BD pen needles are single use, sterile, medical devices designed to be use in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G and 31G) and lengths (5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), nontoxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using a silicone based lube for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needlesticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterility barrier and tamper evidence. The Outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized. The purpose of this 510(k) Premarket Notification is to expand the product offering to include a 32G x 4mm Pen Needle. The intended use for the modified device remains the same as the predicate device.

AI/ML Overview

This document describes the regulatory submission for the BD 32G x 4mm Pen Needle, demonstrating its substantial equivalence to predicate devices. The primary study presented is a clinical evaluation of glycemic control.

1. Acceptance Criteria and Reported Device Performance

Performance Characteristic/Test Description	Acceptance Criteria (Implicit from ISO 11608-2)	Reported Device Performance
Clinical Performance: Comparison of Glycemic Control among Diabetics using the 4mm x 32G BD Pen Needle vs. the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle.	Equivalent glycemic control and a similar safety profile to predicate pen needles. (Implicit)	This study demonstrated that the 4 mm x 32G pen needle tested provides equivalent glycemic control and a similar safety profile to two predicate pen needle products - the 5mm x 31G and 8 mm x 31G pen needles. The clinical study summary can be found in Section XV, Clinical Performance.
Bench Testing (per ISO 11608-2):
Tubing diameters	Section 4.3.1 (tubing dimensions meet OD and ID requirements)	Tubing dimensions meet OD and ID requirements.
Patency of lumen	Section 4.4 (stylet, having a diameter equivalent to 80% ±2% of lumen ID passes through freely)	Stylet, having a diameter equivalent to 80% ±2% of lumen ID, passes through freely.
Needle points	Section 4.5 (visually sharp at 2.5X magnification)	Visually sharp at 2.5X magnification.
Needle dislocation (angularity)	Section 4.8 (4 mm patient end needle length meets needle dislocation requirements)	4 mm patient end needle length meets needle dislocation requirements.
Type A needles (length)	Section 4.3 (patient end within indicated length ± 1.25 mm and cartridge end within 3.5-7.25 mm)	Patient end within indicated length ± 1.25 mm and cartridge end within 3.5-7.25 mm.
Cannula load test (No pre-conditioning)	Section 4.9 (cannula holds force of 22N for 5 seconds)	Cannula holds force of 22N for 5 seconds.
Cannula load test (with pre-conditioning)	Section 4.9 (cannula holds force of 22N for 5 seconds)	Cannula holds force of 22N for 5 seconds.
Siliconization (lubrication)	Section 4.7 (no visible droplets inside/outside surfaces of cannula)	No visible droplets inside/outside surfaces of cannula.
Universal Fit Compatibility Testing	Section 4.1 (connectivity (torque) and dose accuracy testing)	Connectivity (torque) and dose accuracy testing were successfully met for all pen families. The full set of insulin pen families available in the U.S. were tested with the BD 32G x 4mm Pen Needle for compatibility. Connectivity acceptance criteria per ISO 11608-2 were successfully met for all pen families. (From Section 7)

2. Sample Size and Data Provenance

Test Set (Clinical Study): The document does not explicitly state the sample size (number of subjects) for the clinical study "BDDC-08-011". It only mentions "subjects' glycemic control".
Data Provenance: The document does not specify the country of origin for the clinical study data. It is a "clinical study conducted on the BD 32G x 4mm Pen Needle," indicating it was prospective.
Test Set (Bench Testing): The document does not specify sample sizes for each bench test performed according to ISO 11608-2.

3. Number of Experts and Qualifications for Ground Truth

This type of submission (510(k) for a medical device like a pen needle) does not typically involve "experts" establishing ground truth in the way it would for AI/diagnostic algorithms.

For the Clinical Study: The "ground truth" for glycemic control would be established through objective laboratory measurements (fructosamine levels) and clinical observation of safety profiles. While medical professionals (e.g., endocrinologists, nurses) would oversee the study, their role is not to establish a "ground truth" in the diagnostic sense, but to collect and interpret data against pre-defined clinical endpoints. No specific number or qualification of experts for "ground truth establishment" is provided or expected.
For Bench Testing: The "ground truth" is based on adherence to the specified International Standard ISO 11608-2. This is based on objective, quantifiable measurements and visual inspections against defined criteria within the standard. The "experts" involved would be qualified technicians and engineers performing these standardized tests, but their qualifications are not detailed in the summary.

4. Adjudication Method

Clinical Study: Not applicable in the context of diagnostic AI. Clinical endpoints are typically adjudicated by an independent committee (e.g., Clinical Events Committee) if there are subjective elements, but the document does not specify any such process. For glycemic control, the primary data (fructosamine levels) are objective.
Bench Testing: Not applicable. Measurements are objective and compared against ISO standards.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is more relevant for diagnostic imaging or interpretation tasks where human readers might be assisted by AI. For a pen needle, the focus is on physical and functional performance and direct clinical outcomes like glycemic control, not AI-assisted interpretation.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was done. This device is a physical medical device (pen needle), not an AI algorithm. Therefore, "algorithm only performance" is not applicable.

7. Type of Ground Truth Used

Clinical Study (BDDC-08-011): The ground truth for the clinical study was based on outcomes data, specifically "fructosamine levels" to assess glycemic control, and an evaluation of the "safety profile." Fructosamine is an objective biochemical marker indicating average blood glucose levels over a period.
Bench Testing: The ground truth for bench tests was adherence to specified objective criteria and measurements as defined by the international standard ISO 11608-2.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve AI/machine learning algorithms that require a "training set."

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

Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it is irrelevant in this context.

