DUOPRO SAFETY SYRINGE (DUOPROSS)

K022806 · M.K. Meditech Co. , Ltd. · MEG · Sep 19, 2002 · General Hospital

Device Facts

• Record ID: K022806
• Device Name: DUOPRO SAFETY SYRINGE (DUOPROSS)
• Applicant: M.K. Meditech Co. , Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Sep 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified 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

DuoProSS™ is a manual, retractable safety syringe (3 mL or 5 mL) used for fluid injection. Device features a two-part plunger system: distal part holds hypodermic needle; proximal part contains a projection spike. After injection, user manually retracts needle-plunger into syringe barrel, breaks off plunger rod, and discards components to prevent reuse and sharps injury. Available with luer slip or luer lock connectors. Used by clinicians in healthcare settings. Benefits include reduced risk of accidental needlestick injuries and prevention of syringe reuse.

Clinical Evidence

Bench testing only. Verification and validation included standards conformity, FDA guidance testing, biocompatibility, and latex protein measurement. Performance demonstrated to be equivalent to predicate devices.

Technological Characteristics

Piston syringe with two-part plunger and retractable needle mechanism. Available in 3 mL and 5 mL volumes. Features luer slip or luer lock needle connectors. Sterile, single-use, disposable. Manual operation.

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

• DuoPro™ Safety Syringe (DuoProSS™) (K020623)
• E.N.S.I. Retractable Safety Syringe (K003348, K000572)

Submission Summary (Full Text)

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# SEP 1 9 2002

K022806

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

#### 1. SPONSOR

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

Contact Person: I-Ming Shih 886-3-3166399, extension 883 Telephone: Date Prepared: August 21, 2002

#### 2. DEVICE NAME

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

#### 3. PREDICATE DEVICES

- DuoPro™ Safety Syringe (DuoProSSTM) (K020623) ●
- E.N.S.I. Retractable Safety Syringe (K003348, K000572) .

#### 4. DEVICE DESCRIPTION

The modified DuoPro™ Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, 3 mL or 5 mL retractable safety syringe, provided with or without needle in various product configurations.

#### INTENDED USE ડ.

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

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

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

M.K. Meditech Co., Ltd., makes a claim of substantial equivalence of the DuoProSS™ to the cited predicates based on similarities in intended use, design, and 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 modified DuoProSS™ uses either a luer slip or luer lock needle connector, while the E.N.S.I. uses a Luer lock connector. All syringes are provided sterile, single-use, and disposable. The major difference between the modified DuoProSS™ products (3 mL and 5 mL), the original DuoProSS™ (3 mL) and the E.N.S.I. product (5 mL) 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. All 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 modified DuoPro™ Safety Syringe and cited predicate devices are minor and they raise no new issues of safety or effectiveness.

### 7. TESTING

Verification and validation testing provided in this premarket notification includes standards conformity, testing according to FDA guidance, biocompatibility, and measurement of latex protein. Testing shows that the performance of the modified DuoProSS™ is equivalent to predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 1 9 2002

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

Re: K022806

Trade/Device Name: DuoPro™ Safety Syringe (DuoProSSTM) Regulation Number: 880.5860 and 880.5570 Regulation Name: Piston Syringe and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MEG and FMI Dated: August 21, 2002 Received: August 23, 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 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.

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.

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Page 2 - Ms. Robinson

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clue C/on
Timothy A. Ulatowski

Timothy A. Ulatow: 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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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 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)

Patroco Cucente

510(k) Number: K022806

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

M. K. Meditech Co., Ltd., Special 510(k) DuoPro™ Safety Syringe (DuoProSS™)

August 21, 2002