ICC INSULIN SAFEPRO SAFETY SYRINGE

K050134 · Formosa Medical Devices, Inc. · MEG · Apr 5, 2005 · General Hospital

Device Facts

• Record ID: K050134
• Device Name: ICC INSULIN SAFEPRO SAFETY SYRINGE
• Applicant: Formosa Medical Devices, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Apr 5, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

1cc Insulin SafePro* Safety Syringe is a manual, single-use hypodermic syringe designed for insulin delivery. It features an integrated safety mechanism to reduce accidental needlestick injuries. The device consists of a syringe barrel, plunger, gasket, and needle assembly. It is operated manually by clinicians or patients for fluid aspiration and injection. The safety feature is manually actuated and remains engaged during disposal. The device is used in clinical or home settings. By providing a physical barrier or locking mechanism post-injection, it protects the user from sharps injuries, thereby improving safety during insulin administration.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and simulated use studies previously validated in submissions K012726 and K022063. Materials and safety features are identical to predicate devices.

Technological Characteristics

Manual piston syringe; materials include polypropylene (PP) for barrel, plunger, and sheath, stainless steel for needle, and synthetic rubber for gasket. Features integrated manual safety mechanism for sharps injury prevention. Designed for U-100 insulin delivery.

Indications for Use

Indicated for patients requiring insulin therapy. Used for aspirating and injecting insulin fluid and providing needlestick protection for the user.

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 Conventional hypodermic and insulin syringe (K980580)
• 1cc SafePro Safety Syringe (K022063)

Reference Devices

• SafePro Safety Syringe (K012726)

Submission Summary (Full Text)

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APR 5 2005

K050134

### SECTION VIII

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

#### REGULATORY AUTHORITY 1.

Safe Medical Device Act of 1990, CFR 807.92.

#### CONTACT PERSON 2.

C. Y. Lin (Ms) Manager, Quality Assurance & Regulatory Affairs 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: Syringe, Antistick Classification Code: MEG Common/Usual Name: Syringe 1cc Insulin SafePro* Safety Syringe Proprietary Name:

#### DEVICE CLASSIFICATION 4.

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

#### STATEMENT OF SUBSTANTIAL EQUIVALENCE 5.

The 1cc Insulin SafePro* Safety Syringe is essentially equivalent to:

- A) B-D Conventional hypodermic and insulin syringe, K980580, and
- B) The 1cc SafePro Safety Syringe, K022063, in design, materials, instructions for use, and product claims.

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*Trademark

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#### INTENDED USE 6.

The primary intended use for the 1cc Insulin SafePro* Safety Syringe is aspirating and infusing insulin fluid.

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

#### DESCRIPTION OF DEVICE 7.

The 1cc Insulin SafePro* 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. Other than scale graduation for use with U-100 strength insulin, the 1cc Insulin SafePro* Safety Syringe is essentially identical to the legally marketed 1cc SafePro* Safety Syringe in design and materials of construction.

#### SUMMARY OF MATERIAL TESTING 8.

The materials of construction of the 1cc Insulin SafePro* Safety Syringe are identical to those for the SafePro* Safety Syringe and 1cc SafePro Safety Syringe. Those materials were already tested for material safety and biocompatibility as indicated in previous 510(K) submissions, K012726 and K022063. Therefore, no new biocompatibility tests are necessary.

#### SUMMARY OF SIMULATED USE STUDY 9.

The safety feature and other functional and performance characteristics of the Icc Insulin SafePro* Safety Syringe are identical to those for the SafePro* Safety Syringe and 1cc SafePro* Safety Syringe. Those features and characteristics were already verified and validated as shown in the two previous 510(k) notifications K012726 and K022063. Therefore, no new tests are necessary.

#### CONCLUSION 10.

The results obtained indicate that the 1cc Insulin SafePro* Safety Syringe is safe and effective for its intended use.

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# COMPARISON MATRIX 1cc Insulin SafePro* Safety Syringe, B-D Conventional Syringe, and 1cc SafePro* Safety Syringe

This matrix was developed in accordance with the ODE Guidance titled "Supplementary Guidance on the Content of Premarket Notification [510(K)] Submissions for Medical Device with Sharp Injury Prevention Features (March, 1995)".

| Factor | 1cc Insulin SafePro*<br>Safety Syringe | B-D Conventional<br>Insulin Syringe | 1cc SafePro*<br>Safety Syringe |
|---------------------------------------------------------------|----------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------|
| 510(K) Number | To Be Assigned | K980580 | K012726 |
| Intended Use and Claims | | | |
| • Same Intended Use | Yes | Yes | Yes |
| • Tissue Puncture Device | Yes | Yes | Yes |
| • Sharps Injury Prevention Feature | Yes | No | Yes |
| • Reduces Risks of Accidental Needlesticks | Yes | No | Yes |
| • Delivers fluid to or draw blood from<br>patient, short term | Yes | Yes | Yes |
| • Conventional Insertion Technique with<br>minimal training | Yes | Yes | Yes |
| Technological Features | | | |
| • Same Technology Features | No | No | Yes |
| • Safety Mechanism | | | |
| - Manual Actuation | Yes | Not Applicable | Yes |
| • Safety Mechanism Remains Activated<br>During Disposal | Yes | Not Applicable | Yes |
| • Safety Mechanism is an Integral Part of<br>the Device | Yes | Not Applicable | Yes |
| Material of Construction | | | |
| • Needle<br>• Needle Hub | • Stainless Steel<br>•PP* | • Stainless Steel<br>•PP | •Stainless Steel<br>•PP* with more<br>needle gauges<br>(Different hub<br>colorants) |
| • Barrel, Plunger, Sheath | PP | PP | PP |
| • Gasket | Synthetic Rubber | Synthetic Rubber | Synthetic Rubber |

*PP - Polypropylene resin

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

#### APR 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. C.Y. Lin Manager, Quality Assurance & Regulatory Affairs FORMOSA MEDICAL DEVICES, INCORPORATED 16F. No. 182. Section 2 Tunhua South Road Taipei TAIWAN, R.O.C. 106

Re: K050134

Trade/Device Name: 1cc Insulin* SafePro Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: January 21, 2005 Received: January 24, 2005

Dear Ms. Lin:

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.

ff 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. Lin

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/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph D

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

510(k) Number (if known):

K050134

Device Name:

1cc Insulin SafePro* Safety Syringe

Indications For Use:

The primary indicated use for the 1cc Insulin SafePro* Safety Syringe is for aspirating and injecting insulin fluid.

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

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

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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*Trademark

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