SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES

K091167 · Shina Corp. · FMF · Aug 6, 2009 · General Hospital

Device Facts

• Record ID: K091167
• Device Name: SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES
• Applicant: Shina Corp.
• Product Code: FMF · General Hospital
• Decision Date: Aug 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Shina Insulin Syringe is a single-use, disposable, sterile piston syringe designed for subcutaneous insulin delivery. It consists of a graduated barrel, plunger rod, and needle/hub assembly with an orange needle shield. Available in various capacities (3/10cc, 1/2cc, 1cc) and needle gauges (28G to 31G). Operated manually by patients or healthcare providers to draw and inject insulin doses. The device functions via standard piston syringe mechanics. Benefits include accurate insulin dosing and sterile, non-pyrogenic delivery.

Clinical Evidence

Bench testing only. Tests included needle pull-out force, hub pull-off force, needle angularity, needle break-off, and dose accuracy. Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Piston syringe design; graduated barrel, plunger rod, and needle/hub assembly. Available in 3/10cc, 1/2cc, and 1cc volumes; 28G-31G needle gauges. Sterile (EO Gas), non-toxic, non-pyrogenic, single-use disposable. Identical technological characteristics to predicate piston syringes.

Indications for Use

Indicated for subcutaneous injection of insulin in patients requiring insulin therapy.

Regulatory Classification

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.

Predicate Devices

• BD Insulin Syringe (K941657, K955235, K024112)

Submission Summary (Full Text)

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# CORPORATION

OWNER'S TOWER, 16-5, SUNAE-DONG, BUNDANG-GU, SEONGNAM-SI, GYEONGGI-DO, KOREA. TEL : [phone](REP.) FAX : [phone] E-MAIL : [e-mail]

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 : [e-mail] Phone: [phone] Fax: [phone]

#### 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:

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"

> Factory : 691-1, Boheong-Lee, Woosung-Myun, Kongju-City, Choong Nam, Korea. FAX : [phone] E-MAIL : [e-mail] TEL : [phone]

SHINA CORPORATION

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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.

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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.

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# 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 [phone] or [phone] 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

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# 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 _