Top Fine Pen Needle

K152410 · Medexel Co.,Ltd · FMI · Feb 2, 2016 · General Hospital

Device Facts

• Record ID: K152410
• Device Name: Top Fine Pen Needle
• Applicant: Medexel Co.,Ltd
• Product Code: FMI · General Hospital
• Decision Date: Feb 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

Device Story

Top Fine® Pen Needles are single-use, sterile, hypodermic single-lumen needles designed for use with insulin pen injectors. The device assembly includes a hub, needle, needle cap, sterile cap, and sterile paper. It is used by patients, caregivers, and healthcare professionals in various settings (e.g., home, clinic) to deliver insulin subcutaneously. The device is attached to a compatible insulin pen; the user performs the injection manually. The needle facilitates the delivery of insulin from the pen cartridge into the subcutaneous tissue, aiding in diabetes management.

Clinical Evidence

Bench testing only. Performance was evaluated against ISO 11608-2:2012 and ISO 7864:1993 standards. Tests included needle dimensions, elasticity, flexural rigidity, pull strength, lubricant performance, compatibility, dose accuracy, and hub torque removal. Endotoxin testing was performed per USP 39 <85> and KP 11 <32>.

Technological Characteristics

Materials: Stainless steel 304 (needle), Polypropylene (hub, sterile cap), Polyethylene (needle cap). Sterilization: EO gas (ISO 11135:2007). Dimensions: 29G-34G gauges; 4mm-12.7mm lengths. Connectivity: None (mechanical).

Indications for Use

Indicated for subcutaneous injection of insulin in patients requiring insulin therapy using pen injector devices.

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

• Feel Fine Insulin Pen Needle (K080904)

Submission Summary (Full Text)

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

February 2, 2016

MedExel Co., Ltd. c/o Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K152410

Trade/Device Name: Top Fine® Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 16, 2015 Received: December 31, 2015

Dear Mr. Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K152410

Device Name

Top Fine® Pen Needle

Indications for Use (Describe)

Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

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

الص Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary (K152410)

[as required by 807.92(c)]

# Applicant

Company : MedExel Co.,Ltd. Address : 252, Geumgwangosan-ro, Geumgwang-myeon, Anseong-si, Gyeonggi-do, Korea Tel : [phone] Fax : [phone] Prepared date : Dec. 15, 2015 Contact person : Peter Chung, 412-687-3976 Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA Current date : Jan. 15, 2016 510(k) Number : K152410

# Device Information

Trade name : Top Fine® Pen Needle Common name : Hypodermic single lumen needle Classification name : Needle, Hypodermic, Single Lumen Product code : FMI Regulation number : 880.5570 Class of device : Class II Panel : General Hospital Model codes : 13 model codes including Top Fine® Pen Needle 29GX12mm

| Top Fine® Pen Needle 29G X 12mm, 12.7mm |
|------------------------------------------|
| Top Fine® Pen Needle 30G X 8mm |
| Top Fine® Pen Needle 31G X 5mm, 6mm, 8mm |
| Top Fine® Pen Needle 32G X 4mm, 5mm, 6mm |
| Top Fine® Pen Needle 33G X 4mm, 5mm |
| Top Fine® Pen Needle 34G X 4mm, 5mm |

### The legally marketed device to which we are claiming equivalence

K080904 Feel Fine Insulin Pen Needle

### Device description

Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.

Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.

### Indications for Use :

Top Fine® Pen Needle is intended for use with insulin pens for the subcutaneous injection of insulin.

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# Performance data:

Bench tests relating to the performance of the Top Fine® Pen Needles were conducted.

The principal device demonstrated equivalent performance to the predicate devices during bench testing.

