The subject BD Insulin Syringes (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) are a 1.0mL self-contained plastic syringe designed for subcutaneous injection of a desired dose of insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, 12.7mm and 16mm). The BD Insulin Syringes are sterile, single use, and non-toxic. The fluid path of the syringe is sterile and non-pyrogenic. These devices operate on the principles of a piston syringe.

AI/ML Overview

The document describes the acceptance criteria and the study that proves the device meets those criteria for the BD Ultra-Fine™ Insulin Syringe and related insulin syringes.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general categories of testing and confirms that the results were "acceptable" and met "requirements for its intended use." Based on the provided text, the acceptance criteria are implicitly defined by compliance with ISO standards and the demonstrated equivalence to predicate devices.

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Biocompatibility (per ISO 10993-1)	- Cytotoxicity: Acceptable - Hemolysis: Acceptable - Acute Systemic Toxicity: Acceptable - Intracutaneous Reactivity: Acceptable - Pyrogenicity: Acceptable - Sensitization: Acceptable - Comparative Extractables/Leachables: Acceptable - Primary Dermal Irritation: Acceptable
Device Functional Performance	- Cannula-Syringe Bond: Acceptable (met requirements) - Scale Mark Permanency: Acceptable (met requirements) - Scale Mark Legibility: Acceptable (met requirements) - Drug Compatibility/Stability: Acceptable (met requirements)
Sterility	Yes (Gamma Irradiation), SAL 10^-6
Single Use Only	Yes
Non-pyrogenic	Yes
Substantial Equivalence to Predicate Devices	Demonstrated through analysis and testing of modifications.

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

The document does not specify the sample sizes used for any of the described tests (biocompatibility or functional performance tests).

The data provenance is from non-clinical testing performed by Becton, Dickinson and Company. The document does not provide information regarding the country of origin of the data or whether it was retrospective or prospective, as these are non-clinical (laboratory) tests.

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

This information is not applicable as the study described is non-clinical performance and biocompatibility testing of medical devices, not a study involving human subjects or expert assessment of clinical data to establish ground truth. The "ground truth" here is determined by objective laboratory measurements against established standards (ISO 10993-1, ISO 8537) and internal company specifications.

4. Adjudication Method for the Test Set

This information is not applicable to non-clinical laboratory testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for independent review of patient cases.

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. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The described study focuses on the physical and chemical properties and performance of an insulin syringe.

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

This concept is not applicable to this device. A standalone algorithm performance study relates to AI/machine learning algorithms. The device in question is a physical insulin syringe, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing is established by:

Compliance with International Standards: Specifically ISO 10993-1 (Biological evaluation of medical devices) and ISO 8537 (Sterile single-use syringes, with or without needle, for insulin).
Established Test Methodologies: Standardized laboratory tests for properties like cytotoxicity, bond strength, scale readability, and material compatibility.
Substantial Equivalence: Comparison against the performance characteristics of predicate devices already cleared by the FDA.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The testing focuses on manufacturing processes, materials, and mechanical/chemical performance.

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

This information is not applicable for the same reason as above.

Summary

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

April 12, 2017

Becton, Dickinson and Company Mr. Riddhish Patel Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07666

Re: K170386

Trade/Device Name: 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 Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: March 13, 2017 Received: March 15, 2017

Dear Mr. Riddhish Patel:

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.

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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 (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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 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,

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Tina Kiang, Ph.D. 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) K170386

Device Name

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

Indications for Use (Describe)

Becton Dickinson insulin syringes are intended for subcutaneous injection of U100 insulin.

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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K170386 510(k) Summary

Submitted By:	Becton, Dickinson and CompanyRiddhish PatelRegulatory Affairs Specialist, BD Medical1 Becton DriveFranklin Lakes, NJ 07417Tel: (201) 847-5571Fax: (201) 847-5307
Date Prepared:	April 11, 2017
Device Name:	Trade Name: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 NeedleCommon Name:Insulin SyringeClassification Name:Piston SyringeClassification:Class II, 21 CFR 880.5860Product Code:FMF	Trade Name:	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	Common Name:	Insulin Syringe	Classification Name:	Piston Syringe	Classification:	Class II, 21 CFR 880.5860	Product Code:	FMF
Trade Name:	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
Common Name:	Insulin Syringe
Classification Name:	Piston Syringe
Classification:	Class II, 21 CFR 880.5860
Product Code:	FMF

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

. K941657: BD Ultra-Fine™ Insulin Syringe and BD Insulin Syringes with Micro-Fine™ IV Needle
K955235: BD Ultra-Fine™ II Insulin Syringe ●
K024112: BD Insulin Syringes with the BD Ultra-Fine™ needle ●

Device Description:

