The MEDRAD Continuum MR Compatible Infusion System (3T Proximity) is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Device Description

The Medrad Continuum Infusion System maintains the same intended use, similar operational parameters, similar labeling and is essentially used in a manner similar to the predicate device. A label will be affixed to the system stating that when using the Continuum Infusion System in the MR environment it's casters brakes should be on and the system should not be placed in a static magnetic field exceeding 2000 gauss. The user's manual has also been updated to include this warning. The Continuum MR Compatible Infusion System (3.0T) is comprised of the same components as the predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an infusion pump, the MEDRAD Continuum MR Compatible Infusion System (3T Proximity). This submission aims to demonstrate substantial equivalence to a predicate device, the MEDRAD Continuum MR Compatible Infusion System - 1.5T. The information primarily focuses on comparing the new device to its predicate, rather than providing detailed acceptance criteria and study results for a novel device.

The study presented is not a typical clinical trial to assess diagnostic or treatment effectiveness, but rather a benchmarking comparison and safety assessment to demonstrate that the new device (3T Proximity) performs equivalently to an existing, legally marketed predicate device (1.5T). The goal is to show that the minor modifications, particularly its compatibility with a 3.0T MR environment, do not introduce new safety or effectiveness concerns while maintaining the same performance characteristics.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the new device is substantial equivalence to the predicate device. This means the new device must have the "same intended use, similar operational parameters, similar labeling and is essentially used in a manner similar to the predicate device."

The "reported device performance" is a direct comparison of parameters between the new device (MEDRAD Continuum MR Compatible Infusion System - 3.0T) and the predicate device (MEDRAD Continuum MR Compatible Infusion System - 1.5T). The key finding is that all listed performance parameters are "Same" between the two devices, except for the explicit mention of MRI compatibility up to "2000 gauss" for the new device, whereas the predicate was simply "Yes".

Parameter (Acceptance Criteria: Must be "Same" as Predicate unless otherwise specified)	Predicate Device (1.5T) Performance	New Device (3.0T Proximity) Performance	Meets Acceptance Criteria?
Classification	Type CF	Same	Yes (Implicitly)
Compatible IV Administration Set	Standard PVC Single Use Y-Site Set Free Flow Protection	Same	Yes (Implicitly)
Flow Rate	Continuous: 1 to 99.9 ml/h in 0.1 ml/h increments, 100 to 1200 ml/h in 1 ml/h increments	Same	Yes (Implicitly)
Total Infused Volume	Continuous: 1 to 9,999 ml	Same	Yes (Implicitly)
Housing	ABS	Same	Yes (Implicitly)
Microprocessor Controlled	Yes	Same	Yes (Implicitly)
KVO Infusion Rate	1 to 5 ml/h	Same	Yes (Implicitly)
System Accuracy	+/- 10%	Same	Yes (Implicitly)
Occlusion Pressure	User Selectable: Low-0.3 bar (5 psi) Medium-0.5 bar (7.5 psi) High-0.7 bar (10 psi)	Same	Yes (Implicitly)
Battery	Li-Ion Rechargeable	Same	Yes (Implicitly)
Battery Operation	4 hr @ 1200 ml/h	Same	Yes (Implicitly)
Battery Charging	~6 hr to 95% maximum battery capacity	Same	Yes (Implicitly)
Air-In-Line Detector	User Selectable	Same	Yes (Implicitly)
Total Time Setting	100 hours	Same	Yes (Implicitly)
Air Sensor	Ultrasonic	Same	Yes (Implicitly)
Prime Rate	1600 to 1800 ml/h	Same	Yes (Implicitly)
Bolus Rate	0.1 to 1200 ml/h	Same	Yes (Implicitly)
Bolus Volume	0.1 to 100 ml	Same	Yes (Implicitly)
Alarm Conditions (All sub-points)	Yes (for each: Air-In-Line, Down Occlusion, Pump Unattended, Low Battery, End Battery, Fatal Error, End Program, Missing Key, Lock Mode)	Yes (for each)	Yes (Implicitly)
Program Modes (All sub-points)	Yes (for each: Continuous, Dose, Non-Weight Dose)	Yes (for each)	Yes (Implicitly)
Integrated Mounting Clamp for IV Pole	Yes	Same	Yes (Implicitly)
Built in Free Flow Protection	Yes	Same	Yes (Implicitly)
Automatic Bolus Function (Safety Feature)	Yes	Same	Yes (Implicitly)
User Selectable Alarm Volume	Yes	Same	Yes (Implicitly)
Comprehensive Safety Features	Yes	Same	Yes (Implicitly)
Low Battery	Yes	Same	Yes (Implicitly)
MRI Compatible	Yes	Yes (up to 2000 gauss)	Yes (Explicitly extended compatibility)

Note: The primary "study" proving acceptance is the detailed comparison table that asserts the physical and functional identity of the new device with the predicate, with the added MR compatibility for 3.0T environments (up to 2000 gauss static magnetic field) being the key difference and point of assessment.

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

Sample Size: Not applicable in the context of human clinical data. This is a technical comparison for substantial equivalence. The "test set" would refer to the new device itself (MEDRAD Continuum MR Compatible Infusion System - 3.0T), which was designed and tested against the specifications of the predicate.
Data Provenance: The data provenance is from the manufacturer's (MEDRAD, Inc.) engineering and testing documentation, comparing the design and performance specifications of their existing 1.5T compatible device with the proposed new 3.0T compatible device. This is inherently prospective in the sense of designing and testing the new device to meet predicate performance, but the comparison is based on retrospective knowledge of the predicate's performance. The country of origin of the data is implicitly the USA, as MEDRAD, Inc. is located in Pennsylvania.

