The subject BD Insulin Syringes are a plastic syringe designed for subcutaneous injection of a desired dose of U 100 insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. The BD Insulin Syringes are sterile, single use, and non-pyrogenic. These devices operate on the principles of a piston syringe. The BD Insulin Syringe with 6mm length cannula have a sub-brand name of BD Veo™ Insulin Syringe.

AI/ML Overview

This document describes the premarket notification (510(k)) for the BD Insulin Syringe (K190054). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria in the context of diagnostic performance or clinical outcomes.

However, based on the non-clinical testing section, we can infer the acceptance criteria for various performance aspects and that the device met these criteria through testing.

Here's an interpretation of the requested information, focusing on the available details from the document:

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

Since this is a 510(k) submission for an insulin syringe, the "acceptance criteria" discussed are largely related to functional performance and biocompatibility, as defined by international standards. The document states that the "Results of testing demonstrated the BD Insulin Syringes met requirements for its intended use" for all listed tests. Specific numerical acceptance criteria are not provided in this summary, but rather the standards against which compliance was demonstrated.

Acceptance Criteria (Standards Met)	Reported Device Performance
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (for functional performance tests)	Met all requirements for intended use
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices (for functional performance tests)	Met all requirements for intended use
ISO 10993:2019 Biological evaluation of medical devices (for biocompatibility tests)	Met all requirements as safe and effective
ASTM F2148: 2013 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)	Met all requirements for intended use
ISO 11137-1:2006/Amd 2013(E) Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices	Met all requirements for intended use
ISO 11137-2:2013(E) Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose	Met all requirements for intended use
ISO 11137-3: 2017(E) Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control	Met all requirements for intended use
ISO 11737-1:2018(E) Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products	Met all requirements for intended use

Specific functional performance tests mentioned under ISO 8537 and ISO 9626 (for which the device met requirements):

Air Leakage
Cannula Pull Force
Hub Pull Force
Liquid Leakage
Needle Break-Off Force
Penetration Force
Scale Print Permanency
Shield Pull Force
Syringe Filling Force
Syringe Injection Force (Force to Expel Water)
Volumetric Accuracy
Dead Space
Corrosion Resistance

Specific biocompatibility tests mentioned under ISO 10993 (for which the device met requirements):

Cytotoxicity
Sensitization (GP Max)
Sensitization, Intracutaneous Reactivity
Irritation
Acute Systemic Toxicity
Material Mediated Pyrogenicity
Subacute/Subchronic Toxicity
Hemocompatibility
Genotoxicity (Bacterial and Mammalian)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each non-clinical performance and biocompatibility test. It mentions that "required testing was conducted to validate the cumulative modifications." The data provenance (e.g., country of origin) is not detailed, but it would typically be internal testing conducted by Becton Dickinson. These are prospective tests conducted on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. The "ground truth" for a medical syringe is its physical and chemical properties and functional performance, which are evaluated against international standards by laboratory testing, not by expert consensus on clinical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human readers or interpretation. The performance is objectively measured against established criteria in laboratory settings.

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

Not applicable. This is not an AI/imaging device or a diagnostic device, and no MRMC study was performed or required.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" is defined by the technical specifications and performance requirements outlined in the referenced international standards (e.g., ISO 8537, ISO 9626, ISO 10993). Compliance with these standards, as measured by objective laboratory tests, serves as the basis for demonstrating safety and effectiveness.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 21, 2019 Becton Dickinson and Company Meriam Youssef Senior Manager Regulatory Affairs 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K190054

Trade/Device Name: BD Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: September 19, 2019 Received: September 23, 2019

Dear Meriam Youssef:

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

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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 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 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 CAPT Alan M. 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) K190054

Device Name BD Insulin Syringe

Indications for Use (Describe)	Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins
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Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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K190054 510(k) Summary

Submitted By:	Meriam YoussefSr. Manager Regulatory Affairs, BD Medical- Diabetes Care1 Becton DriveFranklin Lakes, NJ 07417Tel: 201 847 6557Fax: 201 847 5307
Date Prepared:	September 19, 2019
Device Name:	Trade Name:	BD Insulin Syringe™
	Common Name:	Syringe, Piston
	Regulation Name:	Piston syringe
	Regulation:	21 CFR 880.5860
	Product Code:	FMF

Legally marketed predicate device to which substantial equivalence is being claimed:

BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the . BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle (K170386)

Device Description:

Syringe size (mL)	Bevel	Cannula length (mm)	Gauge (G)
0.3mL	3	12.7mm	29G
0.3mL	3	12.7mm	30G
0.3mL	3	8mm	29G
0.3mL	3	8mm	31G
0.3mL	3	6mm	31G
0.5mL	3	12.7mm	28G
0.5mL	3	12.7mm	29G
0.5mL	3	12.7mm	30G
0.5mL	3	8mm	31G
0.5mL	3	6mm	31G
1mL	3	16mm	27G
1mL	3	12.7mm	28G
1mL	3	12.7mm	29G
1mL	3	12.7mm	30G
1mL	3	8mm	30G
1mL	3	8mm	31G
1mL	3	6mm	31G
1mL	3	16mm	27G

The BD Insulin Syringes are offered in the following sizes:

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Indications for Use:

Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins.

Differences in Indications for use: The indications for use are the same as the predicate.

