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.

Device Description

The BD SafeAssist" safety 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 SafeAssist™ features a 30G needle gauge size and is offered in needle lengths of 5mm and 8mm. It is a single-use disposable device that is provided sterile (gamma irradiation sterilization). BD SafeAssist™ is non-toxic and non-pyrogenic.

The BD SafeAssist 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 BD SafeAssist" to the pen injector. The shield of the BD SafeAssist" will hide the needle prior to use. As the user presses the BD SafeAssist against the skin at a 90° angle, the shield retracts to expose the needle and allows it to penetrate the skin. After injection is completed and the BD SafeAssist" is removed from the skin, the shield extends automatically and locks in place to cover the needle. The locked shield is designed to reduce the occurrence of accidental needle stick injuries. The device also features a red band indicator which provides the user visual confirmation the needle's safety mechanism has been activated. The BD SafeAssist ""should be removed from the pen and discarded after use.

The BD SafeAssist™ device comprised of modifications to the BD AutoShield™ predicate cleared under K060007. These modifications consist of design, material and labeling changes.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for the "BD SafeAssist™ Pen Needle". It seeks to demonstrate substantial equivalence to legally marketed predicate devices. The information provided is for regulatory clearance, not a study evaluating human reader performance with or without AI assistance. Therefore, many of the requested fields are not applicable.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical study assessing diagnostic accuracy or similar metrics for an AI device. Instead, it outlines non-clinical performance testing to demonstrate that the device meets requirements for its intended use and is substantially equivalent to predicate devices. The "acceptance criteria" are implied by the standards and tests performed.

Acceptance Criteria (Implied by Standards/Tests)	Reported Device Performance
Functional Performance: Conformance to ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles	Met requirements for its intended use and demonstrated substantial equivalence to its predicate devices.
Sterilization: Conformance to ISO 11137-2 (Sterilization of Health Care Product - Radiation Part 2: Establishing the Sterilization Dose)	Met requirements for its intended use and demonstrated substantial equivalence to its predicate devices.
Material Biocompatibility: Conformance to ISO 10993-1 (Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process) for the following tests:	Met requirements for its intended use and demonstrated substantial equivalence to its predicate devices.
- Cytotoxicity in Cell Culture	(Implicitly passed)
- Hemolysis	(Implicitly passed)
- Acute Systemic Toxicity	(Implicitly passed)
- Intracutaneous Reactivity	(Implicitly passed)
- Primary Dermal Irritation	(Implicitly passed)
- Pyrogenicity	(Implicitly passed)
- Sensitization	(Implicitly passed)
- Genotoxicity (Bacterial and Mammalian)	(Implicitly passed)
- Subchronic Toxicity	(Implicitly passed)
- Leachable Colorant	(Implicitly passed)
- Bacterial Endotoxin	(Implicitly passed)

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

The document does not specify a "test set" in the context of an AI study (i.e., a dataset of images/cases for evaluating algorithm performance). The testing mentioned is for the physical device's functional, sterilization, and biocompatibility properties. Therefore, "sample size" would refer to the number of physical devices or materials tested for these engineering and biological properties, not a set of clinical data. This information (specific numbers of needles tested) is not provided in the summary.

Data provenance (country of origin, retrospective/prospective) is not applicable as this is not a study using patient data.

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)

Not applicable. "Ground truth" in the context of an AI system's performance on clinical data is not relevant here. The ground truth for the tests performed would be established by standard accredited laboratory testing methods for functional performance, sterility, and biocompatibility.

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

Not applicable. Adjudication methods are used in clinical studies or studies involving human interpretation of data. This document describes non-clinical laboratory testing.

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. This is not an AI device or a diagnostic device where human reader performance would be a relevant metric. The device is a "Hypodermic Single Lumen Needle" with a safety shield.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for the tests performed are objective measurements based on established scientific and engineering standards (e.g., ISO standards for injection systems, sterilization, and biocompatibility). It is determined by the results of controlled laboratory experiments and chemical/biological assays, rather than expert consensus on clinical findings or pathology.

8. The sample size for the training set

Not applicable. This device does not involve AI/machine learning, and therefore there is no "training set."

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

Not applicable, as there is no training set for an AI model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines beneath them.

