DROPLET® PEN NEEDLES 30G & 33G 4G are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. The pen needles are OTC devices. 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

The provided document is a 510(k) Premarket Notification for a medical device: Droplet Pen Needle 30G & 33G.

This document describes a submission for a new medical device seeking to demonstrate substantial equivalence to a previously cleared predicate device, not a study proving the device meets acceptance criteria for an AI/ML powered device. Therefore, much of the requested information regarding AI/ML device performance metrics, such as ground truth establishment with experts, MRMC studies, and training/test set details, is not applicable to this document.

However, I can extract the acceptance criteria and non-clinical performance data for this specific medical device, which are based on compliance with an international standard (ISO 11608-2:2012) and biocompatibility testing.

Here's a breakdown of the information that can be extracted and what cannot:

Information that can be extracted from the document:

Acceptance Criteria (as defined by standard compliance) and Reported Device Performance: This is derived from the "Non-Clinical Performance Data" section.
Sample size for the test set: Not explicitly stated as "test set" in the context of AI, but the non-clinical tests would have involved samples of the device. The document does not specify the number of units tested for each parameter.
Data Provenance: The tests were performed by HTL-Strefa S.A. (Poland). The data is non-clinical, related to device performance in laboratory settings, not patient data.
Type of Ground Truth: For this type of device, the "ground truth" is defined by the technical specifications and requirements outlined in the ISO standard and the results of various physical, chemical, and biological tests.

Information that CANNOT be extracted from the document (as it's not an AI/ML device submission):

Number of experts used to establish ground truth
Qualifications of those experts
Adjudication method for the test set
Multi-Reader Multi-Case (MRMC) comparative effectiveness study
Standalone (algorithm only) performance
Sample size for the training set
How the ground truth for the training set was established

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for Droplet Pen Needle 30G & 33G

As this is a submission for a physical medical device (hypodermic needle) and not an AI/ML powered device, the "acceptance criteria" are defined by compliance with relevant international standards and successful completion of non-clinical performance and biocompatibility testing. There is no AI model or human-in-the-loop performance measurement.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by its compliance with the requirements of ISO 11608-2:2012 Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles.

Test Parameter	Clause no. & Requirement of ISO 11608-2:2012	Acceptance Criteria (Met if "Meets requirements")	Reported Device Performance
Materials	4.1 The needle shall be made of tubing materials specified in ISO 9626.	Meets requirements	Meets requirements
Dimensions	4.2 The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2.	Meets requirements	Meets requirements
Determination of flow rate through the needle	4.3 The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle.	Meets requirements	Meets requirements
Bond between hub and needle tube	4.4 The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2.	Meets requirements	Meets requirements
Needle points	4.5 When examined under a magnification of x2.5, needle points shall appear sharp and free from feather edges, burrs and hooks.	Meets requirements	Meets requirements
Freedom from defects	4.6 The needle tube shall fulfill the requirements of ISO 7864, 11.3.	Meets requirements	Meets requirements
Lubrication	4.7 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.	Meets requirements	Meets requirements
Dislocation of measuring point at patient end	4.8 Dislocation of the cannula point at the patient end shall be in accordance with Table 2 below when tested as per Clause 8 (of ISO 11608-2).	Meets requirements	Meets requirements
Determination of functional compatibility with needle-based injection systems	4.9 Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11.	Meets requirements	Meets requirements
Ease of assembly and disassembly	4.10 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.	Meets requirements	Meets requirements
Sterility	4.11 The needle in its unit packaging shall has been subjected to a validated sterilization process.	Meets requirements (SAL = 10^-6)	Meets requirements
Pre-conditioning of needles	6 All requirements of the standard related to preconditioning of needles were met.	Meets requirements	Meets requirements

Biocompatibility Testing:

The device also successfully passed all required biocompatibility tests according to the 2016 FDA guidance Use of International Standard ISO 10993-1. These tests included:

Cytotoxicity
Sensitization
Irritation or Intracutaneous Reactivity
Acute Systemic Toxicity
ISO Two Week Systemic Toxicity Study in the Rat, Repeated Parenteral Administration of Two Extracts
Material-Mediated Pyrogenicity
Hemocompatibility
Reported Biocompatibility Performance: Did not show any adverse biological/biocompatibility reactions.

