The BD Hypodermic Syringe operates on the same fundamental scientific technology as the predicate cleared under K980580. The subject device consists of a: graduated barrel, plunger rod and needle/hub assembly. The device is offered with an attached 27G x 16mm cannula integrated with a 1mL syringe barrel capacity. The subject device is offered in self-contained (with a plunger cap) configuration. It is a single-use disposable device that is provided sterile. The BD Hypodermic Syringe is non-toxic and non-pyrogenic.

AI/ML Overview

This document describes the non-clinical testing performed to demonstrate the substantial equivalence of the BD Hypodermic Syringe (the subject device) to its predicate device (K980580: Becton Dickinson Syringes).

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Standard/Acceptance Criteria	Reported Device Performance
Functional Performance
Syringe Functionality	ISO 7886-1: 2017 Sterile hypodermic syringes for single use – Part 1: Syringes for manual use (This standard specifies requirements for sterile hypodermic syringes for single use, including dimensional characteristics, freedom from particles, lubrication, plunger force, fluid leakage, and dead space.)	The subject device met the requirements of ISO 7886-1:2017.
Needle Requirements	ISO 7864: 2016 Sterile hypodermic needles for single use – Requirements and test methods (This standard specifies requirements for sterile hypodermic needles for single use, including needle dimensions, sterility, corrosion resistance, and penetration force.)	The subject device met the requirements of ISO 7864:2016.
Needle Tubing Requirements	ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods (This standard specifies requirements for stainless steel needle tubing used in the manufacture of medical devices, including mechanical properties, surface finish, and freedom from defects.)	The subject device met the requirements of ISO 9626:2016.
Biocompatibility
Overall Biological Evaluation	ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process (Since the device is an externally communicating device with prolonged contact duration (>24 hours to 30 days), specific endpoints as outlined in the standard were required.)	All material modifications met the requirements per ISO 10993-1:2018.
Cytotoxicity	As per ISO 10993-1:2018 guidelines for externally communicating devices with prolonged contact. (Specific cell culture tests to evaluate the potential for the device materials to cause cell lysis or inhibition of cell growth.)	Met the requirements.
Sensitization	As per ISO 10993-1:2018 guidelines. (Tests to assess the potential for the device materials to induce an allergic reaction.)	Met the requirements.
Irritation or Intracutaneous reactivity	As per ISO 10993-1:2018 guidelines. (Tests to evaluate local irritation effects in tissue from direct or intracutaneous contact with device materials or extracts.)	Met the requirements.
Acute Systemic Toxicity	As per ISO 10993-1:2018 guidelines. (Tests to detect harmful effects from a single exposure to device extracts.)	Met the requirements.
Material Mediated Pyrogenicity	As per ISO 10993-1:2018 guidelines. (Tests to detect pyrogenic substances released from the device materials.)	Met the requirements.
Subacute/Subchronic Toxicity	As per ISO 10993-1:2018 guidelines. (Tests to detect adverse effects from repeated or continuous exposure to device extracts over a period longer than acute, but less than chronic.)	Met the requirements.
Indirect Hemolysis	As per ISO 10993-1:2018 guidelines. (Tests to evaluate the potential of device extracts to cause rupture of red blood cells.)	Met the requirements.
Particulate Matter	USP <788> Particulate Matter In Injections. (This standard specifies limits for subvisible particulate matter in parenteral preparations, which is critical for injectable devices to prevent adverse patient reactions.)	Met the requirements.

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

The document does not explicitly state the specific sample sizes for each test within the functional performance and biocompatibility sections. However, it indicates that testing was performed per current ISO and USP standards. These standards typically outline minimum sample size requirements for the tests they prescribe to ensure statistical validity.

The data provenance is not explicitly stated in terms of country of origin. The study is retrospective as it involves validation of design changes for a device for which substantial equivalence is being claimed to a previously cleared predicate device.

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

This type of submission (510(k) for a medical device) typically relies on objective laboratory testing against recognized consensus standards rather than expert consensus for individual test results. Therefore, there is no mention of experts establishing ground truth in the context of radiologists or similar clinical experts. The "ground truth" for these non-clinical tests is established by the specifications and methodologies outlined in the referenced ISO and USP standards. The validation is performed by engineers and scientists, whose qualifications would implicitly align with the requirements of design verification and validation in medical device manufacturing.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation of the test set is based on objective conformity to established international standards, not on subjective expert assessment that would require an adjudication method like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a non-clinical medical device (hypodermic syringe), not an AI-powered diagnostic or imaging device. Therefore, a study comparing human reader performance with and without AI assistance is not relevant to this type of device.

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

Not Applicable. The device is a physical medical device (syringe), not an algorithm or software requiring standalone performance testing in this context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for the non-clinical tests (functional performance and biocompatibility) is defined by the specifications and acceptance criteria outlined in the referenced ISO and USP international consensus standards. For example:

Functional Performance: Ground truth is defined by the quantitative limits (e.g., maximum plunger force, fluid leakage limits, dimensional tolerances) specified in ISO 7886-1, ISO 7864, and ISO 9626.
Biocompatibility: Ground truth is defined by the qualitative and quantitative endpoints (e.g., absence of cytotoxicity, sensitization, irritation) and methodologies specified in ISO 10993-1.

8. The Sample Size for the Training Set

Not Applicable. This is a non-clinical evaluation of a physical medical device. There is no "training set" in the context of machine learning or AI algorithms.

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

Not Applicable. As there is no training set for this type of device submission, the concept of establishing ground truth for a training set does not apply.

