BIOTOP DJT-A SAFETY SYRINGE

K032747 · Biotop Technology Co., Ltd. · MEG · May 11, 2004 · General Hospital

Device Facts

• Record ID: K032747
• Device Name: BIOTOP DJT-A SAFETY SYRINGE
• Applicant: Biotop Technology Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: May 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIOTOP DJT-A Safety Syringe (3cc/mL) serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.

Device Story

BIOTOP DJT-A Safety Syringe is a single-use hypodermic syringe with an integral needle-retraction mechanism. Device consists of a barrel, plunger, single-lumen needle, and needle hub. Operation follows traditional injection techniques; upon completion, user manually retracts the needle into the syringe barrel using a hook-based connection on the plunger head to the needle hub. Used by healthcare professionals in clinical settings for medication delivery or fluid aspiration. Safety mechanism reduces risk of accidental needlestick injuries and prevents syringe reuse. Bench and simulated field testing confirm performance equivalence to predicate devices.

Clinical Evidence

No clinical data. Evidence consists of bench testing, biocompatibility testing, sterility validation, and simulated field testing performed in accordance with FDA guidance for sharps injury prevention devices.

Technological Characteristics

Single-use piston syringe; materials include PP plastic and lubricant; luer-lock needle mechanism; ethylene oxide (EO) sterilization. Manual needle retraction via hook-based plunger-to-hub connection.

Indications for Use

Indicated for use as a vehicle for injecting medication into or withdrawing fluid from the human body via hypodermic needle injection. Intended to limit accidental needlestick injuries and prohibit 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, K022806)

Submission Summary (Full Text)

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MAY 11 2004

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K032717

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#### 510(K) Summary of Safety and Effectiveness II.

## Information

(Per 21 CFR 807.92)

BIOTOP Technology Co., Ltd. 1. Submitter: 12F, No. 130, Chung-Hsiao E. Rd. Sec. 2 Taipei 100 Taiwan

Contact Person: Dr. Ke-Min Jen Official Correspondent 886-3-5208829 (Tel) 886-3-5209783 (Fax)

- Date Prepared: 2003/6/13 2.
- 3. Device Name:

BIOTOP DJT-A Safety Syringe -Proprietary Name: Sharps Injury Prevention Piston Syringe -Common Name: -Classification Name: Antistick Syringe (MEG)

#### Prcdicate Device: 4.

Claim of Substantial Equivalence (SE) is made to M.K. Meditech Company's DuoPro Safety Syringe (DuoProSSTM) (K020623, K022806).

#### 5. Device Description:

The BIOTOP DJT-A Safety Syringe is a single-use hypodermic syringe that is very similar to a traditional syringe, except it possesses an integral needle retracting mechanism. Upon employing traditional syringe injection techniques, the needle can be manually retracted back inside the syringe barrel.

#### Intended Use: 6.

The BIOTOP DJT-A Safety Syringe serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needlestick injuries as well as help to prohibit syringe reuse.

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### 7. Substantial Equivalence (SE) and Safety and Effectiveness Information:

BIOTOP Technology Co., Ltd. makes a Substantial Equivalence claim of the DJT-A safety syringe to M.K. Meditech's DuoProSS™. The two safety syringes are similar with regards to parts, design, material, operating procedure, and intended use, The DJT-A and the DuoProSS™ both consist of a syringe barrel, syringe plunger, single lumen hypodermic needle and needle hub, and a retracting mechanism on the syringe plunger head and the needle hub. The DJT-A needle employs a luer-lock mechanism while the DuoProSS™ can be both luer-slip or luer-lock. The design of the two syringes is similar in most of its parts, appearing like a traditional syringe. The DJT-A and DuoProSS™ uses identical PP plastic, lubricant, and needle. Both safety syringes are sterile and aseptic by employing ethylene oxide (EO) as the sterilization technique. The difference between the two safety syringes is the needle retracting mechanism. Both use a special tip on the head of the syringe plunger to be tightly connected to the needle hub as to allow the whole hub and necdle to be manually retracted back inside the plunger. The difference between the two is the shape of the connecting tip on the syringe plunger. The DJT-A uses a hook to connect to the needle hub while the DuoProSS™ uses a knob-shaped tip to connect to the However, the operating instructions for both safety syringes are needle hub. identical with regards to how the needle is retracted back into the syringe barrel. Performed bench testing revealed similar performance data, under all conditions and stress. In addition, simulated field test suggests that the DJT-A is as safe and effective in its performance as the DuoProSS™. Therefore, no new safety and effectiveness concerns need to be raised. In addition, both syringes share identical purposes in its intended use. The DJT-A and the DuoProSS™ single-use safety syringes both intend to limit disease transmission through accidental necdlestick injurics and through syringe reuse.

### 8. Performance Testing:

Bench, biocompatibility, sterility, substantial equivalence, and simulated clinical testing are employed upon submission of this 510(K) premarket notification according to the Supplementary Guidance on Premarket Notification for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA document provided by CDRH/ FDA.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 11 2004

ROC Chinese-European Industrial Research Society C/O Dr. Ke-Min Jen Official Correspondent Biotop Technology Company Limited 58 Fu-Chiun Street Hsin Chu City, CHINA (TAIWAN) 300

Rc: K032747

Trade/Device Name: BIOTOP DJT-A Safety Syringe (3cc/mL) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: February 12, 2004 Received: February 20, 2004

Dear Dr. Jen:

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 - Dr. Jen

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. or the rever 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 and if the (21 ce e forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicable, 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 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

Sincerely yours,

Smakunna

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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#### Indications for Use Statement IV.

Applicant: BIOTOP TECHNOLOGY CO., LTD.

510(k) Number:

Device Name: BIOTOP DJT-A Safety Syringe (3cc/mL)

### Indications for Use:

The BIOTOP DJT-A Safety Syringe (3cc/mL) serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:_ K