CAREO SAFETY SYRINGE FOR U-100 INSULIN

K061055 · Life-Shield Products, Inc. · MEG · Jul 10, 2006 · General Hospital

Device Facts

• Record ID: K061055
• Device Name: CAREO SAFETY SYRINGE FOR U-100 INSULIN
• Applicant: Life-Shield Products, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAREO Safety Syringe for U-100 Insulin is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient. The CAREO Safety Syringe for U-100 Insulin 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 is a 1cc/mL piston syringe with a permanently attached hypodermic needle. Used for insulin injection; operated manually by clinician or patient. Safety mechanism involves manual retraction of needle-plunger into syringe barrel after injection, followed by snapping off plunger rod to prevent reuse and protect against needlestick injuries. Device is sterile, single-use, and disposable. Benefits include reliable insulin delivery and reduced risk of sharps injuries.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, material safety, and biocompatibility verification/validation performed in previous 510(k) notifications (K030976, K052397, and K060208).

Technological Characteristics

1cc/mL piston syringe; permanently attached single lumen hypodermic needle; manual needle retraction mechanism; plunger-break feature for non-reusability. Sterile, single-use, disposable. Materials and functional characteristics identical to previously cleared CAREO devices.

Indications for Use

Indicated for the injection of insulin into patients. Intended for use as a sterile, single-use, disposable, retractable safety syringe 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 Insulin SafePro* Safety Syringe (K050134)
• CAREO Safety Syringe 1cc/mL (K060208)

Reference Devices

• CAREO Safety Syringe (K030976)
• CAREO Safety Syringe (K052397)

Submission Summary (Full Text)

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KOLOSS ) of 2

# 510(k) Premarket Notification

for

JUL I 0 2006

# Life-Shield Products, Inc. CAREO Safety Syringe for U-100 Insulin (per 21 CFR807.92)

#### 1. Sponsor

Life-Shield Products, Inc. 3FI., No. 10, Wuchiuan 7th Rd., Wugu Industrial Park, Taipei 248 Taiwan, R.O.C. Contact Person: Mr. Hsiao, Chung-Chih Telephone: [phone] Fax: [phone] Date Prepared: April 15, 2006

#### 2. Device Name

| Proprietary Name: | CAREO Safety Syringe for U-100 Insulin |
|----------------------|----------------------------------------|
| Common/Usual Name: | Syringe |
| Classification Code: | MEG |
| Classification Name: | Syringe, Antistick |

#### 3. Predicate Device

- . 1cc Insulin SafePro* Safety Syringe (K050134)
- CAREO Safety Syringe 1cc/mL (K060208)

## Device Description 4.

The Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin is a sterile, single use and disposable, 1cc/mL piston syringe, provided with a permanently attached needle in nine product configurations. The CAREO Safety Syringe for U-100 Insulin 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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#### ട. Intended Use

The CAREO Safety Syringe for U-100 Insulin is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient.

The CAREO Safety Syringe for U-100 Insulin 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 equivalence of the CAREO Safety Syringe for U-100 Insulin to the 1cc Insulin SafePro* Safety Syringe (K050134) and CAREO Safety Syringe 1cc/mL (K060208) based on similarities in intended use, design, technological and operational characteristics. All are indicated for injecting fluids (insulin) 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. Summary for testing of material and simulated use study

The materials of construction, safety feature, and other functional and performance characteristics of CAREO Safety Syringe for U-100 Insulin are identical to those for the other CAREO Safety Syringes. The material safety test, biocompatibility, and safety feature were already indicated, verified, and validated as shown in the previous 510(k) premarket notifications [K030976, K052397, and K060208]. Therefore, no new tests are necessary.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2006

Mr. Chung-Chih Hsiao Senior Regulatory Affairs Consultant Life-Shield Products, Incorporated 3F1, No. 10, Wuchiuan 7th Road Wugu Industrial Park Taipei 248 TAIWAN R.O.C.

Re: K061055

Trade/Device Name: Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: April 15, 2006 Received: April 17, 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 vour 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. 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.

Sincercly yours,

Suite y Michael Oms

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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Kadosss
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510(k) Number (if known):

Device Name : Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin

Indications for Use:

The CAREO Safety Syringe for U-100 Insulin is a sterile, single-use, disposable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient.

The CAREO Safety Syringe for U-100 Insulin is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.

Prescription Use _ (21 CFR 801 Subpart D) OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

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Life-Shield Products, Inc., Abbreviated 510(k) CAREO Safety Syringe for U-100 Insulin

April 15, 2006

CONFIDENTIAL