The ShinaPen® are 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 the of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container. The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube. The ShinaPen® are offered various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ShinaPen®, an insulin pen needle. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, many of the requested elements (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, training set details) are not applicable or cannot be extracted from this document.

Here's an analysis based on the information available:

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

Acceptance Criteria Category	Reported Device Performance (Summary)
Voluntary Standards	ShinaPen® successfully tested to meet requirements of ISO7864, ISO9626, and ISO11608-2.
Internal Standards	Needle shield assembly force and Needle sharpness testing met internal standards.
Biocompatibility	Successfully passed testing as outlined in ISO10993-1 for External communicating devices, Limited exposure.
Sterilization	Validation using half-cycle method (ISO11135). Maximum residues of ethylene oxide and ethylene chlorohydrins will not exceed ISO10993-7 limits.
Shelf-life	Supports a 3-year shelf-life after sterilization.
Technological Characteristics	"Identical technological characteristics and perform equivalently" to predicate devices.

2. Sample sizes used for the test set and the data provenance

Sample sizes: Not explicitly stated for any of the performance tests. The document only mentions "performance testing" and "biocompatibility testing" without providing the number of units tested.
Data provenance: Not explicitly stated. However, the manufacturer is SHINA CORPORATION from Korea. The testing would presumably have been conducted by or for the manufacturer. It is non-clinical safety and performance testing, not data derived from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes non-clinical engineering and laboratory tests (e.g., meeting ISO standards, material biocompatibility, sterilization validation). These types of tests do not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic algorithm validations do. The "truth" is defined by the passing criteria of the standards themselves (e.g., a certain force to remove a needle shield, a concentration limit for residues).

4. Adjudication method for the test set

Not applicable. See point 3.

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

Not applicable. This device is an insulin pen needle, a physical medical device. It is not an AI-powered diagnostic or assistive tool, and therefore, MRMC studies or AI assistance are not relevant.

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

Not applicable. See point 5.

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

Standard-defined criteria/specifications: For the performance tests (ISO standards, internal standards, biocompatibility, sterilization, shelf-life), the "ground truth" or acceptance criteria are defined by the specific requirements and limits set forth in the referenced international standards (e.g., ISO7864, ISO9626, ISO11608-2, ISO10993-1, ISO11135, ISO10993-7) and the manufacturer's own internal specifications for needle shield assembly force and sharpness.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See point 8.

Summary

{0}------------------------------------------------

1-2-2012

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Submitted by :

Jan /05/2012

Jiseop Jeong / Manager / Regulatory affairs SHINA CORPORATION 691-1, boheung-ri useong-myeon, gongju-si, chungchengnam-do, 314-864, Korea Phone : +82 41 853 8571 Fax : +82 41 853 0872

2. Device Name :

Trade Name	: ShinaPen®
Common Names	: Insulin pen needle
Classification Name	: Hypodermic single lumen needle

3. Predicate Device :

UltiMed UltiCareTm Disposable Pen Needles Manufactured by UltiMed Inc.

FlexPen Needle 32G Tip x 6mm (1/4") Disposable Needle Manufactured by Novo Nordisk Inc.

BD 32G x 4mm Pen Needle

Manufactured by Bceton, Dickinson and Company

4. Device Description :

The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.

{1}------------------------------------------------

The ShinaPen® are offered various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

5. Intended For Use :

The ShinaPen® is designed for use with a pen injector for the subcutaneous injection of insulin.

6. Technological Characteristics :

The ShinaPen® and the predicate device have the identical technological characteristics and perform equivalently.

Device Name	Subject Device	Predicate Device #1	Predicate Device #2	Predicate Device #3
Manufacturer	SHINACORPORATION	UltiMed Inc.	Novo Nordisk Inc.	Becton, Dickinson andcompany
510(k) Number	N/A	K100812	K090111	K100005
Intended for use	The ShinaPen® isdesignedfor use with a peninjector for thesubcutaneousinjection of insulin.	The UltiCare DisposablePen needles are usedwith insulin pen injectordevices for thesubcutaneous injectionof insulin in thetreatment of diabetes.	FlexPen needle isIntended for use withpen injector devices forthe subcutaneousinjection of insulin,liraglutide andsomatropin	BD pen Needle isintended for use withpen injector device forsubcutaneous injectionof drugs, includinginsulin and exenatide.
Gauge	29G 30G 31G 32G	29G 31G	30G , 32G	32G
MATERIAL	Needle tube	STS304	STS304	STS304	STS304
	Hub	Polypropylene	Polypropylene	Polypropylene	Polypropylene
	Primarycontainer	Polyethylene	Polyethylene	Polypropylene	Polypropylene
	Silicon	Poly di-methyl siloxane	Poly di-methyl siloxane	Poly di-methyl siloxane	Poly di-methyl siloxane
Sterilization	Ethylene oxide gas(SAL 10-6)	Ethylene oxide gas(SAL 10-6)	Ethylene oxide gas(SAL 10-6)	Gamma irradiationsterilization(SAL 10-6)

7. Testing

The ShinaPen® have been designed and tested to meet the requirements of voluntary standards and FDA Guidance documents applicable to the subject and predicate devices. Results of the non-clinical tesing Supports the conlusion of substantial equivalence of

{2}------------------------------------------------

Performance Testing

ShinaPen® have been designed and successfully tested to meet the applicable requirements outlined in ISO7864, ISO9626 and ISO11608-2.

Additional performance testing to internal standards include:

Needle shield assembly force and Needle sharpness testing

Biocompatibility Testing

The material of the ShinaPen® have successfully passed testing as outlined in ISO10993-1 for devices categorized as External communicating devices, Limited exposure.

Sterilization and Shelf-life Testing

Sterilization of the ShinaPen® has been validated using the half-cycle method as outlined in ISO11135. The maximum levels of residues of ethylene oxide and ethylene chlorohydrins will not exceed the limits presented in ISO10993-7. 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. Conclusion

Based on the information provided in this premarket notification of SHINA CORPORATION. Concludes that ShinaPen® is substantially equivalent to predicate devices

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Public Health Service

APR 1 2 2012

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

Mr. Jiseop Jeong Regulatory Affairs Shina Corporation 691-1. Boheung-Ri Useong-Myeon, Gongju-Si Chungchengnam-Do Republic of Korea 314864

Re: K113186

Trade/Device Name: ShinaPen® Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: March 23, 2012 Received: April 2, 2012.

Dear Mr. Jeong:

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.

{4}------------------------------------------------

Page 2 - Mr. Jeong

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Max

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

SHINA CORPORATION

Indication for use Statement

510(k) Number ( If known ) :

Device Name : ShinaPen®

Indication for use :

ShinaPen® is intended for use with pen injector devices for the subcutaneous injection of insulin.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

4/11/12

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113181

Indication for use statement

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).