DUOPRO SAFETY SYRINGE (DUOPROSS)

K020623 · M.K. Meditech Co. , Ltd. · MEG · May 2, 2002 · General Hospital

Device Facts

• Record ID: K020623
• Device Name: DUOPRO SAFETY SYRINGE (DUOPROSS)
• Applicant: M.K. Meditech Co. , Ltd.
• Product Code: MEG · General Hospital
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Device Story

DuoPro Safety Syringe (DuoProSS™) is a 3 mL manual, retractable safety syringe; sterile, single-use, disposable. Device features two-part plunger; distal part holds hypodermic needle; proximal part contains projection spike. Operation: user performs injection; manually retracts needle-plunger into barrel; breaks off plunger rod to lock needle and prevent reuse. Used by clinicians for fluid administration. Design reduces sharps injury risk via needle retraction mechanism. Bench testing confirms performance equivalence to predicate.

Clinical Evidence

Bench testing only. Testing included biocompatibility, latex protein measurement, packaging integrity, standards conformity, and simulated use testing per FDA guidance.

Technological Characteristics

3 mL piston syringe; manual retractable needle mechanism; two-part plunger with locking spike; Luer slip connector; sterile; single-use. Materials and dimensions vary by configuration. No software or electronic components.

Indications for Use

Indicated for injection of fluids into the body for patients requiring hypodermic delivery; intended to reduce sharps injury risk and prevent syringe 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

• E.N.S.I. Retractable Safety Syringe (K003348, K000572)

Submission Summary (Full Text)

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# MAY 0 2 2002

K620623

# 510(k) Summary for the DuoPro Safety Syringe (DuoProSSTM) (per 21CFR807.92)

#### SPONSOR 1.

M.K. Meditech Co., Ltd. 4th Floor, No. 1221 Chung Cheng Road Taoyuan City Taiwan 330

Contact Person: I-Ming Shih Telephone: [phone], extension 883 Date Prepared: February 25, 2002

#### 2. DEVICE NAME

DuoPro Safety Syringe (DuoProSSTM) Proprietary Name: Common/Usual Name: Hypodermic Syringe (with or without needle) Classification Name: Piston syringe Hypodermic single lumen needle

#### 3. PREDICATE DEVICE

- E.N.S.I. Retractable Safety Syringe (K003348, K000572) .
### DEVICE DESCRIPTION 4.

The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable 3 mL safety syringe, provided with or without needle in various product configurations.

### 5. INTENDED USE

The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of

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fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

### 6.

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

M.K. Meditech Co., Ltd. makes a claim of substantial equivalence of the DuoProSS™ to the E.N.S.I. Retractable Safety Syringe (K003348) based on similarities in intended use, design, technological, and operational characteristics. Both are indicated for injecting fluids into the body, while helping to reduce the risk of sharps injuries. Both syringes are piston syringes that use single lumen hypodermic needles. The DuoProSS™ can be ordered both with and without needles, while the E.N.S.I. is not provided with needles. The DuoProSS™M currently uses a Luer slip needle connector, while the E.N.S.I. uses a Luer lock connector. Both syringes are provided sterile, single-use, and disposable. The major difference between the DuoProSS™ and the E.N.S.I. products is the syringe volume (and associated dimensions). This difference does not affect the performance of the syringe, since syringe size is typically determined by drug volume to be administered and user preference. Bench testing shows that the performance of the DuoProSS™ is equivalent to the E.N.S.I. product. Both syringes have two-part plungers. The distal part holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part, thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle-plunger into the syringe barrel, break off the plunger rod, and discard the pieces. M.K. Meditech Co., Ltd. believes that the differences between the DuoPro Safety Syringe (DuoProSS™) and the predicate device are minor and they raise no new issues of safety or effectiveness.

#### 7. PERFORMANCE TESTING

Testing provided in this premarket notification includes biocompatibility, measurement of latex protein, packaging integrity, standards conformity, and testing according to FDA guidance (including a simulated use test).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three parallel lines forming the shape of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 0 2 2002

M. K. Meditech Company Limited C/O Ms. Rosina Robinson Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K020623

Trade/Device Name: Duopro Safety Syringe (DuoProSSTM) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG and FMI Dated: February 25, 2002 Received: February 26, 2002

Dear Ms. Robinson :

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 approvisions 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.

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

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### Page 2 - Ms. Rosina Robinson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timo A. Ulatowski Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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## 510(k) Number (if known):

### M.K. Meditech Co., Ltd., DuoPro Safety Syringe Device Name: (DuoProSS™)

## Indications For Use:

The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and nonreusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patara Cucente

vision Sian-Off Division of Dental, Infection Control, and General Hospital Device 510(k) Number _

Prescription **Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

M. K. Meditech Co., Ltd. Traditional 510(k) February 25, 2002 DuoPro Safety Syringe (DuoProSSTM)

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