The SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and the needle tube with blister paper sealed on the opening hole of primary container.

The needle hub can be connected with the pen. The hub has internal threads, which allows it to be screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.

The SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization) and non-pyrogenic. The pen needles are disposable, single use devices.

AI/ML Overview

The provided document is a 510(k) premarket notification for the SureFine Pen Needle, a medical device. It does not describe a study proving the device meets acceptance criteria but rather demonstrates substantial equivalence to a predicate device.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document provides a comparative table between the SureFine Pen Needle (Subject Device) and its predicate device (ShinaPen® K113186). The acceptance criteria are implied by the performance specifications of the predicate device, and the "reported device performance" is essentially the subject device's matching of these characteristics.

Feature	Acceptance Criteria (Predicate: ShinaPen®)	Reported Device Performance (SureFine Pen Needle)
Intended Use	For use with a pen injector for the subcutaneous injection of insulin.	For use with a pen injector for the subcutaneous injection of insulin.
Gauge	29G, 30G, 31G, 32G	29G, 30G, 31G, 32G
Material (Needle tube)	STS304	STS304
Material (Hub)	Polypropylene	Polypropylene
Material (Primary container)	Polyethylene	Polyethylene
Material (Silicone)	Poly di-methylsiloxane	Poly di-methylsiloxane
Sterilization	Ethylene oxide gas (SAL 10-6)	Ethylene oxide gas (SAL 10-6)
Tip configuration (Patient-end)	Image: Tip of needle (implied same visual configuration)	Image: Tip of needle (implied same visual configuration)
Tip configuration (Cartridge-end)	Image: Cartridge end of needle (implied same visual configuration)	Image: Cartridge end of needle (implied same visual configuration)
Needle Sharpness (Min)	-27.2g	-27.2g
Needle Sharpness (Average)	-29.20g	-29.20g
Needle Sharpness (Max)	-31.1g	-31.1g
Length	4mm, 6mm, 8mm, 12.7mm	4mm, 6mm, 8mm, 12.7mm
Gauge	29G, 30G, 31G, 32G	29G, 30G, 31G, 32G
Needle shield color	Red / Yellow / Colorless / Blue / Blue / Violet Green Grey	Red / Yellow / Colorless / Blue / Blue / Violet Green Grey
Needle shield dimensions	I.D(2.7mm), O.D(4mm), L(19.35mm)	I.D(2.7mm), O.D(4mm), L(19.35mm)
Needle shield strength (Min)	5.8N	5.8N
Needle shield strength (Average)	8.16N	8.16N
Hub/needle bond strength (Min)	47.5N	47.5N
Hub/needle bond strength (Average)	58.02N	58.02N
Hub/needle bond strength (Max)	61.9N	61.9N

Beyond this comparative table, the document states that the SureFine Pen Needle was "designed and successfully tested to meet the applicable requirements outlined in ISO 7864:1993, ISO 9626:1991 and ISO 11608-2:2012." The specific clauses listed for each ISO standard represent the acceptance criteria for those performance aspects.

For example, for ISO 7864:1993, acceptance criteria would be:

Clause 4: Cleanliness requirements met.
Clause 5: Limits for acidity or alkalinity met.
Clause 6: Limits for extractable metals met.
Clause 7: Size designation accurate.
Clause 11.3: Freedom from defects.
Clause 11.4: Lubricant requirements met.
Clause 12: Needle point specifications met.
Clause 13.1: Bond between hub and needle tube specifications met.
Clause 13.2 a): Patency of lumen demonstrated.

Similar detailed acceptance criteria are implied for the other ISO standards and biocompatibility tests mentioned.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document broadly mentions "Performance Testing", "Biocompatibility Testing", and "Sterilization and Shelf-life Testing" without specifying the exact sample sizes for each test. These were non-clinical tests.

Test Type: Non-clinical (bench testing, biocompatibility, sterilization validation).
Data Provenance: The manufacturer is SHINA MED CORPORATION, located in the Republic of Korea. The testing was conducted to international standards (ISO).
Retrospective/Prospective: These are prospective tests on the SureFine Pen Needle device design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided in the context of this 510(k) submission. This type of submission relies on non-clinical performance and substantial equivalence to a predicate device, not expert-derived ground truth as would be relevant for diagnostic AI/imaging devices. The "ground truth" here is the adherence to established engineering standards (ISO) and the characteristics of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically used in clinical studies, particularly for diagnostic devices where multiple readers interpret images or data, and discrepancies need resolution. This document describes bench testing and demonstrates substantial equivalence, not clinical evaluation with human readers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the SureFine Pen Needle is. The document explicitly states: "No prospective clinical trials were conducted in support of this Traditional 510(k)."

