Shina Insulin Syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Syringes are available in the following sizes:

1/2cc and 1cc 28 gauge x 1/2"
3/10cc, 1/2cc, and 1cc 29 gauge x ½"
3/10cc, 1/2cc, and 1cc 30 gauge x 1/2"
3/10cc, 1/2cc, and 1cc 30 gauge x 5/16"
3/10cc, 1/2cc, and 1cc 31 gauge x 5/16"

These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (EO Gas sterilization), non-toxic, non-pyrogenic, and single use disposable.

AI/ML Overview

The provided text describes a 510(k) summary for Shina Insulin Syringes, which is a submission to the FDA to demonstrate substantial equivalence to a predicate device. This document does not contain an "acceptance criteria and study" in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy compared to a ground truth established by experts.

Instead, the "performance" section refers to bench tests conducted to demonstrate equivalence to a predicate device for the purpose of regulatory clearance.

Here's the information extracted from the document, organized to address your questions as much as possible within the given context:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria	Reported Device Performance
Needle Pull-out (force)	Not explicitly stated, implied equivalence to predicate	"perform equivalent to the predicate devices"
Hub Pull-off (force)	Not explicitly stated, implied equivalence to predicate	"perform equivalent to the predicate devices"
Needle Angularity	Not explicitly stated, implied equivalence to predicate	"perform equivalent to the predicate devices"
Needle Break-off	Not explicitly stated, implied equivalence to predicate	"perform equivalent to the predicate devices"
Dose Accuracy	Not explicitly stated, implied equivalence to predicate	"perform equivalent to the predicate devices"

Note: The document states "The results demonstrate that Shina Insulin Syringes perform equivalent to the predicate devices and are safe and effective when used as intended." This implies that the acceptance criteria for each test were met if the performance was equivalent to the predicate devices (BD Insulin Syringe: K941657, K955235, K024112).

2. Sample Size and Data Provenance

Sample Size for Test Set: The document does not specify the sample size used for the bench tests.
Data Provenance: The tests were conducted internally by Shina Corporation, whose factory is located in Kongju-City, Choong Nam, Korea. The study is retrospective in the sense that it's a submission for regulatory clearance based on testing of the manufactured product, not a prospective clinical trial.

3. Number of Experts and Qualifications for Ground Truth

This question is not applicable to this type of regulatory submission. Bench tests for medical devices like syringes do not typically involve human experts establishing a "ground truth" for diagnostic or predictive purposes. The "ground truth" for these tests is based on objective, measurable physical properties and engineering standards (e.g., force measurements, dimensional accuracy).

4. Adjudication Method for Test Set

Not applicable. Bench tests measure physical properties against defined engineering specifications or in comparison to a predicate device, which does not require adjudication by human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a physical medical device (syringe), not an AI or diagnostic imaging device that would typically involve an MRMC study.

6. Standalone Performance Study

Yes, in the context of bench testing. The "Performance" section describes bench tests (needle pull-out, hub pull-off, needle angularity, needle break-off testing, and dose accuracy) that evaluate the device itself. These are considered standalone performance tests for the physical properties of the syringe.

7. Type of Ground Truth Used

For this type of device, the "ground truth" refers to established engineering specifications, physical measurement standards, and performance characteristics of legally marketed predicate devices. The aim is to demonstrate that the Shina Insulin Syringes meet these specifications and perform equivalently to the predicate.

8. Sample Size for Training Set

Not applicable. This document is about a physical medical device and its bench testing, not an algorithm or AI model that requires a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable. As above, no training set is relevant in this context.

Summary

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

Image /page/0/Picture/0 description: The image shows a simple line drawing of a circle with a small, curved arrow extending from the bottom of the circle and pointing towards the right. A vertical line is present on the left side of the image, positioned close to the circle. The drawing is in black and white.

CORPORATION

OWNER'S TOWER, 16-5, SUNAE-DONG, BUNDANG-GU, SEONGNAM-SI, GYEONGGI-DO, KOREA. TEL : 82-31-711-8180(REP.) FAX : 82-31-711-8190 E-MAIL : shinacor@chollian.net

AUG 0 62009

510K SUMMARY OF SAFETY AND EFFECTIVENESS

Revised 6-22-09

Supplement K091167

1. Submitted by:

Mr. YONG NAM SHIN President

Shina Corporation Establishment Registration No : 8040619 #1005 Owner's Tower 16-5 Sunae- Dong Bundang-GU Seongnam-Si, Gyeonggi-Do Korea Contact person: H. D. Cho. Sales Manager E-Mail : shinacor@shinacor.co.kr Phone: 011-82-31-711-8180 Fax: 011-82-31-711-8190

2. Date Prepared April 1, 2009

3. Device Name:

Trade Name: Insulin Syringes manufactured by Shina Corporation for private label (customer labels) example: Accu-Sure Insulin Syringe Common Name: Insulin Syringe Classification Name: Piston Syringe

4. Predicate Device:

BD Insulin Syringe:	K941657, K955235, K024112
Manufactured by:	Becton Dickinson Consumer Healthcare

5. Device Description:

1/2cc and 1cc 28 gauge x 1/2" 3/10cc, 1/2cc, and 1cc 29 gauge x ½" 3/10cc, 1/2cc, and 1cc 30 gauge x 1/2"

Factory : 691-1, Boheong-Lee, Woosung-Myun, Kongju-City, Choong Nam, Korea. FAX : 82-41-853-0872 E-MAIL : syringes@kornet.net TEL : 82-41-853-0871

SHINA CORPORATION

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

3/10cc, 1/2cc, and 1cc 30 gauge x 5/16" 3/10cc, 1/2cc, and 1cc 31 gauge x 5/16"

These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (EO Gas sterilization), non-toxic, non-pyrogenic, and single use disposable.

6. Intended Use:

This device is a hypodermic insulin syringe for subcutaneous injection of insulin.

7. Technological Characteristics:

Shina insulin syringe and the predicate devices have the identical technological characteristics and perform as piston syringes.

8. Performance:

Bench tests relating to the performance of the needle length were conducted. The tests performed include needle pull-out (force), hub pull-off (force), needle angularity, needle break-off testing and dose accuracy. The results demonstrate that Shina Insulin Syringes perform equivalent to the predicate devices and are safe and effective when used as intended.

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

Image /page/2/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 perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings and body. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

AUG 0 6 2009

Mr. Yong Nam Shin President Shina Corporation #1005, Owner's Tower, 16-5, Sunae- Dong, Bundang-Gu Seongnam -Si, Gyeonggi-Do Republic of Korea

Re: K091167

Trade/Device Name: Insulin Syringe (Manufactured By Shina Corporation) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 28, 2009 Received: July 28, 2009

Dear Mr. Shin:

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 i requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 vour 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.

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

Page 2- Mr. Shin

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.

signature

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

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

Indications for Use

510(k) Number (if known): K091167

Device Name: Insulin Syringe (manufactured by Shina Corporation)

Indications For Use: This device is a hypodermic insulin syringe for subcutaneous injection of insulin.

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

Over-The-Counter Use (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)

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

510(k) Number: K091167 Page 1 of _

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).