The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is designed for patients who require medications and other 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 MR Infusion System with Wireless Remote Accessory is a modification of the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device described in 510(k) submission K061128. Similar to the MEDRAD predicate device, the system is designed for patients requiring medications and other fluids during an MR imaging procedure. Both are designed for use in MR environments up to the 2000 Gauss line in magnet strengths up to and including 3T and are not intended to provide long-term patient care. Both systems connect to the existing patient administration line by the addition of a proprietary disposable and replace the bedside pump during the MR procedure. The proposed device and the predicate device are intended to be used by trained healthcare professionals, medical physicians, and critical care, emergency room, and radiology nursing staff. Neither is intended for the delivery of blood, blood products or nitroglycerine.

AI/ML Overview

The document provided is a 510(k) Pre-market Submission for the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials as would be required for a PMA (Pre-Market Approval). Therefore, the study described is primarily for bench testing and verification/validation against established standards and to confirm design specifications, rather than a clinical study evaluating device performance in humans or against a true "ground truth" derived from patient data.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific acceptance criteria in a quantified table with corresponding performance results. Instead, it states that testing will be conducted against applicable standards, and satisfactory test results are required prior to release of the product. The implicit acceptance criterion is successful compliance with the listed standards and internal design specifications.

The document does provide a comparative table (Table 2 and 3) that lists various parameters of the proposed device against predicate devices. While this isn't "acceptance criteria" in the traditional sense of a performance study, it highlights how the proposed device aims to meet or exceed the predicate's specifications.

Parameter	Predicate Device (K061128) - Acceptance Criteria (Implicit)	Proposed Device - MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Reported Performance)
Flow Rate	Continuous: 0.1 to 99.9 ml/h in 0.1 ml/h increments, 100 to 1200 ml/h in 1 ml/h increments	Same
KVO Infusion Rate	1 to 5 ml/h	0 to 5 ml/h (lowered from 1 to 0 ml/h)
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
Pump Battery Operation	4 hrs at 1200 ml/h	> 8 hrs at 125 ml/h (> 5 hrs at 1200 ml/h) - Slightly higher battery life
Pump Battery Charging	~6 hrs to 95% maximum battery capacity	Same
Total Time Setting	100 hours	Same
Prime Rate	1600 to 1800 ml/h	Same
Bolus Flow Rate	0.1 to 1200 ml/h	Same
Bolus Volume	0.1 to 100 ml	Same
Alarm Conditions Options	Air in line, Down occlusion, Pump unattended, Low battery, End battery, Fatal error, End program, Missing key, Lock mode	Same, plus "Program Nearing End" alarm
MR Compatible	Yes (up to 2000 Gauss)	Same
Usability Software Features	Yes	New features added: Bolus Review Screen, Screen dimming, Reset behavior for "Total Volume Infused", Dose Rate Units setting
RF Wireless Technology	Operates at 2.4 GHz (for Iradimed predicate)	Operates at 2.4 GHz; IEEE 802.11b/g

Study Proving Acceptance Criteria:

The study described is a performance testing program against applicable industry standards.

Standards: IEC 60601-2-24, IEC 60601-1, UL 60601-1, and IEC 60601-1-2. These standards address safety and performance for medical electrical equipment, particularly infusion pumps.
Testing Conducted by: Third-party certified test labs.
Outcome: "Satisfactory test results required prior to release of the product."
Purpose: To confirm that design specifications have been met and that the device meets the applicable requirements of the cited safety and performance standards. This also serves to confirm substantial equivalence to predicate devices.

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

This is a device performance study (bench testing), not an AI or clinical study with patient data. Therefore, there is no "test set" in the context of patient data. The "test set" would refer to the physical devices or components subjected to testing. The sample size for these engineering tests is not specified in the document, but it typically involves a representative number of units to ensure manufacturing consistency and reliability, as governed by engineering and quality assurance protocols.

Data provenance (country of origin, retrospective/prospective) is not applicable here as it pertains to patient or clinical data, which is not the focus of this 510(k) submission's described study.

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

Not applicable. "Ground truth" typically refers to verified diagnoses or outcomes in clinical studies, often established by expert consensus or pathology. For this device, the "ground truth" equivalent is compliance with engineering specifications and regulatory standards. The "experts" involved are the engineers, regulatory specialists, and third-party testers who verify adherence to these standards. Their specific number and qualifications (e.g., years of experience) are not detailed in this submission but would be internal to the device manufacturer and the testing labs.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human reviewers assess cases and discrepancies are resolved by a tie-breaker or consensus. For engineering bench testing, "adjudication" is the process of comparing test results against predefined functional and safety specifications, with clear pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an MRMC or comparative effectiveness study. It's a technical verification and validation of a medical device against safety and performance standards and comparison to predicate devices, not an AI or diagnostic imaging product comparison.

