The Disetronic Multifuse Pump with its accessories is intended 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. These control functions can only be performed by using the Multifuse Computer Software. This proprietary control software runs on IBM compatible personal computers in the Windows® environment and communicates with the pump through an optical interface. The pump can be re-programmed as required for different patients. This versatility enables the health care provider minimize the different types of pumps and still provide for almost all infusion therapies.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Disetronic Multifuse Pump System.

The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to currently marketed devices rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed study results as one might expect for a novel AI device. Therefore, much of the requested information, particularly around AI-specific testing, ground truth, and expert involvement, is not applicable or not present in this document.

Summary of Device Acceptance Criteria and Performance (Based on provided text):

The document doesn't explicitly list "acceptance criteria" in the format typically seen for AI device performance. Instead, it refers to regulatory and engineering standards. The reported device performance is primarily described through its functional equivalence to predicate devices and adherence to relevant standards.

Acceptance Criterion (Inferred/Standard)	Reported Device Performance
Functional Equivalence	Functionally equivalent to Disetronic Panomat and Dolomat Infusion Pumps, and SIMS Deltec CADD-PLUS, CADD-PCA and CADD-TPN.
Safety - IEC 601-2-24	Designed and tested in accordance with IEC 601-2-24 (Particular requirements for safety of infusion pumps and controllers).
General Safety - IEC 601-1	Incorporates requirements of IEC 601-1, including IEC 801-2 and 801-3 for EMI and ESD.
Software Performance	All test results demonstrate that the system specifications and functional requirements were met.
Biocompatibility	Drug contact materials are either used in legally marketed devices for similar uses or comply with ISO 10993-1: 1992 (E) for externally communicating devices, blood path - indirect, prolonged use (< 24 hours to 30 days).

Detailed Information as Requested (with explanations for missing data):

A table of acceptance criteria and the reported device performance:
(Refer to the table above).
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not specified. The document describes compliance with standards and functional testing, but does not provide details on the number of devices or test conditions used for "testing." This is typical for a 510(k) where the focus is on engineering and safety validation, not large-scale clinical trials with "test sets" in the AI sense.
- Data Provenance: Not applicable. The testing appears to be primarily engineering verification and validation, not data-driven performance evaluation from patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not specified. The concept of "ground truth" established by human experts is not relevant to this type of device submission. The "ground truth" for a medical device like an infusion pump is its adherence to its specifications, safety standards, and functional requirements, which are typically verified through engineering tests, not expert consensus on diagnoses or interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None / Not applicable. Adjudication methods are typically used in clinical studies where human interpretation of medical data is involved. This device's testing relates to its physical and software functionality.
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:
- No. This is not an AI-assisted diagnostic or interpretive device. It is an infusion pump. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied, but not detailed as "algorithm only" in the AI sense. The pump operates autonomously based on its programming. The software was tested independently to ensure it met specifications and functional requirements ("All test results demonstrate that the system specifications and functional requirements were met."). This isn't a "standalone AI algorithm" test, but rather a standard V&V for embedded software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Regulatory Standards. For this type of device, the "ground truth" against which performance is measured consists of:
  - The device's own design specifications (e.g., flow rate accuracy, alarm thresholds, battery life).
  - Industry and international safety standards (e.g., IEC 601-2-24, IEC 601-1, ISO 10993-1).
  - Functional equivalence to predicate devices.
- There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of approving the pump's core functionality.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that requires a "training set" of data.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.

Conclusion regarding the Disetronic Multifuse Pump 510(k) Summary:

This 510(k) submission for the Disetronic Multifuse Pump System focuses on demonstrating substantial equivalence to existing legally marketed infusion pumps. The "acceptance criteria" are primarily implicit in the adherence to established international safety and performance standards (IEC 601-2-24, IEC 601-1) and the device's functional similarity to predicate devices. The "study" mentioned is the verification and validation (V&V) testing against these standards and specifications, which is typical for a medical device of this nature but does not involve AI-specific concepts like training sets, test sets derived from patient data, expert ground truthing, or MRMC studies. The document confirms that "All test results demonstrate that the system specifications and functional requirements were met," indicating successful completion of the V&V activities.

Summary

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MAY 2 4 1996

K 9548836

9.0 SUMMARY OF SAFETY AND EFFECTIVENESS

"510(k) SUMMARY"
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9.1 Trade/Proprietary Name:	Disetronic Multifuse™ Pump System
9.2 Common/Usual Name:	Peristaltic Infusion Pump and Accessories
9.3 Classification Name:	Infusion Pump/Intravascular Administration Set

9.4 Comparison to Currently Marketed Devices

The Disetronic Multifuse Infusion Pump is functionally equivalent to the Disetronic Panomat and Dolomat Infusion Pumps and the SIMS Deltec CADD-PLUS, CADD-PCA and CADD-TPN.

9.5 Device Description

9.5.1 Discussion

9.5.2 Physical Description

The base housing holds the pumping mechanism, electronics, and batteries. This housing is sealed against water to help prevent internal damage. The front panel on this housing has a dotmatrix LCD display, four input buttons, and two LED status indicator lights. Specific infusion parameters can be programmed using the input buttons on the front panel. There is also an optical interface on the panel for two way communication with a computer or modem.

