. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products. lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
. By the following delivery routes: arterial, epidural, intrathecal, subcutaneous, and enteral.
. By the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
. In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
. Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

The PharmGuard® Toolbox 2 Medication Safety Software is indicated to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medfusion® Model 4000 Syringe Infusion Pump with software version 1.X. The PharmGuard® Toolbox 2 Medication Safety Software collects and downloads operational, infusion and alarm history events, library usage counts, and PharmGuard® safety events from the Medfusion® Model 4000 Syringe Infusion Pump. It is intended to provide a dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medfusion® Model 4000 Syringe Infusion Pump.

The PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software.

Device Description

The Medfusion® Model 4000 Syringe Infusion Pump software version 1.1 is a wireless capable electro-mechanical syringe infusion pump.

The PharmGuard® Toolbox 2 Medication Safety Software is designed to accommodate the features and capabilities of the 4000 pump with software version 1.X.

AI/ML Overview

The provided 510(k) summary for K111386 describes the Medfusion® Model 4000 Syringe Infusion Pump and its associated software and accessories. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain the kind of detailed acceptance criteria, study design, or performance metrics typically seen in studies for AI/CADe devices.

In the context of the provided document, the "acceptance criteria" are implied by the performance of the predicate devices and general safety/effectiveness standards for infusion pumps. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical bench tests that ensure the device functions as intended and safely.

Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted from this type of regulatory submission for a traditional medical device like an infusion pump.

Here's an attempt to answer the questions based only on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of the device and submission:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are broadly aligned with ensuring its safety, effectiveness, and functional performance, demonstrating substantial equivalence to its predicate devices. The "reported device performance" refers to the successful completion of various bench tests and validation studies.

Acceptance Criteria Category	Specific Criterion (Implied)	Reported Device Performance (Summary from Submission)
Functional Performance	Accurate and controlled infusion rates; correct operation of programming functions (e.g., continuous, volume/time, mass mode).	Accuracy Testing with All Supported Syringes conducted; Programming Functions (Continuous, Volume/Time, Dose/Time, Mass, Body Weight, Body Surface Area, Intermittent, Dose/Kg/Time, Bolus) confirmed to be present and functional (Table 2.1).
Safety - Mechanical/Electrical	Compliance with relevant electrical and mechanical safety standards.	Mechanical and Electrical Safety Testing in Accordance with EN IEC 60601-1 and EN IEC 60601-2-24 performed.
Safety - Environmental Durability	Resistance to impact, environmental conditions (altitude), moisture ingress, and chemical exposure.	Impact Testing, Environmental Testing, Accuracy Testing at Simulated Altitude, Moisture Ingress Testing, Chemical Compatibility Testing performed.
Safety - Electromagnetic	Compatibility with electromagnetic environments (EMC) and resistance to radio frequency interference (RFI).	EMC Testing in Accordance with EN IEC 60601-2 and Radio Frequency Interference Testing performed.
Safety - MRI Compatibility	Safe operation within specified MRI environments.	Magnetic Resonance Testing in Accordance with ASTM-F2052 performed. Device compatible up to ≤ 150 Gauss/1.5 Tesla.
Safety - Occlusion Detection	Timely and accurate detection of occlusions to prevent patient harm.	Fast Occlusion Detection present and functional. Force Occlusion Alarm present and functional. Pressure Increasing Alarm present and functional.
Safety - Alarms	Proper functioning of various safety alarms (e.g., KVO, Infusion Complete, Empty, Syringe Not in Place, Low Battery).	All listed alarms (KVO, Infusion Complete, Near Empty, Empty, Invalid Syringe Size, Syringe Not in Place, Pressure Increasing, Force Occlusion, Battery Failed, Low Battery) confirmed to be present and functional.
Software Functionality	Software operates as designed, allows for parameter upload/download, collects data, and supports medication safety features.	Software Validation Testing performed. PharmGuard® Toolbox 2 designed to accommodate pump features, allows creation and upload of parameters, collects operational/infusion/alarm history, and facilitates data analysis to lessen operator error.
Human Factors	Ease of use, intuitiveness of pump programming and operation, preventing user error.	Human Factors Engineering validation studies conducted in a simulated use environment demonstrated product understanding, pump programming, and operation. Concluded the device performed as designed and is safe and effective.
Biocompatibility	Materials in contact with patient or fluids are biocompatible.	Biocompatibility assessment performed, concluding the device is biocompatible based on similarity of materials to other marketed devices from Smiths Medical ASD, Inc.
Product Reliability	Device maintains performance over its expected lifespan.	Product Reliability Testing performed.
Fault Conditions	Device responds appropriately to error or fault states.	Fault Condition Testing performed.
Sensor Functionality	All sensors (e.g., plunger force, other system sensors) function correctly.	Sensor Testing performed. Plunger Force Sensing confirmed.
Power Management	Efficient and safe power usage (battery, AC).	Power Management testing performed.
Drug Compatibility	Materials contacting drugs/fluids do not adversely interact.	Drug Compatibility Testing performed.
Wireless Communications	Wireless capabilities function as intended and securely.	Device has Wireless Communications Capabilities. (No specific test details provided beyond enablement).