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

Not applicable. This is not an algorithm or AI device. It is an infusion pump system. The "performance" being evaluated is the physical and functional operation of the pump, not an algorithm's diagnostic output.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance study is adherence to predefined engineering specifications, safety standards (e.g., IEC 60601 series, UL 60601-1), and functional requirements for an infusion pump. This is confirmed through bench testing and verification/validation activities. It does not involve expert consensus on clinical cases, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (infusion pump), not an AI algorithm that requires a "training set" of data.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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K073051

510(k) Summary of Safety and Effectiveness

DATE PREPARED:	October 26, 2007			MAY 30 200-
NAME OF SUBMITTER:	MEDRAD, Inc.One MEDRAD DriveIndianola, PA 15051
OFFICIAL CONTACT:	Leslie S. O'NanPhone: 412-767-2400 ext. 3165Fax: 412-767-2451
PROPRIETARY NAME:	MEDRAD Continuum MR Infusion System with Wireless RemoteAccessory
CLASSIFICATION NAME:	Infusion Pump - Class II (see 21 CFR 880.5725)
COMMON NAME:	Peristaltic Pump
PRODUCT CODE:	FRN
PREDICATE DEVICES:	K061128, MEDRAD Continuum MR Compatible Infusion System(3T Proximity)K050301, Iradimed MRidium 3850 MRI Infusion Pump System
INDICATIONS FOR USE:	The MEDRAD Continuum MR Infusion System with WirelessRemote Accessory is designed for patients who requiremedications and other fluids during an MR procedure. It isintended to provide infusion therapy directly prior to, during andimmediately after the MR procedure functioning while eitherstationary or mobile. It is not intended to provide long-termpatient care outside the MR environment. The system is to beused by trained medical staff, primarily critical care, emergencyroom and radiology nursing staff.

DEVICE DESCRIPTION AND COMPARISON TO PREDICATE DEVICES

The Continuum MR Infusion System with Wireless Remote Accessory maintains the same intended use, similar operational parameters, and similar labeling (with the addition of a remote display specific operation manual) as the predicate device. The proposed device is used in a similar manner as both of the predicate devices described in the submission.

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· MEDRAD, Inc. · 510(k) Pre-market Submission● MEDRAD Continuum Wireless MR Infusion System ●

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The MEDRAD Continuum MR Infusion System included in the proposed device has a similar design, similar materials of construction, similar components and similar infusion pump technology as the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device. The primary difference between the two MEDRAD devices is the addition of the remote accessory and wireless radio technology. However, the proposed device and the Iradimed MRidium 3850 MRI Infusion Pump System with 3855 Optional Wireless Remote Control described in 510(k) submission K050301 have a similar intended use, similar wireless radio technology, and similar remote control functionality.

A tabular comparison of features and principles of operation for the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) (Predicate) and MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Proposed) is contained in Table 2.

Table 2 Comparison of the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) (Predicate) and MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Proposed)

