WILLCARE, MODEL GW-1020

K052594 · Icu Medical, Inc. · FRN · Feb 10, 2006 · General Hospital

Device Facts

• Record ID: K052594
• Device Name: WILLCARE, MODEL GW-1020
• Applicant: Icu Medical, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Feb 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The WillCare GX-1020 external pump is indicated for intravenous and non-intravenous infusion of medicinal products at set and variable rates.

Device Story

WillCare GX-1020 is an electromechanical infusion pump for delivery of small volumes of medication. Device utilizes a DC motor and reduction gear drive to deliver fluid via a 3.0 ml syringe. Supports continuous, intermittent, and demand dose delivery modes. Operated by healthcare providers to administer medicinal products at set or variable rates. Output is fluid delivery with 0.002 ml resolution. Device features include lock mode and alarms for low battery, low volume, safety, and high pressure. Powered by 3.6V DC battery. Intended to provide accurate, controlled medication delivery to patients.

Clinical Evidence

Bench testing only. Safety compliance testing (SCR043S-004) conducted to demonstrate reliability and conformance to IEC 60601-2-24. Results confirmed device performance and accuracy are equivalent to the predicate device.

Technological Characteristics

Electromechanical infusion pump; DC motor with reduction gear drive; 3.0 ml syringe capacity; 3.6V DC (1/2 AA) power source; dimensions 3.4 x 1.7 x 0.7 inches; conforms to IEC 60601-2-24.

Indications for Use

Indicated for patients requiring intravenous or non-intravenous infusion of medicinal products at set or variable rates.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Minimed Model 404-SP (K922670)

Submission Summary (Full Text)

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510(k) Submission: ICU WillCare Infusion Pump

KøS2594(P.1002)

# 510(k) Summary

FEB 1 0 2006

Name of Device: Trade name: WillCare GW-1020 Common name: Infusion pump Device Class: II Product Code: FRN Regulation number: 21 CFR 880.5725

Name of Predicate Device:

Minimed Model 404-SP Trade name: 510(k) number: K922670 Common name: Infusion pump Device Class: II Product Code: FRN Regulation number: 21 CFR 880.5725

## Submitted by:

ICU Medical, 951 Calle Amanecer, San Clemente, CA 92673

## Description:

The WillCare GW-1020 is an electromechanical infusion pump designed for use with therapies requiring accurate delivery of small volumes of medication. The pump delivers fluid with a resolution of 0.002 milliliters and allows for continuous delivery, for intermittent delivery, or for a combination of both. Components of the pump that are essential for effective operation are listed in the operators manual (Components - Basic Kit), and must ONLY be supplied by ICU to ensure proper and safe operation.

#### Indication for use:

The WillCare GX-1020 external pump is indicated for intravenous infusion of medicinal products at set and variable rates.

| Item | WillCare GX-1020 | MiniMed 404-SP |
|--------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Size | 3.4 x 1.7 x .7 inches | 2.0 x 3.4 x 0.8 inches |
| Battery life | 4 days minimum at 0.800 ml/hr<br>6 weeks minimum at 0.002 ml/hr | 2 days minimum at 0.720 ml/hr<br>6 weeks minimum at 0.002 ml/hr |
| Rate mode | Maximum – 0.800 ml/hr<br>Minimum – 0.020 ml/hr<br>Increment – 0.002 ml/hr<br>Default – 0.050 ml/hr | Maximum – 0.720 ml/hr<br>Minimum – 0.000 ml/hr<br>Increment – 0.002 ml/hr |

## Technological Characteristics to the Predicate Device:

Confidential ICU Medical, Inc.

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510(k) Submission: ICU WillCare Infusion Pump

K452594 (82002)

| Item | WillCare GX-1020 | MiniMed 404-SP |
|-----------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Interval mode | Maximum - 0.998 ml/dose<br>Minimum - 0.100 ml/dose<br>Increment - 0.002 ml/dose<br>Default - 0.250 ml/dose | Maximum - 0.998 ml/dose<br>Minimum - 0.000 - 0.250 ml/dose<br>Intervals - 5, 10, 15, 20, 30, 45, 60, and 90 minutes and 2, 3, 4, 6, 8, and 12 hours |
| Demand dose | Maximum - 0.998 ml/dose<br>Minimum - 0.100 ml/dose<br>Increment - 0.002 ml/dose<br>Default - 0.250 ml/dose | Maximum - 0.998 ml/dose<br>Minimum - 0.002 ml/dose |
| Syringe<br>capacity | 3.0 ml | 3.0 ml |
| Power source | 3.6V DC (1/2 AA) | 3 standard 1.5 V silver oxide<br>watch batteries |
| Alarms | Low battery<br>Low volume<br>Safety alarm<br>High pressure | Low battery<br>Safety/program alarm<br>Empty syringe<br>Occlusion<br>Maximum total exceeded |
| Physical<br>Characteristics | DC Motor<br>Reduction Gear Drive | DC Motor<br>Reduction Gear Drive |
| Other features | Lock mode | Three lock levels |

# Performance Testing:

Safety compliance testing (SCR043S-004) has been conducted to demonstrate device reliability and conformance to IEC 60 601-2-24. The results are in conformity to the technical specifications and all referenced standards. Detailed testing information is included in attachments H, I and J of this submission,

# Conclusions:

Results of testing and comparisons to the predicate device show that the WillCare GX-1020 is substantially equivalent to the MiniMed 404-SP predicate device. The minimum demand dose of the WillCare GX-1020 is 0.100 ml/dose and that of the predicate device is 0.002 ml/dose, these differences do not impact the performance, safety or accuracy of either device, rather they are intended to be used as information to the prescribing doctor when issuing medication to a patient. Furthermore, it is concluded that the performance and accuracy of the device is as safe and effective as that of the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2006

ICU Medical. Incorporated C/O Mr. Morten Simon Christensen Responsible Third Party Official Underwriters Laboratories, Incorporated 1655 Scott Boulevard Santa Clara, California 95050

Re: K052594

Trade/Device Name: WillCare ()X-1020 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 26. 2006 Received: January 27, 2006

Dear Mr. Christensen:

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 cnactment 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. Christensen

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,

Simar Cumas

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: K (52594

Device Name: WillCare GX-1020

### Indications for Use:

The WillCare GX-1020 external pump is indicated for intravenous and non-intravenous infusion of medicinal products at set and variable rates.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (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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tm vma

Division of Epidemiology, General Hospital,
Infection Control Services

K452594