Study Details (Based on Provided Text):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for individual bench tests. The testing involved various units of the Medfusion® 4000 Syringe Infusion Pump and associated software.
Data Provenance: Not specified, but generally, bench testing is conducted in-house by the manufacturer. Retrospective/Prospective is not applicable as this describes non-human, laboratory-based testing.

3. 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 provided. The "ground truth" for an infusion pump's performance is objective measurement against engineering specifications and industry standards, not expert consensus in the medical imaging sense. Human Factors Engineering studies involved "clinicians" but their specific number or qualifications beyond being "clinicians" is not detailed.

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

Not applicable / Not provided. Adjudication methods are typically for subjective assessments (e.g., reading medical images). Bench testing involves objective pass/fail criteria against predefined specifications.

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. This device is an infusion pump, which is a hardware device with software, not an AI/CADe system designed to assist human readers in image interpretation or diagnosis.

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

Not applicable. While the software operates within the pump, "standalone performance" in the context of AI/CADe is not relevant here. The device's performance is inherently its function (algorithm and hardware combined) in delivering fluids.

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

Engineering Specifications and Performance Standards: The "ground truth" for the tests mentioned are the specific acceptable ranges for flow rates, alarm thresholds, resistance levels, and compliance with national/international safety and performance standards (e.g., EN IEC 60601-1, ASTM-F2052).

8. The sample size for the training set

Not applicable. The device is not an AI/ML model that is "trained" on a dataset in the conventional sense. Its software is programmed and validated.

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

Not applicable. As above, there is no "training set" for this type of device. The software is developed based on engineering requirements and validated through testing.

Summary

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510(k) Number: K111386

Date Prepared 24 August, 2011

Submitter Information

Submitter's Name:	Smiths Medical ASD, Inc.
Address:	1265 Grey Fox RoadSt. Paul, MN 55112

Establishment Registration: 2183502

Contact Person:	James Chapman
	Senior Regulatory Affairs Specialist
Phone:	(651) 628-7611
Fax:	(651) 628-7457

Device Information

Trade Name:	Medfusion® Model 4000 Syringe Infusion Pump,PharmGuard® Toolbox 2 Medication Safety SoftwarePharmGuard® Supported Syringes (PSS)
Common Name:	Syringe Infusion Pump, Medication Safety Software
Classification Name:	Infusion Pump
Product Code:	FRN, MRZ
Regulation:	21 CFR §880.5725

Predicate Device(s)

The predicate devices are the currently marketed Medfusion® Model 3500 Syringe Infusion Pump (K040899), PharmGuard® Toolbox (K042432), ALARIS Medical Systems, Inc. Medley™ Syringe Pump Module (K023264), and the ALARIS Medical Systems Inc. Medley™ System with Medication Management System (K030459).