The Multifuse pump uses four AA-size main batteries. It also accepts rechargeable batteries or can be powered with an available AC adapter. The pump has a separate back-up battery to maintain the pump's memory while the main batteries are being changed or if they become depleted.

The pump infuses fluid by means of a sterile disposable tubing cassette that snaps into the pump. . The cassette has a short section of pumping fube which is squeezed by the pump mechanism

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to cause the pumping action. The cassettes are available with several different diameters of pumping tubing which offer different flow rate ranges. The cassette has an optical code corresponding to the tube's diameter which is read by the pump's electronics to safely and automatically adjust the flow rate range. The cassette has an air detection chamber, a pressure detection chamber, and an antifreeflow valve. The air and pressure detection chambers work together with detectors in the pump housing. The cassettes are available in a number of different configurations including different lengths, connectors, filters, injection ports, etc.

A cover for the cassette snaps in place to protect the cassette and sensors during use. This cover also provides a back-up plate against which the pumping mechanism squeezes the flexible tubing.

The tubing cassette connects to a bag-type reservoir which holds the liquid medication. This reservoir may be any suitable standard W bag or Disetronic Multifuse Reservoirs. The Multifuse reservoirs are made to fit into one of the pump's reservoir holders. These holders slide into a dovetail on the housing and can be changed to the appropriate size. The reservoir holders help protect the reservoir, improve the portability, and may also be locked for security.

Other accessories available for use with the Multifuse include an AC adapter, a belt carrying clip, various carrying pouches, a remote bolus buttori, and a modem.

9.5.3 Pumping Method and Flow Characteristics

The basic pumping method used in the Disetronic Multifuse Pump is an elastic tube acted upon by three squeezing fingers. The first and third of these fingers, together with the tube, act as valves. The middle finger, together with the tube, is a volume displacement chamber. The tube is positioned between the fingers and a platen. This platen acts as a back-up plate against which the tubing is squeezed. The fingers are moved by a camshaft and motor in a specific sequence so that the tube passively fills from the upstream side and is actively emptied into the downstream side. This is done repetitively to effect an accurate, relatively ccnstant flow.

The Disetronic Multifuse Pump delivers a small, accurate volume each cycle of the pumping mechanism. Different flow rate ranges are obtained with different diameters of elastic tubing. The low range cassette dispenses 100 µ-liters and the high range cassette 250 µ-liters per cycle, respectively.

Each complete output cycle is further resolved into approximately 25% segments by the position sensing electronics. By doing so, the size of, and thus time between, incremental infusion volumes is one-fourth as small as with complete cycles. Thus, the actual incremental volumes are 25 u-liters and 62.5 u-liters for the low and high range cassettes, respectively. This is particularly valuable at low flow rates and helps to improve the continuity of flow. Although the 25% segments are approximated, the overall flow accuracy is not affected due to the accuracy of each complete cycle.

For low flow rates, the pump delivers the one-fourth cycle volume each incremental output and calculates the time, in multiples of one minute, necessary to achieve the correct flow rate. For higher flow rates, the pump delivers an incremental volume every one minute. The volume of these increments is calculated to achieve the correct flow rate.

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Bolus volumes are calculated and delivered directly based on the necessary number of cycles or parts of cycles. Therefore, the bolus volume accuracy is independent of its flow rate.

9.5.4 Flow profiles

The Disetronic Multifuse Pump has five different basic modes of infusion profiles, or types that can be selected. These are called the C-type (Continuous), V-type (Variable), PCA-type (Patient Controlled Analgesia), INT-type (Intermittent), and TPN-type (Total Parenteral Nutrition), Each of these profiles can modified by adding or eliminating certain characteristics to meet the specific needs of the patient. The basic parameters of these types are:

Continuous Infusion	constant rate output
Infusion Rate	rate at which drug is infused
Infusion Volume	volume to be infused
Infusion Time	time duration of therapy
KVO Rate	rate of infusion to maintain an open vein between infusions or
	boluses
Start Delay	time delay before therapy begins
Cycle Time	time for each therapy for repetitive therapies
Demand Bolus	amount of a patient demand bolus
Physician Bolus	amount of a bolus programmed by the physician to be
	automatically delivered

9.6 Indications for Use

9.7 Testing
The Disetronic Multifuse Infusion Pump has been designed and tested in accordance with IEC 601-2-24 of the:

INTERNATIONAL ELECTROTECHNICAL COMMISSION TECHNICAL COMMITTEE No. 62: ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE SUB-COMMITTEE 62D: ELECTROMEDICAL EQUIPMENT Draft Date: August 29, 1994 Part 2: Particular requirements for safety of infusion pumps and controllers.

IEC 601-2-24 incorporates the requirements of IEC 601-1 for all general safety requirements including IEC 801-2 and 801-3 for Electromagnetic Interference (EMI)) and Electrostatic Discharge (ESD).

The electronic and mechanical design is not unique and therefore the specifications fully address pump performance.

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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.

9.9 Biocompatibilty

The drug contact materials are either used in devices legally marketed in the USA for similar intended uses or comply with ISO 10993-1: 1992 (E) - Externally communicating device, Blood path -Indirect, Prolonged use (< 24 hours to 30 days)

9.10 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 devices currently marketed in the United States.

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).