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

Sample Size for Test Set: The document does not specify the exact number of units tested for each parameter within the non-clinical performance and biocompatibility testing. This information is typically detailed in the full test reports, which are summarized here.
Data Provenance: The testing was conducted by HTL-Strefa S.A. based in Poland (ul. Adamówek 7, 95-035 Ozorków, POLAND). The data pertains to non-clinical laboratory testing of the physical device, not patient data, and is thus "prospective" in the sense that the new device was manufactured and then subjected to these tests.

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

Not applicable for this type of medical device submission. Ground truth for physical device performance is established by standardized testing methods and international standards, not by human expert consensus or annotation of data. The qualifications of the personnel conducting the tests would be subject to internal quality system requirements (e.g., ISO 13485).

4. Adjudication method for the test set

Not applicable for this type of medical device submission. Adjudication methods like 2+1 or 3+1 are used in subjective assessments (e.g., image interpretation) where there might be disagreement among human readers or annotators. For objective physical device tests, results are typically measured and compared against defined thresholds.

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

Not applicable. This device is a physical hypodermic needle, not an AI-powered device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This device does not involve any algorithm.

7. The type of ground truth used

The "ground truth" for this device is defined by the technical specifications and performance requirements outlined in the ISO 11608-2:2012 standard and the established biocompatibility criteria from ISO 10993-1. Performance is measured objectively against these established standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical device, not an AI model.

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

Not applicable. There is no "training set" or need for "ground truth establishment" in the AI/ML sense for this device.

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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 15, 2020

HTL-Strefa S.A. Aleksandra Prazmowska-Wilanowska OA/RA Director Adamowek 7 Ozorkow. 95-035 Poland

Re: K202340

Trade/Device Name: Droplet Pen Needle 30G & 33G Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 4, 2020 Received: August 17, 2020

Dear 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. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CPT 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

Enclosure

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Indications for Use

510(k) Number (if known) K202340

Device Name Droplet Pen needle 30G &33G

Indications for Use (Describe)

The DROPLET PEN NEEDLES 30G & 33G are intended for use with pen injector devices for the subcutaneous injection of drugs.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K202340

Date Prepared:	October, 7th, 2020
Submitted By:	HTL-STREFA S.A.ul. Adamówek 795-035 OzorkówPOLAND
Primary Contact:	Aleksandra Prażmowska-WilanowskaRA DirectorPhone: +48 42 270 00 16ola.prazmowska-wilanowska@htl-strefa.pl
Secondary Contact:	Izabela BanaśSenior RA SpecialistPhone: +48 42 270 02 93izabela.banas@htl-strefa.pl
Trade Name:	DROPLET® PEN NEEDLE 30G & 33G
Common Name:	Pen Needle
Regulation Number:	21 CFR § 880.5570
Product Code:	FMI
Device Classification:	II
Review Panel:	80 General Hospital
Predicate Device
[807.92(a)(3)]

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

Predicate device:

Manufacturer Name	Trade Name	510(k) Number
HTL-Strefa S.A.	Droplet pen needle 34G	K192082

Description of Device:

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[807.92(a)(4)]

DROPLET® PEN NEEDLES 30G & 33G 4G are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. The pen needles are OTC devices.

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.

Indications for Use:

[807.92(a)(5)]

The DROPLET® PEN NEEDLES 30G & 33G 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 NEEDLE 30G, 33G and the predicate device is shown in the table below:

Device Comparison between Subject Device and Predicate Device Including Indications for Use

