The U-500 Insulin Syringe is a standard single use 0.5mL plastic syringe intended for the injection of U-500 insulin into the subcutaneous tissue. It features a 31G needle and 6 mm needle length with unique U-500 scale markings on the syringe barrel. The U-500 syringe also features a green needle shield and a green U-500 symbol. It is a single use, sterile, nontoxic syringe. The fluid path of the syringe is sterile and non-pyrogenic.

AI/ML Overview

This document pertains to a 510(k) premarket notification for a medical device, specifically the BD U-500 Insulin Syringe. The information provided describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided text in relation to your request:

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

Acceptance Criteria (from ISO 8537, Volumetric Accuracy)	Reported Device Performance
At volumes < half of nominal capacity (including the lowest selectable dose): Volumetric accuracy shall be within ± [1.5% of nominal capacity + 2% of expelled volume].	Device met requirements for its intended use.
At volumes ≥ half of nominal capacity: Volumetric accuracy shall be ± 5%.	Device met requirements for its intended use.

Other acceptance criteria for functional performance (from ISO 8537, but specific values not detailed):

Device functional performance at time-zero and shelf-life (e.g., plunger force, break loose force, etc., though not explicitly stated with values in this summary). The summary states "met requirements."

Other acceptance criteria for various tests (specific values not detailed):

Device material biocompatibility per ISO 10993-1. The summary states "met requirements."
Human factor evaluations per ANSI/AAMI/IEC 62366-1. The summary states "met requirements."
Device sterilization per ISO 11737. The summary states "met requirements."
U-500 Insulin Stability. The summary states "met requirements."
Extractables and Leachables Testing. The summary states "met requirements."
Sterility Assurance Level (SAL): 10^-6. The summary states the subject device has an SAL of 10^-6, which matches the predicate.

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

The document primarily discusses non-clinical (laboratory) testing. It does not specify sample sizes (e.g., number of syringes tested) for each test or the country of origin of the data. The testing would be considered prospective, as it involves testing newly manufactured devices according to established protocols.

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 device is not an AI/ML or diagnostic device that requires expert review for "ground truth" establishment in the typical sense. The "ground truth" for the performance tests (e.g., volumetric accuracy) would be established by the physical measurements themselves, compared against the specified ISO standards.

Human factors evaluations (per ANSI/AAMI/IEC 62366-1) likely involved user studies or expert review to assess usability and identify potential use errors, but the number and qualifications of individuals involved in these evaluations are not specified in this summary.

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

Not applicable for this type of non-clinical device performance testing. Adjudication methods are typically used in clinical studies or for diagnostic/interpretive devices where expert agreement is needed to establish a reference standard.

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 a physical medical device (insulin syringe), not an AI/ML-driven diagnostic or image analysis system. No "human readers" or "AI assistance" are involved in its performance assessment.

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

Not applicable. This is a physical medical device.

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

For the volumetric accuracy and other functional tests, the "ground truth" is defined by the objective, measurable criteria set forth in recognized international standards (e.g., ISO 8537) and internal company specifications. For biocompatibility, it's defined by ISO 10993. For sterility, it's defined by ISO 11737.

8. The sample size for the training set

Not applicable. This is a physical device, and the testing described is performance verification/validation, not the training of an AI/ML model.

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

Not applicable. As above, this document does not describe the training of an AI/ML model.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.

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

July 8, 2016

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

Re: K151870

Trade/Device Name: BD U-500 Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 5. 2015 Received: July 6, 2015

Dear Mr. Trachtenberg:

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 yours, Tina Kiang

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for 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) K151870

Device Name BD U-500 Insulin Syringe

Indications for Use (Describe)

The BD U-500 Insulin Syringe is intended for the subcutaneous injection of U-500 insulin for patients requiring more than 200 units per day.

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:	Matthew S. TrachtenbergStaff Regulatory Affairs Specialist, BD Medical1 Becton DriveFranklin Lakes, NJ 07417Tel: 201 847 6337Fax: 201 847 5307
Date Prepared:	March 29, 2016
Device Name:	Trade Name: BD U-500 Insulin SyringeCommon Name: U-500 Insulin SyringeClassification: Class II device; 21 CFR 880.5860, Piston SyringeProduct Code: FMF (Syringe, Piston)

Legally marketed predicate device(s) to which substantial equivalence is being claimed: K024112 - BD Insulin Syringe

Reason for Submission

To introduce the new BD U-500 Insulin Syringe that comprises modifications to an existing device with new packaging, labeling, and indications for use.

Device Description:

Indications for Use:

The BD U-500 Insulin Syringe is intended for the subcutaneous injection of U-500 insulin for patients requiring more than 200 units per day.

Comparison with Predicate Devices:

The BD U-500 Insulin Syringe has a similar intended use and operational principle as its predicate device for the subcutaneous injection of insulin. It also shares several similarities in technology compared to its predicate device consisting of a barrel, a movable plunger, the needle, and needle cover. These syringes are Gamma sterilized and are for single use only.

The only differences between the subject device and the predicate device are the syringe barrel scale markings, the color of the needle shield (green) and the packaging graphics. Each scale mark line on the U-500 Insulin Syringe measures 5 units of U-500 insulin due to the 5times concentrated U-500 insulin product. Caution should be observed in the measurement of dosage to avoid overdose. The green needle shield, green U-500 symbol on the syringe, and the syringe packaging graphics are designed to match the color of the U-500 insulin vial labeling.

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Feature	Subject Device:BD U-500 Insulin Syringe	Predicate Device:BD Insulin Syringe - Ultra-Fine™ and Ultra-Fine™ II
510(k) Number	K151870	K024112
Manufacturer	BD	BD
Syringe Type	Insulin	Insulin
Intended Use	For the subcutaneousinjection of U-500 insulinfor patients requiring morethan 200 units per day.	For subcutaneous injection ofinsulin.
Principle of Operation	Piston Syringe	Piston Syringe
Specific Drug Use	U-500 Insulin	U-100 Insulin
Needle (Cannula) Cover Color	Green	Orange
Needle (Cannula) Gauge	31G	30G and 31G
Scale Marking	5 unit lines	1 unit lines
Needle (Cannula) Length	6mm	6mm, 8mm, and 12.7mm
Single Use Only	Yes	Yes
Non-Pyrogenic	Yes	Yes
Sterile	Yes	Yes
Sterility Assurance Level (SAL)	10-6	10-6

Testing:

BD has performed non-clinical performance testing to demonstrate substantial equivalence to the predicate device. This testing includes the following:

Device material biocompatibility per ISO 10993-1, Biological evaluation of medical devices:
. Device functional performance at time-zero and shelf-life per ISO 8537, Sterile singleuse syringes, with or without needle, for insulin. This includes Volumetric Accuracy; both what was described within the standard, and an evaluation at the lowest selectable dose.
- o At volumes < half of nominal capacity (including the lowest selectable dose), volumetric accuracy shall be within ± [1.5% of nominal capacity + 2% of expelled volumel.
- At volumes ≥ half of nominal capacity, volumetric accuracy shall be ± 5%. o
Human factor evaluations per ANSVAAMI/IEC 62366-1 Medical devices –Application ● of usability engineering to medical devices;
Device sterilization per ISO 11737 Sterilization of Medical Devices; ●
U-500 Insulin Stability: and ●
Extractables and Leachables Testing. ●

Results of testing demonstrated the BD U-500 Insulin Syringe device met requirements for its intended use.

Conclusion:

The analysis and testing performed demonstrate that the BD U-500 Insulin Syringe device is substantially equivalent to its 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).