Device Description

The Medfusion® Model 4000 Syringe Infusion Pump software version 1.1 is a wireless capable electro-mechanical syringe infusion pump.

The PharmGuard® Toolbox 2 Medication Safety Software is designed to accommodate the features and capabilities of the 4000 pump with software version 1.X.

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Intended Use/Indications for Use

The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses:

. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products. lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
. By the following delivery routes: arterial, epidural, intrathecal, subcutaneous, and enteral.
. By the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
. In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
. Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

Medfusion® 4000 Pump and PharmGuard® Toolbox 2 Smiths Medical ASD, Inc.

Traditional 510(k) Tab 6 - 2 of 5

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Parameter	Medfusion 4000Syringe Infusion Pump510(k) K111386	Medfusion 3500Syringe Infusion Pump510(k) K040899	ALARIS Medley™Syringe Pump Module510(k) K023264
System Features®
Plunger Force Sensing	Yes	Yes	Unknown
MRI Compatibility	≤ 150 Gauss/1.5 Tesla	≤ 150 Gauss/1.5 Tesla	Unknown
Fluid Resistance	Level IPX 3	Level IPX 3	Level IPX 1
Fast Occlusion Detection	Yes	Yes	Yes
Minimum Flow Rate	0.01 mL/hr	0.01 mL/hr	0.1 mL/hr
Maximum Flow Rate	1130 mL/hr	1130 mL/hr	999 mL/hr
Wireless CommunicationsCapabilities	Yes	No	Yes
Programming Functions
Continuous Mode	Yes	Yes	Yes
Volume/Time Mode	Yes	Yes	Yes
Dose/Time Mode	Yes	Yes	Yes
Mass Mode	Yes	Yes	No
Body Weight Mode	Yes	Yes	Yes
Body Surface Area Mode	Yes	Yes	Yes
Intermittent Mode	Yes	Yes	Yes
Dose/Kg/Time Mode	Yes	Yes	No
Bolus	Yes	Yes	Yes
Alarms
KVO Alarm	Yes	Yes	Yes
Infusion Complete Alarm	Yes	Yes	Yes
Near Empty Alarm	Yes	Yes	No
Empty Alarm	Yes	Yes	Yes
Invalid Syringe SizeAlarm	Yes	Yes	No
Syringe Not in PlaceAlarm	Yes	Yes	Yes
Pressure Increasing Alarm	Yes	Yes	No
Force Occlusion Alarm	Yes	Yes	Yes
Battery Failed Alarm	Yes	Yes	Yes
Low Battery Alarm	Yes	Yes	Yes

Comparison of Technological Features

Traditional 510(k) Tab 6 - 3 of 5

{3}------------------------------------------------

Summary of Non-Clinical Testing

The non-clinical testing included assessment of the physical properties of the Medfusion® 4000 Syringe Infusion Pump and PharmGuard® Toolbox 2 Medication Safety Software and their ability to achieve their intended use. Bench testing of the Medfusion® 4000 Syringe Infusion Pump confirmed the suitability of the device for its intended use. The following physical tests were performed:

. Accuracy Testing with All Supported Syringes
I Impact Testing
Environmental Testing I
. Accuracy Testing at Simulated Altitude
I Magnetic Resonance Testing in Accordance with ASTM-F2052
. Moisture Ingress Testing
r Chemical Compatibility Testing
트 Power Management
I Fault Condition Testing
. Sensor Testing
. Software Validation Testing
. Drug Compatibility Testing
Mechanical and Electrical Safety Testing in Accordance with EN IEC 60601-1 트 and EN IEC 60601-2-24
바 EMC Testing in Accordance with EN IEC 60601-2
Radio Frequency Interference Testing l
트 Product Reliability Testing

In addition to the above, Human Factors Engineering validation studies were conducted in a simulated use environment to verify product understanding and pump programming and operation. Human Factors Engineering testing demonstrated that the Medfusion® Model 4000 Syringe Infusion Pump performed as designed and is safe and effective for its intended use.

