The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector in 3ml, 5ml and 10ml 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 polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed 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 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 acceptance criteria and the study that proves the device meets those criteria for the BD Single Use, Hypodermic Syringe.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document states that the subject device met all predetermined acceptance criteria. The specific acceptance criteria are broadly described by the tests performed, and the reported performance is that the device performed in an equivalent manner to the predicate device and met the acceptance criteria.

Acceptance Criteria Category/Test	Reported Device Performance
Performance Tests
Break Out Force	Performed in an equivalent manner to the predicate device
Sustaining Force	Performed in an equivalent manner to the predicate device
Flange Bend Force	Performed in an equivalent manner to the predicate device
Dimensional Stability of Barrel ID (inner diameter)	Performed in an equivalent manner to the predicate device
Barrel Scale Permanency	Performed in an equivalent manner to the predicate device
Barrel Impact Test	Performed in an equivalent manner to the predicate device
ISO 7886 and ISO 594 Leakage Testing	Performed in an equivalent manner to the predicate device
Sterilization Validation
ISO 11137-2:2013 (Gamma Irradiation process)	Validated per standard
SAL	10-6
Biocompatibility Evaluation (ISO 10993-1:2009)
Cytotoxicity (Per ISO 10993-5)	Non-cytotoxic
Hemolysis (Per ISO 10993-4)	Non-hemolytic
Acute Systemic Toxicity (Per ISO 10993-11)	Non-toxic
Intracutaneous Reactivity (Per ISO 10993-10)	Non-Irritant
Sensitization (Per ISO 10993-10)	Non-Sensitizer
Pyrogenicity (Per ISO 10993-11 and USP <151>)	Non-Pyrogenic
Acidity/Alkalinity/Extractable Metals (Per ISO 7886-1)	Met acceptance criteria
Chemical Extractables Analysis (Per ISO 10993-18)	No toxicologically significant differences in extractables profiles
Overall	Met all predetermined acceptance criteria and demonstrated substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for each specific test (e.g., how many syringes were tested for "Break Out Force"). It mentions "design verification testing" for the performance tests and "biocompatibility evaluation" for the biological tests. The data provenance is not specified, but it can be inferred that these are prospective tests conducted on the newly designed device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests performed are primarily engineering and biological tests, not clinical evaluations requiring expert interpretation of results in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" here is established by adherence to recognized international standards (ISO, USP) and predefined performance specifications.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. Given the nature of the tests (physical, chemical, biological), standard adjudication methods like 2+1 or 3+1 consensus, typically used for qualitative or subjective assessments (e.g., image interpretation), are not relevant. The results are quantitative measurements against predefined criteria or qualitative observations against biological safety standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical devices that involve human interpretation, particularly in diagnostic imaging and AI-assisted diagnoses. The BD Single Use, Hypodermic Syringe is a physical device for fluid aspiration/injection, and its evaluation does not involve human readers or AI assistance in this context. The document explicitly states: "Clinical testing was not required for this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This device is not an algorithm or AI-driven system.

7. The type of ground truth used

The ground truth for this device is based on:

Adherence to recognized international standards (e.g., ISO 7886, ISO 594, ISO 11137-2:2013, ISO 10993 series, USP <151>).
Predetermined acceptance criteria for specific performance parameters (e.g., "Non-cytotoxic," "Non-hemolytic," "met acceptance criteria" for Acidity/Alkalinity/Extractable Metals).
Equivalence to a legally marketed predicate device (K980987 BD Single Use, Hypodermic Syringe) in terms of intended use, materials, and performance characteristics.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is not an AI/ML model, so there is no concept of a "training set" in the context of its evaluation. The evaluation involves testing physical properties and biological compatibility.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 23, 2018

Becton, Dickinson and Company Victoria Morrow Sr. Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K172670

Trade/Device Name: BD Single Use, Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 2, 2018 Received: February 5, 2018

Dear Victoria Morrow:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Alan M.
Stevens -S

Tina Kiang, Ph.D. for Acting 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)

K172670

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 (21 CFR §807.92)

