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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices, specifically the Medifine Pen Needle 3 Bevel & Medifine Pen Needle Quinta 5 Bevel (K171144) and the CareFine Pen Needle by Facet Technologies, LLC (K140568) for an Over-the-Counter (OTC) claim.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Medifine Pen Needles are based on compliance with various ISO and ASTM standards. The document states that the "test results show that the subject device is substantially equivalent to the predicate devices in the market," implying the device performance met these criteria. However, specific numerical performance results for each test item are not provided in this document. The table below lists the test items and the relevant standards used as acceptance criteria.

No	Test Item	Test Method / Acceptance Criteria (Standard)	Reported Device Performance
1	Dimensions	ISO 11608-2:2012 Clause 4.2.1 General; ISO 9626 1991_Amd2001, clause 8	Met substantial equivalence (specific data not provided)
2	Dimensions for needles	ISO 11608-2:2012 Clause 4.2.2 Dimensions for needles	Met substantial equivalence (specific data not provided)
3	Determination of flow rate through the needle	ISO 11608-2:2012 Clause 4.3 Determination of flow rate through the needle	Met substantial equivalence (specific data not provided)
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	Met substantial equivalence (specific data not provided)
5	Needle points	ISO 11608-2:2012 Clause 4.5 Needle point	Met substantial equivalence (specific data not provided)
6	Freedom from defects	ISO 11608-2:2012 Clause 4.6 Freedom from defects; ISO 7864 Clause 11.3	Met substantial equivalence (specific data not provided)
7	Lubrication	ISO 11608-2:2012 Clause 4.7 Lubrication	Met substantial equivalence (specific data not provided)
8	Dislocation of measuring point at patient end	ISO 11608-2:2012 Clause 4.8 Dislocation of measuring point at patient end	Met substantial equivalence (specific data not provided)
9	Determination of functional compatibility with needle-based injection systems	ISO 11608-2:2012 Clause 4.9; Test Method - Clause 11.	Met substantial equivalence (specific data not provided)
10	Ease of assembly and disassembly	ISO 11608-2:2012 Clause 4.10; Test Method - Clause 11	Met substantial equivalence (specific data not provided)
11	Compatibility of Needles and Injector systems	ISO 11608-2:2012 Clause 11; Test Method - Clause 11	Met substantial equivalence (specific data not provided)
12	Cannula Test	ISO 9626 Clause 4, 5, 6, 7, 8, 9, 10, 11	Met substantial equivalence (specific data not provided)
13	Extraction Test	ISO 7864 Clause 6	Met substantial equivalence (specific data not provided)
14	Corrosion Test	ISO 9626 Clause 11	Met substantial equivalence (specific data not provided)
15	Sterility Test	ISO 11737-2	Met substantial equivalence (specific data not provided)
16	Packaging/Aging Test	ASTM D4169-09, ISO 11608-2, ASTM F1929, ISO 11608-2	Met substantial equivalence (specific data not provided)
17	Biocompatibility	Same raw material, manufacturing processes, and sterilization method as predicate device (K171144)	Met substantial equivalence (specific data not provided)

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each test item. It only states that "The following tests were performed on the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel." The data provenance is not explicitly mentioned (e.g., country of origin or retrospective/prospective). However, the testing is performed to satisfy international standards (ISO, ASTM), implying a standardized testing environment rather than a clinical data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document describes a submission for a medical device (pen needles) based on engineering performance testing and substantial equivalence to existing devices, not on diagnostic accuracy requiring expert interpretation of medical images or data. Therefore, the concept of "ground truth" and "experts" in the context of clinical interpretation, as typically applied to AI/ML medical devices, is not applicable to this type of submission. The ground truth for the performance tests would be defined by the specifications and measurement techniques within the cited ISO and ASTM standards.

4. Adjudication Method for the Test Set

As explained above, this submission is for a medical device that relies on engineering and material performance criteria. Therefore, an adjudication method for a test set, in the sense of resolving discrepancies between expert interpretations, is not applicable. The results of the performance tests would be objective measurements against predefined criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically conducted for AI/ML diagnostic or prognostic devices to assess the impact of AI assistance on human reader performance. The Medifine Pen Needle is a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No. This document describes the performance testing of a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria and performance testing of the Medifine Pen Needle is based on established engineering and safety standards (ISO, ASTM). These standards define acceptable dimensions, flow rates, bond strengths, material properties, sterility, and other physical and safety features. It is not based on expert consensus for clinical diagnosis, pathology, or outcomes data.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a physical medical device. It does not involve any artificial intelligence or machine learning algorithms that would require a "training set." Therefore, the concept of a training set sample size is not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm involved in this device, the question of how its ground truth was established is not applicable.

