CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)

K052397 · Life-Shield Products, Inc. · MEG · Dec 22, 2005 · General Hospital

Device Facts

• Record ID: K052397
• Device Name: CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
• Applicant: Life-Shield Products, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

CAREO Safety Syringe is a sterile, single-use, disposable piston syringe (3, 5, 10 mL) with a permanently attached needle. Operated manually by clinicians for intramuscular or subcutaneous medication delivery. Device features a retractable needle mechanism to prevent needlestick injuries; user manually retracts needle-plunger into barrel and breaks off plunger rod after use to prevent reuse. Used in clinical settings for fluid injection. Benefits include reduced risk of sharps injuries and prevention of syringe reuse.

Clinical Evidence

Bench testing only. Includes physiochemical compatibility, biocompatibility, and standard conformity testing. Simulated use testing demonstrated the device performs according to specifications.

Technological Characteristics

Piston syringe with permanently attached single lumen hypodermic needle. Sterile, single-use, disposable. Available in 3, 5, and 10 mL sizes. Manual needle retraction and plunger-break mechanism for safety.

Indications for Use

Indicated for intramuscular and subcutaneous injection of medication in 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

• SafePro Safety Syringe (K012726)
• SECUREGARD Retractable Safety Syringe (K012121)
• CAREO Retractable Safety Syringe (K030976)

Submission Summary (Full Text)

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K052397

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DEC 2 2 2005

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

#### SPONSOR !.

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

Contact Person: Mr. Kurt Lo, Vice President 011-866-2-2299-6033 Telephone:

Date Prepared: May 30, 2005

#### DEVICE NAME 2.

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

#### PREDICATE DEVICE 3.

- SafePro* Safety Syringe (K012726) .
- SECUREGARD® Retractable Safety Syringe (K012121) .
- CAREO Retractable Safety Syringe (K030976) .

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# 2 23

#### DEVICE DESCRIPTION 4.

The Life-Shield Products, Inc., CAREO Safety Syringe is a sterile, single use and disposable, 3, 5, 10 mL piston syringe, provided with a permanently attached needle in twelve product configurations. The CAREO Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.

#### 5. INTENDED USE

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

#### SUBSTANTIAL CHARACTERISTICS AND AND AND 6. TECHNOLOGICAL EQUIVALENCE

Life-Shield Products, Inc., makes a claim of substantial equivalence of the CAREO Safety Syringe to the SafePro* Safety Syringe (K012726), SECUREGARD® Retractable Safety Syringe (K012121) and CAREO Retractable Safety Syringe (K030976) based on similarities in intended use, design, technological and operational characteristics. All three 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, break off the plunger rod, and discard the pieces.

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1052397 3 83

#### TESTING 7.

Testing provided in this premarket notification includes physiochcmical Side-by-side compatibility, biocompatibility, and standard conformity. CAREO Safety Syringe, SafePro* Safety Safety Syringe, of comparison SECUREGARD® Retractable Safety Syringe and the CAREO Retractable Safety Syringe shows that three products are equivalent. Simulated use testing has demonstrated that the CAREO Safety Syringe performs according to specification. Testing also supports the claimed Indications for Use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular arrangement of text around an emblem. The emblem is a stylized design of three overlapping human figures, possibly representing health, family, and community. The text is "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2005

Dr. Jen, Ke-Min Consultant Life-Shield Products, Incorporated 3F, No.10, Wuchiuan 7th Road Wugu Industrial Park Taipei, 248, Taiwan

Re: K052397

R032397
Trade/Device Name: CAREO Safety Syringe (3cc/mL, 5cc/mL, 10cc/mL) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 2, 2005 Received: December 8, 2005

Dear Dr. Ke-Min:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the enactment date of the Medical Device interstate colliments, or to triay 20, 1978, and same with the provisions of Amendments, of to devices that nave been formselves approval of a prematice the fleaths the fleast of the Federal Food, Drug, and Oosmene 110 (710) -------------------------------------------------------------------------------------------------------------------------------approval application (1 MrY). Fou Fray, crow sions of the Act include controls provisions of the Fet. "The genting of devices, good manufacturing practice, requirements for and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III if your device is Classified (sec above) into enner cos. Existing major regulations affecting (PMA), it may be subject to such adultions, Title 21, Parts 800 to 899. In
your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Code of Peacharies.
addition, FDA may publish further announcements concerning your device in the Federal Register.

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# Page 2 - Dr. Ke-Min

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC s loodines of about of the complies with other requirements mean that iDA nas made a decemind regulations administered by other Federal agencies. of the Act of any I oderal barates and squirements, including, but not limited to: registration You must comply with an the Hec Fee s reg (21 CFR Part 801); good manufacturing practice and and ilsting (21 CFR Part 807), labeling (21 cm (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) I mis letter will anow you to begal mading of substantial equivalence of your device to a premiarket notification. The PDF Intelligence can also 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), II you desire specific advice for your see at [phone]. Also, please note the regulation in prease contact the Other or Sommerces to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain other general mironial and Consumer Assistance at its toll-free Division of Binas-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylvette Y. Michaud, DmX

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:

Device Name:

LIFE-SHIELD Products, Inc. CAREO Safety Syringe (3cc/mL, 5cc/mL, 10cc/mL)

# INTENDED USE

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

Prescription Use _ V (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)

Shuli H. Maugher D/MCB/6 HON 12/22/65

K 052397

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