Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel

K180720 · Medibio USA, LLC · FMI · Jun 27, 2018 · General Hospital

Device Facts

• Record ID: K180720
• Device Name: Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
• Applicant: Medibio USA, LLC
• Product Code: FMI · General Hospital
• Decision Date: Jun 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated for use with a pen injector device for the subcutaneous injection of insulin.

Device Story

Medifine Pen Needle consists of a stainless steel needle, polypropylene hub, and polyethylene shield assembly. Device connects to pen injector devices for subcutaneous insulin delivery. User selects needle type (3 Bevel or 5 Bevel) based on preference. Device is sterile, single-use, and intended for both prescription and over-the-counter (OTC) use. Primary container maintains sterility until use. No electronic or software components.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included dimensions, flow rate, bond strength, needle point integrity, lubrication, functional compatibility with injection systems, corrosion resistance, sterility, and packaging/aging validation per ISO 11608-2, ISO 9626, ISO 7864, and ASTM standards. Biocompatibility is supported by identical materials and processes to the predicate device.

Technological Characteristics

Needle: Stainless steel; Hub: Polypropylene; Shield: Polyethylene; Container: Polypropylene. Dimensions: 29G-32G diameters; 4mm-12.7mm lengths. Lubricant: Dow Corning MDX4-4159 (patient-end) and Dow Corning 360 Medical Fluid (cartridge-end). Sterilization: EO Gas. Connectivity: None. Software: None.

Indications for Use

Indicated for use with a pen injector device for the subcutaneous injection of insulin in patients requiring insulin therapy.

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

• Medifine Pen Needle 3 Bevel & Medifine Pen Needle Quinta 5 Bevel (K171144)
• CareFine Pen Needle (K140568)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 27, 2018

Medibio USA, LLC. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine. California 92620

Re: K180720

Trade/Device Name: Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: May 14, 2018 Received: May 18, 2018

Dear Priscilla 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.

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

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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.

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for 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

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# 510(K) SUMMARY (K180720)

#### 1. 510k Submitter

June 27, 2018

MEDIBIO USA LLC. 8050 SW 10th Street, Suite 4200 Plantation, FL 33324

## 2. US Agent/Contact Person:

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Email: [e-mail]

#### 3. Device Name:

| • Trade Name | : Medifine Pen Needle 3 Bevel<br>Medifine Pen Needle Quinta 5 Bevel |
|--------------------------|---------------------------------------------------------------------|
| • Classification | : Class II |
| • Regulation Description | : Hypodermic single lumen needle |
| • Product Code | : FMI |
| • Regulation Number | : 21 CFR 880.5570 |
| • Review Panel | : General Hospital |

## 3. Predicate Device:

- . Predicate Device: Medifine Pen Needle 3 Bevel & Medifine Pen Needle Quinta 5 Bevel (K171144) by MEDIBIO USA LLC.
- . Secondary Predicate Device: CareFine Pen Needle by Facet Technologies, LLC (K140568)

#### 4. Device Description:

The Medifine Pen Needle consists of a needle with hub, and shield assembly. The needle shield is intended to provide physical protection to the needle with the hub. Blister paper covers the primary container maintains sterility of the needle covering the hub and the shield with the blister paper. The needle hub can be connected onto the pen injector device for the subcutaneous injection of insulin. The device offers two compatible types of needle (patient contact point) as below. The user can choose the needle as per their preference.

#### 5. Indications For Use:

The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated for use with a pen injector device for the subcutaneous injection of insulin.

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# 6. Technological Characteristics:

The Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel is substantially equivalent to the K 171144. There is no modification to the device since the 510k clearance (K171144). The subject device and the predicate device are identical including manufacturing processes. This 510k is to include OTC claim since the predicate device only has the prescription claim. The secondary predicate device is presented for the OTC claim.

