The Becton Dickinson Ultra-Fine™ III Pen Needle is designed for use with a pen injector for subcutaneous injection of a desired dose of insulin. The pen needle consists of a needle, hub, and shield assembly. The Becton Dickinson Ultra-Fine™ III 31G pen needles are offered in two lengths, 5/16" and 3/16". The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. BD Pen Needles are disposable, single use devices.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BD Ultra-Fine™ III Pen Needle:

Based on the provided 510(k) summary, the device is a BD Ultra-Fine™ III Pen Needle, and the study is focused on demonstrating its substantial equivalence to a predicate device, the BD Ultra-Fine™ III Pen Needle (presumably an earlier version or identical in core design).

Here's a breakdown of the requested information:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary)
Equivalence to Predicate Device	The B-D ULTRA-FINE ® III 31G Pen Needle and the predicate device have identical technological characteristics and perform equivalently.
Needle Pull-out Force	Results demonstrate performance equivalent to the predicate device.
Hub Pull-off Forces	Results demonstrate performance equivalent to the predicate device.
Needle Angularity	Results demonstrate performance equivalent to the predicate device.
Needle Break-off Testing	Results demonstrate performance equivalent to the predicate device.
Dose Accuracy	Results demonstrate performance equivalent to the predicate device.
Safety and Effectiveness	The device is safe and effective when used as intended, based on equivalence to the predicate.

Note: The document states that the only difference between the new device and the predicate is the "inner bore diameter." The performance tests implicitly confirm that this difference does not compromise the device's functional equivalence or safety.

Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the bench tests. It only mentions that "Bench tests relating to the performance of the pen needle were conducted."
- Data Provenance: Not explicitly stated. Given that it's a 510(k) for a medical device by a US-based company, the tests would typically be conducted according to relevant US standards and within the company's testing facilities or by contracted labs. The data would be prospective in the sense that the tests were specifically designed and executed for this submission.

Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The concept of "ground truth" established by experts (like radiologists for imaging) is not applicable here. This study is a series of bench tests on physical device characteristics, not a diagnostic or clinical study requiring expert interpretation of results. The "ground truth" would be the measurable physical properties of the device as determined by the testing equipment and protocols.

Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical trials or studies where human interpretation or consensus is required (e.g., classifying medical images). These are bench tests measuring physical parameters.

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
- No, an MRMC comparative effectiveness study was not done. This is a physical device (pen needle) and the study is for substantial equivalence through bench testing, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI assistance" is entirely irrelevant to this submission.

If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not software or an algorithm.

The Type of Ground Truth Used
- The "ground truth" for this study was based on measurable physical properties and functional performance as determined through standard engineering and quality control bench tests (e.g., force measurements for pull-out and hub pull-off, dimensional checks for angularity and bore diameter, and functional testing for dose accuracy). The comparison was made against the established performance of the predicate device.

The Sample Size for the Training Set
- Not applicable. This is a study comparing a physical device to a predicate based on explicit bench testing demonstrating equivalence. There is no AI model involved, and therefore no "training set."

How the Ground Truth for the Training Set was Established
- Not applicable, as there is no AI model or training set.

Summary

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510K SUMMARY OF SAFETY AND EFFECTIVENESS

1 . Submitted By:

DEG 3 0 2002

John Schalago Manager, Regulatory Affairs

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

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

2. Device Name:

BD Ultra-Fine™ III Pen Needle Trade Name:

Common Names: Insulin Pen Needle

Hypodermic Single Lumen Needle Classification Name:

3. Predicate Device:

BD Ultra-Fine™ III Pen Needle

Manufactured by: Becton Dickinson Consumer Healthcare

4. Device Description:

న్. Intended Use:

Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

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510K Summary of Safety and Effectiveness (Continued)

6. Technological Characteristics:

The B-D ULTRA-FINE ® III 31G Pen Needle and the predicate device have the identical technological characteristics and perform equivalently.

The only difference between the ULTRA-FINE ® III 31G and the predicate device is the inner bore diameter.

7. Performance:

Bench tests relating to the performance of the pen needle 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 Ultra-Fine III 31G Pen Needles perform equivalent to the predicate device 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Corporate: Boulevar Rockville MD 20850

DEC 30 2002

Mr. John Schalago Manager. Regulatory Affairs Becton Dickinson & Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1883

Re: K024109

Trade/Device Name: BD Ultra-Fine™ III Pen Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 10, 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). 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

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Attachment XI .1

Page l of

510(k) Number (if known): |< 0 d 4 l

Device Name: Becton Dickinson Pen Needle

Indications For Use:

Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

(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)

ith Mr. Burbank &
Patricia Ciconte

v. General Hospital,

510(k) Number: K024409

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).