Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and biocompatibility of a pen needle, with no mention of AI or ML.

Therapeutic

No
The device is a pen needle, intended for the injection of drugs. While it facilitates the administration of medication that may be therapeutic, the needle itself does not directly treat or cure a disease or condition. Its function is limited to delivering substances.

Diagnostic

No

Explanation: The device is a pen needle intended for drug subcutaneous injection, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like cannulas, hubs, shields, and covers, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "subcutaneous injection of drugs" using pen injector devices. This is a direct medical intervention on the body, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The description details a needle assembly designed for injecting substances into the body. It does not describe any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is clearly a medical device used for drug delivery, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Pen needles are used by consumers, caregivers and healthcare professionals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Data:
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
- Materials: Requirement met
- Dimensions: Requirement met
- Determination of flow rate through the needle (not required by the standard): Requirement met
- Bond between hub and needle tube: Requirement met
- Freedom from defects: Requirement met
- Lubrication: Requirement met
- Dislocation of measuring point at patient end: Requirement met
- Determination of functional compatibility with needle-based injection systems: Requirement met
- Ease of assembly and disassembly: Requirement met
- Pre-conditioning of needles: Requirement met

Biocompatibility testing:

Cytotoxicity Study Using the ISO Elution Method: The test article showed no evidence of causing cell lysis or toxicity.
ISO Guinea Pig Maximization Sensitization Test: 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: The test article met the requirements of the test.
ASTM Hemolysis Study: 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: 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: 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: 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: The test article was judged as nonpyrogenic.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162516, K143437

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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.

1

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

2

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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3

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 7
95-035 Ozorków
POLAND
Primary Contact:	Aleksandra Prażmowska-Wilanowska
RA Director
Phone: +48 42 270 00 10
ola.prazmowska-wilanowska@htl-strefa.pl
Secondary Contact:	Izabela Banaś
Senior RA Specialist
Phone: +48 42 270 00 10
izabela.banas@htl-strefa.pl
Trade Name:	Droplet® Pen Needles
Device models:	Droplet® Pen Needles 4 mm x 32G
Droplet® Pen Needles 5 mm x 32G
Droplet® Pen Needles 6 mm x 32G
Droplet® Pen Needles 8 mm x 32G
Droplet® Pen Needles 5 mm x 31G
Droplet® Pen Needles 6 mm x 31G
Droplet® Pen Needles 8 mm x 31G
Droplet® Pen Needles 10 mm x 29G
Droplet® 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:

4

[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)]

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.

5

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

6

| 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 ISO
10993-1 | Conforms to ISO
10993-1 | Conforms to ISO
10993-1 |
| Sterility | SAL = 10-6 | SAL = 10-6 | SAL = 10-6 |
| Sterilization
method | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Shelf Life | 5 years | 5 years | 3 years |
| Unit Packaging | Polypropylene
container with seal
made of medical
grade paper | Polypropylene
container with seal
made of medical
grade paper | Polypropylene
container with seal
made of medical
grade paper |
| User Packaging | Cardboard sales
box | Cardboard sales box | Cardboard sales box |
| Materials | | | |
| • Needle Tube | Medical Grade
Stainless Steel | Medical Grade
Stainless Steel | Medical Grade
Stainless Steel |
| • Hub, Primary
Container,
Needle Shield | Plastic resins | Plastic resins | Plastic resins |
| • Lubricant | Medical grade
silicone | Medical grade
silicone | Medical grade
silicone |

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.

7

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 secondary predicate device.

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 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

8

| 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 testing: •

Biocompatibility Test Summary – no adverse biocompatibility effects were observed:

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.

9

Test method	Compliance with	Result
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 ,
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.

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.