BD Single Use, Hypodermic Syringe

SubmitterInformation	Submitter Name:Submitter Address:Contact Person:Email Address:Phone Number:Fax Number:Date of Preparation:	Becton, Dickinson and Company1 Becton DriveFranklin Lakes, NJ 07417Victoria MorrowSr. Regulatory Affairs SpecialistVictoria_morrow@bd.comPhone: (201) 847-6626Fax: (201) 847-5307October 23, 2018
Subject Device	Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel:	BD Single Use, Hypodermic SyringePiston Syringe21 CFR §880.5860Piston SyringeClass II deviceFMF (Syringe, Piston)General Hospital
Predicate Device	Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel:	BD Single Use, Hypodermic SyringeK980987Piston Syringe21 CFR §880.5860Piston SyringeClass II deviceFMF (Syringe, Piston)General Hospital
DeviceDescription	The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single usehypodermic syringe with a 6% (Luer) male connector in 3ml, 5ml and 10ml Luer-Loksyringe sizes. The BD Single Use, Hypodermic Syringe is intended for use byhealth care professionals for general purpose fluid aspiration/injection. The syringeassembly consists of a lubricated polypropylene barrel with a graduated scale, alubricated synthetic rubber stopper and a polypropylene plunger rod. The plungerrod is pulled back to aspirate fluids or depressed to inject or expel fluids. Thesyringe barrel incorporates a male 6% (Luer) connector which is connectable to acompatible female 6% (Luer) connector. The modified BD Single Use, HypodermicSyringe includes a new resin material in the barrel of the syringe. The syringeperformance characteristics are equivalent to the predicate device.
Indications forUse		The BD Single Use, Hypodermic Syringe is intended for use by health careprofessionals for general purpose fluid aspiration/injection.
TechnologicalCharacteristics		The subject BD Single Use, Hypodermic Syringe, which uses a new polyproplyenebarrel resin is equivalent to that of the predicate BD Single Use, HypodermicSyringe in intended use, materials and performance characteristics.

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Element of Comparison	Subject Device	Predicate Device
Indications for Use/Intended Use	The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.	The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
Syringe materials	Barrel	Polypropylene	Polypropylene
	Barrel	Silicone	Silicone
	Lubricant
	Plunger Rod	Polypropylene	Polypropylene
	Stopper	Polyisoprene Rubber	Polyisoprene Rubber
	Stopper	Silicone	Silicone
	Lubricant
Sterilization Method	Gamma IrradiationE-beam	Gamma IrradiationE-beam
SAL	10-6	10-6
Shelf Life	5 Years	5 Years

Performance Tests

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.

Break Out Force ●
Sustaining Force ●
Flange Bend Force ●
Dimensional Stability of Barrel ID (inner diameter) ●
. Barrel Scale Permanency
Barrel Impact Test
ISO 7886 and ISO 594 Leakage Testing ●

The device is sterilized using a gamma irradiation process and was validated per ISO 11137-2:2013.

In addition, a biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2009, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process. Based on the evaluation, the following biological tests were conducted:

Cytotoxicity (Per ISO 10993-5, Non-cytotoxic) ●
Hemolysis (Per ISO 10993-4, Non-hemolytic
Acute Systemic Toxicity (Per ISO 10993-11, Non-toxic) ●
Intracutaneous Reactivity (Per ISO 10993-10, Non-Irritant) ●
Sensitization (Per ISO 10993-10, Non-Sensitizer) ●
Pyrogenicity (Per ISO 10993-11 and USP <151>, Non-Pyrogenic) ●
Acidity/Alkalinity/ Extractable Metals (Per ISO 7886-1, met acceptance ● criteria)
. Chemical Extractables Analysis (Per ISO 10993-18, no toxicologically significant differences in extractables profiles.)

Per the design control requirements specified in 21 CFR 820.30. the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device.

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Clinical Testing	Clinical testing was not required for this submission
Summary ofSubstantialEquivalence	The BD Single Use, Hypodermic Syringe is substantially equivalent to the predicatedevice in intended use, principles of operation, technology, design, materials andperformance.

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).