Like the predicate devices, BD pen needles are single use, sterile, medical devices designed to be used 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 and lengths. BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and nonpyrogenic.

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 allow 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 silicone based lubes 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 sterile 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 polybags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to an SAL 10-6 by gamma irradiation. The above information is the same as the predicate device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test)	Standard/Section Applied	Reported Device Performance
Tubing Diameters	ISO 11608-2, section 4.3.1	Tubing dimensions meet OD and ID requirement.
Patency of Lumen	ISO 11608-2, section 4.4	Stylet, having a diameter equivalent to 80% ±2% of lumen ID, passes through freely.
Needle Points	ISO 11608-2, section 4.5	Visually sharp at 2.5X magnification, designed to minimize coring and fragmentation.
Type A Needle (length)	ISO 11608-2, section 4.3.2	Patient end within indicated length ± 1.25 mm.
Cannula Load Test (No Pre-conditioning)	ISO 11608-2, section 4.9 and 9; ISO 7864 Section 13.1	Cannula holds force of 22N for 5 seconds.
Cannula Load Test (with Pre-conditioning)	ISO 11608-2, section 4.9 and 9; ISO 7864 section 13	Cannula holds force of 22N for 5 seconds.
Lubrication	ISO 11608-2, section 4.7	No visible droplets inside/outside surfaces of cannula.
Compatibility Testing	ISO 11608-2, section 4.10	Connectivity (torque) was within acceptable limits.
Freedom from Defects	ISO 11608-2, Section 4.6	Needle to be straight and of regular cross section and wall thickness.
Needle Dislocation	ISO 11608-2, section 4.8 and 8	Patient end max dislocation: 4mm PN=0.58mm, 5mm PN=0.65mm, 8mm PN=0.9mm. Angular deviation on patient end not to exceed ±3°.
Penetration Testing	BD Test Method TP700279	Demonstrated equivalent performance (details not fully provided in this summary).
Thumb Force Testing	BD Test Method TP700381	Demonstrated equivalent performance (details not fully provided in this summary).

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

The document states "Bench tests relating to the performance of the BD 31G and 32G XTW Pen Needle with PentaPoint™ were conducted." However, it does not specify the exact sample sizes used for each individual test.

The data provenance is prospective bench testing, conducted by Becton, Dickinson and Company. There is no information regarding country of origin of data beyond the manufacturer's location in Franklin Lakes, New Jersey, USA.

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

This document describes bench testing, which typically relies on established engineering principles, international standards (like ISO 11608-2 and ISO 7864), and standardized test methods rather than expert consensus on medical images or clinical data. Therefore, the concept of "experts establishing ground truth" in the context of medical image interpretation (e.g., radiologists) is not applicable to this type of device and study. The "ground truth" for these tests is defined by the technical specifications and performance criteria outlined in the ISO standards and internal test methods.

4. Adjudication Method for the Test Set

As this is bench testing against established performance standards, an adjudication method (like 2+1, 3+1, none) typically used for subjective assessments or disagreements in clinical trials is not applicable. The results are objectively measured against predefined thresholds in the standards.

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 study focuses on the physical and mechanical performance of the pen needle against predicate devices and international standards, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a mechanical pen needle, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not applicable. The performance described is the device's inherent physical performance.

7. The Type of Ground Truth Used

The ground truth used for these bench tests is based on:

International Standards: Primarily ISO 11608-2 (Pen-injectors for medical use - Part 2: Needles) and ISO 7864 (Sterile hypodermic needles for single use). These standards define specific measurement criteria, tolerances, and test methodologies.
Manufacturer's Internal Test Methods: BD Test Method TP700279 for Penetration Testing and BD Test Method TP700381 for Thumb Force Testing.
Predicate Device Performance: The primary goal of the study was to demonstrate equivalent performance to previously cleared predicate devices (K123300, K100005, K051899).

8. The Sample Size for the Training Set

Not Applicable. This is a mechanical device, and bench testing does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. See point 8.

