TOP FINE INSULIN SYRINGE

K063348 · Daejin Tech Medical Manufacturing Co., Ltd. · FMF · Mar 1, 2007 · General Hospital

Device Facts

• Record ID: K063348
• Device Name: TOP FINE INSULIN SYRINGE
• Applicant: Daejin Tech Medical Manufacturing Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Mar 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Top Fine® disposable sterile insulin syringes are intended for subcutaneous injection of insulin.

Device Story

Top Fine® Insulin Syringe is a single-use, disposable, sterile piston syringe; consists of a calibrated hollow barrel with a fixed needle and plunger/gasket assembly. Used for subcutaneous insulin injection. Operates via manual piston mechanism; user draws insulin into barrel and injects. Intended for use by patients or clinicians. Provides physical protection via color-coded orange needle cap. Available in 0.3 ml/cc, 0.5 ml/cc, and 1 ml/cc sizes. Benefits include accurate insulin delivery and sterile, non-toxic, non-pyrogenic administration.

Clinical Evidence

Clinical testing was performed to evaluate instructions for use, patient population range, performance characteristics, and reliability. Results were satisfactory, demonstrating safety and effectiveness equivalent to the predicate device. Bench testing included biocompatibility, mechanical testing, and sterility testing (including EO residues).

Technological Characteristics

Piston syringe design; calibrated barrel with fixed needle; plunger and gasket assembly; color-coded orange needle cap. Available in 0.3, 0.5, and 1 ml/cc volumes. Sterilized via Ethylene Oxide (EO).

Indications for Use

Indicated for subcutaneous insulin injection 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 (K024112)

Submission Summary (Full Text)

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K063348 page 1 of 1

MAR 0 ] 2007

510(K) Summary Daejin Tech Medical Manufacturing Co., Ltd. 536-70 Kumkwang-Ri KumKwang-Myun, Ansung-Si, Kyunggi-Do, Korea Contact person: Simon Bang, President Tel : [phone] Fax : [phone] Date prepared: October 25, 2006

- 1. Trade Name: Top Fine® Insulin Syringe Common Name: Insulin syringe Classification Name: Syringe, piston, product code FMF, Regulation: 880.5860 Class of device: Class II.
- 2. The legally marketed device to which we are claiming equivalence [807.92(a)(3)| : BD Insulin Syringe K024112.
- 3. Description of device: Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. Rx only. The devices operate on the principles of common piston syringes.
- 4. Intended use: For the subcutaneous injection of insulin.
- 5. Technological characteristics: The Top Fine® Insulin Syringes and the predicate devices have identical technological characteristics and perform the same way as common piston syringes. Whereas the predicate syringes are gamma sterilized, these syringes are EO sterilized.
- 6. Performance: Both bench and clinical tests were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. Clinical testing was performed to determine adequacy of instructions for use, the range of patient population, performance characteristics, and reliability. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.

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MAR 0 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Daejin Tech Medical Manufacturing Company Limited C/O Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K063348

Trade/Device Name: Top Fine® Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 20, 2007 Received: February 23, 2007

Dear Mr. Kamm:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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## Page 2 - Mr. Kamm

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours

Suser Runne

\$\theta\$

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K063348

## Indications for Use

510(k) Number (if known):

Device Name:_ Top Fine® Insulin Syringe

Indications For Use:

The Top Fine® disposable sterile insulin syringes are intended for subcutaneous injection of insulin.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

C

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

510(k) Number. K96374