SAFEPRO PLUS SAFETY SYRINGE

K031830 · Formosa Medical Devices, Inc. · MEG · Aug 5, 2003 · General Hospital

Device Facts

• Record ID: K031830
• Device Name: SAFEPRO PLUS SAFETY SYRINGE
• Applicant: Formosa Medical Devices, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Aug 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

SafePro* Plus Safety Syringe is a manual syringe assembly with an integrated needle retraction mechanism. Designed for general fluid aspiration and injection; incorporates a safety feature to retract the needle into the barrel post-use to mitigate accidental needlestick injuries. Operated manually by clinicians in general hospital settings. Output is the delivery of injected fluids; safety mechanism provides physical protection for the user. Benefits include reduced risk of sharps injuries to healthcare personnel.

Clinical Evidence

Simulated use study conducted with 50 participants evaluating 500 units. Primary endpoints included assessment of safety mechanism functionality and incidence of sharps injuries. Results showed zero sharps injuries and no failures of the safety mechanism. Evaluators reported positive feedback on functional and performance aspects.

Technological Characteristics

Manual syringe assembly with integrated needle retraction mechanism. Materials of construction meet ISO 10993-1 and FDA G-95 biocompatibility standards. Device is a standalone, non-powered, mechanical instrument.

Indications for Use

Indicated for general purpose fluid aspiration and injection, and for needlestick injury reduction 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 conventional syringe
• VanishPoint™ syringe
• SafePro Safety Syringes (K012726)

Submission Summary (Full Text)

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# 510(K) Application Number: K031830

#### SECTION VIII

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

## 1. REGULATORY AUTHORITY

Safe Medical Device Act of 1990, CFR 807.92.

# 2. CONTACT PERSON

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

### 3. NAME OF MEDICAL DEVICE

| Classification Name: | Syringe, Antistick |
|----------------------|------------------------------|
| Classification Code: | MEG |
| Common/Usual Name: | Syringe |
| Proprietary Name: | SafePro* Plus Safety Syringe |

#### 4. DEVICE CLASSIFICATION

The General Hospital Panel has classified Antistick Syringes (21CFR880.5600) into Class II, Special Controls under section 513 of the Act.

# 5. STATEMENT OF SUBSTANTIAL EQUIVALENCE

The SafePro* Plus Safety Syringe is substantially equivalent to:

- A) B-D Luer Lok conventional syringe with regard to the conventional syringe/needle and B) VanishPoint™ syringe with regard to retraction of the needle assembly into the barrel
- for needlestick protection feature, and
- C) The previously approved SafePro Safety Syringes (K012726) in design, Instructions for Use, and product claims.

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#### 6. INTENDED USE

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

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

### 7. DESCRIPTION OF DEVICE

The SafePro* Plus Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.

### 8. SUMMARY OF MATERIAL TESTING

The materials of construction for the SafePro* Plus Safety Syringe are identical to those for the SafePro* Safety Syringe which were already tested for biocompatibility by an independent. ISO certified, outside testing laboratory. Test results indicated that the entire Safety Syringe meets ISO 10993-1 and US FDA G-95 requirements.

#### 9. SUMMARY OF SIMULATED USE STUDY

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

#### 10. CONCLUSION

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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with its wings spread, with three wavy lines below it.

Public Health Service

AUG - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Formosa Medical Devices, Incorporated C/O Joseph J Chang General Manager and Chief Technology Officer Safepro USA, Incorporated 11497 Columbia Park Drive West Suite #9 Jacksonville, Florida 32258

Re: K031830

Trade/Device Name: SafePro* Plus Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: June 11, 2003 Received: June 13, 2003

Dear Dr. 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.

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Page 2 -Dr. Chang

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,

Susan Runnes

Susan Runner, DDS, MA Interim 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

## Device Name

SafePro* Plus Safety Syringe

# Indication for Use

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

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

Patricia Cucenite

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

510(k) Number: K031830

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

V Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96)

OR Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

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*Trademark