DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs. DropSafe Safety Pen Needles are OTC devices intended to be used by clinical and non-clinical users. DropSafe Safety Pen Needles are already offered in one gage - 31 G and in two lengths: 6mm and 8 mm. This submission covers the addition of a new length: 5 mm with the same gage - 31G. DropSafe Safety Pen Needles are gamma sterilized, non-toxic single use devices.

The device is designed to minimize the risk from accidental needle sticks with a used needle by application of a sharps injury prevention feature. Following use, the needle is locked out preventing reuse. The shield also serves to hide the needle before and after injection. Each DropSafe safety pen needle is individually packaged in a sealed container. The DropSafe safety pen needle is used by removing the seal and attaching it to the pen injector device to administer a drug subcutaneously. While inserting the needle into the skin at a 90° angle, the slider glides into the shield. While the slider glides into the shield, the safety feature is activated. Following injection, the slides back into its initial position, completely covering the needle where it remains locked. The red safety lock indicator tells the safety lock has been activated. Once the safety pen needle is in the locked mode, it cannot be reused. The safety pen needle is detached from the pen injector device and disposed of into a sharps container.

The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using an adhesive. The hub has internal threads which allows it to be screwed onto the pen injector device. This allows the cartridge end of the needle 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.

An injection molded inner shield is assembled over the patient end of the cannula to prevent needle point damage and accidental needle-sticks. This needle assembly is inserted into a protective injection molded container and sealed with a peel away medical grade paper tab which provides a sterility barrier and tamper evident seal.

AI/ML Overview

The provided text describes the 510(k) summary for the DropSafe Safety Pen Needles, specifically focusing on the addition of a new 5mm length. While it details non-clinical performance data and mentions a simulated use study for clinical performance, the structured format of an AI device's acceptance criteria and proven performance based on specific metrics (like sensitivity, specificity, AUC) is not directly present.

The document primarily demonstrates substantial equivalence to a predicate device (DropSafe Safety Pen Needle K170988) by showing that the new device's technical characteristics, intended use, operation principle, and materials are same, with the only difference being the needle length (5mm vs. 6mm and 8mm for the predicate). The "performance data" presented is largely a compliance check against ISO 11608-2:2012, which covers physical and functional requirements for pen needles.

Therefore, I cannot extract the information required for a typical AI device's acceptance criteria and study proving its performance in the requested format, as this submission pertains to a mechanical medical device (a safety pen needle) and not an AI/ML powered device.

However, I can describe the acceptance criteria and proven device performance as they relate to the information provided for this specific device:

Device Type: Mechanical medical device (Safety Pen Needle), not an AI/ML medical device.

1. Table of Acceptance Criteria and Reported Device Performance (as per ISO 11608-2:2012 for a mechanical device):

Parameter and Clause from ISO 11608-2:2012	Acceptance Criteria (Requirements)	Reported Device Performance (Result)
4.1 Materials	The needle shall be made of tubing materials specified in ISO 9626.	Meets standard
4.2.2 Dimensions	Needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2. Dimensions shall be in accordance with the standard.	Meets standard
4.3 Determination of flow rate through the needle	The flow rate is at the border: min 2.14 ml/min.	Meets standard
4.4 Bond between hub and needle tube	Clause 9 of ISO 11608-2 and clause 13.1. The union of the hub and needle tube shall not break for at least 5 sec. while a force of at least 11 N is applied.	Meets standard
4.5 Needle points	Visually under a magnification of x2.5, needle points shall appear sharp and free from feather edges, burrs and hooks.	Meets standard
4.6 Freedom from defects	Visually inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the outer surface of the tubing shall be smooth and free from defects.	Meets standard
4.7 Lubrication	No visible droplets on the outside surface of the needle.	Meets standard
4.8 Dislocation of measuring point at patient end	Clause 8 of ISO 11608-2:2012 maximum allowable dislocation acc. Clause 4.8, Table 2 for 5mm: 0.65m.	Meets standard
4.9 Determination of functional compatibility with needle-based	Clause 11 of ISO 11608-2:2012. Needle assembly torque: 0.07 +/- 0.01 Nm. Needle hub removal: less than 0.100 Nm. Dose accuracy: for doses ≤ 20 ml the calculated values were within ± 0.01 ml of the targeted dose; for doses > 20 ml the calculated values were within ± 5 % of the targeted dose.	Meets standard
4.10 Ease of assembly and disassembly	(Implicitly covered by 4.9 related to torque and removal, and also by the simulated use study for user interaction).	Meets standard
4.11 Sterility	The needle in its unit packaging has undergone an approved sterilization process. Sterilization method: Gamma irradiation. Sterilization conditions 17.5-40kGy.	Meets standard
6. Pre-conditioning of needles	All pen safety needles to be tested were preconditioned atmosphere in: a dry-heat, a cold-storage, a cyclical atmosphere. Prepared in accordance with the requirements specified in clauses 6.1, 6.2, 6.3 of ISO 11608-2:2012.	Meets standard
12.2.1 Marking on the unit packaging	Any marking on the unit packaging that is essential for the safe use of the NIS shall be visible and easily legible.	Meets standard
12.2.2 Marking on the unit packaging	The marking on the unit packaging shall comprise at least the particulars listed in ISO 11608-2:2012 item 12.2.2.	Meets standard
12.2.3 Marking on the user packaging	The marking on the user packaging shall comprise at least the particulars listed in ISO 11608-2:2012 item 12.2.3.	Meets standard
Simulated Use Study (Clinical Performance)	The function of the safety feature should be evaluated in a simulated clinical environment with the participation of both clinical and non-clinical users. The IFU should be validated. The device should not affect injection technique or pen injector functionality, and be safe and effective when used as per IFU.	Device does not affect injection technique or functionality and is safe and effective as per IFU.