Summary

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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 (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 BevelMedifine 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:

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 PredicateDevice
Device Name	Medifine Pen Needle3 BevelMedifine Pen Needle Quinta5 Bevel	Medifine Pen Needle3 BevelMedifine Pen Needle Quinta5 Bevel	CareFine Pen Needle
Manufacturer	TAE-CHANGINDUSTRIAL CO.,LTD	TAE-CHANGINDUSTRIAL CO.,LTD	TAE-CHANGINDUSTRIAL 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 Needle3 Bevel and the MedifinePen Needle Quinta 5 Bevelare indicated for use with apen injector device for thesubcutaneous injection ofinsulin.	The Medifine Pen Needle3 Bevel and the MedifinePen Needle Quinta 5 Bevelare indicated for use with apen injector device for thesubcutaneous injection ofinsulin.	The CareFinePen Needle isintended for use with a peninjector device for thesubcutaneous injection ofinsulin.
Structure	Cannula / Hub / Needle Cap/ Primary Container	Cannula / Hub / Needle Cap/ Primary Container	Cannula / Hub / Needle Cap/ Primary Container
Principle ofOperation	Pen needle is indicated foruse with pen injectordevices for thesubcutaneous injection ofinsulin.	Pen needle is indicated foruse with pen injectordevices for thesubcutaneous injection ofinsulin.	Pen needle is intended foruse with pen injectordevices for thesubcutaneous injection ofinsulin.
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 TubeLength	4mm, 5mm, 6mm, 8mm,12.7mm	4mm, 5mm, 6mm, 8mm,12.7mm	4mm, 5mm, 6mm, 8mm,12.7mm
Needle TubeMaterial	Stainless steel	Stainless steel	Stainless steel
Needle HubMaterial	Polypropylene	Polypropylene	Polypropylene
Needle shieldMaterial	Polyethylene	Polyethylene	Polyethylene
Primary containerMaterial	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 ContainerLength	29.93mm	29.93mm	29.93 [mm]
Primary ContainerColor	Transparent	Transparent	Transparent
Primary ContainerRemoval Force	220~1100 [gf]	220~1100 [gf]	220~1100 [gf]
Needle Hub/needleTube bondStrength	Min. 22 [N]	Min. 22 [N]	Min. 22 [N]
LubricantComposition	Patient-end point:Dow Corning®Mdx4-415950% Medical GradeCartridge-end point :Dow Corning®360 MedicalFluid, 100CST	Patient-end point:Dow Corning®Mdx4-415950% Medical GradeCartridge-end point :Dow Corning®360 MedicalFluid, 100CST	Patient-end point:Dow Corning®Mdx4-415950% Medical GradeCartridge-end point :Dow Corning®360 MedicalFluid, 100CST
Sterilizationmethod	EO Gas	EO Gas	EO Gas
Prescription/Over-the-Counter	Prescription/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 GeneralISO 9626 1991_Amd2001, clause8
2	Dimensions for needles	ISO 11608-2:2012 Clause 4.2.2 Dimensionsfor needles
3	Determination of flowrate through the needle	ISO 11608-2:2012 Clause 4.3Determination of flow rate through theneedle
4	Bond between hub andneedle tube	ISO 11608-2:2012 Clause 4.4 Bondbetween hub and needle tubeISO 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 Freedomfrom defectsISO 7864 Clause 11.3
7	Lubrication	ISO 11608-2:2012 Clause 4.7 Lubrication

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8	Dislocation ofmeasuring point atpatient end	ISO 11608-2:2012 Clause 4.8 Dislocationof measuring point at patient end
ರ	Determination offunctional compatibilitywith needle-basedinjection systems	ISO 11608-2:2012 Clause 4.9Test Method - Clause 11.
10	Ease of assembly anddisassembly	ISO 11608-2:2012 Clause 4.10Test Method - Clause 11
11	Compatibility ofNeedles and Injectorsystems	ISO 11608-2:2012 Clause 11Test 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, ASTMF1929, ISO 11608-2
17	Biocompatibility	The raw material of the subject device aswell as the manufacturing processes andsterilization method are the same as thepredicate 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.

Regulation Number and Section

§ 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).