A biocompatibility assessment of the device was also performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the Medfusion Model 4000 pump. The device is biocompatible based on the similarity of the materials of construction to other devices currently marketed by Smiths Medical ASD, Inc.

Summary of Clinical Testing

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the Medfusion® Model 4000 Syringe Infusion Pump and PharmGuard® Toolbox 2 Medication Safety Software.

Statement of Equivalence

The Medfusion® Model 4000 Syringe Infusion Pump and PharmGuard® Toolbox 2 Medication Safety Software are substantially equivalent to the currently marketed Medfusion® Model 3500 Syringe Infusion Pump, PharmGuard® Toolbox, ALARIS Medical Systems, Inc. Medley Syringe Pump Module, and the ALARIS Medical Systems Inc. Medley™ System with Medication Management System based on a comparison of the indications for use and the technological characteristics of the devices.

{4}------------------------------------------------

Conclusion

The Medfusion® Model 4000 Syringe Infusion Pump and PharmGuard® Toolbox 2 Medication Safety Software are substantially equivalent to the currently marketed Medfusion® Model 3500 Syringe Infusion Pump, PharmGuard® Toolbox, ALARIS Medical Systems, Inc. Medley Syringe Pump Module, and the ALARIS Medical Systems Inc. Medley™ System with Medication Management System based on the technological characteristics of the devices. Bench tests confirmed the suitability of the devices for their intended uses. .

Traditional 510(k) Tab 6 - 5 of 5

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. James Chapman Senior Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

AUG 2 9 2011

Re: K111386

Trade/Device Name: Medfusion® Model 4000 Syringe Infusion System, PharmGuard® Toolbox 2 Medication Safety Software, PharmGuard® Supported Svringes Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, MRZ Dated: August 8, 2011 Received: August 10, 2011

Dear Mr. Chapman:

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 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{6}------------------------------------------------

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson. B.S., M.S., M.B.A. 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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SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification

Indications for Use Statement

KIII386 510(k) Number:

Device Name: PharmGuard® Supported Syringes

Indications for Use:

"The PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software."

Prescription Use X (Per 21 CFR 801 .109)

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)

/// C. A
(Division Sign-Off) 8/20/11

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111386

Medfusion® 4000 Pump and PharmGuard® Toolbox 2 Smiths Medical ASD, Inc.

Traditional 510(k) Tab 5 - 3

{8}------------------------------------------------

SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification

Indications for Use Statement

510(k) Number:

Device Name: Medfusion® Model 4000 Syringe Infusion Pump

Indications for Use:

"The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses:

. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, Enteral solutions and other therapeutic fluids.
. By the following delivery routes: arterial, epidural, intrathecal, subcutaneous, and enteral.
By the following delivery modes: continuous, volume/time, mass, body weight, custom . dilution, intermittent and bolus.
. In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
. Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

Prescription Use Over-The Counter Use X AND/OR (Per 21 CFR 801 .109) (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)

Rhd C. Chaye 8/25/14

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111386

Medfusion® 4000 Pump and PharmGuard® Toolbox 2 Smiths Medical ASD, Inc.

Traditional 510(k) Tab 5 - 1

{9}------------------------------------------------

SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification

Indications for Use Statement

510(k) Number: _ < < 111 386

Device Name: PharmGuard® Toolbox 2 Medication Safety Software

Indications for Use:

"The PharmGuard® Toolbox 2 Medication Safety Software is indicated to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medfusion® Model 4000 Syringe Infusion Pump with software version V1.0 or higher. The PharmGuard® Toolbox 2 Medication Safety Software collects and downloads operational, infusion and alarm history events, library usage counts, and PharmGuard® safety events from the Medfusion® Pump. It is intended to provide a dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medfusion® Pump."

Prescription Use x (Per 21 CFR 801 .109)

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)

Rell C. 8/25/14
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111386

Traditional 510(k) Tab 5 - 2

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).