The BD Insulin Syringes - Ultra-Fine™ and Ultra-Fine™ II are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Ultra-Fine™ Insulin Syringe has a 30g x 1/2" (12.7mm) needle and is available in 1cc (100 units), 1/2 cc (50 units), and 1/3 cc (30 units) sizes. The Ultra-Fine™ II 31g x 1/2" (8mm) needle and is available in 1cc (100 units), ½ cc (50 units), and 1/3 cc (30 units) sizes. These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, non-pyrogenic and single use, disposable.

AI/ML Overview

Here's an analysis of the provided information regarding the BD Insulin Syringe K024112, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Performance Aspect)	Reported Device Performance (as stated in the 510(k) summary)
Needle pull-out force	Demonstrated equivalence to predicate devices (K941657 and K955235)
Hub pull-off forces	Demonstrated equivalence to predicate devices (K941657 and K955235)
Needle angularity	Demonstrated equivalence to predicate devices (K941657 and K955235)
Needle break-off testing	Demonstrated equivalence to predicate devices (K941657 and K955235)
Dose accuracy	Demonstrated equivalence to predicate devices (K941657 and K955235)

Note: The 510(k) summary does not specify quantitative acceptance limits (e.g., "pull-out force must be > 5 N"). Instead, the acceptance criteria are implicitly met by demonstrating "equivalence" to the predicate devices across these performance aspects.

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

The document does not provide details on the specific sample sizes used for each of the "bench tests" or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Bench tests relating to the performance of the needle length were conducted."

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

This information is not applicable to this type of device and study. The "ground truth" for the performance tests of an insulin syringe is based on objective physical measurements and engineering specifications, not expert consensus on interpretations like in medical imaging.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the performance tests involve objective physical measurements, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic devices where human readers interpret medical images or data, and the focus is on how an AI system can assist or replace human performance. The BD Insulin Syringe is a physical medical device, not a diagnostic AI tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone study was not performed. This concept applies to AI algorithms. The BD Insulin Syringe is a physical device, and its performance is evaluated through bench tests directly on the device itself.

7. Type of Ground Truth Used

The ground truth used for the performance tests was based on objective engineering and physical measurements demonstrating the functional characteristics of the syringe (e.g., force required for needle pull-out, accuracy of dose delivery). The standard for comparison (the "ground truth" for demonstrating acceptable performance) was the performance of the predicate devices (K941657 and K955235).

8. Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device. The study involves bench testing of a physical product, not training of an algorithm.

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

This is not applicable as this is not an AI/machine learning device, and there is no "training set."

Summary

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K024112

510K SUMMARY OF SAFETY AND EFFECTIVENESS

l . Submitted By:

John Schalago Manager, Regulatory Affairs

Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, NJ 07417-1883

201-847-5663 Phone: 201-848-0457 Fax:

2. Device Name:

BD Insulin Syringe - Ultra-Fine™ and Ultra-Fine™ II Trade Name:

Insulin Syringe Common Names:

Classification Name: Piston Syringe

3. Predicate Device:

BD Insulin Syringe - K941657 and K955235

Manufactured by: Becton Dickinson Consumer Healthcare

4. Device Description:

These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, non-pyrogenic and single use, disposable.

Continued...

00001.6

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510K Summary of Safety and Effectiveness (Continued)

5. Intended Use:

BD Insulin Syringes are intended for the subcutaneous injection of insulins

Technological Characteristics: 6.

The BD Ultra-Fine™ and Ultra-Fine™ II insulin syringes and the predicate devices have the identical technological characteristics and perform as piston syringes.

The only difference between the principal devices and the predicate device is the needle gauge.

7. Performance:

Bench tests relating to the performance of the needle length were conducted. The tests performed included needle pull-out force, hub pull-off forces, needle angularity, needle break-off testing and dose accuracy. The results demonstrate that the BD Insulin Syringes performs equivalent to the predicate devices and is safe and effective when used as intended.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US patent Laws or their application by the courts.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, depicted in black.

JAN 0 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Schalago Manager, Regulatory Affairs Becton Dickinson & Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1880

Re: K024112

Trade/Device Name: BD Insulin Syringe-Ultra-Fine™ and Ultra-Fine™ II Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: December 11, 2002 Received: December 13, 2002

Dear Mr. Schalago:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Schalago

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment XI.1

Page 1 of 1

510(k) Number (if known): < 024112

Device Name: Becton Dickinson Insulin Syringe

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Division Sign-Off)

v. General Hospital ision of Anest ction Control. De

510(k) Number. K024112

000024

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).