As the device is not an AI/ML medical device, the following points are not applicable in their typical sense for an AI/ML context:

2. Sample size used for the test set and data provenance:
* The document does not specify a numerical sample size for each performance test listed in the table, nor does it detail data provenance in terms of country of origin or if it's retrospective/prospective outside of the "simulated clinical environment" for the simulated use study. The tests are in vitro compliance tests.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not applicable for this type of device and testing. Ground truth for these criteria is based on international standards (ISO 11608-2:2012) and engineering measurements/observations, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. Test results are objective measurements against specified standard requirements.

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 is not an AI-powered device, and no human reader comparative study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a mechanical device, not an algorithm. Its "standalone" performance is measured by its physical compliance to standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for this device's performance is compliance with established international standards (ISO 11608-2:2012) and engineering specifications, along with functional testing for elements like the safety feature. For the 'Simulated Use Study', the ground truth is functional validation and user experience.

8. The sample size for the training set:
* Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:
* Not applicable. There is no "training set."

Summary

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January 7, 2022

Htl Strefa Sa Justyna Zemigala RA Manager ul. Adamówek 7 Ozorków. 95-035 Poland

Re: K211716

Trade/Device Name: DropSafe Safety Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 30, 2021 Received: December 6, 2021

Dear Justyna Zemigala:

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 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

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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,

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

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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

[807.92 (a)(1,2)]

Date SummaryPrepared:	May 26th, 2021
Submitted By:	HTL-STREFA S.A.
	ul. Adamówek 7
	95-035 Ozorków
	POLAND
	Phone: +48 42 270 00 10
	Fax: +48 42 270 00 20
Primary Contact:	Justyna Żemigała
	RA Manager
	justyna.zemigala@htl-strefa.pl
Secondary Contact:	Izabela Banaś
	Senior RA Specialist
	izabela.banas@htl-strefa.pl
Trade Name:	DropSafe Safety Pen Needles
Models:	31G x 5 mm
Common Name:	Insulin Pen Needle
Regulation Number:	21 CFR § 880.5570
Product Code:	FMI
Device Classification:	II
Review Panel:	80 General Hospital

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Predicate Device [807.92(a)(3)]

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

Predicate Device:

Manufacturer	Trade Name	510(k) Number
HTL-Strefa S.A.	DropSafe Safety Pen Needle	K170988

Description of Device: [807.92(a)(4)]

Device description

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Indications for Use: [807.92(a)(5)]

The DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs.

Technological Characteristics: [807.92(a)(6)]

A comparison of characteristics of DropSafe Safety Pen Needles and the predicate device is shown in the table below:

Device Name	New Device	Predicate Device
Manufacturer	HTL-STREFA S.A.	HTL-STREFA S.A.
510(k) Number	K211716	K170988
Brand name	DropSafe Safety Pen Needle	DropSafe Safety Pen Needle
Intended use	Intended for use with pen injectordevices for the injection of drugs	Intended for use with pen injectordevices for the injection of drugs
Operation principle	Manual	Manual
Design	Needle assembly -cannula, hub, primary container,seal, needle shield, slider, plug,spring- operated	Needle assembly -cannula, hub, primary container,seal, needle shield, slider, plug, spring-operated
Product Code	FMI	FMI
Length	5 mm	6mm, 8 mm
Gage	31G	31G
Biocompatibility	Conforms toISO 10993-1 & USP <788> Method 1	Conforms to ISO10993-1
Sterilization	Gamma radiation	Gamma radiation
Needle tube	Medical Grade Stainless Steel	Medical Grade Stainless Steel
Hub, PrimaryContainer,Shield, Plug	Plastic resin	Plastic resin
Spring	Stainless steel wire	Stainless steel wire

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The new 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 indications for use of the new device and the predicate and devices is identical (intended for use with pen injector devices for the injection of drugs).

