Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel

K171144 · Medbio, LLC · FMI · Sep 12, 2017 · General Hospital

Device Facts

• Record ID: K171144
• Device Name: Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
• Applicant: Medbio, LLC
• Product Code: FMI · General Hospital
• Decision Date: Sep 12, 2017
• 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 Needles are sterile, single-use hypodermic needles designed for attachment to pen injector devices. The device consists of a stainless steel cannula, polypropylene hub, needle cap, and primary container. The user attaches the needle to a pen injector to perform subcutaneous insulin injections. The device provides a physical interface between the insulin pen and the patient's subcutaneous tissue. It is intended for use by patients or healthcare providers in clinical or home settings. The device facilitates insulin delivery, which is essential for glycemic control in diabetic patients. No electronic or software components are involved.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through testing against ISO 11608-2:2012, ISO 9626:1991/Amd 2001, and ISO 7864 standards, covering dimensions, flow rate, bond strength, needle point integrity, lubrication, and functional compatibility with injection systems.

Technological Characteristics

Cannula: Stainless steel. Hub: Polypropylene. Shield: Polyethylene. Primary container: Polypropylene. Lubricant: Dow Corning MDX4-4159 (patient end) and Dow Corning 360 Medical Fluid (cartridge end). Sterilization: EO Gas. Dimensions: 29G-32G diameters; 4mm-12.7mm lengths. Standards: ISO 11608-2:2012, ISO 9626, ISO 7864.

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

• CareFine Pen Needle (K140568)

Submission Summary (Full Text)

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Public Health Service

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

September 12, 2017

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

Re: K171144

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: August 1, 2017 Received: August 8, 2017

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

Image /page/0/Picture/11 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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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 (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 Industry and Consumer Education (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

Tara A. Ryan -S 2017.09.12 19:46:14 -04'00"

for Lori Wiggins, MPT, CLT 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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# Indications for Use

510(k) Number (if known) K171144

#### Device Name

Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="padding-right:5px">☒</span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span style="padding-left:20px"> <span style="padding-right:5px">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |
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# 510(K) SUMMARY (K171144)

### 1. 510k Submitter

September 8, 2017

MEDBIO LLC. 4846 Citrus Way Cooper City, Florida 33330, U.S.A

#### 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:

CareFine Pen Needle (K140568) manufactured by Facet Technologies, LLC

#### Device Description: 4.

The Medifine Pen Needle consists of a needle with hub, and shield assembly. The need to provide physical protection to the needle with the hub. Blister paper covers the primary container. 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.

The Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel is substantially equivalent to the CareFine Pen Needle (K140568) by Facet Technologies, LLC. The manufacturer of the predicate device and the subject device is the same, TAE-CHANG INDUSTRIAL CO., LTD. The subject device and the predicate device are identical including manufacturing facility and manufacturing processes.

| | Subject Device | Predicate Device |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | 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 |
| 510k Applicant | MEDBIO LLC. | Facet Technologies, LLC |
| Product Code | FMI | FMI |
| 510k Number | 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 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<br>Cap / 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 intended for<br>use with pen injector<br>devices for the<br>subcutaneous injection of<br>insulin. |
| Shape | Image: Medifine Pen Needle | Image: CareFine Pen Needle |
| Needle Diameter | 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 |
| Needle Tube<br>Material | Stainless steel | Stainless steel |
| Needle Hub<br>Material | Polypropylene | Polypropylene |
| Needle shield<br>Material | Polyethylene | Polyethylene |
| Primary container<br>Material | Polypropylene | Polypropylene |
| Tip Configuration<br>(Patient Side) | Image: 3 Bevel | Image: 3 Bevel |
| | Image: 5 Bevel | Image: 5 Bevel |
| Primary Container<br>Length | 29.93[mm] | 29.93 [mm] |
| Primary Container<br>Color | Transparent | Transparent |
| Primary Container<br>Removal Force | 220~1100 [gf] | 220~1100 [gf] |
| Needle Hub/needle<br>Tube bond<br>Strength | 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 |
| Sterilization<br>method | EO Gas | EO Gas |

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# 7. 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 |
| 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 |
| 9 | 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 | ISO 11608-2:2012 Clause 11 |

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| | Needles and Injector<br>systems | 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 |

#### 8. Conclusion

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