The BD Contoured Base 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. It consists of a needle, base, and shield assembly. The BD Contoured Base Pen Needle is offered in a 32 gauge size and 4mm length. It is a single-use disposable device that is provided sterile. The BD Contoured Base Pen Needle is non-toxic and non-pyrogenic.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device: the BD Contoured Base Pen Needle. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through a full clinical trial with novel acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria in the context of a study definitively proving the device meets those criteria for novel performance. Instead, it describes how the new device is substantially equivalent to a previously cleared device.

However, I can extract the information related to the performance tests performed to demonstrate substantial equivalence, which can be seen as meeting "requirements" rather than "acceptance criteria" in the traditional sense of a novel device proving its efficacy.

Here's an interpretation based on the provided text, structured to answer your questions where possible, and noting when the information is not applicable (N/A) or not present in the document.

Device: BD Contoured Base Pen Needle (K182320)
Predicate Device: BD Nano™ Pen Needle (K162516)
Purpose of Submission: To demonstrate substantial equivalence of the subject device to the predicate device, especially considering modifications to components like the pen needle hub, inner needle shield, and outer cover.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present "acceptance criteria" in a typical quantitative sense (e.g., "sensitivity must be >X%"). Instead, it states that the device was tested per ISO standards, and the results "passed" or "successfully demonstrated the subject device has met the requirements." The acceptance criteria are implicitly defined by the standards themselves.

Test Category	Specific Test (per ISO Standard)	Acceptance Criteria (Implicit from Standard)	Reported Device Performance
Functional Performance	Determination of Flow Rate through needle (ISO 11608-2)	Meets flow rate requirements specified in ISO 11608-2.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Bond between hub and cannula (ISO 11608-2)	Meets bond strength requirements specified in ISO 11608-2.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Pen Installation and Removal Torque (ISO 11608-2)	Meets torque requirements specified in ISO 11608-2.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Dose Accuracy (ISO 11608-2)	Meets dose accuracy requirements specified in ISO 11608-2.	"Passed" and "successfully demonstrated the subject device has met the requirements."
Biocompatibility	Chemical Characterization (ISO 10993-1)	Meets biocompatibility requirements specified in ISO 10993-1.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Cytotoxicity (ISO 10993-1)	Meets biocompatibility requirements specified in ISO 10993-1.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Intracutaneous Reactivity (ISO 10993-1)	Meets biocompatibility requirements specified in ISO 10993-1.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Skin Sensitization (ISO 10993-1)	Meets biocompatibility requirements specified in ISO 10993-1.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Acute Systemic Toxicity (ISO 10993-1)	Meets biocompatibility requirements specified in ISO 10993-1.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Subacute/Subchronic Toxicity (ISO 10993-1)	Meets biocompatibility requirements specified in ISO 10993-1.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Genotoxicity - Bacterial and Mammalian (ISO 10993-1)	Meets biocompatibility requirements specified in ISO 10993-1.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Hemolysis Test (ISO 10993-1)	Meets biocompatibility requirements specified in ISO 10993-1.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Material Mediated Pyrogenicity (ISO 10993-1)	Meets biocompatibility requirements specified in ISO 10993-1.	"Passed" and "successfully demonstrated the subject device has met the requirements."
	Bacterial Endotoxin (USP <85> and ISO 10993-1)	Meets requirements for bacterial endotoxin, specifically referencing USP <85>.	"Passed" and "successfully demonstrated the subject device has met the requirements."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document simply states "Testing" and lists the tests performed. It does not specify the sample sizes for any of the non-clinical functional performance or biocompatibility tests. These details would typically be in the full test reports referenced by the submission, but are not in this summary.
Data Provenance: The document does not specify the country of origin of the data. Given it's a US FDA submission for a US-based company (Becton, Dickinson and Company, Franklin Lakes, New Jersey), it's highly likely the testing was conducted in the US or in labs compliant with US regulatory requirements, but this is not explicitly stated. The tests are described as non-clinical (lab-based) performance and biocompatibility testing, not human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of submission. The ground truth for functional performance (e.g., flow rate, dose accuracy) and biocompatibility is established by the physical and chemical properties of the device and its interaction with biological systems, as measured by standardized laboratory methods (ISO standards), not by human expert consensus or interpretation of images/data. Human experts would perform the tests and analyze the results, but they are not establishing a "ground truth" in the way a radiologist establishes disease presence for an AI algorithm.

