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K Number
K180720
Device Name
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
Manufacturer
Medibio Usa LLC.
Date Cleared
2018-06-27

(100 days)

Product Code
FMI
Regulation Number
880.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
More Information

K171144, K140568

Not Found

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

Yes.
The device is a pen needle used for the subcutaneous injection of insulin, which is a therapeutic intervention for conditions like diabetes.

No
The device is a pen needle used for drug delivery (subcutaneous injection of insulin), not for diagnosing a condition. Its function is to facilitate the administration of medication.

No

The device description clearly outlines physical components (needle, hub, shield assembly, blister paper) and performance studies focus on physical characteristics and compatibility with hardware (pen injector device). There is no mention of software as a component or function of the device.

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

Here's why:

  • Intended Use: The intended use is for the "subcutaneous injection of insulin" using a pen injector device. This describes a device used for administering medication directly into the body, not for testing samples in vitro (outside the body).
  • Device Description: The description details a needle, hub, and shield assembly designed for injection. There is no mention of components or functions related to analyzing biological samples.
  • Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing blood, urine, or other biological samples.
    • Detecting or measuring substances in biological samples.
    • Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.

The device described is a medical device used for drug delivery, specifically insulin injection.

N/A

Intended Use / 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.

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

FMI

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.

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

Not Found

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)

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:

  1. Dimensions (ISO 11608-2:2012 Clause 4.2.1 General; ISO 9626 1991_Amd2001, clause8)
  2. Dimensions for needles (ISO 11608-2:2012 Clause 4.2.2 Dimensions for needles)
  3. Determination of flow rate through the needle (ISO 11608-2:2012 Clause 4.3 Determination of flow rate through the needle)
  4. Bond between hub and needle tube (ISO 11608-2:2012 Clause 4.4 Bond between hub and needle tube; 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 from defects; ISO 7864 Clause 11.3)
  7. Lubrication (ISO 11608-2:2012 Clause 4.7 Lubrication)
  8. Dislocation of measuring point at patient end (ISO 11608-2:2012 Clause 4.8 Dislocation of measuring point at patient end)
  9. Determination of functional compatibility with needle-based injection systems (ISO 11608-2:2012 Clause 4.9; Test Method - Clause 11.)
  10. Ease of assembly and disassembly (ISO 11608-2:2012 Clause 4.10; Test Method - Clause 11)
  11. Compatibility of Needles and Injector systems (ISO 11608-2:2012 Clause 11; 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)
  15. Sterility Test (ISO 11737-2)
  16. Packaging/Aging Test (ASTM D4169-09, ISO 11608-2, ASTM F1929, ISO 11608-2)
  17. Biocompatibility (The raw material of the subject device as well as the manufacturing processes and sterilization method are the same as the predicate device (K171144).)

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.

K171144, K140568

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

§ 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).

0

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: juhee.c@lkconsultinggroup.com

3. Device Name:

| • Trade Name | : Medifine Pen Needle 3 Bevel
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.

4

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
Device |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Medifine Pen Needle
3 Bevel
Medifine Pen Needle Quinta
5 Bevel | Medifine Pen Needle
3 Bevel
Medifine Pen Needle Quinta
5 Bevel | CareFine Pen Needle |
| Manufacturer | TAE-CHANG
INDUSTRIAL CO.,LTD | TAE-CHANG
INDUSTRIAL CO.,LTD | TAE-CHANG
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
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. | 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. | The CareFinePen Needle is
intended for use with a pen
injector device for the
subcutaneous injection of
insulin. |
| Structure | Cannula / Hub / Needle Cap
/ Primary Container | Cannula / Hub / Needle Cap
/ Primary Container | Cannula / Hub / Needle Cap
/ Primary Container |
| Principle of
Operation | Pen needle is indicated for
use with pen injector
devices for the
subcutaneous injection of
insulin. | Pen needle is indicated for
use with pen injector
devices for the
subcutaneous injection of
insulin. | Pen needle is intended for
use with pen injector
devices for the
subcutaneous injection of
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
Length | 4mm, 5mm, 6mm, 8mm,
12.7mm | 4mm, 5mm, 6mm, 8mm,
12.7mm | 4mm, 5mm, 6mm, 8mm,
12.7mm |
| Needle Tube
Material | Stainless steel | Stainless steel | Stainless steel |
| Needle Hub
Material | Polypropylene | Polypropylene | Polypropylene |
| Needle shield
Material | Polyethylene | Polyethylene | Polyethylene |
| Primary container
Material | Polypropylene | Polypropylene | Polypropylene |
| | Image: 3 Bevel | Image: 3 Bevel | Image: 3 Bevel |
| Tip Configuration
(Patient Side) | Image: 5 Bevel | Image: 5 Bevel | Image: 5 Bevel |
| Primary Container
Length | 29.93mm | 29.93mm | 29.93 [mm] |
| Primary Container
Color | Transparent | Transparent | Transparent |
| Primary Container
Removal Force | 2201100 [gf] | 2201100 [gf] | 220~1100 [gf] |
| Needle Hub/needle
Tube bond
Strength | Min. 22 [N] | Min. 22 [N] | Min. 22 [N] |
| Lubricant
Composition | Patient-end point:
Dow Corning®Mdx4-4159
50% Medical Grade
Cartridge-end point :
Dow Corning®360 Medical
Fluid, 100CST | Patient-end point:
Dow Corning®Mdx4-4159
50% Medical Grade
Cartridge-end point :
Dow Corning®360 Medical
Fluid, 100CST | Patient-end point:
Dow Corning®Mdx4-4159
50% Medical Grade
Cartridge-end point :
Dow Corning®360 Medical
Fluid, 100CST |
| Sterilization
method | EO Gas | EO Gas | EO Gas |
| Prescription
/Over-the-Counter | Prescription
/Over-the-Counter | Prescription | Over-the-Counter |

5

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.

NoTest itemTest Method
1DimensionsISO 11608-2:2012 Clause 4.2.1 General
ISO 9626 1991_Amd2001, clause8
2Dimensions for needlesISO 11608-2:2012 Clause 4.2.2 Dimensions
for needles
3Determination of flow
rate through the needleISO 11608-2:2012 Clause 4.3
Determination of flow rate through the
needle
4Bond between hub and
needle tubeISO 11608-2:2012 Clause 4.4 Bond
between hub and needle tube
ISO 7864 Clause 13.1
5Needle pointsISO 11608-2:2012 Clause 4.5 Needle point
6Freedom from defectsISO 11608-2:2012 Clause 4.6 Freedom
from defects
ISO 7864 Clause 11.3
7LubricationISO 11608-2:2012 Clause 4.7 Lubrication

6

| 8 | Dislocation of
measuring point at
patient end | ISO 11608-2:2012 Clause 4.8 Dislocation
of measuring point at patient end |
|-----|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ರ | Determination of
functional compatibility
with needle-based
injection systems | ISO 11608-2:2012 Clause 4.9
Test Method - Clause 11. |
| 10 | Ease of assembly and
disassembly | ISO 11608-2:2012 Clause 4.10
Test Method - Clause 11 |
| 11 | Compatibility of
Needles and Injector
systems | ISO 11608-2:2012 Clause 11
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
F1929, ISO 11608-2 |
| 17 | Biocompatibility | The raw material of the subject device as
well as the manufacturing processes and
sterilization method are the same as the
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.