Sure-Fine Insulin Syringes

K152879 · Shina Med Corporation · FMF · Sep 9, 2016 · General Hospital

Device Facts

• Record ID: K152879
• Device Name: Sure-Fine Insulin Syringes
• Applicant: Shina Med Corporation
• Product Code: FMF · General Hospital
• Decision Date: Sep 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Device Story

Sure-Fine Insulin Syringes are single-use, disposable, sterile piston syringes designed for subcutaneous injection of U-100 insulin. The device consists of a graduated polypropylene barrel, plunger rod, isoprene rubber piston, and a stainless steel needle permanently affixed to the tip with epoxy. Available in various volumes (0.3cc, 0.5cc, 1cc) and needle gauges (28G-31G). The device is intended for use by patients or healthcare providers to deliver precise insulin doses. Operation follows standard manual piston syringe mechanics: the user draws insulin into the barrel and manually depresses the plunger to inject. The device provides a simple, reliable method for insulin administration, facilitating self-management of diabetes.

Clinical Evidence

No clinical data. Bench testing only. Performance verified per ISO 8537:2007 (freedom from extraneous matter, extraction, lubrication, graduated scale, barrel/plunger assembly, needle tubing). Biocompatibility verified per ISO 10993-1 (cytotoxicity, irritation, sensitization, systemic toxicity, blood interaction). Sterilization validated per ISO 11135.

Technological Characteristics

Piston syringe; materials: STS304 (needle), polypropylene (barrel/plunger), isoprene rubber (piston), polyethylene (caps), polydimethylsiloxane (lubricant). Sterilization: Ethylene oxide (SAL 10^-6). Sizes: 0.3cc, 0.5cc, 1cc; 28-31 gauge needles. Biocompatibility: ISO 10993-1 compliant. Manual operation; no software or electronics.

Indications for Use

Indicated for subcutaneous injection of U100 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

• Accu-Sure Insulin syringe (K091167)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

September 9, 2016

Shina Med Corporation c/o Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E. Chapman Ave., Ste. 110 Irvine, California 92831

Re: K152879

Trade/Device Name: Sure-Fine Insulin Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 4, 2016 Received: August 10, 2016

### Dear Ms. 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.

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

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 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/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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Image /page/1/Picture/8 description: The image shows a signature and the name "Tina Kiang" in black font. The signature is illegible and consists of a series of loops and curves. There is a faint watermark in the background that is difficult to read.

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K152879

Device Name

Sure-Fine Insulin Syringes

Indications for Use (Describe)

Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

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

| <input type="checkbox"/> Registration (Part 21 CFR 201.1 Subpart D) | <input checked="checked" type="checkbox"/> Drug Use Compounding (21 CFR 201.1 Subpart G) |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------|

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(K) SUMMARY

(K152879)

September 07, 2016

### 1. Submitted by:

Il-hwan, Jeong / Quality Management Representative SHINA MED CORPORATION 455-30, Bogaewonsam-ro, Bogae-myun, Anseong-si, Gyeonggido, 456-871, Republic of Korea Phone: [phone] 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

#### Device Name : 3.

- Trade Name : Sure-Fine Insulin Syringes
- Classification : Class II .
- Regulation Name : Piston syringe .
- Product Code . : FMF
- . Regulation Number : 21 CFR 880.5860
- · Review Panel : General Hospital

#### Predicate Device : 4.

Accu-Sure Insulin syringe (K091167) manufactured by SHINA CORPORATION

#### 5. Device Description:

Sure-Fine Insulin Syringes are designed for the subcutaneous injection of a dose of U-100 insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color.

| Category | Insulin syringe | Needle<br>Gauge | Needle<br>Length | Cap color | |
|----------|-----------------------|-----------------|------------------|------------|-----------------|
| | | | | Needle cap | Plunger Cap |
| U-100 | 1/2cc and 1cc | 28Gauge | 1/2" | Orange | Orange or white |
| U-100 | 3/10cc, 1/2cc and 1cc | 29Gauge | 1/2" | Orange | Orange or white |
| U-100 | 3/10cc, 1/2cc and 1cc | 30Gauge | 1/2" | Orange | Orange or white |
| U-100 | 3/10cc, 1/2cc and 1cc | 30Gauge | 5/16" | Orange | Orange or white |
| U-100 | 3/10cc, 1/2cc and 1cc | 31Gauge | 5/16" | Orange | Orange or white |

This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.

