CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,

K060208 · Life-Shield Products, Inc. · MEG · Mar 10, 2006 · General Hospital

Device Facts

• Record ID: K060208
• Device Name: CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
• Applicant: Life-Shield Products, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Mar 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAREO Safety Syringe 1cc/mL is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The CARFO Safety Syringe 1cc/mL is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.

Device Story

CAREO Safety Syringe 1cc/mL is a sterile, single-use, disposable piston syringe with a permanently attached needle. Used by clinicians for intramuscular or subcutaneous medication delivery. Device features a retractable needle mechanism; after injection, user manually retracts needle-plunger into barrel, snaps off plunger rod, and discards components to prevent needlestick injuries and syringe reuse. Operates as a standard manual syringe; no electronic or automated components.

Clinical Evidence

Bench testing only. Includes biocompatibility, packaging integrity, standards conformity, and simulated use testing. Simulated use testing demonstrated performance according to specifications.

Technological Characteristics

Piston syringe with permanently attached single lumen hypodermic needle. Sterile, single-use, disposable. Manual needle retraction and plunger-breaking mechanism for safety. No electronic components or software.

Indications for Use

Indicated for intramuscular and subcutaneous injection of medication into patients. Intended to prevent needlestick injuries and prevent 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

• 1cc SafePro Safety Syringe (K022063)
• CAREO Safety Syringe (3cc/mL, 5cc/mL, 10cc/mL) (K052397)

Submission Summary (Full Text)

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MAR 1 0 2006

K060205

l of 2

# 510(k) Premarket Notification for the Life-Shield Products, Inc. CAREO Safety Syringe 1cc/mL (per 21 CFR807.92)

# 1. Sponsor

| Life-Shield Products, Inc. | |
|---------------------------------|-----------------------|
| 3Fl., No. 10, Wuchiuan 7th Rd., | |
| Wugu Industrial Park, | |
| Taipei 248 | |
| Taiwan, R.O.C. | |
| Contact Person: | Mr. Hsiao, Chung-Chih |
| Telephone: | [phone] |

Date Prepared: January 26, 2006

# 2. Device Name

| Proprietary Name: | CAREO Safety Syringe 1cc/mL |
|----------------------|--------------------------------------------------|
| Common/Usual Name: | Hypodermic Syringe (with needle) |
| Classification Name: | Piston syringe<br>Hypodermic single lumen needle |

### 3. Predicate Device

- 1cc SafePro* Safety Syringe (K022063)
- . CAREO Safety Syringe (3cc/mL, 5cc/mL, 10cc/mL) (K052397)

# 4. Device Description

The Life-Shield Products, Inc., CAREO Safety Syringe 1cc/mL is a sterile, single use and disposable, 1cc/mL piston syringe, provided with a permanently attached needle in fifteen product configurations. The CAREO Safety Syringe 1cc/mL is similar in appearance, size, materials operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.

Appendix Q - page 1

January 26, 2006

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#### Intended Use 5.

The CAREO Safety Syringe 1cc/mL is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.

The CARFO Safety Syringe 1cc/mL is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.

#### 6. Technological Characteristics and Substantial Equivalence

Life-Shield Products, Inc., makes a claim of substantial cquivalence of the CAREO Safety Syringe 1cc/mL to the 1cc SafePro* Safety Syringe (K022063) and CAREO Safety Syringe (3cc/mL, 5cc/mL, 10cc/mL) (K052397) based on similarities in intended use, design, technological and operational characteristics. All are indicated for injecting fluids into the body, while helping to reduce the risk of sharps injuries. All syringes are piston syringes that use permanently attached single lumen hypodermic needles. All syringes are provided sterile, single-use, and disposable. All syringes require the user to manually retract the needle-plunger into the syringe barrel, snap off the plunger rod, and discard the pieces.

#### 7. Testing

Testing provided in this premarket notification includes biocompatibility, packaging integrity, standards conformity, and simulated use testing. Side-by-side testing of the CAREO Safety Syringe Icc/mL and the 1cc SafePro* Safety Syringe shows that the two products are equivalent. Simulated use testing has demonstrates that the CAREO Safety Syringe performs according to specification. Testing also supports the claimed Indications for Use.

Appendix Q - page 2

Life-Shield Products, Inc., Special 510(k) CAREO Safety Syringe 1cc/mL

January 26, 2006

CONFIDENTIAL

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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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2006

Mr. Chung-Chih Hsiao Senior Regulatory Affairs Consultant Life-Shield Products, Incorporated 3F, No. 10 & 12, Wuchiuan 7th Rd. Wugu Industrial Park Taipei, Taiwan 248 Republic of China

Re: K060208

Trade/Device Name: CAREO Safety Syringe 1 CC/ML Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: January 26, 2006 Received: February 8, 2006

Dear Mr. Hsiao:

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 -- Mr. Chung-Chih Hsiao

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/industry/support/index.html.

Sincerely yours,

Sydie Y. M. chae Ond.

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):__K060208

Device Name:_Life-Shield Products, Inc., CAREO Safety Syringe 1cc/mL

Indications For Use:

The CAREO Safety Syringe 1cc/mL is a sterile, single-use, disposable and non-The CARLO Salery Syringe Toomie is intended to provide a safe and reliable reduable, Tetractable Baret) Symrge injection of medication into patient.

The CAREO Safety Syringe 1cc/mL is also intended to prevent needlestick injuries. In The OARCO Outley offinge is the plunger, reuse of the syringe is prevented

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

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)

Cinta Keter

General Hospilli O Dental Devices

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