Droplet Pen Needles

K143437 · Htl-Strefa S.A · FMI · Jun 25, 2015 · General Hospital

Device Facts

• Record ID: K143437
• Device Name: Droplet Pen Needles
• Applicant: Htl-Strefa S.A
• Product Code: FMI · General Hospital
• Decision Date: Jun 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Droplet® Pen Needles are intended for use with pen injector device for the subcutaneous injection of insulin.

Device Story

Droplet® Pen Needles are sterile, single-use, double-ended cannulas assembled into injection-molded hubs. Used with commercially available pen injectors for subcutaneous insulin delivery. Operated by patients, caregivers, or healthcare professionals. The hub features internal threads for attachment to the pen injector; the cartridge-end cannula penetrates the pen's rubber septum. Both cannula ends are silicone-lubricated to facilitate injection and septum penetration. The device includes an inner needle shield and outer protective container with a peel-away sterility seal. Users remove the seal and outer cap, attach the needle to the pen, remove the inner cap, perform the injection, and use the outer cap for safe removal and disposal. Gamma-sterilized. Benefits include ease of use and compatibility with standard pen injectors.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1) and functional performance testing (ISO 11608-2:2012). Tests included flow rate, bond strength, dimensional accuracy, and ease of assembly/disassembly. All tests met established requirements.

Technological Characteristics

Materials: AISI 304 stainless steel (needle), polypropylene (hub/shields). Principle: Manual subcutaneous injection. Dimensions: 29G-32G gauges; 4mm-12mm lengths. Sterilization: Gamma radiation (ISO 11137-1, SAL 10^-6). Connectivity: None (mechanical).

Indications for Use

Indicated for patients requiring subcutaneous insulin injections using a pen injector device. Suitable for use by consumers, caregivers, and healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• BD Ultra-Fine (K031200)
• BD Ultra-Fine (K100005)

Reference Devices

• Novofine® Plus (K133738)
• Penfine® Insulin Injection Pen Needle (K013782)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 25, 2015

HTL-Strefa S.A. Ms. Aleksandra Prazmowska-Wilanowska QA/RA/ Director Adamówek 7 95-035 Ozorków Poland

Re: K143437

Trade/Device Name: Droplet® Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 21, 2015 Received: May 26, 2015

Dear Ms. 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}------------------------------------------------

### Page 2 - Ms. Prazmowska-Wilanowska

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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) K143437

Device Name Droplet® Pen Needles

Indications for Use (Describe)

The Droplet® Pen Needles are intended for use with pen injector device for the subcutaneous injection of insulin.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) Summary - K143437

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 Summary Prepared: | June 11, 2015 |
|------------------------|----------------------------------------------------------------------------------------------------------------|
| Submitted By: | HTL-STREFA S.A.<br>Adamówek 7,<br>95-035 Ozorków<br>POLAND<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Aleksandra Prazmowska-Wilanowska<br>QA/RA Director<br>[e-mail] |
| Trade Name: | Droplet® Pen Needles |
| Models: | 4mm x 32G, 5mm x 32G, 6mm x 32G, 8mm x 32G, 5mm x 31G, 6mm x 31G, 8mm x 31G, 10mm x 29G, 12mm x 29G |
| Common Name: | Insulin Pen Needle |
| Classification name: | Hypodermic Single Lumen Needle |
| Device Classification: | Class II, 21 CFR § 880.5570<br>Product Code: FMI |
| Review Panel: | 80 General Hospital |

# Predicate Devices: [807.92(a)(3)]

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

| Manufacturer | Trade Name | 510(k) Number |
|----------------------|---------------|---------------|
| Becton Dickson & Co. | BD Ultra-Fine | K031200 |
| Becton Dickson & Co. | BD Ultra-Fine | K100005 |

## Reference devices:

| Manufacturer | Trade Name | 510(k) Number |
|----------------------------|------------------------------------------|---------------|
| Novo Nordisk Inc. | Novofine® Plus | K133738 |
| Disetronic Medical Systems | Penfine® Insulin Injection<br>Pen Needle | K013782 |

{4}------------------------------------------------

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

The Droplet® Pen Needles are sterile, single use needles designed to be used with commercially available pen-injectors for the subcutaneous injection of insulin. 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 protective container. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier. To use a pen needle, the user needs to remove the seal, remove the outer protective cap and attach it to the pen injector. Then the user removes the inner protective cap to expose the needle and make an injection. Following the injection the user inserts the used pen needle into the outer cap to remove the pen needle from the pen injector and dispose of it immediately. The pen needle is individually packaged and sterilized with Gamma radiation. It is intended for single use only. Droplet® Pen Needles are available in the following lengths and gauges: 4 mm x 32G, 5 mm x 32G, 6 mm x 32G, 8 mm x 32G, 5 mm x 31G, 6 mm x 31G, 8 mm x 31G, 10 mm x 29G, 12 mm x 29G.

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

The Droplet® Pen Needles are intended for use with pen injector device for the subcutaneous injection of insulin.