Bench testing consisted of:

| Inside and outside dimensions of needles | |
|------------------------------------------|------------------|
| Size designation | |
| Elasticity of the needle tube | |
| The flexural rigidity | Test standard |
| Pull | ISO 11608-2:2012 |
| Lubricant | ISO 7864:1993 |
| Compatibility test | |
| Needle dose accuracy | |
| Needle hub torque removal | |

# COMPATIBLE Pens

| PEN NAME | | | |
|------------|-------------|-----------------|----------------|
| BD Pen | InDuo | Novopen 3ml | Novopen Junior |
| FlexPen | InnoLet | Sanofi SoloStar | Sanofi Optiset |
| HumalogPen | Humulin Pen | Sanofi OptiPen | Owen Autopen |

# Predicate device comparison table

| Manufacturer | | MedExel Co.,Ltd. | Feel Tech | Remark | | | | | | | | | | | | | | | | | | | | |
|--------------------------|--|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--------------------|
| 510(k) No. | | K152410 | K080904 | N/A | | | | | | | | | | | | | | | | | | | | |
| Indication for use | | Top Fine® Pen Needle is intended for use with insulin pens for the subcutaneous injection of insulin. | These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes. | Similar | | | | | | | | | | | | | | | | | | | | |
| Product name | | Hypodermic single lumen needle | Hypodermic single lumen needle | Same | | | | | | | | | | | | | | | | | | | | |
| Trade name | | Top Fine® Pen Needle | Feel Fine Insulin Pen Needle | N/A | | | | | | | | | | | | | | | | | | | | |
| Model/type | | 13 model codes including Top Fine® Pen Needle 29GX12mm | Feel Fine Insulin Pen Needle-29<br>Feel Fine Insulin Pen Needle-30<br>Feel Fine Insulin Pen Needle-31 | N/A | | | | | | | | | | | | | | | | | | | | |
| Appearance | | Image: MedExel Co.,Ltd. needle | Image: Feel Tech needle | Similar | | | | | | | | | | | | | | | | | | | | |
| Product configuration | | Hub<br>Needle cap<br>Sterile cap<br>Needle<br>Sterile paper | Hub<br>Needle cap<br>Sterile cap<br>Needle<br>Sterile paper | Similar | | | | | | | | | | | | | | | | | | | | |
| Material | | Part Material Sterile cap Polypropylene Needle cap Polyethylene Needle Stainless steel 304 Hub Polypropylene | | | | | | | | | | | Part Material Sterile cap Polypropylene Needle cap Polypropylene Needle Stainless steel 304 Hub Polypropylene | | | | | | | | | | | Same or<br>Similar |
| Length of parts (mm) | | | | | | | | | | | | | | | | | | | | | | | | |
| Total length of assembly | | 29.8 | 28.8 | Similar | | | | | | | | | | | | | | | | | | | | |
| Side length of | | 15.2 | 15.5 | | | | | | | | | | | | | | | | | | | | | |

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| Manufacturer | MedExel Co.,Ltd. | Feel Tech | Remark |
|----------------------------------|------------------------------------------------------|-------------------------------|---------|
| assembly(max) | | | |
| Inner diameter of<br>sterile cap | 11.2 | 12.95 | Similar |
| Gauge | 29G, 30G, 31G, 32G, 33G, 34G | 29, 30, 31G | Similar |
| Length of needle | 4 mm, 5 mm, 6 mm, 8 mm, 12 mm, 12.7 mm | 5 mm, 8 mm, 12.7 mm | Similar |
| Sterilization | EO Gas sterilization<br>According to ISO 11135: 2007 | EO Gas sterilization | Same |
| Packaging | Sterile cap(PP or PE)+sterile paper | Sterile cap(PP)+sterile paper | Similar |

The bench tests of Needles with 32G, 33G, 34G demonstrated conformances to ISO 11608-2 and ISO 7864. Therefore the differences do not raise new concerns to establish substantial equivalence to the predicate.

Endotoxin Test was based on USP 39: <85> Bacterial Endotoxin test and KP 11: <32> Endotonix Test Method.

# Conclusion:

The vast similarities of the Top Fine® Pen Needle to the predicate devices support the substantial equivalence in indications for use, function and basic composition.

The differences between the Top Fine® Pen Needle and the predicate device do not raise new issues.

The testing that conformance with ISO 11608-2 and ISO 7864 provides additional evidence that the Top Fine® Pen Needle is substantially equivalent to the predicate device in terms of efficacy and performance.