Feature	Subject DeviceDROPLET® PENNEEDLE 30G	Subject DeviceDROPLET® PENNEEDLE 33G	Predicate DeviceDROPLET® PENNEEDLE 34G	Conclusion
510(k)Number	K202340	K202340	K192082
Product Code	FMI	FMI	FMI	Same
Feature	Subject DeviceDROPLET® PENNEEDLE 30G	Subject DeviceDROPLET® PENNEEDLE 33G	Predicate DeviceDROPLET® PENNEEDLE 34G	Conclusion
PrimaryContainer	Image: Primary Container for DROPLET® PEN NEEDLE 30G	Image: Primary Container for DROPLET® PEN NEEDLE 33G	Image: Primary Container for DROPLET® PEN NEEDLE 34G	Same
DesignNeedle Shield	Image: Needle Shield for DROPLET® PEN NEEDLE 30G	Image: Needle Shield for DROPLET® PEN NEEDLE 33G	Image: Needle Shield for DROPLET® PEN NEEDLE 34G	Same
Needle Tube andHub	Image: Needle Tube and Hub for DROPLET® PEN NEEDLE 30G	Image: Needle Tube and Hub for DROPLET® PEN NEEDLE 33G	Image: Needle Tube and Hub for DROPLET® PEN NEEDLE 34G	DifferentNo impacton safetyoreffective
Indicationsfor use	The DROPLET®PEN NEEDLE30G is intendedfor use with a peninjector devicefor thesubcutaneousinjection of	The DROPLET®PEN NEEDLE33G is intendedfor use with a peninjector devicefor thesubcutaneousinjection of	The DROPLET®PEN NEEDLE34G is intendedfor use with a peninjector devicefor thesubcutaneousinjection of	Same
Length	8 mm	4 mm	3.5 mm	DifferentNoimpacton safety
Gage	30G	33G	34G	DifferentNoimpacton safety
Method ofattachmentto peninjector	Screw threads	Screw threads	Screw threads	Same
Feature	Subject DeviceDROPLET® PENNEEDLE 30G	Subject DeviceDROPLET® PENNEEDLE 33G	Predicate DeviceDROPLET® PENNEEDLE 34G	Conclusion
Biocompatibility	Conforms to ISO10993-1	Conforms to ISO10993-1	Conforms toISO 10993-1	Same
Sterility	SAL = 10-6	SAL = 10-6	SAL = 10-6	Same
Sterilizationmethod	EtO	EtO	EtO	Same
UnitPackaging	Polypropylenecontainer with sealmade of medicalgrade paper	Polypropylenecontainer with sealmade of medicalgrade paper	Polypropylenecontainer with sealmade of medicalgrade paper	Same
UserPackaging	Cardboard sales box	Cardboard sales box	Cardboard sales box	Substantiallyequivalent
	Materials
Needle Tube	Stainless steelAISI 304L	Stainless steelAISI 304L	Stainless steelAISI 304L	Same
HubPrimaryContainerNeedleShield	Plastic resins	Plastic resins	Plastic resins	Same
Lubricant	Medical gradesilicone	Medical gradesilicone	Medical gradesilicone	Same

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HTL-STREFA S.A. has determined that the Droplet® Pen Needle 30G & 33G is substantially equivalent to a predicate device currently cleared for marketing in the United States.

The subject device and the 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."

The Droplet® Pen Needle 30G&33G is substantially equivalent to the Droplet® Pen Needle 34G cleared under K192082 in terms of indications for use, compositions, material, design and performance. Specifically, the following performance comparisons were made to determine equivalence to the predicate device pen needles referenced: length, gauge, biocompatibility,

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materials, shelf life and sterility. Based on the comparisons above of the predicate devices the Droplet® Pen Needle 30G & 34G has raised no different questions of safety and effectiveness.

The difference in needle hub color between the proposed device and the predicate device - 30G x 8 mm and 33G x 4 mm vs. 34G x 3.5 mm has been analyzed. The different colored hubs were introduced for easy needle size identification (color coding for the user). The hubs, irrespective of their color, are made of the same raw materials and were assessed with regard to biocompatibility. No negative biological reaction is expected to occur as a result of the different color. Consequently, the hub color is considered not to have any impact on safety or performance of the proposed device.

