The Droplet® Pen Needles are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. Pen needles are used by consumers, caregivers and healthcare professionals.

The pen needle assembly consists of a double-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 cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end and the cartridge end of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration.

There is an inner needle shield assembled over the patient end of the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer cover. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier.

AI/ML Overview

This is a 510(k) summary for a medical device (pen needles), not an AI/ML device. Therefore, the requested information about acceptance criteria, study sizes, expert involvement, and ground truth establishment is not applicable in the context of AI/ML device evaluation.

The document describes non-clinical performance data for the pen needles as part of the substantial equivalence determination process for a Class II medical device.

Here's a breakdown of the relevant sections from the document that align with your request (non AI/ML related):

Table of Acceptance Criteria and Reported Device Performance: This information is available in the "Non-Clinical Performance Data" section on pages 7-9. It outlines the requirements from ISO 11608-2:2012 for various test parameters and states that the device met these requirements.

Test Parameter	Requirement - ISO 11608-2:2012	Reported Device Performance
Materials	The needle shall be made of tubing materials specified in ISO 9626.	Requirement met
Dimensions	The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2.	Requirement met
Determination of flow rate through the needle (not required by the standard)	The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle.	Requirement met
Bond between hub and needle tube	The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2.	Requirement met
Freedom from defects	The needle tube shall fulfill the requirements of ISO 7864, clause11.3.	Requirement met
Lubrication	The needle tube should be lubricated at both the patient end and the cartridge end. The lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outside surface of the needle tube.	Requirement met
Dislocation of measuring point at patient end	Dislocation of the cannula point at the patient end shall be in accordance with Table 2 when tested in accordance with Clause 8 (of ISO 11608-2).	Requirement met
Determination of functional compatibility with needle-based injection systems	Compatibility with any NIS (Needle-based Injection System) shall be claimed only after testing in accordance with Clause 11.	Requirement met
Ease of assembly and disassembly	Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11.	Requirement met
Pre-conditioning of needles	All requirements of the standard related to preconditioning of needles were met.	Requirement met

Biocompatibility Test Summary:

Test method	Compliance with	Result
Cytotoxicity Study Using the ISO Elution Method	ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	The test article showed no evidence of causing cell lysis or toxicity.
ISO Guinea Pig Maximization Sensitization Test	ISO 10993-10 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization	The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test.
ISO Intracutaneous Study in Rabbits	ISO 10993-10 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization	The test article met the requirements of the test.
ASTM Hemolysis Study	ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-4 - Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood	Both the test article in direct contact with blood and the test article extract were non-hemolytic.
ISO Two Week Toxicity Study in the Rat, Repeated Parenteral Administration of Two Extracts	ISO 10993-11 - Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	There were no microscopic changes considered to be a test article related response. Parenteral administration of the test article extract did not produce systemic toxicity in rats.
ISO Systemic Toxicity Study in Mice	ISO 10993-11 - Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article met the requirements of the study.
USP Rabbit Pyrogen Study, Material-mediated	ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	The total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP limits. The test article was judged as non-pyrogenic.
USP Pyrogen Study - Material Mediated	USP, General Chapter <151>, Pyrogen Test as recommended by ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	The test article was judged as nonpyrogenic.

Sample size used for the test set and the data provenance: This information is not specified in the document beyond the tests being performed in accordance with the listed ISO standards. The document doesn't provide details on the number of pen needles used for each specific test or the country of origin of the testing data. It only states the device "successfully passed all the required non-clinical testing." The nature of these tests (mechanical and biological safety testing) often does not involve human subjects, thus "retrospective or prospective" is not applicable in the typical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to the non-clinical performance and biocompatibility testing described for a physical medical device like a pen needle. The "ground truth" for these tests is defined by the objective performance criteria outlined in the ISO and ASTM standards.
Adjudication method for the test set: Not applicable. The tests involve objective measurements against established technical standards.
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: Not applicable. This document is not about AI/ML or diagnostic imaging that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: For the non-clinical performance data, the ground truth is the objective technical specifications and safety requirements defined by international standards (ISO 11608-2:2012, ISO 9626, ISO 7864) and biocompatibility standards (ISO 10993 parts 5, 10, 11; ASTM F756; USP General Chapter <151>).
The sample size for the training set: Not applicable, as this is not an AI/ML device that undergoes training.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains 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 ADMINISTRATION' in blue text.

