SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

K152803 · Sung Shim Medicare Co., Ltd. · FMF · Jul 12, 2016 · General Hospital

Device Facts

• Record ID: K152803
• Device Name: SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
• Applicant: Sung Shim Medicare Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Jul 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SUNGSHIM® Sterile single use Insulin Syringe is hypodermic insulin syringe for subcutaneous injection of U-100 insulin. (Unit scale : U-100)

Device Story

SUNGSHIM® Sterile single use Insulin Syringe is a disposable, manual hypodermic syringe used for subcutaneous delivery of U-100 insulin. The device consists of a calibrated hollow barrel, plunger, rubber gasket, fixed needle, and protective color-coded orange cap. Available in 0.5ml/cc and 1ml/cc volumes with needle gauges ranging from 28G to 31G. Operated manually by patients or healthcare providers to draw and inject insulin. The device provides a physical means for precise insulin dosing and administration.

Clinical Evidence

Bench testing only. Testing included performance evaluation per ISO 8537:2007, particulate matter testing per USP <788>, and biocompatibility testing (cytotoxicity, hemolysis, acute systemic toxicity, skin sensitization, intracutaneous reactivity, and endotoxin) per ISO 10993 and USP 39<85> standards.

Technological Characteristics

Materials: Polypropylene (barrel, plunger), Polyethylene (cap), Rubber (gasket), Stainless steel STS304 (needle). Dimensions: 0.5ml/cc and 1ml/cc capacities; 28G-31G needles. Sterilization: EO Gas. Design: Manual piston syringe with fixed needle and color-coded cap.

Indications for Use

Indicated for subcutaneous injection of U-100 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

• Feel-ject Insulin Syringe (K070917)

Submission Summary (Full Text)

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

July 12, 2016

Sung Shim Medicare Co., Ltd. c/o Mr. Peter Chung Plus Global 300 Atwood St. Pittsburgh, Pennsylvania 15213

Re: K152803

Trade/Device Name: SUNGSHIM® Sterile Single Use Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 14, 2016 Received: April 20, 2016

#### Dear Mr. 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.

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K152803

Device Name

SUNGSHIM® Sterile single use Insulin Syringe

Indications for Use (Describe) SUNGSHIM® Sterile single use Insulin Syringe is hypodermic insulin syringe for subcutaneous injection of U-100 insulin. (Unit scale : U-100)

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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# 510(k) Summary (K152803) [as required by 807.92(c)]

## 1. Applicant

- 1) Company : Sung Shim Medicare Co.,Ltd.
- 2) Address : 190, Maesil-ro, Sojeong-myeon, Sejong-si, Korea
- 3) Tel : [phone]
- 4) Fax : [phone]
- 5) Prepared date : July 12, 2016
- 6) Contact person : Peter Chung, 412-687-3976
- 7) Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA

### 2. Device Information

- 1) Trade name : SUNGSHIM® Sterile single use Insulin Syringe
- 2) Common name : Syringe, piston
- 3) Classification name : Piston syringe
- 4) Product code : FMF
- 5) Requlation number : 880.5860
- 6) Class of device : Class II
- 7) Panel : General Hospital
- 8) Model codes : Insulin Syringe 0.5ml/cc, Insulin Syringe 1ml/cc

#### 3. The legally marketed device to which we are claiming equivalence

K070917 Feel-ject Insulin Syringe

#### 4. Device description

SUNGSHIM® Sterile single use Insulin Syringe is a disposable, single use syringe which consists of a calibrated hollow barrel, plunger, gasket, cap and fixed needle is a fixed and the needle cap is intended to provide physical protection to the needle. The cap is color coded orange for U-100 insulin, same as equivalent insulin syringes. The SUNGSHIM Sterile single is available in 0.5ml/cc and 1ml/cc sizes in gauges 28g to 31g.

#### 5. Intended Use :

SUNGSHIM® Sterile single use Insulin Syringe is hypodermic insulin syringe for subcutaneous injection of U-100 insulin. (Unit scale : U-100)

#### 6. Performance data:

- (1) Bench test
Test standard : ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin

- (2) Particulate matter in injections Test standard : USP <788> Test item : Particulate matter in injections
- (3) Biocompatibility

Category : External communicating device Contact : Blood path, indirect Contact duration : A-limited (≤24h)

Test standard : ISO 10993-1, ISO 10993-4, ISO 10993-10, ISO 10993-10, ISO 10993-11, USP 39<85>

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Test item : Cytotoxicity, In vitro hemolysis, Acute systemic toxicity, Skin sensitization, Intracutaneous reactivity, Endotoxin

The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device.

| Manufacturer | Sung Shim Medicare Co.,Ltd. | Feel Tech | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------|-------------------------|
| 510(k) No. | K152803 | K070917 | | |
| Indication for use | SUNGSHIM® Sterile single use Insulin<br>Syringe is hypodermic insulin syringe for<br>subcutaneous injection of U-100 insulin. (Unit<br>scale : U-100) | The Feel-ject disposable sterile insulin<br>syringes are intended for injection of U100<br>insulin only. | | |
| Product name | Syringe, piston | Syringe, piston | | |
| Trade name | SUNGSHIM® Sterile single use Insulin Syringe | Feel-ject Insulin syringe | | |
| Model/type | Insulin syringe 0.5ml/cc<br>Insulin syringe 1ml/cc | FIS-1001 1.0ml<br>FIS-0502 0.5ml | | |
| Appearance | Image: Insulin syringe | Image: Insulin syringe | | |
| Product<br>configuration | Barrel<br>Plunger<br>Cap<br>Gasket<br>Needle | Barrel<br>Plunger<br>Cap<br>Gasket<br>Needle | | |
| Material | Part | Material | Part | Material |
| | Barrel | Polypropylene | Barrel | Polypropylene |
| | Plunger | Polypropylene | Plunger | Polypropylene |
| | Cap | Polyethylene | Cap | Polyethylene |
| | Gasket | Rubber | Gasket | Rubber |
| | Needle | Stainless steel STS304 | Needle | Stainless steel STS 304 |
| Length of parts (mm) : 1.0mL | | | | |
| Total length of<br>assembly | 118.2±2 | 116±2 | | |
| Side length of<br>assembly(max) | 19.2±1 | 19.2±1 | | |
| Inner diameter of<br>barrel | 4.74±0.3 | 4.7±0.3 | | |
| Out diameter of<br>barrel | 7.0±0.3 | 6.6±0.3 | | |
| Scale of syringe | 1mL | 1mL | | |
| Gauge | 28G, 29G, 30G, 31G | 28G, 29, 30, 31G | | |
| Length of needle | 8 mm, 12.7 mm | 5 mm, 8 mm, 12.7 mm | | |
| Sterilization | EO Gas sterilization | EO Gas sterilization | | |

### 7. Predicate device comparison table

Although the Indications for Use is not identical to that of the predicate device it does not change the intended use because both are single use insulin syringes intended for the injection of U-100 insulin.

#### 8. Conclusion:

The materials, performance and features of both the subject device and the predicate device are considered to be substantially equivalent.