CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE

K051694 · Medical Device Manufacturer (Thailand) , Ltd. · MEG · Dec 21, 2005 · General Hospital

Device Facts

• Record ID: K051694
• Device Name: CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE
• Applicant: Medical Device Manufacturer (Thailand) , Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Dec 21, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ClickZip™ Needle Retractable Safety Syringe is to be used for intra-muscular or subcutaneous injection of medications into a patient and is intended to prevent needle stick injuries. It is currently available in 1, 3 and 5 ml sizes. ClickZip™ Needle Retractable Safety Syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.

Device Story

ClickZip™ is a sterile, single-use, disposable, needle-retractable safety syringe. It functions as a manual piston syringe for delivering intramuscular or subcutaneous medications. The device features a mechanism that allows the needle to retract into the syringe barrel after use; the user breaks the plunger to prevent reuse, thereby reducing the risk of accidental needle stick injuries. It is intended for use by healthcare professionals or patients in clinical or home settings. The device is supplied with the needle attached. It does not perform automated analysis or data processing.

Clinical Evidence

Bench testing only. The device meets internationally recognized standards including ISO 7864 (sterile hypodermic needles), ISO 7886-1 (sterile hypodermic syringes for single use), ISO 10993 series (biocompatibility), and ISO 11135 (sterilization).

Technological Characteristics

Piston syringe with integrated needle retraction mechanism. Materials meet ISO 10993 biocompatibility standards. Available in 1, 3, and 5 ml capacities. Sterilized per ISO 11135. Manual operation; no electronic components, software, or connectivity.

Indications for Use

Indicated for intramuscular or subcutaneous injection of medications in patients. Not indicated for blood collection. Available in 1, 3, and 5 ml sizes.

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

• SECUREGARD® Retractable Safety Syringe (K012121)

Submission Summary (Full Text)

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K051694

Image /page/0/Picture/1 description: The image shows a black medical cross at the top. Below the cross, the text "Medical Device Manufacturer (Thailand) Limited" is present. The text appears to be part of a logo or company identifier.

# PREMARKET NOTIFICATION (510 (K)) SUBMISSIONS

Section: II

Page: II- 1

## DEC 2 1 2005

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

## 1. SUBMITTER's NAME

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

| Contact: | Ms. Oytip Kunwunlop, Compliance Director |
|----------|------------------------------------------|
| Phone: | 66 1 844 7959 |
| Fax: | 66 38 956 429 |

#### 2. DEVICE NAME

| Trade Name: | ClickZip™ Needle Retractable Safety Syringe |
|----------------------|---------------------------------------------|
| Common Name: | Safety Syringe |
| Classification: | II |
| Classification Name: | Piston Syringe with Safety Feature |
| Classification Code: | MEG |
| Nominal Capacity: | 1, 3 and 5 ml. |

#### 3. PREDICATE DEVICE

SECUREGARD® Retractable Safety Syringe with 510(K) number K012121.

## 4. DEVICE DESCRIPTION

The ClickZip™ Needle Retractable Safety Syringe is sterile, single-use, disposable and nonreusable, needle retractable safety syringe, provided with various size of needle. The products are supplied in many sizes i.e. 1, 3 and 5 ml.

#### 5. INTENDED USE

The ClickZip™ Needle Retractable Safety Syringe is to be used for intra-muscular or The Cheater injection of medications into a patient and is intended to prevent needle stick subculaneous injection of medications into a partent and 5 ml sizes. ClickZip™ Needle Retractable

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- Medical Device Manufacturer

K051694

**PREMARKET NOTIFICATION
(510 (K)) SUBMISSIONS**

Section: II
Page: II-2

Safety Syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.

### 6. SUBSTANTIAL EQUIVALENCE

(Thailand) Limited

Medical Device Manufacturer (Thailand) Ltd. makes a claim of substantial equivalence of the SECUREGARD® Retractable Safety Syringe with 510(K) number K012121 based on similarities in intended use, design, technological and operational characteristics. Both are indicated for injecting fluids into the body and should not be used for blood collection. Both ClickZip™ and SECUREGARDS Retractable Safety Syringe are always supplied with needle attached. 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 has been shown to meet internationally recognized standards for syringe performance i.e. ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11135. These include physical specification, chemical specification, and 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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circle around the symbol. The caduceus is a common symbol for healthcare organizations, and the inclusion of the department's name makes it clear that this is the official logo for the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Mr. Oytip Kunwunlop Compliance Director Comphanee Directorer (Thailand) Limited 7/145 Moo 4 Amata City Industrial Estate Rayong, THAILAND 21140

Re: K051694

K051694
Trade/Device Name: ClickZip™Needle Retractable Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 2, 2005 Received: December 8, 2005

Dear Mr. Kunwunlop:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 510(x) premaince is substantially equivalent (for the referenced above and have determined the de realicated by dicate devices marketed in
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the cholosaro, to tegain. interstate commerce prior to May 20, 1770, the provins with the provisions of
Amendments, or to devices that have been receive epproval of a premarket Amendments, or to devices that have been recuire approval of a prematice and the Federal Food, Drug, and Cosmetic Act (Free) into sket the device, subject to the general approval application (1117). Tournal), and controls provisions of the Act include controls provisions of the Fet. "The genting 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 If your device is classified (sec above) into entrols. Existing major regulations affecting (PMA), it may of Subject to Sach adamental Prairies of Federal Regulations, Title 21, Parts 800 to 898. In the Corporal your device can be found in the Gode of receive of concerning your device in the Federal Register.

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Page 2 - Mr. Kunwunlop

Please be advised that FDA's issuance of a substantial equivalence determination does not I tease be ac nota has made a determination that your device complies with other requirements moun that I DT has mass statutes and regulations administered by other Federal agencies. or are For of any with all the Act's requirements, including, but not limited to: registration 1 ou intine (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT rar 007), assility systems (QS) regulation (21 CFR Part 820); and if requirements as sections are quadion 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) I rins letter will and in Jo The FDA finding of substantial equivalence of your device to a promation hoursean on 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), rr you decited 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,

Snette y. Michael Omid

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

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## STATEMENT OF INDICATIONS FOR USE

- KOS 1694 510K Number (if known): ____--------------------------------------

## Device Name: ClickZip™ Needle Retractable Safety Syringe

## Indications for Use:

The ClickZip™ Needle Retractable Safety Syringe is to be used for intra-muscular of The ChekZip - Needle Ketractaons into a patient and is intended to prevent needle stick
subcutaneous injection of medications into a patient and is intended on the subcutaneous injection of medications into a partificant (1) Needle Retractable
injuries. It is currently available in Imal for withdrewing blood In addition when the injuries. It is currently available in this only and simbleding blood. In addition, when the Safely Syringe 13 not intenably the syringe is prevented.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:flex; align-items:center;">✓</div> | OR | Over-the-Counter |
|------------------------|--------------------------------------------------------|----|--------------------------|
| Use Per 21 CFR 801.109 | | | (Optional Format 1-2-96) |

K951694