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

This question is not applicable as there are no human-interpretable "test sets" or "ground truth" established by multiple readers that would require adjudication. The testing is laboratory-based and objective against predefined ISO standard criteria.

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

This question is not applicable. The device is a physical medical device (pen needle), not an AI algorithm. There was no MRMC study, and no human readers were involved in assessing performance or effectiveness in the context of AI assistance.

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

This question is not applicable. The device is a physical medical device (pen needle), not an algorithm.

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

The "ground truth" is defined by the physical and chemical specifications within the relevant ISO standards (ISO 11608-2 for functional performance and ISO 10993-1 for biocompatibility). For example, "Dose Accuracy" has a defined acceptable range within ISO 11608-2; the ground truth for a given test is whether the device's measured dose delivery falls within that range. For biocompatibility, the ground truth is adherence to established biological safety limits for materials and leachables.

8. The sample size for the training set

This question is not applicable. The device is a physical product, not an AI model that requires a training set. The engineering design process involves iteration and verification, but it's not "training" in the machine learning sense.

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

This question is not applicable as there is no "training set" in the context of this physical device.

Summary of what the document does provide:

It demonstrates that the BD Contoured Base Pen Needle is substantially equivalent to its predicate by showing that, despite minor design changes, it meets the same functional performance and biocompatibility requirements as defined by relevant ISO standards (ISO 11608-2 and ISO 10993-1).
It explicitly states that no clinical study was included in the submission, reinforcing that the demonstration of substantial equivalence relied solely on non-clinical (laboratory) testing.
The "acceptance criteria" are implicitly the requirements of the cited ISO standards, which the device "passed."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

December 23, 2021

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

Re: K182320

Trade/Device Name: BD Contoured Base Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI

Dear Meriam Youssef:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 20, 2018. Specifically, FDA is updating this SE Letter to indication for Use form that the cleared device is an Over-the-Counter and not Prescription only (Rx) as previously indicated.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact CAPT Alan Stevens by phone at 301-796-6294 or email at alan.stevens@fda.hhs.gov.

Sincerely,

Alan M.
Stevens -S3

CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

December 20, 2018

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

Re: K182320

Trade/Device Name: BD Contoured Base Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 19, 2018 Received: November 20, 2018

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sarah B. Mollo

for Tina Kiang, Ph.D. Acting 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) K182320

Device Name BD Contoured Base Pen Needle

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K182320

Manufactures Name:	Becton, Dickinson and Company
Parent Company:	Becton, Dickinson and Company (BD Medical- Diabetes Care)
Corresponding Official:	Meriam YoussefSenior Manager Regulatory Affairs, BD Medical- Diabetes Care1 Becton DriveFranklin Lakes, NJ 07417Tel: 201 847 6557Fax: 201 847 5307
Summary Date:	December 20, 2018
Device Name:	Trade Name:Common Name:Classification:Regulation Name:Regulation Number:Product Code:	BD Contoured Base Pen NeedleInsulin Pen NeedleClass II devicehypodermic single lumen needle21 CFR 880.5570FMI (hypodermic single lumen needle)

Legally marketed predicate device to which substantial equivalence is being claimed: K162516: BD Nano™ Pen Needle

Device Description:

Indications for Use:

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

The indications for use of the subject device remains the same as the predicate device.

Comparison with Predicate Devices:

The subject device has the same materials, fundamental scientific technology and device performance as the predicated device (K162516). The purpose of this submission is to market the BD Contoured Base Pen Needle device with the changes described in the table below. This 510(k) provides supporting evidence on the performance characteristics of the

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subject device. The table below provides a side by side comparison of the subject device compared to its predicate.

