10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE

K034031 · M.K. Meditech Co. , Ltd. · MEG · Jan 21, 2004 · General Hospital

Device Facts

• Record ID: K034031
• Device Name: 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
• Applicant: M.K. Meditech Co. , Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) 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

10 mL manual, retractable safety syringe; sterile, single-use, disposable. Features two-part plunger; distal part holds hypodermic needle; proximal part contains projection spike. Operation: user injects fluid, manually retracts needle-plunger into syringe barrel, breaks off plunger rod to lock needle, and discards. Used by clinicians for fluid injection; design minimizes sharps exposure and prevents reuse. Modification from predicate includes volume change and material update.

Clinical Evidence

No clinical data. Evidence consists of bench testing, verification/validation, and biocompatibility testing per ISO 10993.

Technological Characteristics

Piston syringe with manual retractable needle mechanism. Two-part plunger design with locking projection spike. Sterile, single-use, disposable. Materials conform to ISO 10993 biocompatibility standards. Dimensions: 10 mL capacity.

Indications for Use

Indicated for injection of fluids into the body for patients requiring hypodermic delivery. Intended to reduce risk of sharps injuries and 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

• 5 mL DuoPro™ Safety Syringe (DuoProSS™) (K022806)

Submission Summary (Full Text)

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JAN 2 1 2004

K034031

# 510(k) Summary for the 10 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSS™) (per 21CFR807.92)

#### 1. SPONSOR

M.K. Meditech Co., Ltd. Suite 702, 7th Floor No. 5, Chingdau E. Rd. Taipei, 100 Taiwan, ROC

Contact Person: 1-Ming Shih Telephone: [phone], extension 883

Date Prepared: December 23, 2003

#### 2. DEVICE NAME

| Proprietary Name: | 10 mL Bak'Snap DuoProSS™ Retractable Safety Syringe |
|----------------------|-----------------------------------------------------|
| Common/Usual Name: | Hypodermic Syringe (with needle) |
| Classification Name: | Piston syringe |
| | Hypodermic single lumen needle |

#### 3. PREDICATE DEVICES

- 5 mL DuoPro™ Safety Syringe (DuoProSS™) (K022806) .
#### 4. DEVICE DESCRIPTION

The 10 mL Bak'Snap DuoProSS™ Retractable Safety Syringe is a sterile, single-use, disposable and non-rcusable, manual, retractable safety syringe provided with or without needle. The modifications to the cleared product are the addition of a brand name, a change in syringe volume, and a change in a single syringe material.

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#### INTENDED USE 5.

The Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) 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.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

M.K. Meditech Co., Ltd., makes a claim of substantial equivalence of the 10 mL Bak Snap DuoProSS™ Retractable Safety Syringe to the cited predicate device 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 the 10 mL Bak'Snap DuoProSS™ and predicate device are provided without a needle or with single-lumen hypodermic needles (variety of lengths and gauges).

Both the 10 mL Bak'Snap DuoProSS™ and the predicate device arc provided sterile, single-use, and disposable. Both the 10 mL Bak'Snap DuoProSS™ and the predicate device 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 the 10 mL Bak'Snap DuoProSS™ and the prodicate device require the user to manually retract the needle-plunger into the syringe barrel, break of the plunger rod, and discard the picces. M.K. Meditech Co., Ltd., believes that the differences between the 10 mL Bak'Snap DuoProSS™ Retractable Safety Syringe and cited predicate device are minor and they raise no now issues of safety or effectiveness.

#### TESTING 7.

Verification and validation testing presented in this premarket notification includes testing to demonstrate conformance to standards, testing according to FDA guidance (comparison with predicate device), and biocompatibility testing per ISO 10993.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three wings, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

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

Re: K034031

Trade/Device Name: M.K. Meditech Co., Ltd., Bak'Snap DuoProSSTM Retractable Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 23, 2003 Received: December 29, 2003

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 commercc 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, thereforc, 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 vour 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. Robinson

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/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph. D.

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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K034031

510(k) Number (if known):

## Device Name: M.K. Meditech Co., Ltd., Bak'Snap DuoProSS™ Retractable Safety Syringe

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Viola Hubbard, Interim Branch Chief

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

ਾਲ

Over-The-Counter Use

(Optional Format 1-2-96)

M. K. Meditech Co., Ltd., Special 510(k) December 23, 2003 10 mL Bak'Snap DuoProSS™ Retractable Safety Syringe

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