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

July 6, 2016

Becton, Dickinson And Company Meriam Youssef Staff Regulatory Affairs Specialist 1 Becton Dr Franklin Lakes, New Jersey 07417

Re: K161553

Trade/Device Name: BD SafeAssist™ Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 3. 2016 Received: June 6, 2016

Dear Meriam Youssef:

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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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Tina Kiang
-s

for Erin I. Keith, M.S. 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 Statement

510(k) Number (if known): K161553

BD SafeAssist™ Pen Needle Device Name:

Indications for Use:

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

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

Submitted By:	Meriam YoussefStaff Regulatory Affairs Specialist, BD Medical1 Becton DriveFranklin Lakes, NJ 07417Tel: 201 847 6557Fax: 201 847 5307
Date Prepared:	June 30, 2016
Device Name:	Trade Name:Common Name:Classification:Product Code:	BD SafeAssist™Insulin Pen NeedleClass II device; 21 CFR 880.5570,(hypodermic single lumen needle)FMI (hypodermic single lumen needle)

Legally marketed predicate devices to which substantial equivalence is being claimed: K060007: BD AutoShield™ Pen Needle

Reference device:

K110703: BD AutoShield™ Duo Pen Needle

Device Description:

Device Description.
The BD SafeAssist" safety 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 SafeAssist™ features a 30G needle gauge size and is offered in needle lengths of 5mm and 8mm. It is a single-use disposable device that is provided sterile (gamma irradiation sterilization). BD SafeAssist™ is non-toxic and non-pyrogenic.

The BD SafeAssist™ device comprised of modifications to the BD AutoShield™ predicate cleared under K060007. These modifications consist of design, material and labeling changes.

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Intended Use:

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

Comparison with Predicate Devices:

The BD SafeAssist™ Pen Needle has the same intended use as its predicate device. The modifications made to the device design and materials do not impact the fundamental scientific technology or performance of the device. Non-clinical testing supports substantial equivalence of the subject device despite these technological differences. The table below provides a side by side comparison of the subject device compared to its predicate.

Feature	Subject Device: BDSafeAssistTM	Predicate Device: BDAutoShieldTM PenNeedle	Reference Device: BDAutoShieldTM Duo PenNeedle
510(k) Number	Pending	K060007	K110703
Intended Use	The BD SafeAssistTM PenNeedle is intended foruse with pen injectordevices for the injectionof drugs, includinginsulin and exenatide.Additionally, the attachedsafety shieldautomatically locks inplace and reduces theoccurrence of accidentalneedle sticks from thepatient end of the needle.The shield also serves tohide the needle beforeand after injection.	The AutoShieldTM PenNeedle is intended for usewith pen injector devicesfor the injection of drugs,including insulin andexenatide.Additionally, the attachedsafety shield automaticallylocks in place and reducesthe occurrence ofaccidental needle sticksfrom the patient end of theneedle. The shield alsoserves to hide the needlebefore and after injection.	For use with pen injectordevices for the injection ofdrugs.The product has twosafety shields, which lockin place after use (patient-end) and upon removal ofthe needle from the pen(pen connection-end).The locked shields helpreduce the occurrence ofneedle sticks from bothends of the needle.
Needle Gauge Size(s)	30G	29G, 30G and 31G	30G and 31G
Needle Length Size(s)	5mm and 8mm	5mm, 8mm and 12.7mm	5mm and 8mm
Tip Geometry(Configuration)	3 bevel	3 bevel	3 bevel
Needle insertion method	Manual	Manual	Manual
Sterility Barrier	YES (peel-away label)	YES (label on cover)	YES (peel-away label)
Provided Sterile	YES (Gamma Irradiation)	YES (Gamma Irradiation)	YES (Gamma Irradiation)
Visual Indicator	Red band	Metal Clips/ Tabs	Red band
Patient end shield	Sleeve and Shield	Shield	Sleeve and Shield
Locking Element	YES (molded)	YES (metal clips)	YES (molded)
Component Material
Outer Cover	Polyethylene (White)	Polypropylene (White)	Polyethylene (White)
Sleeve	Polycarbonate (Grey)	N/A	Polycarbonate (White)
Outer Shield	Polycarbonate (Clear)	Polypropylene (White)	Polycarbonate (Clear)
Inner Shield	Polycarbonate (Clear)	N/A	Polycarbonate (Clear)
Non-Patient Shield	Polycarbonate (Clear)	N/A	Polycarbonate (Orange)

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Testing:

BD has performed non-clinical performance testing based on its risk assessment. This testing included functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles, sterilization per ISO 11137-2 (Sterilization of Health Care Product - Radiation Part 2: Establishing the Sterilization Dose), and material biocompatibility per ISO 10993-1 (Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process) for the following tests:

Cytoxicity in Cell Culture ●
Hemolysis ●
Acute Systemic Toxicity ●
Intracutaneous Reactivity ●
Primary Dermal Irritation ●
Pyrogenicity
Sensitization ●
Genotoxicity (Bacterial and Mammalian)
Subchronic Toxicity ●
Leachable Colorant ●
Bacterial Endotoxin

Results of testing demonstrated the BD SafeAssist™ pen needle device met requirements for its intended use and demonstrated substantial equivalence to its predicate devices.

Conclusion:

Based on the testing conducted, the BD SafeAssist" pen needle device is substantially equivalent to its predicate device.

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).