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 <788> 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 <87> (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 <88> (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 <88>	Non-toxic. (Implied to be same as predicate device, which also met these standards).
Material-Mediated Pyrogenicity	ISO 10993-11:2017 & USP <151> (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.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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K203359 510(k) Summary

BD™ Flu+ Syringe

SubmitterInformation	Submitter Name:	Becton, Dickinson and Company
	Submitter Address:	1 Becton DriveFranklin Lakes, NJ 07417
	Contact Person:	Nikita Abirami Mahendra KumarSenior Regulatory Affairs Specialist
	Email Address:	Nikita.Abirami.Mahendra.Kumar@bd.com
	Phone Number:	(201) 847-5641
	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 forSubmission	The basis of this submission is to modify the indications for useof the BD™ Flu+ Syringe.
Device Description	The BD Flu+ Syringe is a sterile two-piece single use, sterilesyringe with an integral needle. It allows for a variable dose upto 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 toreduce medication waste.
	The BD Flu+ Syringe is a 1.0mL maximum dosage with 0.5mLand 1.0mL barrel marking and 0.25mL incremental markings.The Flu+ syringe is assembled with a pre attached needle in thefollowing 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.
TechnologicalCharacteristics	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 ofComparison	Subject Device:BD™ Flu+ Syringe	Predicate DeviceBD™ Flu+ Syringe	Comparison
510(k) Number	K203359	K091377	N/A
Intended Use	Intended foraspiration andinjection of fluids	Intended foraspiration andinjection of theinfluenza vaccine	Different; Subjectdevice is intendedfor general use
Syringe Type	2 Piece (barrel andplunger)	2 Piece (barrel andplunger)	Same
Dose SavingFeature	Low DeadSpace/Volume	Low DeadSpace/Volume	Same
IntegratedNeedle	Yes	Yes	Same
DoseSetting/Volumes	Variable dose scalemarkings with1.0mL max delivery	Variable dose scalemarkings with1.0mL max delivery	Same
Needle Size(Gauge x Length)	23G x 1"25G x 1"25G x 5/8"	23G x 1"25G x 1"25G x 5/8"	Same
Barrel Material	Plastic	Plastic	Same
Plunger Material	Plastic+Colorant(Blue, Orange)	Plastic+Colorant(Blue, Orange)	Same
IntegratedCannula	Stainless Steel	Stainless Steel	Same
Shield	Plastic	Plastic	Same
Adhesive	Epoxy	Epoxy	Same
CannulaLubricant	Silicone	Silicone	Same
Sterilization	Ethylene Oxide (SAL10-6)	Ethylene Oxide (SAL10-6)	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
Biocompatibility Testing:
Testing per ISO 10993:2018
Cytotoxicity	ISO 10993-5 & USP <87>, Non-cytotoxic• LLNA: ISO 10993-10 & ASTM F2148	ISO 10993-5 & USP <87>, Non-cytotoxic• LLNA: ISO 10993-10 & ASTM F2148	Same
Sensitization	• Maximization: ISO 10993-11Non-sensitizer	• Maximization: ISO 10993-11Non-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

SterilizationMethod	Ethylene Oxide (ETO)
SterilizationResiduals	Maximum EO mg/device limit:4mg/deviceMaximum ECH mg/device Limit:9mg/deviceThe above limits are acceptable perISO 10993-7:2008
ValidationMethod	The sterilization process is validatedin accordance with Standard EN ISO11135-1."Sterilization of health careproducts-Ethylene oxide- Part 1:Requirements for development,validation and routine control of asterilization process for medicaldevices".The sterilized product meets the

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		requirements of EN 556 "Sterilizationof Medical Devices - Requirements forMedical Devices to be Labelled Sterile".
	Pyrogenicity/EndotoxinTesting	Test methods are per USP 40-NF 35monographs 85 (Bacterial EndotoxinsTest) and 161 (Medical DevicesBacterial Endotoxin and PyrogensTest).
	Packaging integrity testing, after environmental conditioning aresimulated transportation in accordance with ISO 11607-1:2010and 11135:2014, was conducted on the final packaged, andsterile device. All packaging deemed acceptable for protection ofproduct and sterility maintenance.
	Shelf Life of 5 years is validated using the FDA recognizedstandards ASTM F1980-16 Standard Guide for Accelerated Agingof Sterile Barrier Systems for Medical Devices.
	The subject device continue to meet all the predeterminedacceptance criteria for the above-listed performance tests,demonstrating substantial equivalence to the predicate device.
Clinical Testing		Clinical testing was not required for this submission
Summary ofSubstantialEquivalence		The BD™ Flu+ Syringe is substantially equivalent to thepredicate device in principles of operation, technology, design,

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).