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Models
BD Insulin Syringes with Micro-Fine™ IV Needle 27G X 16mm
BD Insulin Syringes with Micro-Fine™ IV Needle 28G X 12.7mm
BD Ultra-Fine™ Insulin Syringe 29G X 12.7mm
BD Ultra-Fine™ II Insulin Syringe 30G X 8mm
BD Insulin Syringes with the BD Ultra-Fine™ needle 30G X12.7mm
BD Insulin Syringes with the BD Ultra-Fine™ needle 31G X 6mm
BD Insulin Syringes with the BD Ultra-Fine™ needle 31G X 8mm

Indications for Use:

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

Comparison with Predicate Devices:

The subject device has the same device design, fundamental scientific technology and device performance as its predicate devices. The purpose of this submission is to gain 510(k) marketing clearance for a modification to the 1.0mL BD Insulin Syringes which includes two new cannula adhesive materials and a new scale print ink formulation. The table below provides a side by side comparison of the subject device compared to its predicate.

Feature	Subject Device: BD Ultra-Fine™Insulin Syringe, BD Ultra-Fine™ IIInsulin Syringe, BD Insulin Syringeswith the BD Ultra-Fine™ needleand BD Insulin Syringes withMicro-Fine™ IV Needle	Predicate Device: BD Ultra-Fine™Insulin Syringe, BD Ultra-Fine™ IIInsulin Syringe, BD Insulin Syringeswith the BD Ultra-Fine™ needleand BD Insulin Syringes withMicro-Fine™ IV Needle
510(k) Number	K170386	K941657, K955235 and K024112
Manufacturer	Becton, Dickinson and Company	Becton, Dickinson and Company
Indications for Use	Becton Dickinson insulin syringes areintended for subcutaneous injection ofU-100 insulin.	Becton Dickinson insulin syringes areintended for subcutaneous injection ofU-100 insulin.
Specific Drug Use	U-100 Insulin	U-100 Insulin
Principle of Operation	Piston Syringe	Piston Syringe
Cannula cover color	Orange	Orange
Cannula Gauge Size(s)	27G, 28G, 29G, 30G and 31G	27G, 28G, 29G, 30G and 31G
Cannula Length Size(s)	6mm, 8mm, 12.7mm and 16mm	6mm, 8mm, 12.7mm and 16mm
Cannula bondingadhesive	Three different UV cured adhesivematerial options	A single UV cured adhesive material
Scale markings	2 unit lines	2 unit lines
Scale marking ink	Solvent based ink or UV cured inkoption	Solvent based ink
Scale marking ink color	Black	Black
Sterile	Yes (Gamma Irradiation)	Yes (Gamma Irradiation)
SAL10-6	Yes	Yes
Single Use Only	Yes	Yes
Non-pyrogenic	Yes	Yes

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Materials for Cannulashield, Barrel body,Plunger rod, & Plungerrod cap	Plastic	Plastic
Cannula Material	Stainless Steel	Stainless Steel
Plunger stopperMaterial	Natural Rubber	Natural Rubber
Cannula lubricant	Medical Grade Silicone	Medical Grade Silicone

BD has conducted non-clinical testing which supports substantial equivalence of the modifications made to the subject device. The device functional performance risk include risk to cannula-syringe bonding, scale mark permanency and scale mark legibility. The biocompatibility risk include any new chemical and toxicological risk that may result from the material changes. The non-clinical testing included assessments related to device material biocompatibility and device functional performance. Results of these were found to be acceptable and demonstrated the subject insulin syringe device met requirements for its intended use and is substantially equivalent to its predicate device. As a part of the biocompatibility evaluation of the subject device, many factors were considered including materials of of manufacture/ chemical constituents, intended additives, potential residues, leachable substances, degradation products, physical characteristics of the final device, impact of manufacturing processes and product morphology. The consideration of these factors along with the preclinical biocompatibility testing performed adequately supports the assessment that the subject device is appropriate from a biological and toxicological perspective for its intended use.

Non-Clinical Testing:

BD has performed non-clinical performance testing based on its risk assessment utilizing Failure Mode Effect Analysis (FMEA). This testing includes device material biocompatibility testing per ISO 10993-1 Biological evaluation of medical devices and device functional performance testing per ISO 8537 Sterile single-use syringes, with or without needle, for insulin.

The following tests were performed to validate the modifications made to the subject device and also serve to mitigate the identified risks:

1. Biocompatibility testing included: cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, pyrogenicity, sensitization, comparative extractables/ leachables, and primary dermal irritation.
1. Device functional performance testing included: cannula-syringe bond, scale mark permanency and legibility, and drug compatibility/ stability.

Results of non-clinical testing both validated the modifications made and served to mitigate the identified risks such that the subject BD Insulin Syringe device met requirements for its intended use demonstrating substantial equivalence to its predicate device.

Conclusion:

The analysis and testing performed demonstrated that the subject device is substantially equivalent to its predicate devices.

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).