(Proposed)PARAMETER	PREDICATE DEVICE	PROPOSED DEVICE
	Continuum MR CompatibleInfusion System - (3.0T	MEDRAD Continuum MRInfusion System with Wireless
	Proximity) - K061128	Remote Accessory
Classification	CF	Same
Administration sets	Sterile, proprietary, single-use,standard PVC, free-flow protection	Same
Intended Use	The MEDRAD Continuum MRCompatible Infusion System (3TProximity) is designed for patientswho require maintenancemedications and fluids during anMR procedure. It is intended toprovide infusion therapy directlyprior to, during and immediatelyafter the MR procedure functioningwhile either stationary or mobile. Itis not intended to provide long-term patient care outside the MRenvironment. The system is to beused by trained medical staff,primarily critical care, emergencyroom and radiology nursing staff.	The MEDRAD Continuum MRInfusion System with WirelessRemote Accessory is designed forpatients who require medicationsand other fluids during an MRprocedure. It is intended to provideinfusion therapy directly prior to,during and immediately after theMR procedure functioning whileeither stationary or mobile. It is notintended to provide long-termpatient care outside the MRenvironment. The system is to beused by trained medical staff,primarily critical care, emergencyroom and radiology nursing staff.
Flow Rate	Continuous: 0.1 to 99.9 ml/h in 0.1ml/h increments,100 to 1200 ml/h in 1 ml/hincrements	Same
Housing	ABS	Same
Operating principle	Peristaltic Infusion Pump,Microprocessor controlled	Same
KVO Infusion rate	1 to 5 ml/h	0 to 5 ml/hKVO input limit was lowered from 1to 0 ml/h since last 510(k) clearance
System accuracy	+/- 10%	Same
Occlusion pressure	User selectable: Low - 0.3 bar (5psi), Medium - 0.5 bar (7.5 psi),High - 0.7 bar (10 psi)	Same
PARAMETER	PREDICATE DEVICEContinuum MR CompatibleInfusion System - (3.0TProximity) - K061128	PROPOSED DEVICEMEDRAD Continuum MRInfusion System with WirelessRemote Accessory
Pump BatteryPump Batteryoperation	Li-based rechargeable4 hrs at 1200 ml/h	Same> 8 hrs at 125 ml/h(> 5 hrs at 1200 ml/h)
		Slightly higher battery life since last510(k) clearance
Pump Batterycharging	~6 hrs to 95% maximum batterycapacity	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 flow rate	0.1 to 1200 ml/h	Same
Bolus volume	0.1 to 100 ml	Same
Alarm Conditions	➤ Air in line➤ Down occlusion➤ Pump unattended➤ Low battery➤ End battery➤ Fatal error➤ End program➤ Missing key➤ Lock mode	➤ Air in line➤ Down occlusion➤ Pump unattended➤ Low battery➤ End battery➤ Fatal error➤ End program➤ Missing key➤ Lock mode➤ Program Nearing EndAddition of the Program NearingEnd alarm since last 510(k)clearance
User SelectableAlarm Volume	Yes	Same
Program modes	➤ Continuous➤ Dose➤ Non-weight dose	Same
Integrated mountingclamp for IV pole	Yes	Same
Built in Free FlowProtection	Yes	Same
Automatic BolusFunction (SafetyFeature)	Yes	Same
MR compatible	Yes (up to 2000 Gauss)	Same
Usability softwarefeatures	Yes	➤ Bolus Review Screen➤ Screen dimming➤ Reset behavior for the "TotalVolume Infused"➤ Dose Rate Units settingAddition of new usability software
PARAMETER	PREDICATE DEVICEIradimed MRidium 3850 MRIInfusion Pump System withMRidium 3855 Wireless RemoteControl	PROPOSED DEVICEMEDRAD Continuum MRInfusion System with WirelessRemote Accessory
Optional WirelessRemote Accessory	Yes	Same
InfusionManagementFeatures	Status of the pump operation,battery level, flow rate parametersand alarms	Same
Control Features	Start, stop, titrate, bolus	Same
RF WirelessTechnology	Operates at 2.4 GHz	SameIEEE 802.11b/g

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● MEDRAD, Inc. ● 510(k) Pre-market Submission● MEDRAD Continuum Wireless MR Infusion System ●

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● MEDRAD, Inc. ● 510(k) Pre-market Submission● MEDRAD Continuum Wireless MR Infusion System ●

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A tabular comparison of features and principles of operation for the Iradimed MRidium 3850 MRI Infusion Pump System with MRidium 3855 Wireless Remote Control (Predicate) and MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Proposed) is contained in Table 3.

Table 3 Comparison of the Iradimed MRidium 3850 MRI Infusion Pump System with MRidium 3855 Wireless Remote Control (Predicate) and MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Proposed)

SUMMARY OF PERFORMANCE TESTING

Testing of the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is being conducted against applicable standards including IEC 60601-2-24, IEC 60601-1, UL 60601- 1 and IEC 60601-1-2. These standards represent standardized testing for safety and These are the same standards used in the determination of substantial performance. equivalence for the MEDRAD predicate device. Testing to the standards will be completed by third party certified test labs for the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory with satisfactory test results required prior to release of the product.

STATEMENT OF SUBSTANTIAL EQUIVALENCE

The substantial equivalence comparisons demonstrate that the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory contain technological features that do not differ significantly from currently marketed devices.

Verification and validation will be completed according to the Verification and Validation Test Plan to confirm that the design specifications for the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory have been met and that the device meets the applicable requirements of the safety and performance standards cited.

Therefore, it has been determined that the Continuum MR Infusion System with Wireless Remote Accessory is substantially equivalent to the predicate devices described in the submission for its intended use when used as prescribed in the User Operation Manual.

● MEDRAD, Inc. ● 510(k) Pre-market Submission● MEDRAD Continuum Wireless MR Infusion System ●

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Image /page/4/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 its wings spread, and the words "HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2008

Ms. Leslie S. O'Nan Regulatory Affairs Specialist MEDRAD, Incorporated One Medrad Drive Indianola, Pennsylvania 15051

Re: K073051

Trade/Device Name: MEDRAD Continuum MR Infusion System with Wireless Remote Accessory Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 9, 2008 Received: May 12, 2008

Dear Ms. O'Nan:

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 - O'Nan

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 (QS) 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,

Chiu Lin, Ph.D.

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 Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MEDRAD Continuum MR Infusion System with Wireless Remote Accessory

Indications for Use:

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

Over-the-Counter Use (Part 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)

Charles Beard
Division of Oil & Gas

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

510(k) Number: KD73051

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· MEDRAD, Inc. · Abbreviated 510(k) Pre-market Submission · Confidential · MEDRAD Continuum MR Infusion System with Wireless Remote Accessory ●

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).