The Infutest 2000 Infusion Device Analyzer (Infutest) is intended to verify the correct operation of infusion pumps. Infutest is designed to be used by biomedical electronics technicians, third party service personnel, and others who may be charged with the responsibility of determining the functionality of an infusion pump.

Device Description

The Infutest 2000 Infusion Pump Analyzer is an instrument for measuring the volume of fluid delivered by an infusion pump. The instrument is based on an optically instrumented burette. Flow rates from 0.1 to 999.9 millilitres per hour can be derived from the incremental volume measurements in relation to the time of delivery. Infutest 2000 is a two channel system, which can be expanded to four channels by the addition of an accessory two channel sensor assembly called the Remote Sensor Module.

The Infutest 2000 is designed to accurately measure volumes and rates on a wide variety of infusion pump types, including syringe, linear and rotary peristaltic, cassette based, enteral and patient controlled analgesia.

In addition to volume and flow rate, Infutest can measure the pressure developed by an infusion pump that is pumping into an occluded line. This feature is designed to measure the occlusion pressure alarm limits of the infusion pump.

Results of all tests performed can be printed to paper and/or sent to an external device using the serial communications port.

AI/ML Overview

Here's an analysis of the provided text regarding the Infutest 2000 Infusion Pump Analyzer, outlining its acceptance criteria and the study information.

It's important to note that the provided document is a 510(k) summary from 1998 for an infusion pump analyzer, not a medical device designed for direct patient care with AI components. As such, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (like those involving expert labels, MRMC studies, or training/test sets for AI models) will not be present or directly applicable. This device is a measurement tool, and its "performance" is about accuracy and precision in measuring infusion pumps.

Acceptance Criteria and Device Performance for Infutest 2000 Infusion Pump Analyzer

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of "acceptance criteria" with specific numerical targets for accuracy, precision, or other performance metrics. Instead, it describes the device's capabilities and implies that performance is achieved if these capabilities are met and the device is substantially equivalent to predicates. The "Verification and Validation" section confirms that the device was tested to work "per the input design and marketing specifications."

Based on the description of capabilities, here's a reconstructed table reflecting what the device claims to measure and how well it measures based on the context of its intended use as an analyzer, rather than specific acceptance criteria thresholds. The performance is implied by its design for accurate measurement of these parameters.

Feature/Acceptance Criterion (Implied)	Reported Device Performance (as described)
Flow Rate Measurement Range	0.1 to 999.9 milliliters per hour
Volume Measurement Increment	As low as 15 microliters
Occlusion Pressure Range	0-50 psi (measured by internal transducers)
Channel Capacity	Two independently operating channels (expandable to four with Remote Sensor Module)
Test Types	Single Rate, Dual Rate, PCA, Occlusion Pressure
Data Output	Print to paper (Centronics parallel), serial communications port to external device
Alarm Monitoring	Checks nurse call alarm output during occlusion tests
PCA Triggering	Activates trigger input of PCA pump during PCA test
Programmability	Up to 9 user-defined test protocols (timed rate, timed occlusion, formatted output)

Notes on Acceptance Criteria: The document emphasizes "accurate measurement" in its description of the technological characteristics but does not quantify "accuracy" or "precision" with specific tolerances (e.g., ±X% of reading). The primary "acceptance" for this 510(k) is substantial equivalence to predicate devices (Bio-Tek IDA-2 Plus, DNI Nevada 404A). This implies that if the Infutest 2000 performs comparably to these legally marketed devices, it meets the regulatory acceptance.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "extensively tested, verified and validated" but does not provide details on the number of devices or types of infusion pumps used in the testing.
Data Provenance: Not specified. It's internal validation by the manufacturer (Datrend Systems, Inc.). Given the nature of a 510(k) for a test device, this would likely involve new data generated by the manufacturer to demonstrate performance of their device against known reference standards or predicate devices. There's no mention of external data or specific countries of origin beyond the manufacturer's location in Burnaby, BC, Canada. The testing would be prospective in the sense that it was performed specifically for this submission.

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

This information is not applicable and not provided for this type of device. The Infutest 2000 is an analyzer that measures physical parameters (volume, flow rate, pressure) of infusion pumps. Ground truth for its measurements would be established through calibrated reference standards for flow, volume, and pressure, not expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1 consensus) are typically used for establishing ground truth in subjective assessments, such as medical image interpretation by human experts. For a device measuring physical quantities, comparison would be against known, calibrated standards.

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

This information is not applicable and not provided. MRMC studies are used to assess the impact of AI on human reader performance, typically in diagnostic tasks. The Infutest 2000 is a standalone measurement device with no human-in-the-loop AI assistance component in its intended function.

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

Yes, in a sense. The "Verification and Validation" section describes testing of the "Infutest 2000, the remote sensor module, the serial data transfer program and the graphics display program." This implies standalone testing of the device's functionality and its associated software components to ensure they meet design specifications. However, it's not "algorithm only" in the context of an AI/ML algorithm, but rather the integrated system's performance.

7. The Type of Ground Truth Used

The ground truth used for validating this device would be calibrated reference standards. This would involve:

Known Volume Standards: Highly accurate measures of fluid volume (e.g., precise pipettes, gravimetric methods, or certified volumetric containers) to verify the Infutest's volume measurement accuracy.
Known Flow Rate Standards: Systems capable of delivering fluid at precisely controlled and measured flow rates to verify the Infutest's flow rate accuracy.
Calibrated Pressure Transducers/Gauges: To verify the accuracy of the Infutest's internal pressure transducers against known pressure inputs.

