Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.

Device Description

The BD AutoShield™ Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The BD AutoShield™ Pen Needles are offered in various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). The BD AutoShield™ Pen Needle is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. It is a disposable, single use device.

Additionally, the BD AutoShield™ Pen Needle is designed to reduce occurrence of accidental needle sticks from the patient end of the needle by providing a shield that locks over the needle after use. Prior to injection, the user will attach the AutoShield™ Pen Needle to the pen. The shield of AutoShield™ Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the skin at a 90° angle, the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The AutoShield™ Pen Needle should be removed from the pen and discarded.

AI/ML Overview

The provided text describes the BD AutoShield™ Pen Needle and its clearance. However, it does not include the detailed information required to fill out a table of acceptance criteria, reported device performance, or specifics about a study design (like sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies).

The document is a 510(k) Summary of Safety and Effectiveness for the BD AutoShield™ Pen Needle, which details its features and intended use, and states that "Bench testing and simulated clinical testing was performed to confirm the device's safety and efficacy." It also mentions "Clinical testing was performed to evaluate the function of the of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users."

However, it does not provide any specific quantitative acceptance criteria or detailed performance results from these studies. It concludes broadly that "Based on these performance testing results, the BD AutoShield™ Pen Needle is safe and effective when used as intended."

Therefore, based on the input provided, I cannot complete the requested information.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document	"safe and effective when used as intended"
Not specified in the document	"confirms the device's safety and efficacy"
Not specified in the document	"function of the safety feature... evaluated"

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study is described as "simulated clinical testing" and "clinical testing in a simulated clinical environment."

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):

Number of experts: Not specified.
Qualifications of experts: The study involved "professional health care workers and non-clinician pen users," but their specific qualifications or experience levels are not detailed.

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

Not specified.

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:

No MRMC comparative effectiveness study is mentioned. This device is a physical pen needle, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is a physical pen needle and not an algorithm.

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

The document implies that "bench testing and simulated clinical testing" were used to assess safety and efficacy, and the "function of the safety feature" was evaluated. The specific "ground truth" methodology (e.g., direct observation, quantitative measurements against a standard) for these assessments is not detailed.

8. The sample size for the training set:

Not applicable/Not specified. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable/Not specified.

Summary

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K060007

Confidential & Proprietary

Attachment 4

MAR 2 3 2006

510(k) Summary Of Safety and Effectiveness

I. General Information
This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92

Establishment:

	• Address:	BD Medical – Pharmaceutical Systems1 Becton DriveFranklin Lakes, NJ 07417-1885
	• Registration Number:• Contact Person:	2243072James W. HaynesSenior Regulatory Affairs SpecialistTelephone No.: 201-847-4298Fax No.: 201-847-7040
	• Date of Summary:	December 28, 2005
Device	• Trade Name:	BD AutoShield™ Pen Needle
	• Classification Name:• Classification:• Performance Standards:	Single Lumen Hypodermic NeedleClass IINone Established under 514 of the Food, Drugand Cosmetic Act

II. Safety and Effectiveness Information Supporting Substantial Equivalence
- · Device Description

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Confidential & Proprietary

K060007

AutoShield™ Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the skin at a 90° angle, the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The AutoShield™ Pen Needle should be removed from the pen and discarded.

· Intended Use
The BD AutoShield™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide.

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

· Synopsis of Performance Study Results
Bench testing and simulated clinical testing was performed to confirm the device's safety and efficacy. Clinical testing was performed to evaluate the function of the of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users.

Based on these performance testing results, the BD AutoShield™ Pen Needle is safe and effective when used as intended.

III. Predicate Device Summary Table

· Substantial Equivalence

Based on comparison of the device features, materials, intended use and performance, the BD AutoShield™ Pen Needle was shown to be substantially equivalent to the commercially available predicate device indicated in the table below. The predicate device, K number, and clearance date are also identified in the table below.

Manufacturer	Predicate Device	K-Number	Clearance Date
BectonDickinson	BD Pen Needle	K051889	September 13, 2005

James W. Haynes

12/30/05

Date

Semor Regulatory Affairs Specialist Becton Dickinson Medical - Pharmaceutical Systems Becton Dickinson and Company

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is surrounded by the words "Department of Health and Human Services USA" in a circular arrangement.

MAR 2 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James W. Haynes Senior Regulatory Affairs Specialist BD Medical-Pharmaceutical Systems Becton, Dickinson and Company 1 Becton Drive (MC 440) Franklin Lakes, New Jersey 07417

Re: K060007

Trade/Device Name: BD AutoShieldTM Pen Needle Regulation Number: 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: February 8. 2006 Received: February 10, 2006

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 (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 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.

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

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Page 2 - Mr. James W. Haynes

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 continue 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 (240) 276-0115. 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 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,

Sytti Y. Michael M.D

Chiu Lin, Ph.D. 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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INDICATIONS FOR USE

510(K) Number (IF Known):

DEVICE NAME: BD AutoShield™ Pen Needle

INDICATIONS FOR USE:

The BD AutoShield™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide.

PRESCRIPTION USE (Per 21 CFR § 801.109) OR Over-the-Counter Use (OPTIONAL FORMAT 1-2-96)

(Please do not Write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antony D. my

enn logy, General Huspital

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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).