Summary

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January 25, 2021 Becton Dickinson and Company Charlton Foo Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K203453

Trade/Device Name: BD Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 19, 2020 Received: November 23, 2020

Dear Charlton Foo:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

Rumi Young Acting 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

Submission Number (if known)

K203453

Device Name

BD Hypodermic Syringe

Indications for Use (Describe)

BD Hypodermic Syringe is intended for general 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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510(k) Summary

Submitted By:	Charlton Foo
	Staff Regulatory Affairs Specialist
	Becton Dickinson and Company
	1 Becton Drive
	Franklin Lakes, NJ 07417
	Tel: 201 847 6869
	Fax: 201 847 5307
Date Prepared:	January 21, 2021
Device Name:	Trade Name:	BD Hypodermic Syringe
	Common Name:	Hypodermic Syringe
	Classification:	Class II device; 21 CFR 880.5860,(Syringe, Piston)
	Product Code:	FMF (Piston Syringe)

Legally marketed predicate device to which substantial equivalence is being claimed: K980580: Becton Dickinson Syringes

Reason for Submission:

. Expansion of syringe portfolio for general aspiration and injection of fluids in a 16mm needle length and thin wall configuration for the proposed syringe
. Material modifications
Packaging Changes .

Device Description:

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Intended Use:

BD Hypodermic Syringe is intended for general aspiration and injection of fluids.

The intended use of the subject device remains the same as the predicate device K980580 Becton Dickinson Syringes.

Comparison with Predicate Device:

The subject device has the same fundamental scientific technology as the predicate, which operate on the principles of a piston syringe. The modifications of the subject device consist of design, performance, and material. The purpose of this submission is to market the BD Hypodermic Syringe device. The table below provides a side-by-side comparison of the subject device compared to its predicate.

GeneralInformationFeature	Subject Device:BD Hypodermic Syringe	Predicate Device:Becton Dickinson Syringes(K980580)	Comparison
Classification	11	11	Same
Product Code	FMF	FMF	Same
RegulationNumber	880.5860	880.5860	Same
Intended Use	BD Hypodermic Syringe isintended for generalaspiration and injection offluids.	These syringes are intendedfor general purpose fluidaspiration/ injection andinsulin injection.	Same
Gauge	27G	28G, 27G, 26G	Same
Needle Length	16mm	12.7mm and 9.5mm	Addition of16mm length
Needle wallthickness	Regular Wall and Thin Wall	Regular Wall	Addition of ThinWallConfiguration
Needle ShieldColor	Gray	Gray (27G)	Same
Bevel	3 Bevel	3 Bevel	Same
Barrel Size	1mL	1mL and 0.5mL	Same
Maximum DeadSpace	0.01mL	0.07mL	Reduction inmaximum deadspace
Scale Mark	Millimeters (mL)	Millimeters (mL)	Same
Single Use Only	Yes	Yes	Same

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GeneralInformationFeature	Subject Device:BD Hypodermic Syringe	Predicate Device:Becton Dickinson Syringes(K980580)	Comparison
PackagingConfiguration	Self-Contained configuration	Self-contained, Blister packand Tray configuration	Same
Sterile (10-6)	Yes	Yes	Same
SterilizationMethod	Gamma	Gamma	Same
Shelf Life	5 years	5 years	Same
Non-Pyrogenic	Yes	Yes	Same
Component Materials
Needle	Stainless Steel	Stainless Steel	Same
Needle Shield	Polyethylene	Polyethylene / Polypropylene	Same
Needle Lubrication	Medical Grade Silicone	Medical Grade Silicone	Same
Plunger Rod	Polystyrene	Polypropylene	New plungermaterial
Plunger Tip	Polyisoprene Rubber andStyrene Butadiene Rubber	Polyisoprene Rubber	Additionalstopper material
Plunger Cap	Polyethylene	Polyethylene	Same
Barrel	Polypropylene	Polypropylene	Same
Hub	Polypropylene	Polypropylene	Same

Testing:

Non-Clinical Test Summary

The subject device has similar technological characteristics as the predicate device cleared in K980580. BD has validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included functional performance per ISO 7886-1:2017, ISO 7864:2016, and ISO 9626:2016. Material changes were evaluated in accordance with ISO 10993-1:2018: Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process.

Functional Performance Testing

ISO 7886-1: 2017 Sterile hypodermic syringes for single use Part 1: Syringes for . manual use
ISO 7864: 2016 Sterile hypodermic needles for single use Requirements and test . methods

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ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices . - Requirements and test methods

Biocompatibility Testing

BD Hypodermic Syringe is categorized as an externally communicating device, involving direct contact with tissue for a prolonged contact duration (>24 hours to 30 days). A series of biological test were performed in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process with the following endpoints:

Cytotoxicity ●
. Sensitization
. Irritation or Intracutaneous reactivity
. Acute systemic toxicity
. Material mediated pyrogenicity
. Subacute/Subchronic toxicity
. Indirect hemolysis
. USP <788>

All material modifications met the requirements per ISO 10993-1:2018. Results of testing demonstrated the BD Hypodermic Syringe met requirements for its intended use and is as safe and effective as its predicate devices.

Clinical Test Summary Not Applicable.

Conclusion:

The modifications to the design, dimensions and materials of the subject device met the requirements of the FDA recognized consensus standards. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.

The BD Hypodermic Syringe is substantially equivalent to the predicate device cleared under K980580 with respect to the indications for use, target populations, treatment method, use environment and technological characteristics.

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).