Feature	Subject: BD ContouredBase Pen Needle	Predicate Device: BDNano™ Pen Needle	Comments
510(k) Number	K182320	K162516	N/A
Indications for Use	Becton Dickinson PenNeedle is intended for usewith pen injector devices forthe subcutaneous injection ofdrugs.	Becton Dickinson PenNeedle is intended for usewith pen injector devices forthe subcutaneous injection ofdrugs.	N/A
Intended Use	Becton Dickinson PenNeedle is intended for usewith pen injector devices forthe subcutaneous injection ofdrugs.	Becton Dickinson PenNeedle is intended for usewith pen injector devices forthe subcutaneous injection ofdrugs.	N/A
Pen Needle components	Pen needle hub (non-posted)Inner needle shield (flatsquared contour top andgrips)Outer Cover (wider outercover with flat top and longergrips)Cannula (32G x 4mm extrathin wall 5 bevel)	Pen needle hub (posted)Inner needle shield (flat top)Outer Cover (with grips)Cannula (32G x 4mm extrathin wall 5 bevel)	The subject device withmodifications met therequirements per ISO11608-2. Therefore, themodifications do notraise questionsrespective of safety orefficacy of the subjectdevice.
Needle insertion method	Unchanged	Manual	N/A
Product type	Unchanged	Hypodermic single lumenneedle	N/A
Angle of Insertion	Unchanged	Straight 90 degrees	N/A
Tip Geometry	Unchanged	5 Bevel	N/A
Tamper Evident Feature	Unchanged	Yes (peel-away label)	N/A
Replacement Frequency	Unchanged	Disposable, single use	N/A
Provided Sterile (Methodof Sterilization)	Unchanged	YES (Gamma Irradiation)	N/A
Non-pyrogenic	Unchanged	Yes, per USP<85>	N/A
Needle Gauge Size	Unchanged	32G	N/A
Needle Length size	Unchanged	4mm	N/A
Inner Diameter	Unchanged	Dimensions per ISO 9626Table 1 Section 5	N/A
Outer Diameter	Unchanged	Dimensions per ISO 9626Table 1 Section 5	N/A
Cannula	Unchanged	Stainless Steel	N/A
Cannula Lubricant	Unchanged	Medical Grade Lubricant	N/A
Cannula Adhesive	Unchanged	UV Cured Adhesive	N/A
Needle Hub	Unchanged	Polypropylene	N/A
Needle Shield	Unchanged	Polypropylene	N/A
Feature	Subject: BD ContouredBase Pen Needle	Predicate Device: BDNano™ Pen Needle	Comments
Outer Shield (Outer	Unchanged	Polyethylene or	Predicate device outer
Cover)	Polypropylene	Polypropylene	cover material is eitherpolypropylene orpolyethylene; whilesubject device outercover ispolypropylene.
Tear drop Label	Unchanged	Paper	N/A

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Testing:

Non- Clinical Test Summary:

The subject device has the same technological characteristics as the predicate device cleared in K162516. BD has validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods- Part 2: Needles, and Biocompatibility testing per ISO 10993-1: Biological Evaluation of Medical Devices- Part 1: Evaluation and testing.

Functional Performance Testing included the following tests per ISO 11608-2:

· Determination of Flow Rate through needle
Bond between hub and cannula
· Pen Installation and Removal Torque
Dose Accuracy

Biocompatibility Testing included the following tests per ISO 10993-1:

· Chemical Characterization
· Cytotoxicity
Intracutaneous Reactivity
· Skin Sensitization
· Acute Systemic Toxicity
Subacute/ Subchronic Toxicity
Genotoxicity- Bacterial and Mammalian
· Hemolysis Test
· Material Mediated Pyrogenicity
Bacterial Endotoxin

The results of the functional performance and biocompatibility testing passed and successfully demonstrated the subject device has met the requirements.

Clinical Test Summary:

No clinical study is included in this submission.

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Conclusion:
The non-clinical testing demonstrated the subject 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).