Summary

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K 131358

1 Becton Drive Franklin Lakes, New Jersey 07417 tel: 201.847.6800 www.bd.com

JUL 1 6 2013

Image /page/0/Picture/3 description: The image shows the BD logo, which consists of a circular emblem with a stylized figure and sun rays above it. To the right of the emblem are the letters 'BD' in bold, sans-serif font. Below the letters is the tagline 'Helping all people' in a smaller font size.

live healthy lives

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Date of Summary Preparation: May 9, 2013

1 . Submitted By/Contact: Pasquale Amato Staff Regulatory Affairs Specialist
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417

201-847-4513 Phone: Fax: 201-848-8830

Alternate Contact Person:

Sheryl Robinson Bagalio Director, Regulatory Affairs Phone: 201-847- 5326 201-848- 8830 Fax: Email: Shery1 Bagalio@BD.com

1. Device Name:
  Trade Name:

BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™

Insulin Pen Needle Common Names:
Needle, Hypodermic, Single Lumen Classification Name:

Classification: Class II, 21 CFR 880.5570 FMI

3. Predicate Device:

BD Pen Needles:

K123300, BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with . PentaPoint™
K 100005 BD Pen Needle 32G x 4mm .

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K051899 31G x 8mm and the 31G x 5mm Pen Needles . Manufactured by: Becton, Dickinson and Company

Device Description: 4.

The purpose of this Traditional 510(k) is to provide substantiation for the label claims.

Statement of Intended Use/Indications for Use: 5. BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
The intended use for the principal device remains the same as the predicate devices.

Technological Characteristics: 6.

The principal device, BD 31G and 32G XTW Pen Needles with PentaPoint™, of this Premarket Notification has the same design and all design control activities have been conducted in accordance with Quality System Regulations. The principal device is substantially equivalent to the predicate devices given:

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Has the same intended use and indications for use as the predicate . devices
Uses the same operating principles .
Incorporates the same design .
Is manufactured from the same materials .
Is sterilized using the same mode .
Is sterilized to SAL of 10-6 .
Is packaged using same unit and case materials .
Same scientific technology .
Same manufacturing process .

There are little to no differences between the principal device BD 31G and 32G XTW Pen Needles with PentaPoint™ and the predicate devices.

7. Performance:

Bench tests relating to the performance of the BD 31G and 32G XTW Pen Needle with PentaPoint™ were conducted.

The principal device demonstrated equivalent performance to the predicate devices during bench testing. Bench testing consisted of:

Tubing diameters	Per ISO 11608-2, section 4.3.1 (tubing dimensions meet OD and ID requirement).
Patency of lumen	Per ISO 11608-2, section 4.4 (stylet, having a diameter equivalent to 80% ±2% of lumen ID passes through freely).
Needle points	Per ISO 11608-2, section 4.5 (visually sharp at 2.5X magnification, designed to minimize coring and fragmentation).
Type A Needle (length)	Per ISO 11608-2, section 4.3.2 (patient end within indicated length ± 1.25 mm)
Cannula load test(No pre-conditioning)	Per ISO 11608-2, section 4.9 and 9.ISO 7864 Section 13.1(cannula holds force of 22N for 5 seconds).
Cannula load test(with pre-conditioning)	Per ISO 11608-2, section 4.9 and 9.ISO 7864 section 13(cannula holds force of 22N for 5 seconds).
Lubrication	Per ISO 11608-2, section 4.7 (no visible droplets inside/outside surfaces of cannula).
Compatibility Testing	Per ISO 11608-2, section 4.10 (connectivity (torque).

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Freedom form Defects	Per ISO 11608-2, Section 4.6 (needle to bestraight and of regular cross section and wallthickness)
Needle Dislocation	Per ISO 11608-2, section 4.8 and 8 (Patientend max dislocation from center for 4mmPN=0.58mm; 5mm PN=0.65mm; 8mmPN=0.9mm.The angular deviation on the patient end shallnot exceed ±3°
Penetration Testing	Per BD Test Method TP700279
Thumb Force Testing	Per BD Test Method TP700381

8. Substantial Equivalence:

The principal device, BD 31G and 32G XTW Pen Needles with PentaPoint™ is the same as the predicate device cleared in K123300, which was found substantially equivalent to the devices previously submitted and cleared in K100005 and K051899, and is therefore substantially equivalent in intended use, function and composition is not affected.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

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

July 16, 2013

Becton Dickinson & Company Mr. Pasquale Amato Staff Regulatory Affairs Specialist 1 Becton Drive FRANKLIN LAKES NJ 07417-1885

Re: K131358

Trade/Device Name: BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPont™ Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 9, 2013 Received: May 10, 2013

Dear Mr. Amato:

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 commence 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. Amato

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Susan Run DDS, MA 2013.07.16

14:27:39-04'00'

Kwame Ulmer M.S. Acting Division 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): 13/358

Device Name: BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™

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)

Ric
20
-0.

Richard C. Chapman 2013.07.16 11:31:40 -04'00'

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

(Division Sign-Off) livision of Anesthestology, General Hospital ifection Control, Dental Devices

510(k) Number: _ K (313 56

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).