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

A standalone performance evaluation was done in the sense that the device itself (the pen needle) was tested against technical specifications and international standards (ISO). However, this is not an "algorithm-only" standalone performance study as described for AI devices. The device's performance was evaluated inherently by its physical and material properties and its function when used with compatible pen injectors.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's evaluation is primarily engineering specifications, material science standards, and established international performance standards (ISO standards). For biocompatibility, the ground truth is defined by the results of specific biological evaluations (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity tests). For functional compatibility, the ground truth is simply successful operation with specified insulin injectors.

8. The sample size for the training set

This information is not applicable/provided. The SureFine Pen Needle is a mechanical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable/provided. As explained above, there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus or a staff with snakes, but in this case, it features three abstract human profiles.

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

June 7, 2016

Shina Med Corporation % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831

Re: K152877

Trade/Device Name: SureFine Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: February 29, 2016 Received: March 9, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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 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 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 yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. 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)

K152877

Device Name

SureFine Pen Needle

Indications for Use (Describe)

SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY (K152877)

1. Submitted by:

June 5, 2016

Il-hwan, Jeong / Quality Management Representative SHINA MED CORPORATION 455-30, Bogaewonsam-ro, Bogae-myun, Anseong-si, Gyeonggido, 456-871, Republic of Korea Phone: +82 31 8057 2125 Fax : + 82 31 8057 2150

2. US Agent/Contact Person:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831

3. Device Name:

Trade Name : SureFine Pen Needle • Classification : Class II · Classification Name : Needle, Hypodermic, Single Lumen • Product Code : FMI • Regulation Number : 21 CFR 880.5570 · Review Panel : General Hospital

3. Predicate Device:

ShinaPen® (K113186) manufactured by SHINA CORPORATION

Device Description: 4.

5. Intended For Use:

The SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

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6. Technological Characteristics:

The SureFine Pen Needle is substantially equivalent to previously marketed device, ShinaPen® (K113186) manufactured by SHINA CORPORATION. The device design, materials of construction and performance specifications are substantially equivalent to the predicate device.

Device Name		Subject Device	Predicate Device
Manufacturer		SHINA MED CORPORATION	SHINA CORPORATION
510(k) Number		K152877	K113186
Device Name		SureFine Pen Needle	ShinaPen®
Intended for use		The SureFine Pen Needle is intendedfor use with a pen injector for thesubcutaneous injection of insulin.	The ShinaPen® is designedfor use with a pen injector for thesubcutaneous injection of insulin.
Gauge		29G, 30G, 31G, 32G	29G, 30G, 31G, 32G
RawMaterial	Needletube	STS304	STS304
	Hub	Polypropylene	Polypropylene
	Primarycontainer	Polyethylene	Polyethylene
	Silicone	Poly di-methylsiloxane	Poly di-methylsiloxane
Sterilization		Ethylene oxide gas(SAL 10-6)	Ethylene oxide gas(SAL 10-6)
Tip configuration(The patient-endof the needle)		Image: Tip of needle	Image: Tip of needle
Tip configuration(The cartridge-endof the needle)		Image: Cartridge end of needle	Image: Cartridge end of needle
	Min	-27.2g	-27.2g
NeedleSharpness	Average	-29.20g	-29.20g
	Max	-31.1g	-31.1g
Length		4mm, 6mm, 8mm, 12.7mm	4mm, 6mm, 8mm, 12.7mm
Gauge		29G, 30G, 31G, 32G	29G, 30G, 31G, 32G
Needle shield color		Red / Yellow / Colorless /Blue / Blue / Violet Green Grey	Red / Yellow / Colorless /Blue / Blue / Violet Green Grey
Needle shielddimensions		I.D(2.7mm), O.D(4mm), L(19.35mm)	I.D(2.7mm), O.D(4mm), L(19.35mm)
	Min	5.8N	5.8N
Needleshieldstrength	Average	8.16N	8.16N
	Max
Hub/needlebondstrength	Max	9.8N	9.8N
	Min	47.5N	47.5N
	Average	58.02N	58.02N
	Max	61.9N	61.9N

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7. Testing

The SureFine Pen Needle has been designed and tested to meet the applicable requirements of voluntary standards and FDA Guidance documents applicable to the subject and predicate devices. The results of the non-clinical testing supported the conclusion of substantial equivalence.

