The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector in 1ml Luer Slip. 3ml. 10ml and 20ml Luer Lok syringe sizes. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated plastic barrel with a graduated scale, a lubricated synthetic rubber stopper and a plastic plunger rod. The plunger rod is pulled along the inside of the barrel to aspirate fluids and pushed along the inside of the barrel to inject or expel fluids. The syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The BD Single Use, Hypodermic Syringe are provided sterile (EtO) in a syringe only configuration or with a hypodermic needle. The modified BD Single Use, Hypodermic Syringe includes a new resin material in the barrel of the syringe. The syringe performance characteristics are equivalent to the predicate device.

AI/ML Overview

The provided document describes the FDA 510(k) summary for the BD Single Use, Hypodermic Syringe, focusing on its substantial equivalence to a predicate device. This is primarily a regulatory submission based on non-clinical testing and comparison to an existing device, rather than a study demonstrating clinical performance of a novel AI-powered device. Therefore, many of the requested categories related to AI studies (e.g., MRMC, standalone algorithm, training set size, expert qualifications for ground truth) are not applicable to this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Functional Testing
Break Out Force	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Sustaining Force	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Flange Bend Force	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Dimensional Stability of Barrel ID (inner diameter)	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Barrel Scale Permanency	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Barrel Impact Test	Equivalence to Predicate	Performed in an equivalent manner to the predicate device.
Biocompatibility Testing
Cytotoxicity	Per ISO10993-5, Non-toxic	Non-toxic
Hemolysis	Per ISO10993-4, Non-toxic	Non-toxic
Acute Systemic Toxicity	Per ISO10993-11, Non-toxic	Non-toxic
Intracutaneous Reactivity	Per ISO10993-10, Non-Irritant	Non-Irritant
Sensitization	Per ISO10993-10, Non-Sensitizer	Non-Sensitizer
Pyrogenicity	Per ISO 10993-11 and USP 151, Non-Pyrogenic	Non-Pyrogenic
Chemical Extractable Analysis	Per ISO 10993-18, acceptable level of extracts.	Acceptable level of extracts.
Sterilization	SAL $10^{-6}$	SAL $10^{-6}$
Shelf Life	5 Years	5 Years

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each non-clinical test. The testing was conducted by BD (Becton, Dickinson and Company) to demonstrate equivalence to a predicate device. The data provenance is internal testing performed by the manufacturer, likely in a controlled laboratory environment. The country of origin of the data is not explicitly stated but would be associated with BD's testing facilities. These were non-clinical tests, not involving human subjects or real-world patient data in the typical sense of a test set for an AI/algorithm.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. For non-clinical tests like "Break Out Force" or "Cytotoxicity," the "ground truth" is established by the standardized test methods and their defined pass/fail criteria (e.g., ISO standards, equivalence to predicate device), not by clinical experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for clinical studies where subjective expert assessment is involved. For these non-clinical tests, the results are typically quantitative measurements compared against predefined criteria or the performance of a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document does not pertain to an AI device or an MRMC study. It is for a physical medical device (hypodermic syringe) demonstrating substantial equivalence through non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is not an AI/algorithm device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

Standardized Test Methods: Adherence to established international standards (e.g., ISO 10993 for biocompatibility, USP 151 for pyrogenicity).
Predicate Device Performance: Demonstrating performance equivalent to the legally marketed predicate device (K980987 BD Single Use, Hypodermic Syringe).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 2, 2015

Becton, Dickinson and Company Murtaza Rana Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, NJ 07417

Re: K151766

Trade/Device Name: BD Single Use, Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 25, 2015 Received: June 30, 2015

Dear Murtaza Rana:

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. 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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151766

Device Name BD Single Use, Hypodermic Syringe

Indications for Use (Describe)

The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

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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510(k) Summary

Submitted By:	Murtaza Rana
	Regulatory Affairs Specialist
	Becton, Dickinson and Company
	1 Becton Drive
	Franklin Lakes, NJ 07417
	Phone: (201)847-6980
	Fax: (201)847-5307
Date Prepared:	August 3, 2015
Device:
	Trade Name: BD Single Use, Hypodermic Syringe
	Common Name: Piston Syringe
	Classification: Class II device, 21 CFR §880.5860,
	Piston Syringe
	Product Code: FMF (Syringe, Piston)
Predicate Device:	K980987
	BD Single Use, Hypodermic Syringe

Device Description

Intended Use

The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

Technological Characteristics

The subject BD Single Use, Hypodermic Syringe is equivalent to that of the predicate BD Single Use, Hypodermic Syringe in intended use, materials and performance characteristics.

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Element ofComparison	Subject Device	Predicate Device
Indications forUse/Intended Use	The BD Single Use,Hypodermic Syringeis intended for use byhealth careprofessionals forgeneral purpose fluidaspiration/injection.	The BD Single Use,Hypodermic Syringeis intended for use byhealth careprofessionals forgeneral purpose fluidaspiration/injection.
Syringe materials	BarrelPolypropylene	Polypropylene
	BarrelSilicone	Silicone
	Lubricant
	Plunger RodPolypropylene	Polypropylene
	StopperRubber	Rubber
	StopperSilicone	Silicone
	Lubricant
Sterilization Method	Ethylene Oxide	Ethylene Oxide
SAL	$10^{-6}$	$10^{-6}$
Shelf Life	5 Years	5 Years

Non-Clinical Testing

BD has performed the following non-clinical/design verification testing based on the risk analysis conducted and the results of these tests demonstrate that the BD Single Use, Hypodermic Syringe performed in an equivalent manner to the predicate device.

Performance Characteristic	Acceptance Criteria
Functional Testing	Break Out Force	Equivalence to Predicate
	Sustaining Force	Equivalence to Predicate
	Flange Bend Force	Equivalence to Predicate
	Dimensional Stability ofBarrel ID (innerdiameter)	Equivalence to Predicate
	Barrel Scale Permanency	Equivalence to Predicate
	Barrel Impact Test	Equivalence to Predicate
	BiocompatibilityTesting	Cytotoxicity
Hemolysis		Per ISO10993-4, Non-toxic
Acute Systemic Toxicity		Per ISO10993-11, Non-toxic
Intracutaneous Reactivity		Per ISO10993-10, Non-Irritant
Sensitization		Per ISO10993-10, Non-Sensitizer
Pyrogenicity		Per ISO 10993-11 and USP 151, Non-Pyrogenic
Chemical ExtractableAnalysis		Per ISO 10993-18, acceptable level ofextracts.

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Clinical Testing

Clinical testing was not required for this submission.

Substantial Equivalence

The BD Single Use, Hypodermic Syringe is substantially equivalent to the predicate device in intended use, principles of operation, technology, design, materials and performance.

Conclusion

The BD Single Use, Hypodermic Syringe has been verified to meet the established performance criteria above. The results of the non-clinical/design verification testing demonstrate that the BD Single Use, Hypodermic Syringe performs as intended and performs as well as the legally marketed predicate device.

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).