SAFEPRO SAFETY SYRINGE

K022063 · Formosa Medical Devices, Inc. · MEG · Aug 29, 2002 · General Hospital

Device Facts

• Record ID: K022063
• Device Name: SAFEPRO SAFETY SYRINGE
• Applicant: Formosa Medical Devices, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Aug 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The primary intended use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid. The secondary intended use for the lec SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

Device Story

1cc SafePro* Safety Syringe consists of syringe and needle assembly with integrated safety mechanism; designed for fluid aspiration and injection. Safety feature aids in reduction of accidental needlestick injuries. Used in clinical settings by healthcare professionals. Bench testing and simulated use studies (500 units, 50 participants) confirmed functional performance and safety mechanism efficacy; no sharps injuries reported. Biocompatibility verified per ISO 10993-1 and FDA G-95 standards.

Clinical Evidence

Simulated use study conducted with 500 units and 50 participants. Primary endpoints: safety mechanism failure and incidence of sharps injuries. Results: zero injuries or mechanism failures reported. Positive evaluator feedback on functional performance. Biocompatibility testing performed on needle hubs with various colorants per ISO 10993-1 and FDA G-95.

Technological Characteristics

Piston syringe with integrated safety mechanism. Materials tested for biocompatibility per ISO 10993-1 and FDA G-95. Includes needle assembly with color-coded hubs. Manual operation; no energy source or software.

Indications for Use

Indicated for general purpose fluid aspiration and injection, and for providing needlestick protection to reduce the risk of accidental injuries in clinical settings.

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

• B-D Luer Lok syringe
• Retractable Technology, Inc. VanishPoint
• SafePro* Safety Syringe

Submission Summary (Full Text)

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AUG 2 9 2002

Ko22063

### SECTION VIII

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for 1cc SafePro* Safety Syringe

#### REGULATORY AUTHORITY 1-

Safe Medical Device Act of 1990, CFR 807.92.

#### 2. CONTACT PERSON

Joseph J. Chang, Ph.D., PE FORMOSA MEDICAL DEVICES, INC. U.S. Liaison Office 11497 Columbia Park Drive West, Suite #9 Jacksonville, FL 32258

#### NAME OF MEDICAL DEVICE 3.

| Classification Name: |
|----------------------|
| Classification Code: |
| Common/Usual Name: |
| Proprietary Name: |

Syringe, Antistick MEG Syringe 1cc SafePro* Safety Syringe

#### 4. DEVICE CLASSIFICATION

The General Hospital Panel has classified Antistick Syringes (21CFR880 5860) into Class II, Special Controls under section 513 of the Act.

#### ર. STATEMENT OF SUBSTANTIAL EQUIVALENCE

The 1cc SafePro* Safety Syringe is substantially equivalent to:

A) B-D Luet Lok syringe in terms of normal syringe function for fluid transport.

and

B) Retractable Technology, Inc. VanishPoint, and SafePro * Safety Syringe for needlestick protection feature. See also the attached table.

*Trademark

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### INTENDED USE 6.

The primary intended use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid.

The secondary intended use for the lec SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

### DESCRIPTION OF DEVICE 7.

The 1cc SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature which may aid in the reduction of the risk of accidental needlestick injuries.

### SUMMARY OF MATERIAL TESTING 8.

The entire SafePro* Safety Syringe was already tested for material safety and biocompatibility as indicated in a previous 510(K) submission, K012726. Since the 1cc SafePro* Safety Syringes have different gauge size needles, the colorant used are different. Therefore, the hubs molded with all of the colorants for all gauges were tested for biocompatibility. Test results indicated that the hub and thus the entire 1cc SafePro* Safety Syringe meets ISO 10993-1 and US FDA G-95 requirements.

### 9. SUMMARY OF SIMULATED USE STUDY

A total of 500 1cc SafePro* Safety Syringes were evaluated by 50 participants. No sharps injuries or failure of the safety mechanism occurred. Successful completion of the study supports the claim that 1cc SafePro* Safety Syringe can reduce the risk of accidental needlestick injuries. The positive responses from the Evaluators regarding functional and performance aspects also indicated that the 1cc SafePro* Safety Syringe meets customer requirements.

### 10. CONCLUSION

The results obtained from bench testing, material safety, and simulated use tests indicate that the 1cc SafePro* Safety Syringe is safe and effective for it's intended use.

*Trademark

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, arranged in a cascading manner.

AUG 2 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Formosa Medical Devices, Incorporated C/O Mr. Joseph J. Chang SafePro USA. Incorporated 11497 Columbia Park Drive West, Suite #9 Jacksonville, Florida 32258

Re: K022063

Trade/Device Name: 1cc SafePro* Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: June 24, 2002 Received: June 25, 2002

Dear Mr. Chang

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 -- Mr. Chang

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.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Timothy A. Ulatowski

Timothy/A. Ulatowski 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) - Icc SafePro* Safety Syringe

063

### INDICATIONS FOR USE

# Device Name

1cc SafePro* Safety Syringe

### Indication for Use

The primary indicated use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid.

The secondary indicated use for the 1cc SafePro * Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

## (Please don not write below this line-Continue on another page if needed) Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109 (Optional Fornat 1-2-96) OR Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

Patricia Cusente

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

510(k) Number: K022063

*Trademark