| | Subject Device | Predicate Device | Secondary Predicate<br>Device |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Medifine Pen Needle<br>3 Bevel<br>Medifine Pen Needle Quinta<br>5 Bevel | Medifine Pen Needle<br>3 Bevel<br>Medifine Pen Needle Quinta<br>5 Bevel | CareFine Pen Needle |
| Manufacturer | TAE-CHANG<br>INDUSTRIAL CO.,LTD | TAE-CHANG<br>INDUSTRIAL CO.,LTD | TAE-CHANG<br>INDUSTRIAL CO.,LTD |
| 510k Applicant | MEDIBIO USA LLC. | MEDIBIO USA LLC. | Facet Technologies, LLC |
| Product Code | FMI | FMI | FMI |
| 510k Number | K180720 | K171144 | K140568 |
| Indications for use | The Medifine Pen Needle<br>3 Bevel and the Medifine<br>Pen Needle Quinta 5 Bevel<br>are indicated for use with a<br>pen injector device for the<br>subcutaneous injection of<br>insulin. | The Medifine Pen Needle<br>3 Bevel and the Medifine<br>Pen Needle Quinta 5 Bevel<br>are indicated for use with a<br>pen injector device for the<br>subcutaneous injection of<br>insulin. | The CareFinePen Needle is<br>intended for use with a pen<br>injector device for the<br>subcutaneous injection of<br>insulin. |
| Structure | Cannula / Hub / Needle Cap<br>/ Primary Container | Cannula / Hub / Needle Cap<br>/ Primary Container | Cannula / Hub / Needle Cap<br>/ Primary Container |
| Principle of<br>Operation | Pen needle is indicated for<br>use with pen injector<br>devices for the<br>subcutaneous injection of<br>insulin. | Pen needle is indicated for<br>use with pen injector<br>devices for the<br>subcutaneous injection of<br>insulin. | Pen needle is intended for<br>use with pen injector<br>devices for the<br>subcutaneous injection of<br>insulin. |
| Shape | Image: Medifine Pen Needle 3 Bevel Shape | Image: Medifine Pen Needle 3 Bevel Shape | Image: CareFine Pen Needle Shape |
| Needle Diameter | 29G, 30G, 31G, 32G | 29G, 30G, 31G, 32G | 29G, 30G, 31G, 32G |
| Needle Tube<br>Length | 4mm, 5mm, 6mm, 8mm,<br>12.7mm | 4mm, 5mm, 6mm, 8mm,<br>12.7mm | 4mm, 5mm, 6mm, 8mm,<br>12.7mm |
| Needle Tube<br>Material | Stainless steel | Stainless steel | Stainless steel |
| Needle Hub<br>Material | Polypropylene | Polypropylene | Polypropylene |
| Needle shield<br>Material | Polyethylene | Polyethylene | Polyethylene |
| Primary container<br>Material | Polypropylene | Polypropylene | Polypropylene |
| | Image: 3 Bevel | Image: 3 Bevel | Image: 3 Bevel |
| Tip Configuration<br>(Patient Side) | Image: 5 Bevel | Image: 5 Bevel | Image: 5 Bevel |
| Primary Container<br>Length | 29.93mm | 29.93mm | 29.93 [mm] |
| Primary Container<br>Color | Transparent | Transparent | Transparent |
| Primary Container<br>Removal Force | 220~1100 [gf] | 220~1100 [gf] | 220~1100 [gf] |
| Needle Hub/needle<br>Tube bond<br>Strength | Min. 22 [N] | Min. 22 [N] | Min. 22 [N] |
| Lubricant<br>Composition | Patient-end point:<br>Dow Corning®Mdx4-4159<br>50% Medical Grade<br>Cartridge-end point :<br>Dow Corning®360 Medical<br>Fluid, 100CST | Patient-end point:<br>Dow Corning®Mdx4-4159<br>50% Medical Grade<br>Cartridge-end point :<br>Dow Corning®360 Medical<br>Fluid, 100CST | Patient-end point:<br>Dow Corning®Mdx4-4159<br>50% Medical Grade<br>Cartridge-end point :<br>Dow Corning®360 Medical<br>Fluid, 100CST |
| Sterilization<br>method | EO Gas | EO Gas | EO Gas |
| Prescription<br>/Over-the-Counter | Prescription<br>/Over-the-Counter | Prescription | Over-the-Counter |

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# 7. Performance Testing

The following tests were performed on the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel and the test results show that the subject device is substantially equivalent to the predicate devices in the market.

| No | Test item | Test Method |
|----|--------------------------------------------------|-----------------------------------------------------------------------------------------|
| 1 | Dimensions | ISO 11608-2:2012 Clause 4.2.1 General<br>ISO 9626 1991_Amd2001, clause8 |
| 2 | Dimensions for needles | ISO 11608-2:2012 Clause 4.2.2 Dimensions<br>for needles |
| 3 | Determination of flow<br>rate through the needle | ISO 11608-2:2012 Clause 4.3<br>Determination of flow rate through the<br>needle |
| 4 | Bond between hub and<br>needle tube | ISO 11608-2:2012 Clause 4.4 Bond<br>between hub and needle tube<br>ISO 7864 Clause 13.1 |
| 5 | Needle points | ISO 11608-2:2012 Clause 4.5 Needle point |
| 6 | Freedom from defects | ISO 11608-2:2012 Clause 4.6 Freedom<br>from defects<br>ISO 7864 Clause 11.3 |
| 7 | Lubrication | ISO 11608-2:2012 Clause 4.7 Lubrication |

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| 8 | Dislocation of<br>measuring point at<br>patient end | ISO 11608-2:2012 Clause 4.8 Dislocation<br>of measuring point at patient end |
|-----|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ರ | Determination of<br>functional compatibility<br>with needle-based<br>injection systems | ISO 11608-2:2012 Clause 4.9<br>Test Method - Clause 11. |
| 10 | Ease of assembly and<br>disassembly | ISO 11608-2:2012 Clause 4.10<br>Test Method - Clause 11 |
| 11 | Compatibility of<br>Needles and Injector<br>systems | ISO 11608-2:2012 Clause 11<br>Test Method - Clause 11 |
| 12 | Cannula Test | ISO 9626 Clause 4,5,6,7,8,9,10,11 |
| 13 | Extraction Test | ISO 7864 Clause 6 |
| 14 | Corrosion Test | ISO 9626 Clause 11 |
| ા ર | Sterility Test | ISO 11737-2 |
| 16 | Packaging/Aging Test | ASTM D4169-09, ISO 11608-2, ASTM<br>F1929, ISO 11608-2 |
| 17 | Biocompatibility | The raw material of the subject device as<br>well as the manufacturing processes and<br>sterilization method are the same as the<br>predicate device (K171144). |

## 8. Conclusion

Based on the information provided in this premarket notification, MEDIBIO USA LLC. concludes that the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel are substantially equivalent to the predicate devices.