CAREO RETRACTABLE SAFETY SYRINGE

K030976 · Life-Shield Products, Inc. · MEG · May 30, 2003 · General Hospital

Device Facts

• Record ID: K030976
• Device Name: CAREO RETRACTABLE SAFETY SYRINGE
• Applicant: Life-Shield Products, Inc.
• Product Code: MEG · General Hospital
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAREO Retractable Safety Syringe is a sterile, single-use, disposable and nonreusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The CAREO Retractable Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Retractable Safety Syringe reduces the possibility of syringe reuse.

Device Story

CAREO Retractable Safety Syringe is a 3 mL sterile, single-use, disposable piston syringe with a permanently attached hypodermic needle. Used by clinicians for intramuscular or subcutaneous medication delivery. Operation involves manual injection followed by manual retraction of the needle-plunger into the syringe barrel; user then breaks off the plunger rod to prevent reuse and reduce needlestick injury risk. Device provides a physical barrier to needle exposure post-injection.

Clinical Evidence

Bench testing only. Includes biocompatibility, packaging integrity, standards conformity, and simulated use testing on 500 units to confirm performance specifications.

Technological Characteristics

3 mL piston syringe; permanently attached single lumen hypodermic needle; sterile, single-use, disposable; manual retraction mechanism; plunger-break feature for non-reusability.

Indications for Use

Indicated for intramuscular and subcutaneous injection of medication into patients. Not for blood collection.

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

• SECUREGARD® Retractable Safety Syringe (K012121)

Submission Summary (Full Text)

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K030976

# 510(k) Summary for the Life-Shield Products, Inc. CAREO Retractable Safety Syringe (per 21CFR807.92)

#### SPONSOR 1.

Life-Shield Products, Inc. 3F, No. 10, Wuchiuan 7th Rd Wugu Shiang Taipei 248 Taiwan, ROC

Contact Person: Mr. Eric Shih, President 011-866-2-2299-6033 Telephone:

Date Prepared: May 13, 2003

### 2. DEVICE NAME

| Proprietary Name: | CAREO Retractable Safety Syringe |
|----------------------|----------------------------------|
| Common/Usual Name: | Hypodermic Syringe (with needle) |
| Classification Name: | Piston syringe |
| | Hypodermic single lumen needle |

#### 3. PREDICATE DEVICE

- SECUREGARD® Retractable Safety Syringe (K012121) .
#### 4. DEVICE DESCRIPTION

The Life-Shield Products, Inc., CAREO Retractable Safety Syringe is a sterile, single-use and disposable, 3 mL piston syringe, provided with a permanently attached needle in eight product configurations. The CAREO Retractable Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single-use, sterile, disposable syringes.

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# ડ. INTENDED USE

The CAREO Retractable Safety Syringe is a sterile, single-use, disposable and nonreusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection.

The CAREO Retractable Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Retractable Safety Syringe reduces the possibility of syringe reuse.

## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Life-Shield Products, Inc., makes a claim of substantial equivalence of the CAREO Retractable Safety Syringe to the SECUREGARD® Retractable Safety Syringe (K012121) based on similarities in intended use, design, technological and operational characteristics. Both are indicated for injecting fluids into the body, while helping to reduce the risk of sharps injuries. Both syringes are piston syringes that use permanently attached single lumen hypodermic needles. Both syringes are provided sterile, single-use, and disposable. Both syringes require the user to manually retract the needle-plunger into the syringe barrel, break 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 Retractable Safety Syringe and the SECUREGARD® Retractable Safety Syringe shows that the two products are equivalent. Simulated use testing using 500 syringes demonstrates that the CAREO Retractable Safety Syringe performs according to specification. Testing also supports the claimed Indications for Use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2003

Life-Shield Products, Incorporated C/O Ms. Rosina Robinson, RN, Med, RAC Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K030976

Trade/Device Name: Life-Shield Products, Inc., CAREO Retractable Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 27, 2003 Received: March 28, 2003

Dear Ms. Robinson:

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 -- Ms. Robinson:

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 vour 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 vours.

Susa Runnr

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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510(k) Number (if known):

Device Name: Life-Shield Products, Inc., CAREO Retractable Safety Syringe

Indications for Use:

The CAREO Retractable Safety Syringe 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 syringe should not be used for blood collection.

The CAREO Retractable Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Retractable Safety Syringe reduces the possibility of syringe reuse.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pattina Cucente

510(k) Number: K030976

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

CAREO Retractable Safety Syringe Additional Information - K030976

May 13, 2003 Appendix B . Page 1 of 1