The Disetronic Multifuse Infusion Pump, with its accessories, is indicated for the controlled delivery of parenteral fluids, including patient controlled analgesia (PCA), in both the hospital and home care environments.

Device Description

The Disetronic Multifuse pump is a small, battery-operated peristaltic infusion pump that is suited for ambulatory hospital and home use. The pump is extremely versatile. It has been designed to allow the health provider program the pump to provide one of several types of infusion therapies. The pump can be configured as a continuous rate infusion pump with demand bolus capability, a variable rate infusion pump with demand bolus capability, a Patient Controlled Analgesia (PCA) pump, a Total Parenteral Nutrition (TPN) pump or an intermittent infusion pump. The health provider can further customize the pump for a specific patient by allowing or excluding optional programming steps, limiting allowable ranges, adjusting the rate at which boluses are infused and adjusting alarm and display features.

AI/ML Overview

The provided text describes a submission for a Disetronic Multifuse Infusion Pump System (K980259) seeking substantial equivalence to a previously marketed device (K915566). This is a traditional 510(k) summary for a medical device and does not involve clinical studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies in the way that AI/ML devices typically do.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not applicable to this type of regulatory submission.

Here's an assessment based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device (K915566)	Device determined substantially equivalent based on functional comparison, design equivalency, and functional and safety testing.
Compliance with IEC 601-2-24 and associated standards	Device designed and tested in accordance with IEC 601-2-24 and associated standards.
Software development procedures and Good Quality Assurance procedures followed	Adhered to all software development procedures and Good Quality Assurance procedures. All test results demonstrate system specifications and functional requirements were met.
Year-2000 date change unaffected	Certified that the Multifuse Pump system will be unaffected by potential date recording and computational problems associated with the year-2000 date change.

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission is for a physical medical device (infusion pump), not a data-driven AI/ML device that uses test sets of data. The "testing" refers to functional and safety testing of the hardware and software, not evaluation on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth, in the context of AI/ML, refers to definitively labeled data. For an infusion pump, the "ground truth" relates to physical performance metrics (e.g., accuracy of fluid delivery, alarm functionality), not interpretations of data by experts. Testing was likely performed by engineers against predefined specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data (e.g., medical images). This process is not part of the functional and safety testing of an infusion pump.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. MRMC studies are specifically for evaluating the impact of AI on human reader performance, typically in diagnostic tasks. This device is an infusion pump, which does not involve human readers interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. While the pump has software that operates "standalone" in its primary function, this question is typically posed for AI algorithms and their diagnostic accuracy independent of human input. The pump's performance is inherently "standalone" in delivering fluids according to its programming.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable in the traditional sense of AI/ML ground truth. The "ground truth" for this device's testing would be regulatory standards (e.g., IEC 601-2-24), engineering specifications, and validated performance metrics (e.g., flow rate accuracy, pressure limits, alarm thresholds). These are established through engineering design, regulatory requirements, and industry standards, not by expert consensus on data interpretation.

8. The sample size for the training set:

Not Applicable. This is a hardware/software device, not an AI/ML model that undergoes "training" on a dataset. Software development and testing follow different paradigms.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set in the AI/ML sense, there is no ground truth established for it. Software verification and validation are performed against requirements and specifications.

Summary

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2/12/99
2.0 SUMMARY OF SAFETY AND EFF

K980259

9 O SUMMARY OF SAFETY AND EFFECTIVENESS

"510(k) SUMMARY"

9.1 Trade/Proprietary Name:	Disetronic Multifuse Infusion Pump System
9.2 Common/Usual Name:	Peristaltic Infusion Pump and Accessories
9.3 Classification Name:	Infusion Pump/Intravascular Administration Se

9.4 Comparison to Currently Marketed Devices

The Disetronic Multifuse Infusion Pump is substantially equivalent to the currently marketed Disetronic Multifuse Infusion Pump (K915566).

9.5 Device Description

9.6 Indications for Use

The modified Disetronic Multifuse Pump with its accessories has the same indications and intended use as the currently marketed device.

9.7 Testing

The Disetronic Multifuse Infusion Pump has been designed and tested in accordance with IEC 601-2-24 and associated standards.

9.8 Software

Disetronic has adhered to all software development procedures and Good Quality Assurance procedures. All test results demonstrate that the system specifications and functional requirements were met. Disetronic Medical Systems Certifies that it has verified that the Multifuse Pump system will be unaffected by the potential date recording and computational problems associated with the year-2000 date change.

9.9 Conclusion

Based on the functional comparison, design equivalency and the functional and safety testing, Disetronic has determined that the Multifuse Infusion Pump and accessories are substantially equivalent to currently market device in the United States.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Disetronic Medical Systems C/O Mr. Lee Leichter Official Correspondent P/L Biomedical 7690 Cameron Circle Fort Myers, Florida 33912

Re : K990259 Disetronic Multifuse Infusion Pump System Trade Name: Regulatory Class: II Product Code: FRN Dated: January 27, 1999 Received: January 27, 1999

Dear Mr. Leichter

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. ਬੇ 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Leichter

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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

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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INDICATIONS FOR USE STATEMENT

510(k) File Number:

Multifuse Infusion Pump Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.19)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Patricio Caceresle
(Division Sign-Off)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

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).