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.

AI/ML Overview

The ICU WillCare Infusion Pump (GW-1020) is an electromechanical infusion pump designed for accurate delivery of small volumes of medication. It can deliver fluid continuously, intermittently, or both, with a resolution of 0.002 milliliters. The device is indicated for intravenous infusion of medicinal products at set and variable rates.

Here's an analysis of its acceptance criteria and the study proving compliance:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the WillCare GX-1020 are primarily established by demonstrating substantial equivalence to its predicate device, the MiniMed 404-SP Infusion pump, and conformity to safety standards. The document outlines a comparison of technical characteristics to the predicate device, which implies these are the de facto acceptance criteria for performance aspects.

Item	Acceptance Criteria (Implied by Predicate Device Performance)	WillCare GX-1020 Performance (Reported)
Physical Dimensions	Similar to MiniMed 404-SP: 2.0 x 3.4 x 0.8 inches	3.4 x 1.7 x .7 inches (Comparable size)
Battery Life (0.800 ml/hr or 0.720 ml/hr)	At least 2 days at 0.720 ml/hr	4 days minimum at 0.800 ml/hr (Exceeds predicate)
Battery Life (0.002 ml/hr)	At least 6 weeks at 0.002 ml/hr	6 weeks minimum at 0.002 ml/hr (Matches predicate)
Rate Mode - Maximum	Similar to MiniMed 404-SP: 0.720 ml/hr	0.800 ml/hr (Slightly higher, but within acceptable range for similar function)
Rate Mode - Minimum	Similar to MiniMed 404-SP: 0.000 ml/hr	0.020 ml/hr (Slightly higher minimum, but deemed not to impact safety or performance for typical use)
Rate Mode - Increment	Similar to MiniMed 404-SP: 0.002 ml/hr	0.002 ml/hr (Matches predicate)
Interval Mode - Maximum (ml/dose)	Similar to MiniMed 404-SP: 0.998 ml/dose	0.998 ml/dose (Matches predicate)
Interval Mode - Minimum (ml/dose)	Similar to MiniMed 404-SP: 0.000 - 0.250 ml/dose	0.100 ml/dose (Within range for similar function)
Demand Dose - Maximum (ml/dose)	Similar to MiniMed 404-SP: 0.998 ml/dose	0.998 ml/dose (Matches predicate)
Demand Dose - Minimum (ml/dose)	Similar to MiniMed 404-SP: 0.002 ml/dose	0.100 ml/dose (Higher minimum, but deemed not to impact safety or performance)
Syringe Capacity	3.0 ml	3.0 ml (Matches predicate)
Power Source	3 standard 1.5 V silver oxide watch batteries	3.6V DC (1/2 AA) (Different, but functionally equivalent and deemed safe)
Alarms	Low battery; Safety/program alarm; Empty syringe; Occlusion; Maximum total exceeded	Low battery; Low volume; Safety alarm; High pressure (Comparable safety alarms)
Physical Characteristics	DC Motor; Reduction Gear Drive	DC Motor; Reduction Gear Drive (Matches predicate)
Other Features	Three lock levels	Lock mode (Comparable functionality)
Safety Compliance	Conformity to IEC 60601-2-24 (Safety standard for infusion pumps)	Demonstrated through "Safety compliance testing (SCR043S-004)" with results in conformity to technical specifications and referenced standards.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a numerical sample size for "test sets" in the conventional sense of clinical trials or algorithm validation (e.g., patient data). The testing described is "Safety compliance testing (SCR043S-004)," which typically involves a set of physical devices undergoing various performance and safety evaluations.

Sample Size: Not explicitly stated as a number of devices or data points for a "test set." It refers to the physical device undergoing testing.
Data Provenance: The testing was conducted by ICU Medical, the manufacturer, presumably in a controlled laboratory environment. The country of origin for the data is not specified, but the manufacturer is based in San Clemente, CA, USA. The testing is prospective in the sense of evaluating the newly manufactured device against established standards and the predicate device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since the testing is primarily hardware performance and safety compliance against engineering specifications and a predicate device, the concept of "experts establishing ground truth for a test set" in the context of diagnostic algorithms or clinical outcomes does not apply directly.

The "ground truth" for this medical device's performance is derived from:

Engineering specifications and design requirements.
The performance characteristics of the predicate device (MiniMed 404-SP).
International safety and performance standards (IEC 60601-2-24).

Therefore, there wouldn't be a panel of human "experts" like radiologists or pathologists to establish this type of ground truth. The "experts" involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists who ensured the device met these technical benchmarks and standards. Their qualifications would be in engineering, medical device manufacturing, and regulatory compliance.

4. Adjudication Method for the Test Set

Again, given the nature of the device and testing (performance and safety compliance against specifications), a clinical adjudication method like "2+1" or "3+1" is not applicable.

The "adjudication" for this type of testing is typically:

Comparison of measured device performance against pre-defined acceptance limits derived from specifications and predicate device data.
Verification against the requirements of the referenced safety standards (IEC 60601-2-24).
Review by regulatory bodies (FDA) to confirm substantial equivalence.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices to assess how human readers' performance (e.g., diagnostic accuracy) is impacted by AI assistance. The ICU WillCare Infusion Pump is a hardware device for drug delivery, not a diagnostic or AI-powered system that directly assists human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A (Not Applicable). As established, this is a hardware infusion pump, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant. The device's performance is inherently its "standalone" performance.

7. The Type of Ground Truth Used

The ground truth used for evaluating the WillCare GX-1020 is primarily based on:

Engineering Specifications: The design and performance parameters defined for the device itself.
Predicate Device Performance: The established, legally marketed performance characteristics of the MiniMed 404-SP.
International Safety and Performance Standards: Specifically, IEC 60601-2-24 for safety compliance.

The document directly states: "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." This confirms that compliance with established technical specifications and standards forms the core of the ground truth.

8. The Sample Size for the Training Set

No "training set" is applicable or mentioned. This device is an electromechanical infusion pump, not a machine learning model that requires a training set. Its functionality is based on programmed logic and physical mechanics, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. Since there is no training set, there is no ground truth established for a training set.

Summary

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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:

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/hr6 weeks minimum at 0.002 ml/hr	2 days minimum at 0.720 ml/hr6 weeks minimum at 0.002 ml/hr
Rate mode	Maximum – 0.800 ml/hrMinimum – 0.020 ml/hrIncrement – 0.002 ml/hrDefault – 0.050 ml/hr	Maximum – 0.720 ml/hrMinimum – 0.000 ml/hrIncrement – 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/doseMinimum - 0.100 ml/doseIncrement - 0.002 ml/doseDefault - 0.250 ml/dose	Maximum - 0.998 ml/doseMinimum - 0.000 - 0.250 ml/doseIntervals - 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/doseMinimum - 0.100 ml/doseIncrement - 0.002 ml/doseDefault - 0.250 ml/dose	Maximum - 0.998 ml/doseMinimum - 0.002 ml/dose
Syringecapacity	3.0 ml	3.0 ml
Power source	3.6V DC (1/2 AA)	3 standard 1.5 V silver oxidewatch batteries
Alarms	Low batteryLow volumeSafety alarmHigh pressure	Low batterySafety/program alarmEmpty syringeOcclusionMaximum total exceeded
PhysicalCharacteristics	DC MotorReduction Gear Drive	DC MotorReduction 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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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.

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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 (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

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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)

Page 1 of 1

tm vma

Division of Epidemiology, General Hospital,
Infection Control Services

K452594

Regulation Number and Section

§ 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).