SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC

K070117 · Dolomite Biotech Sdn Bhd · MEG · Aug 6, 2007 · General Hospital

Device Facts

• Record ID: K070117
• Device Name: SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
• Applicant: Dolomite Biotech Sdn Bhd
• Product Code: MEG · General Hospital
• Decision Date: Aug 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Safe Plus Disposable Safety Syringe is a sterile, non-pyrogenic, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.

Device Story

Safe Plus Disposable Safety Syringe is a manual retractable hypodermic syringe; used for intramuscular/subcutaneous injections or fluid withdrawal. Device features a safety mechanism activated by pushing the plunger forward until the gasket locks onto the adaptor, hub, and needle; this action retracts and encloses the needle within the puncture-resistant barrel. Prevents finger access to the needle and renders it unusable. Operated by clinicians; used in clinical settings. Benefits include reduction of needle stick injuries and prevention of needle reuse.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance for medical devices with sharps injury prevention features and ISO standards for syringe performance.

Technological Characteristics

Manual retractable piston syringe. Materials: polypropylene (barrel), thermoplastic elastomer (gasket/O-ring), polyester/polyethylene (packaging). Conforms to ISO 7886-1:1993(E) for scale markings and ISO 10993-1 for biocompatibility. Sterilization: ethylene oxide (SAL 10^-6). Nozzle: female conical lock fitting with rotatable internally threaded neck.

Indications for Use

Indicated for use in humans for the injection of medication or withdrawal of fluids. Intended for single-use to aid in the prevention of needle stick injuries and needle reuse.

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

• SEZ Safety Syringe (K031163)

Submission Summary (Full Text)

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

K070117

## 5. 510(k) Summary

AUG - 6 2007

#### Submitted on behalf of:

Dolomite Biotech Sdn. Bhd 3 Jalan SBC 2, Taman Sri Batu Caves, 68100 Batu Caves, Selangor Darul Ehsan, Malaysia Tel: [phone] Fax: [phone] Email: [e-mail]

#### By official correspondent and contact:

Timothy Liew Tel: [phone] Tel: [phone] Email: [e-mail]

Date Prepared: 01/05/2007

Proprietary Name: Safe Plus Disposable Safety Syringe Common Name: Piston Syringe Classification Name: Piston Syringe Class: II Panel: 80 Product Code: MEG - Antistick Syringe

Predicate Device: SEZ Safety Syringe by SEZ Corporation (K031163)

#### Device Description:

The Safe Plus Disposable Syringe is a single use hypodermic syringe similar to a traditional syringe in application and function except for its safety mechanism which when activated:

1. completely retracts and encloses the needle in the barrel thereby preventing finger access

2. renders the needle unusable again as it is crushed within the puncture resistant barrel.

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

No special techniques are required to use the safety mechanism and the user is clearly able to visualize the results when the sharps prevention feature has been activated.

#### Indications for Use:

The Safe Plus Disposable Safety Syringe is a sterile, non-pyrogenic, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.

| Device Name | Predicate Device:<br>SEZ Safety Syringe (K031163) | Safe Plus Disposable Safety<br>Syringe |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is a safety hypodermic<br>syringe for intramuscular and<br>subcutaneous injection. This device<br>aids in prevention of needle stick<br>injuries. | Identical |
| Principal of<br>Operation | Activation of safety feature consists<br>of:<br>1. disassemble needle assembly<br>from the plunger by turning the<br>plunger<br>2. retract needle into the barrel<br>and confine it by pushing<br>plunger forward before<br>disposal | Activation of safety feature consist<br>of:<br>1. pushing the plunger forward<br>until the gasket locks onto<br>adaptor, hub and needle.<br>2. Identical |
| Volume | 3 and 5 ml sizes | Identical |
| Nozzle Type | Female conical lock fitting with<br>rotatable internally threaded neck | Identical |
| Barrel Marking | Scale: conforms to ISO 7886-<br>1:1993(E). | Identical |
| Reuse | Non-reusable | Identical |
| Biocompatibility | Conforms to ISO 10993-1 | Identical |
| Materials | 1. Plastic parts: polypropylene (homo<br>type)<br>2. Gasket: thermoplastic rubber<br>3. O-Ring: nitrile rubber<br>4. Packing film: Medipeel film | 1. Identical<br>2. thermoplastic elastomer<br>3. thermoplastic elastomer<br>4. Polyester/polyethylene |
| Sterility | Sterilized by ethylene oxide gas<br>SAL=10-6 | Identical |

#### Safety and Effectiveness, comparison to predicate device

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

# K 070117

#### Conclusion:

Based on tests performed in accordance with "Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features", "Guidance on the Content of Premarket Notification 510(k) Submissions for Piston Syringes" and internationally recognized standards for syringe performance, the Safe Plus Disposable Safety Syringe has been shown to be substantially equivalent to the legally marketed predicate device.

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

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2007

Dolomite Biotech Sdn Bhd C/O Mr. Timothy Liew President Epitome Enterprises 417 Whitney Street San Leandro, California 94577

Re: K070117

Trade/Device Name: Safe Plus Disposable 2.5, 3cc syringes with needles 23 g x 1 inch, 25 g x 1 inch and 5 cc syringes with needles 21g x 1 1/2 inches, 20g x 1 inch, 20g x 1 1/2 inches and 21g x 1 inch Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: June 4, 2007 Received: June 11, 2007

Dear Mr. Liew:

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.

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

Page 2 -- Mr. Liew

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,

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

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

K070117

### 4. Indications for Use

510(k) Number (if known): K070117

Device Name: Safe Plus Disposable Safety Syringe

Indications for Use:

The Safe Plus Disposable Safety Syringe is an ETO sterile, non-toxic, non-pyrogenic, latex free, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and and (Division Sign-Off) (Division of Anesthesiology, General Hospital Page of of nfection Control, Dental Devices

10(k) Number: _kg7947