The intended medical application of MRI-Caddy with three 2000-Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times. The MRI-Caddy is designed for use in an MR-environment at a maximum magnetic field strength of 20mT.

Device Description

The MRI-Caddy® is a cart with an integrated chassis, which is equipped with three Medex syringe pumps and a power supply. The MRI-Caddy's mechanical construction makes it possible to position the system with the MR-room. For this purpose the system was equipped with adequate screening following the principle of a Faraday cage. The function principle corresponds to that of the Medex syringe pumps already on the market.

AI/ML Overview

The provided 510(k) summary for the MRI-Caddy Infusion Pump does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Medex syringe pumps Model 3001 and Medfusion Model 2001) based on design, materials, chemical composition, and operational principles, as well as compliance with a general safety standard.

Here's an breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The submission does not define specific performance metrics or acceptance criteria for the MRI-Caddy beyond compliance with a general safety standard. It asserts that the function principles correspond to existing Medex syringe pumps.

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

No test set or clinical data is mentioned. The submission explicitly states: "The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence."

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

Not applicable, as no test set or clinical studies were conducted.

4. Adjudication method for the test set

Not applicable, as no test set or clinical studies were conducted.

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, not an AI-based diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

Not applicable. The equivalence is primarily based on device design and manufacturing, not clinical performance data with ground truth.

8. The sample size for the training set

Not applicable, as no AI model or training was performed.

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

Not applicable, as no AI model or training was performed.

Summary of the Study and Basis for Equivalence (as reported in the document):

The submission for the MRI-Caddy Infusion Pump relies on two key aspects to establish substantial equivalence to legally marketed predicate devices:

Non-Clinical Testing and Standards Compliance: The company cites compliance with EN 60601-1 / IEC 601-1 "Medical Electrical Equipment - Part 1: General Requirements for Safety" including its amendments. This suggests that the device underwent engineering and safety testing to meet general electrical and medical device safety standards.
Design and Functional Equivalence to Predicate Devices: The core argument for substantial equivalence is that "The basic design, material, chemical composition of the Medex pump series 2000 used in the MRI-Caddy are the same as for the current corresponding Medex Medfusion model pumps. They are identical in operation, features, and form as their predicate devices, and represent no technological differences." The MRI-Caddy essentially integrates pre-existing, legally marketed Medex syringe pumps into a new housing designed for an MR-environment, with appropriate screening (Faraday cage).

Conclusion:

The K030323 submission does not involve specific acceptance criteria or a performance study as would be seen for a novel diagnostic or therapeutic device. Instead, it leverages the substantial equivalence pathway by demonstrating that the MRI-Caddy is fundamentally the same in design, materials, and operation as existing, cleared infusion pumps, with the added feature of an MR-compatible housing that meets safety standards. No clinical studies were conducted or relied upon for this submission.

Summary

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Date:

Page 1 of 2

APR - 2 2003

K030323

510(k) Summary

Introduction

This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.

510(k) Submitted by

Mammendorfer Institut für Physik und Medizin GmbH Oskar-von-Miller-Strasse 6 82291Mammendorf / Munich, Germany

510(k) Correspondent

Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 7th Ave., Golden, CO USA Tel: 303-234-9412 / Fax: 303-234-9413

Date Prepared

January 24, 2003

Trade Name of Device

MRI-Caddy

Common Name of Device

Infusion Pump

Classification Name

Infusion Pump

510(k) Classification

880.5725 Class II

Device Description and Intended Use

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510(k) Number:
Date:

Page 2 of 2

Predicate Devices

Syringe Infusion Pump. Model 3001 Syringe Infusion Pump. and Medfusion Model 2001 Syringe Infusion Pump manufactured by Medex, Inc.

The basic design, material, chemical composition of the Medex pump series 2000 used in the MRI-Caddy are the same as for the current corresponding Medex Medfusion model pumps. They are identical in operation, features, and form as their predicate devices, and represent no technological differences.

Non-Clinical Testing

The requirements of the following standards have been used in part to establish substantial equivalence:

EN 60601-1 / IEC 601-1 "Medical Electrical Equipment - Part 1: General Requirements for Safety", including Amendment 1 (1991) & Amendment 1 (1995)

The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence.

Risk Management

This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program.

The user must be qualified in MRI and infusion pump procedures, and must be familiar with all labeling and instructions for use associated with the device. The company believes many device health hazards are due to user error, or failure to follow instructions for use.

Mammendorfer Institut für Physik und Medizin GmbH believes that the MRI-Caddy is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized representation of a human figure. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2003

Mammendorfer Institut Für Physik und Medizin GmbH C/O Mr. Robert N. Clark Medical Device Regulatory Advisors 13605 West 7th Avenue Golden, Colorado 80401

Re: K030323

Trade/Device Name: MRI-Caddy® Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 24, 2003 Received: January 30, 2003

Dear Mr. Clark:

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. Clark

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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours,

Susan Rusner

Susan Runner, DDS, MA Interim 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: K030323

Device Name:

MRI-Caddy®

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patuxn Cusenite

510(k) Number: K030323

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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).