BETEC RETRACTABLE SAFETY SYRINGE (5ML)

K031909 · Betec Medical Science Co., Ltd. · MEG · Oct 7, 2003 · General Hospital

Device Facts

• Record ID: K031909
• Device Name: BETEC RETRACTABLE SAFETY SYRINGE (5ML)
• Applicant: Betec Medical Science Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Oct 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BeTeC Retractable Safety Syringe is designed as an anti-stick syringe to aid in the prevention of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into or withdraw from the body.

Device Story

BeTeC Retractable Safety Syringe is a 5ml manual, single-use, disposable piston syringe; designed to prevent sharps injuries and syringe reuse via a retractable needle mechanism. Components include barrel, plunger, plunger ring, nozzle, nozzle ring, needle cap, and needle hub. Used by healthcare professionals for fluid injection or withdrawal. Operation involves manual retraction of the needle post-injection to mitigate accidental needlestick risk. Device is sterile and non-reusable.

Clinical Evidence

The submission references clinical testing alongside bench testing to support substantial equivalence. Specific clinical study metrics, sample sizes, or results are not detailed in the provided documentation.

Technological Characteristics

5ml manual retractable piston syringe. Materials conform to ISO 10993 series (biocompatibility). Sterilization via ISO 11135 standards. Complies with ISO 7864 (hypodermic needles) and ISO 7886-1 (sterile hypodermic syringes). Mechanical retraction mechanism for sharps injury prevention.

Indications for Use

Indicated for use by clinicians for the injection of medical fluids into or withdrawal of fluids from the body, while providing a mechanism to aid in the prevention of sharps injuries and syringe reuse. Intended for prescription use.

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

• TMD™ Safety Syringe (FA13 Series 5ml) (K022278)

Submission Summary (Full Text)

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## OCT = 7 2003

# 510(K) SUMMARY

K631909

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

| 1. | Submitter's Name:<br>Address:<br>Phone:<br>Fax:<br>Contact: | BeTeC Medical Science Co., Ltd.<br>55 Tower, No. 84/53, 84 Sukhumvit 55, Prakanong, Bangkok, Thailand 10110.<br>66-2-3810781<br>66-2-3810780<br>Mr. Ching Chao Hou, Director |
|----|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. Device Name :<br>Trade Name:<br>Common Name:<br>Classification name | BeTeC Retractable Safety Syringe (5ml)<br>Safety Syringe (with or without needle)<br>Anti-Stick Syringe/ Piston Syringe<br>Single lumen Hypodermic Needle |
| 3. | Classification:<br>Regulatory Number: | Class II<br>880.5860 & 880.5570 |
| 4. | Predicate Device: | • TMD™ Safety Syringe (FA13 Series 5ml )with 510K number K022278<br>Marketed by Taiject Medical Device Co., Ltd. |
| 5. | Device Description: | BeTeC Retractable Safety Syringe<br>The BeTeC Retractable Safety Syringe is sterile, single-use, disposable,<br>Non-reusable, Manual , Retractable, 5ml Piston Syringe, provided with or<br>without needle, which is used for injection of fluids into or withdraw from the<br>body. (Only use needle 11/2" or shorter, 21-28 gauge)<br>The BeTeC Retractable Safety Syringe consists of the following major<br>components :barrel, plunger, plunger ring, nozzle, nozzle ring, needle cap, needle<br>+ needle hub. |
| 6. | Intended Use: | The BeTeC Retractable Safety Syringe is designed as an anti-stick syringe to<br>aid in the prevention of sharps injuries and the potential for syringe reuse and is a<br>single use, disposable and manual retractable safety syringe which is intended for<br>injection of medical fluids into or withdraw from the body. |

Page 1 of 2 FDA 510(K) SUMMARY Page Revision 【A3】

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## 7. Performance Summary:

In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards----etc.

#### 8. Conclusions:

The BeTeC Retractable Safety Syringe has the same intended use and similar technological characteristics as the TMD™ Safety Syringe --FA13 Series 5ml markdet by Taiject Medical Device Co., Ltd. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the BeTeC Retractable Safety Syringe is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles connected to three wave-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 7 2003

Harvest Consulting Company C/O Ms. Jennifer Reich Betec Medical Science Company, Incorporated 3892 South America West Trail Flaggstaff. Arizona 86001

Re: K031909

Trade/Device Name: BeTeC Retractable Safety Syringe (5ml) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 12, 2003 Received: September 17, 2003

Dear Ms. Reich:

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.

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Page 2 -Ms. Reich

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 vours.

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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NUMBER (IF KNOWN):__K031909_ ਦ 10 (k)

BeTeC Retractable Safety Syringe ·DEVICE NAME: BeTeC Medical Science Co., Ltd.

### INDICATIONS FOR USE:

The BeTeC Retractable Safety Syringe (5ml) is designed as an anti-stick syringe to aid in the prevention of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into or withdraw from the body.

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

OR

Concurrence of CDRH, Office of Device Evaluation

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR 801.109)

Over-The-Counter

Pultacia Cucemitz

vision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: *K031907*