CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE

K062780 · Medical Device Manufacturer (Thailand) , Ltd. · MEG · Jan 5, 2007 · General Hospital

Device Facts

• Record ID: K062780
• Device Name: CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE
• Applicant: Medical Device Manufacturer (Thailand) , Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Jan 5, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. with U-100 strength insulin is to be used for subcutaneous injection of insulin into a patient and is intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, re-use of the syringe is prevented.

Device Story

ClickZip™ is a sterile, single-use, disposable, needle-retractable safety syringe (1 ml capacity) for U-100 insulin delivery. Operated by clinicians or patients; user manually activates safety mechanism by retracting needle into syringe barrel after injection. Plunger is broken off post-use to prevent re-use. Device minimizes risk of needle stick injuries. No electronic or automated components.

Clinical Evidence

Bench testing only. Device performance verified against ISO 7864 (sterile hypodermic needles), ISO 8537 (sterile single-use syringes with or without needle for insulin), ISO 10993 series (biocompatibility), and ISO 11135 (sterilization).

Technological Characteristics

1ml piston syringe with integrated needle retraction safety mechanism. Materials meet ISO 10993 biocompatibility standards. Sterilization per ISO 11135. Manual operation; no electronic components or software.

Indications for Use

Indicated for subcutaneous injection of U-100 insulin in patients requiring insulin therapy; includes integrated safety feature to prevent needle stick injuries and plunger-break mechanism to prevent syringe re-use.

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

• 1cc Insulin SafePro Safety Syringe (K050134)
• ClickZip™ Needle Retractable Safety Syringe (K051694)

Submission Summary (Full Text)

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# PREMARKET NOTIFICATION (510 (K)) SUBMISSIONS

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for ClickZip Needle Retractable Safety Syringe Insulin 1 ml. (per 21CFR807.92)

## 1. SUBMITTER's NAME

JAN - 5 2007

Medical Device Manufacturer (Thailand) Ltd. 7/145 Amata City Industrial Estate Pluakdaeng, Rayong 21140 Thailand

Contact: Ms. Oytip Kunwunlop, Compliance Director 66 1 844 7959 Phone: Fax: [phone]

### 2. DEVICE NAME

ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. Trade Name: Common Namc: Safety Syringe Classification: II Classification Name: Piston Syringe with Safety Feature Classification Code: MEG Nominal Capacity: 1ml. Insulin Unit: U-100

### 3. PREDICATE DEVICE

- 1cc Insulin SafePro Safety Syringe with 510(K) number K050134 ●
- ClickZip™ Needle Retractable Safety Syringe with 510(K) number K051694 .

### 4. DEVICE DESCRIPTION

The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. is sterile, single-use, disposable and non-reusable, needle retractable safety syringe, provided with various size of needle.

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# PREMARKET NOTIFICATION (510 (K)) SUBMISSIONS

Section: II

Page: III- 2

Kob2780

## 5. INTENDED USE

The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. with U-100 strength insulin is to be used for subcutaneous injection of insulin into a patient and is intended to prevent needle stick injuries.

In addition, when the syringe user breaks the plunger, re-use of the syringe is prevented.

### 6. COMPARISON of MODIFIED & PREDICATE DEVICE and SUBSTANTIAL EQUIVALENCE

Medical Device Manufacturer (Thailand) Ltd. makes a claim of substantial equivalence of the ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. to the cited predicates based on similarities in intended use, design, technological and operational characteristics. The syringes are indicated for injecting insulin into the body, while helping to prevent needle stick injuries. ClickZip™ is supplied with needle attached while SafePro is supplied with or without needle packing.

All syringes requires the user to manually activate the safety mechanism. This is done by retracting the needle into the syringe barrel, breaking off the plunger and discarding the pieces.

Medical Device Manufacturer (Thailand) Ltd. believes that the difference between the ClickZip™ Needle Retractable Safety Syringe and the predicate device are minor and they raise no new issues of safety or effectiveness.

### 7. PERFORMANCE SUMMARY

ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. has been shown to meet internationally recognized standards for syringe performance i.e. ISO 7864, ISO 8537, ISO 10993 series, and ISO 11135. These include physical specification, chemical specification, biocompatibility and sterilization specification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circle around the eagle. The logo is black and white and appears to be a seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

- 5 2007

Ms. Oytip Kunwunlop Compliance Director Medical Device Manufacturer (Thailand) Limited 7/145 Moo 4 Amata City Industrial Estate Rayong, Thailand 21140

Re: K062780

Trade/Device Name: ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml, Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: November 23, 2006 Received: November 29, 2006

Dear Ms. Kunwunlop:

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 -- Ms. Kunwunlop

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 vour 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.

Susan Quan
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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#### STATEMENT OF INDICATIONS FOR USE

#### 510K Number (if known): 上の62子80

#### Device Name: ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml.

#### Indications for Use:

The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. with U-100 strength insulin is to be used for subcutaneous injection of insulin into a patient and is intended to prevent needle stick injuries.

In addition, when the syringe user breaks the plunger, re-use of the syringe is prevented.

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

| Prescription Use | | OR | Over-the-Counter |
|--------------------|--|----|--------------------------|
| Use | | | |
| Per 21 CFR 801.109 | | | (Optional Format 1-2-96) |

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