br>25G x 1"<br>25G x 5/8" | Same |
| Barrel Material | Plastic | Plastic | Same |
| Plunger Material | Plastic+Colorant<br>(Blue, Orange) | Plastic+Colorant<br>(Blue, Orange) | Same |
| Integrated<br>Cannula | Stainless Steel | Stainless Steel | Same |
| Shield | Plastic | Plastic | Same |
| Adhesive | Epoxy | Epoxy | Same |
| Cannula<br>Lubricant | Silicone | Silicone | Same |
| Sterilization | Ethylene Oxide (SAL<br>10-6) | Ethylene Oxide (SAL<br>10-6) | Same |
| Shelf Life | 5 years | 5 years | Same |
| Functional Testing: | | | |
| Leakage | ISO 7886-1 | ISO 7886-1 | Same |
| Dose Accuracy | ISO 7886-1 | ISO 7886-1 | Same |
| Dead Space | ISO 7886-1 | ISO 7886-1 | Same |
| Activation Forces | ISO 7886-1 | ISO 7886-1 | Same |
| Cannula Pull Force | ISO 7864 | ISO 7864 | Same |
| Shield Pull Force | BD Internal Requirement | BD Internal Requirement | Same |
| Scale Mark Permanency | BD Internal Requirement | BD Internal Requirement | Same |
| <b>Biocompatibility Testing:</b> | | | |
| Testing per ISO 10993:2018 | | | |
| Cytotoxicity | ISO 10993-5 & USP <87>, Non-cytotoxic<br>• LLNA: ISO 10993-10 & ASTM F2148 | ISO 10993-5 & USP <87>, Non-cytotoxic<br>• LLNA: ISO 10993-10 & ASTM F2148 | Same |
| Sensitization | • Maximization: ISO 10993-11<br>Non-sensitizer | • Maximization: ISO 10993-11<br>Non-sensitizer | Same |
| Intracutaneous Reactivity | Per ISO 10993-10 & USP<88>, Non-irritant | Per ISO 10993-10 & USP<88>, Non-irritant | Same |
| Primary Dermal Irritation | ISO 10993-10 | ISO 10993-10 | Same |
| Acute Systemic Toxicity | ISO 10993-11 & USP<88>, Non-toxic | ISO 10993-11 & USP<88>, Non-toxic | Same |
| Pyrogenicity | Per ISO 10993-11:2017 & USP<151>, Non-pyrogenic | Per ISO 10993-11:2017 & USP<151>, Non-pyrogenic | Same |
| Extractables/Leachables | Per ISO 10993-18:2005, Acceptable | Per ISO 10993-18:2005, Acceptable | Same |
| Hemolysis | Per ISO 10993-4, Non-hemolytic | Per ISO 10993-4, Non-hemolytic | Same |

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Performance Tests

BD has performed the following bench and biocompatibility testing on BD™ Flu+ Syringe. Modifications of the subject device's intended use does not affect the results of this analysis.

Bench Performance:

- Leakage (ISO 7886-1:2017) .
- Dose Accuracy (ISO 7886-1:2017) .

Confidential & Proprietary Page 3 of 5

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- Dead Space (ISO 7886-1:2017) ●
- Activation Forces (ISO 7886-1:2017)
- Cannula Pull Force (ISO 7864:2016) ●
- Shield Pull Force (BD Internal Requirement)
- Scale Mark Permanency (BD Internal Requirement) ●
- Package Integrity (ISO 11607-1:2010). ●

Material Biocompatibility Performance:

In accordance with ISO 10993-1, the Flu+ Syringe is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (<24 hours). The following testing was conducted:

- Cytotoxicity ●
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- . Hemocompatibility

Particulate matter testing was conducted in accordance with USP<788> Particulate Matter in Injections and met the USP acceptance criteria.

## Sterility, Shipping and Shelf-Life

| Sterilization<br>Method | Ethylene Oxide (ETO) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization<br>Residuals | Maximum EO mg/device limit:<br>4mg/device<br>Maximum ECH mg/device Limit:<br>9mg/device<br>The above limits are acceptable per<br>ISO 10993-7:2008 |
| Validation<br>Method | The sterilization process is validated<br>in accordance with Standard EN ISO<br>11135-1."Sterilization of health care<br>products-Ethylene oxide- Part 1:<br>Requirements for development,<br>validation and routine control of a<br>sterilization process for medical<br>devices".<br>The sterilized product meets the |

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| | | requirements of EN 556 "Sterilization<br>of Medical Devices - Requirements for<br>Medical Devices to be Labelled Sterile<br>". |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Pyrogenicity<br>/Endotoxin<br>Testing | Test methods are per USP 40-NF 35<br>monographs 85 (Bacterial Endotoxins<br>Test) and 161 (Medical Devices<br>Bacterial Endotoxin and Pyrogens<br>Test). |
| | Packaging integrity testing, after environmental conditioning are<br>simulated transportation in accordance with ISO 11607-1:2010<br>and 11135:2014, was conducted on the final packaged, and<br>sterile device. All packaging deemed acceptable for protection of<br>product and sterility maintenance. | |
| | Shelf Life of 5 years is validated using the FDA recognized<br>standards ASTM F1980-16 Standard Guide for Accelerated Aging<br>of Sterile Barrier Systems for Medical Devices. | |
| | The subject device continue to meet all the predetermined<br>acceptance criteria for the above-listed performance tests,<br>demonstrating substantial equivalence to the predicate device. | |
| Clinical Testing | | Clinical testing was not required for this submission |
| Summary of<br>Substantial<br>Equivalence | | The BD™ Flu+ Syringe is substantially equivalent to the<br>predicate device in principles of operation, technology, design, |