The difference in needle gage and length between the proposed device and the predicate device - 30G x 8 mm and 33G x 4 mm vs. 34G x 3.5 mm has also been analyzed. Based on all available design, technical and technological information as well as the published scientific and clinical data and based on information on pen needles by other manufacturers available in the USA, we have concluded that the two proposed needle gages and lengths ensure the same level of confidence for device safety and performance with regard to ensuring subcutaneous injection. They are being introduced to meet individual needs of patients based on their skin type. BMI, and drug dosing and treatments.

Based on the above analysis of the needle length, it has been concluded that difference in needle gage or length between the Droplet 30G & 33G and the Droplet 34G device does not impact safety or performance of the former device and raises no different questions of safety and performance.

The proposed device and the 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."

The subject device and the predicate device use statements similar to the underlined portion of the excerpt from the regulation.

HTL-STREFA S.A. has determined that the Droplet® Pen Needle 30G and 33G is substantially equivalent to a predicate device currently cleared for marketing in the United States.

Non-Clinical Performance Data:

[(807.92(b)(1)]

DROPLET® PEN NEEDLE 30G & 33G 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

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The table below presents the requirements of the 11608-2:2012 Needle-based injection . systems for medical use -- Requirements and test methods -- Part 2: Needles standard and the result of the testing conducted.

Test Parameter	Clause no. & requirement of ISO 11608-2:2012	Result
Materials	4.1 The needle shall be made of tubing materials specified inISO 9626.	Meetsrequirements
Dimensions	4.2 The needles shall fit the test apparatus specified in item 7.3of ISO 11608-2.	Meetsrequirements
Determination offlow rate throughthe needle	4.3 The needle was tested in accordance with Annex A to ISO11608-2 to determine flow rate through the needle.	Meetsrequirements
Bond betweenhub and needletube	4.4 The union of the hub and needle tube shall not break whentested in accordance with Clause 9 of ISO 11608-2.	Meetsrequirements
Needle points	4.5 When examined under a magnification of x2,5, needlepoints shall appear sharp and free from feather edges, burrs andhooks.	Meetsrequirements
Freedom fromdefects	4.6 The needle tube shall fulfill the requirements of ISO 7864,11.3.	Meetsrequirements
Lubrication	4.7 The needle tube should be lubricated at both the patient endand the cartridge end. The lubricant shall not, under normalor corrected-to-normal vision, be visible as droplets of fluidon the outside surface of the needle tube.	Meetsrequirements
Dislocation ofmeasuring point atpatient end	4.8 Dislocation of the cannula point at the patient end shall be inaccordance with Table 2 below when tested as per Clause 8(of ISO 11608-2).	Meetsrequirements
Determination offunctionalcompatibility withneedle-basedinjection systems	4.9 Compatibility with any NIS shall be claimed only aftertesting in accordance with Clause 11.	Meetsrequirements
Ease of assemblyand disassembly	4.10 Attachment of the needle shall be possible withoutremoving the needle from its opened unit packaging.Compliance is checked according to the requirements ofClause 11.	Meetsrequirements
Sterility	4.11 The needle in its unit packaging shall has been subjectedto a validated sterilization process.	Meetsrequirements
Pre-conditioningof needles	6 All requirements of the standard related to preconditioning ofneedles were met.	Meetsrequirements

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Biocompatibility testing:

Selection of Biological Evaluation Tests

The Biological Tests selected to be performed on the sterile final product that has direct contact with the end-user according to the 2016 FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" considering contact type and duration were as follows:

1. Cytotoxicity
1. Sensitization
1. Irritation or Intracutaneous Reactivity
1. Acute Systemic Toxicity
1. ISO Two Week Systemic Toxicity Study in the Rat, Repeated Parenteral Administration of Two Extracts
1. Material-Mediated Pyrogenicity
1. Hemocompatibility

Biocompatibility tests selected as per the requirements of 2016 FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" considering contact type and duration for the DROPLET® PEN NEEDLE 30G & 33G did not show any adverse biological / biocompatibility reactions.

Clinical Performance Data:

[(807.92(b)(2)]

Clinical data is not required.

Conclusion:

[(807.92(b)(3)]

DROPLET® PEN NEEDLE 30G & 33G concluded to be substantially equivalent in the intended use, technology/principle of operation, materials and performance to the legally market 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).