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

A comparison of characteristics of Droplet pen needles and the predicate devices is shown in the table below:

| Device Name | Subject Device | Predicate<br>Device #1 | Predicate Device<br>#2 |
|---------------|-----------------|------------------------|------------------------|
| Manufacturer | HTL STREFA S.A. | Becton Dickinson | Becton Dickinson |
| 510(k) Number | Pending | K031200 | K100005 |

{5}------------------------------------------------

| Intended use | | intended for use<br>with pen injector<br>device for the<br>subcutaneous<br>injection of insulin | intended for use<br>with pen injector<br>device for<br>the subcutaneous<br>injection of insulin | intended for use<br>with pen injector<br>device for<br>the subcutaneous<br>injection of drugs,<br>including insulin<br>and exenatide |
|--------------|-------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | Operation principle | Manual | Manual | Manual |
| | Design | Needle assembly –<br>cannula, needle hub,<br>inner protective cap,<br>outer protective cap,<br>seal | Needle assembly –<br>cannula, needle<br>hub, inner<br>protective cap,<br>outer protective<br>cap, seal | Needle assembly –<br>cannula, needle<br>hub, inner<br>protective cap, outer<br>protective cap, seal |
| | Product Code | FMI | FMI | FMI |
| | Length | 4mm, 5mm,<br>6mm,<br>8mm,10mm,<br>12mm | 5mm, 8mm,<br>12.7mm | 4mm |
| Materials | Needle<br>tube | AISI 304<br>Grade Stainless<br>Steel | AISI 304<br>Grade Stainless<br>Steel | AISI 304<br>Grade Stainless<br>Steel |
| | Hub | Polypropylene | Polypropylene | Polypropylene |
| | Primary<br>Container<br>and<br>Needle<br>Shield | Polypropylene | Polypropylene | Polypropylene |
| | Biocompatibility | Conforms to<br>ISO10993-1 | Conforms to<br>ISO10993-1 | Conforms to<br>ISO10993-1 |
| | Sterilization | Gamma radiation<br>(validated in<br>accordance with<br>ISO 11137-1 to<br>achieve SAL 10-<br>6) | Gamma radiation | Gamma radiation |

{6}------------------------------------------------

# Size characteristics of the reference devices:

| Manufacturer | Trade Name | Size |
|----------------------------|------------------------------------------|-------------|
| Disetronic Medical Systems | Penfine® Insulin Injection<br>Pen Needle | 29G x 6mm |
| | | 30G x 6mm |
| | | 31G x 6mm |
| | | 29G x 10mm |
| | | 30G x 10mm |
| | | 31G x 10mm |
| | | 29G x 12mm |
| | | 30G x 12mm |
| | | 31G x 12 mm |
| Novo Nordisk Inc. | Novofine® Plus | 32G x 6mm |

The reference devices are provided for purposes of sizes and lengths that are not available with the predicate devices. The reference devices have same or similar IFUs as the subject device.

# Non-Clinical Performance Data: [(807.92(b)(1)]

Verification/Validation testing was done according to the requirements of ISO 11608-2:2012 as summarized below. All testing met the applicable requirements.

| Test Parameter | Requirement – ISO 11608-2:2012 | Result |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Materials | The needle shall be made of tubing<br>materials specified in ISO 9626. | Meets standard |
| Dimensions | The needles shall fit the test apparatus<br>specified in item 7.3 of ISO 11608-2. | Meets standard |
| Determination of flow rate<br>through the needle | The needle was tested in accordance with<br>Annex A to ISO 11608-2 to determine<br>flow rate through the needle. | Meets standard |
| Bond between hub and needle<br>tube | The union of the hub and needle tube<br>shall not break when tested in accordance<br>with Clause 9 of ISO 11608-2. | Meets standard |
| Freedom from defects | The needle tube shall fulfill the<br>requirements of ISO 7864, 11.3. | Meets standard |
| Lubrication | The needle tube should be lubricated at<br>both the patient end and the cartridge end.<br>The lubricant shall not, under normal or | Meets standard |

{7}------------------------------------------------

| Test Parameter | Requirement – ISO 11608-2:2012 | Result |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| | corrected-to-normal vision, be visible as droplets of fluid on the outside surface of the needle tube. | |
| Dislocation of measuring point at patient end | 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 standard |
| Determination of functional compatibility with needle-based injection systems | Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11. | Meets standard |
| 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. | Meets standard |
| Pre-conditioning of needles | All requirements of the standard related to preconditioning of needles were met. | Meets standard |

# Biocompatibility testing

The following biocompatibility testing has been conducted on the Droplet® Pen Needles. The selection of biocompatibility tests was made based on the requirements of ISO 10993-1. All the tests have been successfully passed.

| Test | Result |
|-----------------------------------------|--------|
| Cytotoxicity | Passed |
| Sensitization | Passed |
| Intracutaneous Reactivity | Passed |
| Haemocompatibility | Passed |
| System toxicity (acute) | Passed |
| Subchronic toxicity (subacute toxicity) | Passed |

{8}------------------------------------------------

# Sterility testing

Droplet® Pen Needles are sterilized with Gamma radiation. To ensure sterility of the device over its shelf life, relevant sterility testing is conducted. Droplet® Pen Needles have passed all relevant sterility tests successfully.

Clinical Performance Data: [(807.92(b)(2)] Clinical data were not provided.

Conclusion: [(807.92(b)(3)]

Droplet® Pen Needles are substantially equivalent in the intended use, technology/principle of operation, materials and performance to the predicate devices and do not raise any new questions of safety and effectiveness.