March 21, 2018

HTL-STREFA S.A. Aleksandra Prazmowska-Wilanowska Regulatory Affairs Director ul. Adamowek 7 95-035 Ozorkow POLAND

Re: K171982

Trade/Device Name: Droplet® Pen Needles (Models: Droplet® Pen Needles 4mm x 32G, Droplet® Pen Needles 5mm x 32G, Droplet® Pen Needles 6mm x 32G, Droplet® Pen Needles 8mm x 32G, Droplet® Pen Needles 5mm x 31G, Droplet® Pen Needles 6mm x 31G, Droplet® Pen Needles 8mm x 31G, Droplet® Pen Needles 10mm x 29G, Droplet® Pen Needles 12mm x 29G)

Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: February 21, 2018 Received: February 21, 2018

Dear Ms. Aleksandra Prazmowska-Wilanowska:

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 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.

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.

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, Tina Kiang

-S

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) K171982

Device Name

Droplet® Pen Needles (Models:	Droplet® Pen Needles 4mm x 32G
Droplet® Pen Needles	Droplet® Pen Needles 5mm x 32G
Droplet® Pen Needles	Droplet® Pen Needles 6mm x 32G
Droplet® Pen Needles	Droplet® Pen Needles 8mm x 32G
Droplet® Pen Needles	Droplet® Pen Needles 5mm x 31G
Droplet® Pen Needles	Droplet® Pen Needles 6mm x 31G
Droplet® Pen Needles	Droplet® Pen Needles 8mm x 31G
Droplet® Pen Needles	Droplet® Pen Needles 10mm x 29G
Droplet® Pen Needles	Droplet® Pen Needles 12mm x 29G)

Indications for Use (Describe)

Droplet® Pen Needles are 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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K171982 510(k) Summary

As required by the Medical Devices Act of 1990 and in accordance with 21 CFR ട്ല807.92(a).

Summary
[807.92 (a)(1,2)]
Date Prepared:	March 15, 2018
Submitted By:	HTL-STREFA S.A.ul. Adamówek 795-035 OzorkówPOLAND
Primary Contact:	Aleksandra Prażmowska-WilanowskaRA DirectorPhone: +48 42 270 00 10ola.prazmowska-wilanowska@htl-strefa.pl
Secondary Contact:	Izabela BanaśSenior RA SpecialistPhone: +48 42 270 00 10izabela.banas@htl-strefa.pl
Trade Name:	Droplet® Pen Needles
Device models:	Droplet® Pen Needles 4 mm x 32GDroplet® Pen Needles 5 mm x 32GDroplet® Pen Needles 6 mm x 32GDroplet® Pen Needles 8 mm x 32GDroplet® Pen Needles 5 mm x 31GDroplet® Pen Needles 6 mm x 31GDroplet® Pen Needles 8 mm x 31GDroplet® Pen Needles 10 mm x 29GDroplet® Pen Needles 12 mm x 29G
Common Name:	Pen Needle
Regulation Number:	21 CFR § 880.5570
Product Code:	FMI
Device Classification:	II
Review Panel:	80 General Hospital
Predicate Device:

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[807.92(a)(3)]

The legally marketed device to which substantial equivalence is claimed is:

Manufacturer	Trade Name	510(k) Number
Becton Dickson & Co.	BD Pen Needle	K162516

Secondary Predicate Device

Manufacturer Name	Trade Name	510(k) Number
HTL-Strefa S.A.	Droplet® Pen Needle	K143437

The secondary predicate device cleared under K143437 has been included in this submission to cover all gages and lengths of the new device. All design features remain unchanged with regard to the device submitted and cleared under K143437.