The document does not explicitly state how these ground truths were implemented, but this is the standard practice for calibrating and validating such an analyzer.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Infutest 2000 is not described as utilizing AI/ML algorithms that would require a "training set" in the conventional sense. Its operation is based on optical measurement and embedded logic, not learned patterns from data.

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

This information is not applicable for the same reasons as point 8. There is no mention of a training set for an AI/ML model for this device.

Summary

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K 980165

APR 2 0 1998

Appendix F

510(k) Summary of Safety and Effectiveness

Date:	January 5, 1998
Submitter:	Datrend Systems, Inc.Unit #106 - 3070 Norland Ave.Burnaby, BC V5B 3A6Tel # (604) 291-7747Fax # (604) 294-2355
Contact Person:	Ron Evans,VP Research and Development,Quality Assurance Manager
Classification Name:	Infusion Pump, accessory to (per 21 CFR section 880.5725)
Common Name:	Infusion Pump Tester/Analyzer
Trade Name:	Infutest 2000

Equivalency:

The Datrend Systems Infutest 2000 Infusion Pump Analyzer is substantially equivalent to the Bio-Tek IDA-2 Plus Infusion Device Analyzer (K961862) and the DNI Nevada 404A Infusion Pump Analyzer (K897096).

Description:

The Infutest 2000 is designed to accurately measure volumes and rates on a wide variety of infusion pump types, including syringe, linear and rotary peristaltic, cassette based, enteral and

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patient controlled analgesia.

Results of all tests performed can be printed to paper and/or sent to an external device using the serial communications port.

Intended Use:

The Infutest 2000 is intended to verify the correct operation of infusion pumps. Infutest 2000 is intended to be used by biomedical electronics technicians, manufacturers, third party service personnel, and others who may be charged with the responsibility of verifying the performance of infusion devices that operate in the flow rate range stated above.

Technological Characteristics:

The Infutest 2000 measurement system is based on an optically instrumented burette, placed horizontally in the instrument. The fluid flow is calculated by measuring the time required by the pump under test to deliver small increments of fluid volume, as low as 15 microlitres. The individual volume increments vary in size, depending on the fluid flow rate. The increments of volume are detected optically, by monitoring the position of a meniscus in the burette. The meniscus is created by injection of a bubble of air into the burette. This system allows continuous, uninterrupted fluid flow during a test. Flow rates in the range of 0.1 to 999.9 millilitres per hour can be measured accurately with this system.

Internal pressure transducers with a range of 0-50 psi measure the pressure developed by an infusion pump, which is pumping into an occluded line. A valve in the Infutest that is normally open during flow tests can be closed during pressure tests to create an occlusion.

The main unit of the Infutest 2000 system is capable of measuring flow rate, volume and pressures on two independently operating channels at the same time. The system can be expanded to four channels by the addition of a two channel remote sensor module. The main unit controls the remote sensor module, and results of tests are displayed on the main unit's LCD.

Operation of the instrument is controlled by four 'soft keys', which change function depending on the current display. The display is a 40 character by 8 line LCD, capable of graphical presentation. An external device, through the serial communications port, may also control the operation of the instrument by control codes that mimic the function of the direct kevboard input.

Infutest 2000 can perform any one of four basic tests on any of up to four test channels. The four

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basic tests are: a) Single Rate, b) Dual Rate, c) PCA and d) Occlusion Pressure. The results from a test can be printer to paper using the Centronics parallel printer output port, or sent to an external storage device, such as a personal computer, using the serial communications port. Up to 9 test protocols, combining a timed rate test, a timed occlusion test and a formatted output, can be defined and saved by the user to increase productivity.

Inputs are provided to connect to an infusion pump's nurse call alarm output, and the operation of the alarm is checked as part of the occlusion pressure test.

Outputs are provided to activate the trigger input of a patient controlled analgesia pump during a PCA test.

Verification and Validation:

The Infutest 2000, the remote sensor module, the serial data transfer program and the graphics display program were extensively tested, verified and validated to be working per the input design and marketing specifications. The results of the testing indicates that the Infutest 2000 Infusion Pump Analyzer is substantially equivalent to the Bio-Tek IDA-2 Plus Infusion Device Analyzer (K961862) and the DNI Nevada 404A Infusion Pump Analyzer (K897096), and is safe and effective for its intended use.

The above information is submitted in accordance with the requirements of 21 CFR 807.92.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which consists of a stylized human figure with three heads, representing the department's focus on health, human services, and well-being. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 20 1998

Mr. Ron Evans ·President Datrend Systems Incorporated Unit 106 - 3070 Norland Avenue Burnaby, B.C. V5B 3A6

Re : K980165 Trade Name: Infutest 2000 Infusion Device Analyzer Regulatory Class: II Product Code: MRZ Dated: April 8, 1998 Received: April 10, 1998

Dear Mr. Evans:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Evans

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at " its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page __ 1__ of _______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):__K980165

Device Name: Infutest 2000, Infusion Device Analyzer

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuceniti
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K980165

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)

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).