The only difference between the new device and the predicate device is the needle length on patient end. The new device is 5 mm, whereas the already cleared versions are 6mm and 8mm.

The production process, sterilization process, production facilities and conditions, operation principle, biocompatibility and shelf life aspects are identical for the new and predicate device.

The difference in needle length on patient end between the new device and the predicate device does not raise any new or different questions of safety or effectiveness.

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Non-Clinical Performance Data:

[(807.92(b)(1)]

Verification/Validation testing was conducted in compliance with the requirements of ISO 11608- 2:2012 as summarized below. All testing met the applicable requirements.

Parameters and clausefrom ISO 11608-2:2012	Requirements	Result
4.1 Materials	The needle shall be made of tubingmaterials specified in ISO 9626	Meets standard
4.2.2 Dimensions	Needles shall fit the test apparatusspecified in item 7.3 of ISO 11608-2.Dimensions shall be in accordance with	Meets standard
4.3 Determination offlow rate through theneedle	The flow rate is at the border: min 2,14ml/min	Meets standard
4.4 Bond between huband needle tube	Clause 9 of ISO 11608-2 and clause 13.1.The union of the hub and needle tubeshall not break for at least 5 sec. while aforce of at least 11 N is applied	Meets standard
4.5 Needle points	Visually under a magnification of x2,5,needle points shall appear sharp and freefrom feather edges, burrs and hooks	Meets standard
4.6 Freedom from defects	Visually inspected by normal orcorrected-to-normal vision withoutmagnification under an illuminance of300 lx to 700 lx, the outer surface of thetubing shall be smooth and free from	Meets standard
4.7 Lubrication	No visible droplets on the outside surfaceof the	Meets standard
4.8 Dislocation ofmeasuring point atpatient end	Clause 8 of ISO 11608-2:2012 maximumallowable dislocation acc. Clause 4.8,Table 2 for 5mm: 0.65m	Meets standard
4.9 Determination offunctional compatibilitywith needle-based	Clause 11 of ISO 11608-2:2012Needle assembly torque: 0.07 +/- 0.01Nm Needle hub removal: less than 0.100	Meets standard
4.10 Ease of assemblyand disassembly	Nm Dose accuracy: for doses ≤ 20 ml thecalculated values were within ± 0.01 mlof the targeted dose; for doses > 20 ml thecalculated values were within ± 5 % ofthe targeted dose	Meets standard
4.11 Sterility	The needle in its unit packaging hasundergone an approved sterilizationprocess. Sterilization method: Gammairradiation. Sterilization conditions 17,5-40kGy.	Meets standard
6. Pre-conditioning ofneedles	All pen safety needles to in tested werepreconditioned atmosphere in: a dry-heat,a cold-storage, a cyclical atmosphere.Prepared in accordance with therequirements specified in clauses 6.1, 6.2,6.3 of ISO 11608-2: 2012	Meets standard
12.2.1 Marking on theunit packaging	Any marking on the unit packaging that isessential for the safe use of the NIS shallbe visible and easily legible	Meets standard
12.2.2 Marking on theunit packaging	The marking on the unit packaging shallcomprise at least the particulars listed inISO 11608-2:2012 item 12.2.2	Meets standard
12.2.3 Marking on theuser packaging	The marking on the user packaging shallcomprise at least the particulars listed inISO 11608-2:2012 item 12.2.3	Meets standard

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Clinical Performance Data:

[(807.92(b)(2)]

FDA GUIDANCE Medical Devices with Sharps Injury Prevention Features (issued on August 9, 2005).

Testing was performed to evaluate the function of the safety feature in a simulated clinical environment with the participation of both clinical and non-clinical users. The Simulated Use Study was performed to validate the Instructions For Use (IFU) with the participation of clinical and non-clinical users. As evidenced in the study, the use of this device does not affect the injection technique or the functionality of the pen injector and is safe and effective when used as per the Instructions for Use.

Conclusion:

[(807.92(b)(3)]

DropSafe Safety Pen Needle 5mm is substantially equivalent in the intended use, technology/principle of operation, materials and performance to the predicate device and does not raise any new questions of safety and effectiveness.

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).