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

Not applicable for this type of submission. "Ground truth" in this context is established by the engineering specifications and performance characteristics of the predicate device, which have already been deemed safe and effective by the FDA. The submission relies on the manufacturer's internal engineering and quality assurance processes to confirm the new device meets these established specifications and the new MRI compatibility requirements. There are no "experts" establishing a clinical ground truth for a test set in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable. There is no multi-reader adjudication process described, as it's not a clinical diagnostic performance study. The adjudication is essentially the FDA's review determining if the provided technical comparison demonstrates substantial equivalence to the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC study was done. This is not an AI-enabled device or a diagnostic imaging device requiring human reader interpretation. It is an infusion pump.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, in a conceptual sense. The "study" here is the technical comparison and engineering validation of the device itself (the "algorithm only" being the device's operational design and components). The device functions somewhat autonomously according to its programming (flow rate, alarms, etc.), but it requires human users (trained medical staff) for setup and monitoring. The "performance" is based on its ability to meet the established operational parameters, not on human-in-the-loop diagnostic accuracy.

7. The Type of Ground Truth Used

The ground truth used is the engineering specifications and established performance characteristics of the legally marketed predicate device (MEDRAD Continuum MR Compatible Infusion System - 1.5T), combined with new safety testing to confirm compatibility with the higher magnetic field environment (3.0T). The implicit ground truth is that if the new device performs identically to a predicate already cleared for market, and addresses the new environmental concerns, it is also safe and effective.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The device is hardware-based with embedded software, and its design principles are based on established medical device engineering.

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

Not applicable, as there is no "training set" in the context of this device.

Summary

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K061128

510(k) Summary

OFFICIAL CONTACT:

John M Kiste Regulatory Affairs Analyst MEDRAD, Inc. One Medrad Drive Indianola, PA 15051 (412) 767-2400 ext. 3444

Infusion Pump & Accessories [21 CFR 880.5725] CLASSIFICATION NAME:

MEDRAD

Peristaltic Pump System

COMMON NAME(S):

PROPRIETARY NAME:

PREDICATE DEVICE:

INTENDED USE:

(K032771) MEDRAD Continuum MR Compatible The Infusion System is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

MR Continuum Infusion System

MEDRAD Continuum MR Infusion System

DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:

The Medrad Continuum Infusion System maintains the same intended use, similar operational parameters, similar labeling and is essentially used in a manner similar to the predicate device.

A label will be affixed to the system stating that when using the Continuum Infusion System in the MR environment it's casters brakes should be on and the system should not be placed in a static magnetic field exceeding 2000 gauss. The user's manual has also been updated to include this warning.

The Continuum MR Compatible Infusion System (3.0T) is comprised of the same components as the predicate device. Differences between the predicate device and the new Continuum MR Compatible Infusion System (3.0T) are detailed in the table below. The following Comparison Matrix identifies the similarities and differences between the new device and the predicate device.

10 -

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Parameter	MEDRAD ContinuumMR Compatible InfusionSystem - 1.5T	MEDRAD ContinuumMR Compatible InfusionSystem - 3.0T
Classification	Type CF	Same
Compatible IVAdministration Set	Standard PVCSingle UseY-Site SetFree Flow Protection	Same
Flow Rate	Continuous: 1 to 99.9 ml/hin 0.1 ml/h increments,100 to 1200 ml/h in 1 ml/hincrements	Same
Total Infused Volume	Continuous: 1 to 9,999 ml	Same
Housing	ABS	Same
MicroprocessorControlled	Yes	Same
KVO Infusion Rate	1 to 5 ml/h	Same
System Accuracy	+/- 10%	Same
Occlusion Pressure	User Selectable:Low-0.3 bar (5 psi)Medium-0.5 bar (7.5 psi)High-0.7 bar (10 psi)	Same
Battery	Li-Ion Rechargeable	Same
Battery Operation	4 hr @ 1200 ml/h	Same
Battery Charging	~6 hr to 95% maximumbattery capacity	Same
Air-In-Line Detector	User Selectable	Same
Total Time Setting	100 hours	Same
Air Sensor	Ultrasonic	Same
Prime Rate	1600 to 1800 ml/h	Same
Bolus Rate	0.1 to 1200 ml/h	Same
Bolus Volume	0.1 to 100 ml	Same
Alarm Conditions
> Air-In-Line	Yes	Yes
> DownOcclusion	Yes	Yes
> PumpUnattended	Yes	Yes
> Low Battery	Yes	Yes
> End Battery	Yes	Yes
> Fatal Error	Yes	Yes
> End Program	Yes	Yes
> Missing Key	Yes	Yes
> Lock Mode	Yes	Yes
Program Modes
> Continuous	Yes	Yes
> Dose	Yes	Yes
> Non-WeightDose	Yes	Yes
Integrated MountingClamp for IV Pole	Yes	Yes
Built in Free FlowProtection	Yes	Yes
Automatic Bolus Function(Safety Feature)	Yes	Yes
User Selectable AlarmVolume	Yes	Yes
Comprehensive SafetyFeatures	Yes	Yes
Low Battery	Yes	Yes
MRI Compatible	Yes	Yes (up to 2000 gauss)

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and the comments of the comments of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2006

Mr. John M. Kiste Regulatory Affairs Analyst MEDRAD, Incorporated One Medrad Drive Indianola, Pennsylvania 15051

Re: K061128

Trade/Device Name: MEDRAD Continuum MR Compatible Infusion System (3T Proximity) Regulation Number: 21 CFR 880.5725

Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 20, 2006 Received: April 25, 2006

Dear Mr. Kiste:

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.

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. Kiste

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 (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.

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 vours.

Syette y. Michael Smis.

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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ MEDRAD Continuum MR Compatible Infusion System (3T Proximity)

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Colody, General Hospits). .. Lartal Devic

Page 1 of

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).