Description of Device:

[807.92(a)(4)]

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Indications for Use:

[807.92(a)(5)]

Droplet® Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

Technological Characteristics:

[807.92(a)(6)]

A comparison of characteristics of Droplet® Pen Needles, the predicate device and the secondary predicate device is shown in the table below:

Device Comparison between New Device, Predicate Device and the Secondary Predicate Device Including Indications for Use

		New Device	Predicate Device	Secondary Predicate Device
	Manufacturer	HTL-STREFA S.A.	Becton Dickinson	HTL-STREFA S.A.
	510(k) Number	K171982	K162516	K143437
	Product Code	FMI	FMI	FMI
Design	Primary Container	Image: Primary Container New Device	Image: Primary Container Predicate Device	Image: Primary Container Secondary Predicate Device
	Needle Shield	Image: Needle Shield New Device	Image: Needle Shield Predicate Device	Image: Needle Shield Secondary Predicate Device
	Needle Tube and Hub	Image: Needle Tube and Hub New Device	Image: Needle Tube and Hub Predicate Device	Image: Needle Tube and Hub Secondary Predicate Device
	Indications for Use	The Droplet® Pen Needle is intended for use with a pen injector device for the subcutaneous injection of drugs.	BD Pen Needle is intended for use with a pen injector device for the subcutaneous injection of drugs.	The Droplet® Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.
	Principle of operation	Manual	Manual	Manual
	Method of attachment to pen injector	Screw threads	Screw threads	Screw threads

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Length	4mm, 5mm, 6mm,8mm, 10mm, 12mm	4mm, 5mm, 8mm,12.7mm	4mm, 5mm, 6mm,8mm, 10mm, 12mm
Gage	29G, 31G, 32G	29G, 30G, 31G, 32G	29G, 31G, 32G
Biocompatibility	Conforms to ISO10993-1	Conforms to ISO10993-1	Conforms to ISO10993-1
Sterility	SAL = 10-6	SAL = 10-6	SAL = 10-6
Sterilizationmethod	Gamma irradiation	Gamma irradiation	Gamma irradiation
Shelf Life	5 years	5 years	3 years
Unit Packaging	Polypropylenecontainer with sealmade of medicalgrade paper	Polypropylenecontainer with sealmade of medicalgrade paper	Polypropylenecontainer with sealmade of medicalgrade paper
User Packaging	Cardboard salesbox	Cardboard sales box	Cardboard sales box
Materials
• Needle Tube	Medical GradeStainless Steel	Medical GradeStainless Steel	Medical GradeStainless Steel
• Hub, PrimaryContainer,Needle Shield	Plastic resins	Plastic resins	Plastic resins
• Lubricant	Medical gradesilicone	Medical gradesilicone	Medical gradesilicone

The new device, the predicate device and the secondary predicate device are classified under 21 CFR 880.5570, which states: "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."

There are no significant differences in the design, principle of operation, method of attachment to pen injector, biocompatibility, sterilization method, materials, or intended use between the Droplet® pen needle device and the predicate device.

The Droplet® pen needle differs from the predicate device as follows:

The Droplet® pen needle has slightly different molded features of its primary container, needle shield, and hub.
The Droplet® pen needle product line does not include a 30G model.
The Droplet® pen needle product line includes an additional model with a 6 mm needle length.
The Droplet® pen needle product line's longest needle length is 12 mm, while the predicate's longest needle length is 12.7 mm.

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The Droplet® pen needle differs from the secondary predicate device as follows:

1. In the indications for use the clarification to the intended use of the Droplet® pen needle does not introduce critical differences or new risks to the intended use of the device.
  The differences do not raise new questions of safety or effectiveness for the subject device. Droplet® pen needle product line and the predicate products line cover a substantially equivalent range of options in gage and needle lengths and the few specific differences between the product lines do not have any impact on performance.

Based upon the above comparisons to the predicate device. Droplet® Pen Needles are substantially equivalent to the predicate device.

