TOP FINE

K063466 · Daejin Tech Medical Manufacturing Co., Ltd. · FMI · Mar 2, 2007 · General Hospital

Device Facts

• Record ID: K063466
• Device Name: TOP FINE
• Applicant: Daejin Tech Medical Manufacturing Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Mar 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Top Fine® disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes..

Device Story

Top Fine® Insulin Pen needle is a sterile, single-use, disposable device for subcutaneous insulin delivery. Components include a needle hub, needle cap, and sterile cap with blister paper seal. The device is designed to screw onto standard insulin pens. Available in 29, 30, and 31 gauge sizes. Used by patients for self-administration of insulin or by healthcare providers in clinical settings. The device provides a physical interface for insulin injection; it does not involve electronic processing or automated decision-making. Benefits include sterile, reliable subcutaneous access for diabetes management.

Clinical Evidence

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

Technological Characteristics

Single-lumen hypodermic needle; 29G, 30G, and 31G sizes; ETO sterilized; non-toxic; non-pyrogenic; screw-on hub interface; manual operation.

Indications for Use

Indicated for subcutaneous insulin injection in patients with diabetes.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• B.Braun one.click™ needle (K033575)
• Terumo® Micro tapered Pen Needle (K052561)
• BD Pen Needles (K051899)

Submission Summary (Full Text)

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

K063466 Page 1 of 1

510(K) Summary MAR 0 2 2007 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: November 13, 2006

- 1. Trade Name: Top Fine® Insulin Pen Common Name: Insulin syringe Classification Name: Syringe, piston, product code FMI, Regulation: 880.5570 Class of device: Class II.
- 2. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : Multiple: B.Braun "one.click™ needle", K033575, Terumo® Micro tapered Pen Needle K052561, BD Pen Needles K051899
- 3. Description of device: Top Fine® insulin pen needle consists of a sterile cap, a needle cap, and a needle hub which holds the needle. Blister papers the cap. The sterile cap maintains sterility the of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected screwed onto the pen. The needle cap cover is intended to provide physical protection to the needle tube. The device is for single patient single time use. The pens come in three sizes, 29 gauge, 30 gauge, and 31 gauge. They are ETO sterilized, non toxic and nonpyrogenic.
- 4. Intended use: For the subcutaneous injection of insulin in the treatment of diabetes.
- ನ. Technological characteristics: The Top Fine® Insulin Pen needles and the predicate devices have identical technological characteristics and perform the same way.
- Performance: Both bench and clinical tests were performed. Bench testing 6. 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.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, depicted with stylized lines.

MAR 0 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K063466

Trade/Device Name: Top Fine® Insulin Pen Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI 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.

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

## 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 (OS) 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,

Soulette y. Michael MD.

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

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

K063466

## Indications for Use

510(k) Number (if known):

Device Name: Top Fine® Insulin Pen

Indications For Use:

The Top Fine® disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes..

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)

Chr

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

**SO(k) Number:** K463441

Page 1 of 1