Summary

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KIGO COS

. I

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 1 6 2010

1. Submitted By:

April 7, 2010

。

James Haynes Manager, Regulatory Affairs

Becton, Dickinson and Company BD Medical Diabetes Care 1 Becton Drive MC 372 Franklin Lakes, NJ 07417

201-847-4298 Phone: Fax: 201-847-4859

2. Device Name:

Trade Name: BD 32G x 4mm Pen Needle Common Names: Pen Needle Classification Name: Hypodermic Single Lumen Needle Classification: Class II

3. Predicate Device:

BD Pen Needle 31G x 5mm BD Pen Needle 31Gx 8mm Manufactured by: Becton, Dickinson and Company

4. Device Description:

The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using a silicone based lube for ease of injection and rubber septum

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penetration. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needlesticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterility barrier and tamper evidence. The Outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized.

The purpose of this 510(k) Premarket Notification is to expand the product offering to include a 32G x 4mm Pen Needle. The intended use for the modified device remains the same as the predicate device.

5. Intended Use:

BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

Technological Characteristics: 6.

The principal device of this premarket notification is the result of a design change to the predicate device (K051899) conducted in accordance with Quality System Regulations. The only change to the modified device is that the cannula gauge is smaller (32G) and the cannula length is shorter (4mm). The modified BD Pen Needle is equivalent to the predicate BD Pen Needle devices, given that the modified device:

. Has the same intended use and indications for use
Provides equivalent glycemic control and similar safety profile �
Uses the same operating principles ◆
Incorporates the same basic design .
Has the same identical technological characteristics and perform ◆ equivalently.
. Is manufactured from the same materials
. Is sterilized using the same mode
Is sterilized with SAL of 10-6 .
. Is packaged using similar unit, carton and case materials

The only difference between the Principle and Predicate BD Pen Needle device is the smaller size of the cannula.

7. Substantial Equivalence:

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A clinical study was conducted on the BD 32G x 4mm Pen Needle. This study demonstrated that the 32G x 4mm Pen Needle provides equivalent glycemic control compared to the predicate pen needle products, the BD 31G x 5mm and 31G x 8mm Pen Needles. Further, bench testing to ISO Standard 11608-2, was conducted on the 32G x 4mm Pen Needle and met all acceptance criteria as listed in the following Validation /Verification Table. Additionally, the full set of insulin pen families available in the U.S. were tested with the BD 32G x 4mm Pen Needle for compatibility. Connectivity acceptance criteria per ISO 11608-2 were successfully met for all pen families.

Based on comparison of the device features, materials, intended use, bench testing and clinical performance, the BD Pen Needle has shown to be substantially equivalent to the commercially available predicate devices.

The results of these tests demonstrate that the modified BD Pen Needle performs equivalent to the predicate device and is safe and effective when used as intended.

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The following table summarizes the validation and verification testing that was performed.

PerformanceCharacteristic/Test description	Test Performed	Results
BDDC-08-011:Comparison ofGlycemic Controlamong Diabetics usingthe 4mm x 32G BD PenNeedle vs. the 8mm x31G BD Pen Needleand the 5mm x 31G BDPen Needle.	Clinical Evaluation comparingsubjects' glycemic control, by meansof fructosamine levels.	This study demonstrated that the 4 mm x 32Gpen needle tested provides equivalentglycemic control and a similar safety profile totwo predicate pen needle products - the 5mmx 31G and 8 mm x 31G pen needles. Theclinical study summary can be found inSection XV, Clinical Performance.
	Tubing diameters	Per ISO 11608-2, section 4.3.1 (tubingdimensions meet OD and ID requirement).
	Patency of lumen	Per ISO 11608-2, section 4.4 (stylet, having adiameter equivalent to 80% ±2% of lumen IDpasses through freely).
	Needle points	Per ISO 11608-2, section 4.5 (visually sharp at2.5X magnification).
	Needle dislocation (angularity)	Per ISO 11608-2, section 4.8 (4 mm patientend needle length meets needle dislocationrequirements).
	Type A needles (length)	Per ISO 11608-2, section 4.3 (patient endwithin indicated length ± 1.25 mm andcartridge end within 3.5-7.25 mm)
	Cannula load test(No pre-conditioning)	Per ISO 11608-2, section 4.9 (cannula holdsforce of 22N for 5 seconds).
	Cannula load test(with pre-conditioning)	Per ISO 11608-2, section 4.9 (cannula holdsforce of 22N for 5 seconds).
	Siliconization (lubrication)	Per ISO 11608-2, section 4.7 (no visibledroplets inside/outside surfaces of cannula).
	Universal Fit Compatibility Testing	Per ISO 11608-2, section 4.1 (connectivity(torque).Dose accuracy testing)

Validation/Verification Tests

The results of these tests demonstrate that the modified BD Pen Needle performs equivalent to the predicate device and is safe and effective when used as intended.

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Public Health Service

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

APR 1 6 2010

Mr. James Haynes Manager, Regulatory Affairs Becton, Dickinson and Company 1 Becton Drive MC 372 Franklin Lakes, New Jersey 07417-0741

Re: K100005

Trade/Device Name: BD 32G x 4mm Pen Needle Regulation Number: 21CFR 880.5570 Regulation Name: Hypodermic Single Limen Needle Regulatory Class: II Product Code: FMI Dated: February 5, 2010 Received: February 16, 2010

Dear Mr. Haynes:

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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Page 2- Mr. Haynes

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 CDRF1'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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Anthony D. Watson, B.S., M.S., M.B.A. Division 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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Indications for Use

510(k) Number (if known):

Device Name: BD 32G x 4mm Pen Needle

Indications For Use:

. . . .

BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Page 1 of __1

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K00005

K 100005

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).