Non-Clinical Performance Data:

[(807.92(b)(1)]

Droplet® pen needles successfully passed all the required non-clinical testing which included the following:

Testing for compliance with the requirements of 11608-2:2012 Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles

Test Parameter	Requirement - ISO 11608-2:2012	Result
Materials	The needle shall be made of tubing materialsspecified in ISO 9626.	Requirement met
Dimensions	The needles shall fit the test apparatus specified initem 7.3 of ISO 11608-2.	Requirement met
Determination of flowrate through the needle(not required by thestandard)	The needle was tested in accordance with Annex Ato ISO 11608-2 to determine flow rate through theneedle.	Requirement met
Bond between hub andneedle tube	The union of the hub and needle tube shall notbreak when tested in accordance with Clause 9 ofISO 11608-2.	Requirement met
Freedom from defects	The needle tube shall fulfill the requirements ofISO 7864, clause11.3.	Requirement met
Lubrication	The needle tube should be lubricated at both thepatient end and the cartridge end. The lubricantshall not, under normal or corrected-to-normalvision, be visible as droplets of fluid on the outsidesurface of the needle tube.	Requirement met

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Dislocation ofmeasuring point atpatient end	Dislocation of the cannula point at the patient endshall be in accordance with Table 2 when tested inaccordance with Clause 8 (of ISO 11608-2).	Requirement met
Determination offunctionalcompatibility withneedle-based injectionsystems	Compatibility with any NIS (Needle-basedInjection System) shall be claimed only aftertesting in accordance with Clause 11.	Requirement met
Ease of assembly anddisassembly	Attachment of the needle shall be possible withoutremoving the needle from its opened unitpackaging. Compliance is checked according tothe requirements of Clause 11.	Requirement met
Pre-conditioning ofneedles	All requirements of the standard related topreconditioning of needles were met.	Requirement met

Biocompatibility testing: •

Biocompatibility Test Summary – no adverse biocompatibility effects were observed:

Test method	Compliance with	Result
Cytotoxicity StudyUsing the ISOElution Method	ISO 10993-5 - Biologicalevaluation of medical devices -Part 5: Tests for in vitrocytotoxicity	The test article showed no evidenceof causing cell lysis or toxicity.
ISO Guinea PigMaximizationSensitization Test	ISO 10993-10 - Biologicalevaluation of medical devices --Part 10: Tests for irritation andskinsensitization	The test article extracts showed noevidence of causing delayed dermalcontact sensitization in the guineapig. The test article was notconsidered a sensitizer in the guineapig maximization test.
ISO IntracutaneousStudy in Rabbits	ISO 10993-10 - Biologicalevaluation of medical devices --Part 10: Tests for irritation andskin sensitization	The test article met the requirementsof the test.
ASTM HemolysisStudy	ASTM F756, Standard Practicefor Assessment of HemolyticProperties of Materials and ISO10993-4 - Biological evaluationof medical devices -- Part 4:Selection of tests for interactionswith blood	Both the test article in direct contactwith blood and the test article extractwere non-hemolytic.
ISO Two WeekToxicity Study in theRat, RepeatedParenteralAdministration ofTwo Extracts	ISO 10993-11 - Biologicalevaluation of medical devices --Part 11: Tests for systemictoxicity	There were no microscopic changesconsidered to be a test articlerelated response. Parenteraladministration of the test articleextract did not produce systemictoxicity in rats.
ISO SystemicToxicity Study inMice	ISO 10993-11 - Biologicalevaluation of medical devices --Part 11: Tests for systemictoxicity	There was no mortality or evidenceof systemic toxicity from the extractsinjected into mice. Each test articlemet the requirements of the study.

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Test method	Compliance with	Result
USP Rabbit PyrogenStudy, Material-mediated	ISO 10993-11 Biologicalevaluation of medical devices --Part 11: Tests for systemictoxicity	The total rise of rabbit temperaturesduring the 3 hour observation periodwas within acceptable USP limits.The test article was judged as non-pyrogenic.
USP Pyrogen Study -Material Mediated	USP, General Chapter <151>,Pyrogen Test as recommended byISO 10993-11 Biologicalevaluation of medical devices --Part 11: Tests for systemictoxicity	The test article was judged asnonpyrogenic.

Clinical Performance Data:

[(807.92(b)(2)]

Clinical data is not required.

Conclusion:

[(807.92(b)(3)]

Droplet® Pen Needles are concluded to be substantially equivalent in the intended use, technology/principle of operation, materials and performance to the 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).