(142 days)
Not Found
No
The summary describes a standard electromechanical infusion pump and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is an infusion pump for delivering medicinal products, which is a therapeutic function.
No
The device is described as an "electromechanical infusion pump" used for "intravenous and non-intravenous infusion of medicinal products." Its function is to deliver medication, not to diagnose a condition.
No
The device description explicitly states it is an "electromechanical infusion pump" and lists essential hardware components, indicating it is a physical device with software control, not a software-only device.
Based on the provided information, the WillCare GX-1020 external pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "intravenous and non-intravenous infusion of medicinal products." This describes a device used to deliver substances into the body, not to test samples outside the body.
- Device Description: The description focuses on the electromechanical nature of the pump and its function in delivering fluid. This aligns with a medical device for infusion, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The WillCare GX-1020's function is purely for delivering substances to a patient.
N/A
Intended Use / Indications for Use
The WillCare GX-1020 external pump is indicated for intravenous infusion of medicinal products at set and variable rates.
Product codes
FRN
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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,
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 | |
| 6 weeks minimum at 0.002 ml/hr | 2 days minimum at 0.720 ml/hr | |
| 6 weeks minimum at 0.002 ml/hr | ||
| Rate mode | Maximum – 0.800 ml/hr | |
| Minimum – 0.020 ml/hr | ||
| Increment – 0.002 ml/hr | ||
| Default – 0.050 ml/hr | Maximum – 0.720 ml/hr | |
| Minimum – 0.000 ml/hr | ||
| Increment – 0.002 ml/hr |
Technological Characteristics to the Predicate Device:
Confidential ICU Medical, Inc.
1
510(k) Submission: ICU WillCare Infusion Pump
K452594 (82002)
| Item | WillCare GX-1020 | MiniMed 404-SP |
|---|---|---|
| Interval mode | Maximum - 0.998 ml/dose | |
| Minimum - 0.100 ml/dose | ||
| Increment - 0.002 ml/dose | ||
| Default - 0.250 ml/dose | Maximum - 0.998 ml/dose | |
| Minimum - 0.000 - 0.250 ml/dose | ||
| 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 | |
| Minimum - 0.100 ml/dose | ||
| Increment - 0.002 ml/dose | ||
| Default - 0.250 ml/dose | Maximum - 0.998 ml/dose | |
| Minimum - 0.002 ml/dose | ||
| Syringe | ||
| capacity | 3.0 ml | 3.0 ml |
| Power source | 3.6V DC (1/2 AA) | 3 standard 1.5 V silver oxide |
| watch batteries | ||
| Alarms | Low battery | |
| Low volume | ||
| Safety alarm | ||
| High pressure | Low battery | |
| Safety/program alarm | ||
| Empty syringe | ||
| Occlusion | ||
| Maximum total exceeded | ||
| Physical | ||
| Characteristics | DC Motor | |
| Reduction Gear Drive | DC Motor | |
| 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and a curved line representing its body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
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)
Page 1 of 1
tm vma
Division of Epidemiology, General Hospital,
Infection Control Services