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 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and effectiveness studies as would be seen for higher-risk devices or novel technologies.

Therefore, the information you've requested regarding acceptance criteria and performance studies, particularly in the context of AI/algorithm performance and expert adjudication, is largely not applicable to this document as it describes a medical device (hypodermic pen needles), not an AI/software as a medical device (SaMD).

However, I can extract the closest information available from the document that aligns with your request, interpreting "acceptance criteria" as the performance standards met by the device through testing.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device (pen needles), the "acceptance criteria" are the performance specifications defined by international standards (ISO standards) for hypodermic needles. The document states that the device met these criteria through testing. It does not provide specific numerical thresholds for acceptance or numerical results for each test item. Instead, it indicates that the device conforms to the standards.

Test Item	Test Method (Reference Standard)	Reported Device Performance
Dimensions	ISO 11608-2:2012 Clause 4.2.1 GeneralISO 9626 1991_Amd2001, clause8	Meets standard requirements (implied by "tests show... substantially equivalent")
Dimensions for needles	ISO 11608-2:2012 Clause 4.2.2 Dimensionsfor needles	Meets standard requirements (implied)
Determination of flow rate through the needle	ISO 11608-2:2012 Clause 4.3Determination of flow rate through theneedle	Meets standard requirements (implied)
Bond between hub and needle tube	ISO 11608-2:2012 Clause 4.4 Bondbetween hub and needle tubeISO 7864 Clause 13.1	Meets standard requirements (implied), specifically "Min. 22 [N]"
Needle points	ISO 11608-2:2012 Clause 4.5 Needle point	Meets standard requirements (implied)
Freedom from defects	ISO 11608-2:2012 Clause 4.6 Freedomfrom defectsISO 7864 Clause 11.3	Meets standard requirements (implied)
Lubrication	ISO 11608-2:2012 Clause 4.7 Lubrication	Meets standard requirements (implied)
Dislocation of measuring point at patient end	ISO 11608-2:2012 Clause 4.8 Dislocationof measuring point at patient end	Meets standard requirements (implied)
Determination of functional compatibility with needle-based injection systems	ISO 11608-2:2012 Clause 4.9Test Method - Clause 11.	Meets standard requirements (implied)
Ease of assembly and disassembly	ISO 11608-2:2012 Clause 4.10Test Method - Clause 11	Meets standard requirements (implied)
Compatibility of Needles and Injector systems	ISO 11608-2:2012 Clause 11	Meets standard requirements (implied)
Cannula Test	ISO 9626 Clause 4,5,6,7,8,9,10,11	Meets standard requirements (implied)
Extraction Test	ISO 7864 Clause 6	Meets standard requirements (implied)
Corrosion Test	ISO 9626 Clause 11	Meets standard requirements (implied)
Primary Container Removal Force	N/A (Internal specification)	220~1100 [gf]

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the document. The tests performed are typically batch-release or design verification tests, which would involve a statistically significant sample size based on the specific ISO standards, but the exact number is not detailed here.
Data Provenance: Not specified. Standard medical device testing is typically conducted by the manufacturer or accredited testing laboratories. The country of origin of the data is not mentioned. It is assumed to be part of the manufacturer's quality system which adheres to international standards. The study is prospective in the sense that the new device was tested against established standards and specifications.

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

This question is not applicable as the device is a physical pen needle, not an AI/software device requiring expert interpretation of diagnostic images or data. Performance is assessed against physical and mechanical standards using laboratory testing, not human expert "ground truth."

4. Adjudication Method for the Test Set

This question is not applicable for the same reason as point 3. Testing involves objective measurements and adherence to engineering and material specifications, not subjective expert adjudication.

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

This question is not applicable. MRMC studies are used for diagnostic imaging devices or SaMD where human readers interpret cases. This document concerns a physical device (pen needle).

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

This question is not applicable. This device is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by international standards (ISO standards) for hypodermic needles and pen needles (e.g., ISO 11608-2, ISO 9626, ISO 7864) and manufacturer's internal specifications derived from these standards. These standards define the acceptable physical properties, mechanisms, and safety characteristics.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train an AI model. This device is not an AI/software device.

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

This question is not applicable for the same reason as point 8.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
☒Prescription Use (Part 21 CFR 801 Subpart D) ☐Over-The-Counter Use (21 CFR 801 Subpart C)
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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: 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:

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

Device Description: 4.

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 Needle3 BevelMedifine Pen Needle Quinta5 Bevel	CareFine Pen Needle
Manufacturer	TAE-CHANGINDUSTRIAL CO.,LTD	TAE-CHANGINDUSTRIAL CO.,LTD
510k Applicant	MEDBIO LLC.	Facet Technologies, LLC
Product Code	FMI	FMI
510k Number	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 CareFinePen Needle isintended for use with a peninjector device for thesubcutaneous injection ofinsulin.
Structure	Cannula / Hub / Needle Cap/ Primary Container	Cannula / Hub / NeedleCap / Primary Container
Principle ofOperation	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	Image: CareFine Pen Needle
Needle Diameter	29G, 30G, 31G, 32G	29G, 30G, 31G, 32G
Needle TubeLength	4mm, 5mm, 6mm, 8mm,12.7mm	4mm, 5mm, 6mm, 8mm,12.7mm
Needle TubeMaterial	Stainless steel	Stainless steel
Needle HubMaterial	Polypropylene	Polypropylene
Needle shieldMaterial	Polyethylene	Polyethylene
Primary containerMaterial	Polypropylene	Polypropylene
Tip Configuration(Patient Side)	Image: 3 Bevel	Image: 3 Bevel
	Image: 5 Bevel	Image: 5 Bevel
Primary ContainerLength	29.93[mm]	29.93 [mm]
Primary ContainerColor	Transparent	Transparent
Primary ContainerRemoval Force	220~1100 [gf]	220~1100 [gf]
Needle Hub/needleTube bondStrength	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
Sterilizationmethod	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 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
8	Dislocation ofmeasuring point atpatient end	ISO 11608-2:2012 Clause 4.8 Dislocationof measuring point at patient end
9	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 of	ISO 11608-2:2012 Clause 11

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	Needles and Injectorsystems	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.

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).