Performance Testing

SureFine Pen Needle has been designed and successfully tested to meet the applicable requirements outlined in ISO 7864:1993, ISO 9626:1991 and ISO 11608-2:2012.

Tests performed per ISO 7864:1993:
· ISO 7864:1993 Clause 4 Cleanliness
· ISO 7864:1993 Clause 5 Limits for acidity or alkalinity
· ISO 7864:1993 Clause 6 Limits for extractable metals
· ISO 7864:1993 Clause 7 Size designation
· ISO 7864:1993 Clause 11.3 Freedom from defects
· ISO 7864:1993 Clause 11.4 Lubricant
· ISO 7864:1993 Clause 12 Needle point
· ISO 7864:1993 Clause 13.1 Bond between hub and needle tube
· ISO 7864:1993 Clause 13.2 a) Patency of lumen
Tests performed per ISO 9626:1991 Amd1:2001 (Stainless tubing for SureFine Pen Needle)
· ISO 9626:1991 Amd1:2001 Clause 3 Materials
· ISO 9626:1991 Amd1:2001 Clause 4 Surface finish
· ISO 9626:1991 Amd1:2001 Clause 5 Cleanliness
· ISO 9626:1991 Amd1:2001 Clause 6 Limits for acidity and alkalinity
· ISO 9626:1991 Amd1:2001 Clause 7 Size designation
· ISO 9626:1991 Amd1:2001 Clause 8 Dimensions
· ISO 9626:1991 Amd1:2001 Clause 9 Stiffness
· ISO 9626:1991 Amd1:2001 Clause 10 Resistance to breakage
· ISO 9626:1991 Amd1:2001 Clause 11 Resistance to corrosion
Tests performed per ISO 11608-2:2012
· ISO 11608-2:2012 Clause 4.2 Dimensions / Clause 4.2.2 Dimensions for needles
· ISO 11608-2:2012 Clause 4.3 Determination of flow rate through the needle
· ISO 11608-2:2012 Clause 4.4 Bond between hub and needle tube
· ISO 11608-2:2012 Clause 4.5 Needle point
· ISO 11608-2:2012 Clause 4.6 Freedom from defects
· ISO 11608-2:2012 Clause 4.7 Lubrication
· ISO 11608-2:2012 Clause 4.8 Dislocation of measuring point at patient end

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· ISO 11608-2:2012 Clause 4.9 Determination of functional compatibility with needle-based injection systems
· ISO 11608-2:2012 Clause 4.10 Ease of assembly and disassembly

And the following insulin injectors are successfully tested and found to be functionally compatible with the following insulin pen-injectors according to ISO 11608-2:2012 section 4.9.

· HUMULIN PEN (3ml) Eli Lilly
LANTUS SOLOSTAR (3ml) Sanofi Aventis
FlexPen (3ml) Novo Nordisk

Biocompatibility Testing

The material of the SureFine Pen Needle has successfully passed testing as outlined in ISO 10993-1 for devices categorized as External communicating devices, Limited exposure.

· ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
· ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Test for Irritation and Sensitization 5.4 Intracutaneous reactivity test
· ISO 10993-10 2010 Biological evaluation of medical devices Part 10: Teat for Irritation and Sensitization 6.2 Maximization sensitization test
· ISO 10993-11 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity 6.5 Acute systemic toxicity
· ISO 10993-4:2002 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood.
· The United States Pharmacopeia <151> (Pyrogen test)

Sterilization and Shelf-life Testing

Sterilization of the SureFine Pen Needle has been validated using the half-cycle method as outlined in ISO11135. Testing demonstrated maximum levels of residues of ethylene chlorohydrins do not exceed the limits presented in IS010993-7. LAL testing was performed to demonstrate that bacterial endotoxins are adequately mitigated. Shelf-life testing supports a shelf-life of 3-years after sterilization.

Clinical Data

No prospective clinical trials were conducted in support of this Traditional 510(k).

8. Discussion

SureFine Pen Needle has the same intended use, technological characteristics, materials of construction and performance specifications as the predicate K113186 (Shina Pen Needle) and thus it performs in a substantial equivalent manner to the predicate device.

9. Conclusion

Based on the information provided in this premarket notification, SHINA MED CORPORATION concludes that the SureFine Pen Needle is 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).