Substantial Equivalence Discussion:

		Predicate Device	Comparison
General InformationFeature	Subject Device:BD Insulin Syringe	BD Ultra-Fine™ InsulinSyringe, BD Ultra-Fine™II Insulin Syringe, BDInsulin Syringes with theBD Ultra-Fine™ needleand BD Insulin Syringeswith Micro-Fine™ IVNeedle
510(k) Number	K190054	K170386	N/A
Device Classification	Syringe Piston	Same	Same
Regulation Number	880.586	Same	Same
Product Code	FMF	Same	Same
Indications of Use	Becton Dickinson insulinsyringes are intended forsubcutaneous injection ofU 100 insulins	Becton Dickinson insulinsyringes are intended forsubcutaneous injection ofU-100 insulins.	Same
Specific Drug Use	U-100 Insulin	Same	Same
Capacity	1mL,0.5mL,0.3mL	1mL	The subject deviceincludes a 0.5mL and0.3ml model.
Bevel	3	3	Dimensionalmodifications toprimary bevel ofcannula
Cannula Gauge Size(s)	27G, 28G, 29G, 30G, 31G	27G, 28G, 29G, 30G, 31G	Same
Nozzle Tip Type	Snap fit needle hub for0.3mL and 0.5mL designsfor permanentlyattached needlesIntegral barrel for 1mLdesign forpermanently attached	Integral barrel for 1mLdesign forpermanently attachedneedles	Introduction of one gluewell design for 1mLbarrel configuration
Scale Markings	needles1 unit increments and ½unit increments (0.3mL)1 unit increments (0.5mL)2 units increments (1mL)	2 units increments(1mL)	Addition of ½ unit scalemark increments
General InformationFeature	Subject Device:	Predicate Device	Comparison
General InformationFeature	Subject Device:BD Insulin Syringe	BD Ultra-Fine™ InsulinSyringe, BD Ultra-Fine™II Insulin Syringe, BDInsulin Syringes with theBD Ultra-Fine™ needleand BD Insulin Syringeswith Micro-Fine™ IVNeedle
Packaging Configuration	Polybag for self-containedsyringe and blister pack(multiple blister packs perperforated sheet) offerings	Polybag for self-containedsyringe and blister pack(individual blister pack)offerings	Addition of retentionring to 1mLself-contained insulinsyringeMultiple blister packsper perforated sheet
Cannula Length Size(s)	6mm, 8mm, 12.7mm,16mm	6mm, 8mm, 12.7mm,16mm	Same
Cannula (Needle) material	304 Stainless Steel	304 Stainless Steel	Same
Cannula (Needle) shieldmaterial and Cap (forplunger rod) material	Polyethylene	Polyethylene	Modification to the co-monomer ofpolyethylene material
Cannula cover color	Orange	Orange	Same
Lubricant	Medical Grade Silicone	Medical Grade Silicone	Modification tolubricant formulationcarrier solvent
Cannula bondingadhesive (UV cured)	UV Cured Adhesive	UV Cured Adhesive	New 0.3mL & 0.5mLUV Cured Adhesive
Scale marking ink	Solvent based Markemblack colored ink	Solvent based Markemblack colored ink	Same
Plunger rod material	Polystyrene	Polystyrene	Remove colorantadditive from theplunger rod component
Plunger tip (stopper)material	Rubber stopper	Rubber stopper	Same
Barrel and Hub Material	Polypropylene	Polypropylene	New materialformulation ofpolypropylene
Single Use Only	YES	YES	Same
Non-Pyrogenic	YES	YES	Same
Sterile (10-6)	YES	YES	Same

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Discussion:

Apart from the above mentioned modifications to the design and materials, there are no technological differences between the subject and the predicate devices. The design modifications were assessed through performance testing per ISO 8537 and ISO 9626. The material changes were evaluated per ISO 10993-1.

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.

Non-Clinical Testing:

Following BD's Quality System processes, required testing was conducted to validate the cumulative modifications made to the subject devices.

Substantial Equivalence is being supported with full performance testing the current BD Insulin Syringe devices currently marketed.

Bench functional performance

Testing was conducted according to ISO 8537:2016 Sterile single-use syringes, with or without needle, ● for insulin, and ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices. This testing included Air Leakage, Cannula Pull Force, Hub Pull Force, Hub Pull Force, Liquid Leakage, Needle Break-Off Force, Penetration Force, Scale Print Permanency, Shield Pull Force, Syringe Filling Force, Syringe Injection Force (Force to Expel Water), Volumetric Accuracy, Dead Space and Corrosion Resistance.

Biocompatibility testing

Testing was conducted according to relevant sections of ISO 10993:2019 Biological evaluation of ● medical devices. This testing included Cytotoxicity, Sensitization (GP Max), Sensitization, Intracutaneous Reactivity, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Hemocompatibility, and Genotoxicity (Bacterial and Mammalian). The medical device is classified as: externally communicating, blood path indirect, with prolonged contact duration.

Additional Testing:

ASTM F2148: 2013 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA), ISO 11137-1:2006/Amd 2013(E) Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. ISO 11137-2:2013(E) Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose, ISO 11137-3: 2017(E) Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control, and ISO 11737-1:2018(E) Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products .
Results of testing demonstrated the BD Insulin Syringes met requirements for its intended use and is as safe and effective as its predicate device.

Clinical Testing:

Not Applicable

Conclusion:

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

The BD Insulin Syringes are substantially equivalent to the BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle cleared under K170386 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).