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

#### 6. Indications for Use :

Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

### 7. Technological Characteristics :

The Sure-Fine Insulin Syringes are substantially equivalent to previously marketed device, Accu-Sure Insulin Syringe (K091167) manufactured by Shina Corporation. The device design, materials of construction, manufacturing method, release specifications and performance specifications are the same as the predicate device.

| Device Name | Subject Device | Predicate Device | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Manufacturer | SHINA MED CORPORATION | SHINA CORPORATION | |
| 510(k) Number | K152879 | K091167 | |
| Product Code | FMF | FMF | |
| Intended Use | Sure-Fine Insulin Syringes are<br>hypodermic insulin syringes for<br>subcutaneous injection of insulin. | Accu-Sure Insulin Syringe is a<br>hypodermic insulin syringe for<br>subcutaneous injection of insulin | |
| Design (Syringe) | Design | Needle / Barrel / Gasket /<br>Plunger / Needle Cap /<br>Protective end cap | Needle / Barrel / Gasket /<br>Plunger / Needle Cap /<br>Protective end cap |
| | Volume | 0.3cc, 0.5cc, 1.0cc | 0.3cc, 0.5cc, 1.0cc |
| | Gauge | 28, 29, 30,31Gauge | 28, 29, 30,31Gauge |
| | Length | 1/2", 5/16" | 1/2", 5/16" |
| Materials | Needle | STS304 | STS304 |
| | Barrel | Polypropylene | Polypropylene |
| | Plunger | Polypropylene | Polypropylene |
| | Piston | Isoprene Rubber | Isoprene Rubber |
| | Needle Cap | Polyethylene | Polyethylene |
| | Protective end cap | Polyethylene | Polyethylene |
| | Silicone | Polydimethylsiloxane | Polydimethylsiloxane |
| | Biocompatibility | Conform ISO10993-1 | Conform ISO10993-1 |
| Sterilization method<br>and S.A,L | Sterilized by ethylene<br>oxide gas SAL = 10-6 | Sterilized by ethylene<br>oxide gas SAL = 10-6 | |

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

#### 8. Non-clinical testing

The Sure-Fine Insulin Syringes have been designed and tested to meet the requirements of voluntary standards (listed below) and FDA Guidance documents (Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes) applicable to the subject and predicate devices. The results of the non-clinical testing supported the conclusion of substantial equivalence.

### Performance Testing

The Sure-Fine Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO8537.

- Test performed per ISO8537:2007
- · ISO 8537-2007 Clause 5 Freedom from extraneous matter
- · ISO 8537-2007 Clause 6.Extraction testing
- · ISO 8537-2007 Clause 7 Lubrication of syringes and needles
- · ISO 8537-2007 Clause 8 Range of sizes
- ISO 8537-2007 Clause 9 Graduated scale
- ISO 8537-2007 Clause 10 Barrel
- · ISO 8537-2007 Clause 11 Piston/Plunger assembly
- · ISO 8537-2007 Clause 12 Nozzle
- · ISO 8537-2007 Clause 13 Needles tubing and needles
- · ISO 8537-2007 Clause 14 Performance of assembled syringe

### Biocompatibility Testing

The material of the Sure-Fine Insulin Syringes have successfully passed testing as outlined in ISO10993-1 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 Sure-Fine Insulin Syringes has been validated using the half-cycle method as outlined in ISO11135. Testing demonstrated maximum levels of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in IS010993-7. Shelf-life testing supports a shelf-life of 5-years after sterilization.

### Clinical Data

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

### 9. Discussion

Sure-Fine Insulin Syringes have the same intended use, technological characteristics, materials of construction and performance specifications as the predicate device, Accu-Sure Insulin Syringe (K091167), and thus it performs in a substantial equivalent manner to the predicate device.

{6}------------------------------------------------

### 10. Conclusion

Based on the information provided in this premarket notification, SHINA MED CORPORATION concludes that the Sure-Fine Insulin Syringes are substantially equivalent to predicate device.