TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)

K042426 · Taiject Medical Device Co., Ltd. · MEG · Sep 22, 2004 · General Hospital

Device Facts

• Record ID: K042426
• Device Name: TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
• Applicant: Taiject Medical Device Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Sep 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid. The TMD™ 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin. The TMD™ 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin. All the three syringes above incorporate a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.

Device Story

Single-use, sterile, disposable piston syringe with integrated active safety feature; manually activated by user to protect needle after administration. Input: fluid medication (insulin, tuberculin, or other). Output: delivered injection. Used in clinical or home settings by patients or healthcare providers. Safety mechanism reduces risk of sharps injuries and prevents syringe reuse. Device is a smaller volume (0.5ml) variant of existing predicate product lines.

Clinical Evidence

Bench testing only. Performance data generated in compliance with design control requirements demonstrated equivalence to predicate devices.

Technological Characteristics

Piston syringe; materials: polypropylene (barrel, plunger, needle holder), butyl rubber (piston), lubricant. Fixed needle (25-31G, 5/8" or shorter). Active, manually activated safety feature. 0.5ml volume. Sterile, single-use.

Indications for Use

Indicated for patients requiring subcutaneous insulin injection, intradermal tuberculin injection, or general fluid injection. Syringes include safety features to reduce needle stick injuries and prevent 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

• FA11 Series 1ml/FA51 Series U-100 Insulin/FA71 Series Tuberculin (K031062)
• FA12 Series 3 ml/FA13 Series 5 ml (K022278)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2004

Taiject Medical Device, Company Limited C/O Dr. Jim-Son Chou Vice President Achevé Technology, Incorporated P.O. Box 8853 Newport Beach, California 92658

Re: K042426

Trade/Device Name: TMD 0.5mL Safety Syringe (FA18 Series 0.5mL/FA58 Series U-100 Insulin/FA78 Series Tuberculin) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 3, 2004 Received: September 8, 2004

Dear Dr. Chou:

This letter corrects our substantially equivalent letter of September 22, 2004 regarding the trade name.

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 (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 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. Chou

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 (OS) 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 continue 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,

Carls

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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### SEP 2 2 2004

## 510(k) Summary of Safety and Effectiveness for the TMDTM 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) (per 21CFR807.92)

#### 1. SPONSOR

Taiject Medical Device Co., Ltd. 1F, No. 22, KeDung 3 rd Road , Science-Based Industrial Park Chu Nan, MiaoLi, Taiwan 350 Republic of China Tel: [phone] Fax: [phone] Contact person: Mr. David Huang Date Prepared: September 3rd, 2004

#### 2. DEVICE NAME

| Proprietary Name: | TMD TM 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58<br>Series U-100 Insulin / FA78 Series Tuberculin) |
|----------------------|---------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Safety Syringe |
| Classification Name: | Piston syringe (FMF)<br>Anti-Stick Syringe (MEG) |

#### Predicate Device (Legally Marketed Device): 3.

Legally Marketed Device:

FA11 Series Iml/FA51 Series U-100 Insulin/FA71 Series Tuberculin) with 510K number K031062 and FA12 Series 3 ml/FA13 Series 5 ml with 510K number K022278

#### DEVICE DESCRIPTION 4.

The TMD 1 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) is a single use, sterile, disposable syringes that is designed to reduce the risk of sharps injuries. The insulin syringe has scale lines in insulin

Taiject Medical Device, Co., Ltd. Special 510(k) September 3, 2004 TMDTM 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) Page 18

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units. The Tuberculin syringe has scale lines of Tuberculin.

#### INTENDED USE ડ.

--- The TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid.

--- The TMD™ 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin.

--- The TMD™ 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin.

All the three syringes above incorporate a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.

#### TECHNOLOGICAL CHARACTERISTICS 6.

The technological characteristics are the same as the legally market device, FA11 Series 1ml/FA51 Series U-100 Insulin/FA71 Series Tuberculin) with 510K number K031062 and FA12 Series 3 ml/FA13 Series 5 ml with 510K number K022278

#### 7. PERFORMANCE DATA

Performance data has been generated in compliance with the design control requirement and appropriate standards. The result demonstrated equivalent to the predicate devices.

#### COMPARISON INFORMATION 8.

Comparison of the TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) with Legally Marketed Device TMD™ Safety Syringe (FA12 Series 3ml/FA13 Series 5ml)

| | Submission Device | Legally Market Device |
|--|-------------------|-----------------------|
|--|-------------------|-----------------------|

September 3, 2004 Taiject Medical Device, Co., Ltd. Special 510(k) TMDTM 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) Page 19

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| | TMD™ 0.5ml Safety<br>Syringe (FA18 Series<br>0.5ml/FA58 Series U-100<br>Insulin / FA78 Series<br>Tuberculin) | TMD™ Safety Syringe<br>(FA11 Series 1ml/FA51 Series<br>U100 insulin/FA71 Series<br>Tuberculin ) |
|------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | As a single use, hypodermic<br>syringe. Safety feature<br>protects after administration. | As a single use, hypodermic<br>syringe. Safety feature<br>protects after administration. |
| Volume (ml) | 0.5ml | 1ml |
| Needles | 25~31Garge | 25~31Garge |
| Gauge | 5/8" or Shorter | 5/8" or Shorter |
| Needle<br>Connection | Fixed needle | Fixed needle |
| Safety<br>Features | Active safety feature,<br>manually activated by users | Active safety feature, manually<br>activated by users |
| Syringe<br>Type | Plunger, Antistick with fixed<br>needles | Plunger, Antistick with<br>hypodermic needles |
| Material | Piston-Butyl Rubber<br>Barrel, plunger, Needle<br>holder - Polypropylene<br>Lubricant | Piston-Butyl Rubber<br>Barrel, plunger, Needle holder<br>- Polypropylene<br>Lubricant |
| Color | Parts- Clear<br>Printing-Black<br>Orange - Insulin<br>Gray - Tuberculin<br>Transparent - Safety syringe | Parts- Clear<br>Printing-Black<br>Orange - Insulin<br>Gray - Tuberculin<br>Transparent - Safety syringe |

In summary, TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) is a smaller version of the legally marketed TMD™ Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin/FA71 Series Tuberclin) and FA12 Series 3 ml/FA13 Series 5 ml with 510K number K022278.

Taiject Medical Device, Co., Ltd. Special 510(k) September 3, 2004 TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 Series Tuberculin) Page 20

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## Indications for Use

K042426 510(k) Number (if known):

Device Name:TMDTM 0.5ml Safety Syringe (FA58 Series U-100 Insulin)

Indications For Use:

--- The TMD™ 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin.

This syringe above incorporates a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

ivision Sian-Off on of Anesthesiology, General Hospital. Infection Control, Dental Devices

Page i of ii

510(k) Number: K092896

Special 510(K) Tailect Medical Device, Co., Ltd. TMDTM 0.5ml Safety Syringe

September 3rd, 2004

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# Indications for Use

K042426 510(k) Number (if known):

Device Name: TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml/ FA78 Series Tuberculin)

Indications For Use:

--- The TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid.

--- The TMD™ 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin.

All these two syringes above incorporate a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runge

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Anosthoental Devices

Page ii of iii

Koy2a4b

iect Medical Device, Co., Ltd. TMDTM 0.5ml Safety Syringe

Special 510(K)

September 3rd, 2004