(28 days)
Not Found
No
The document describes a standard infusion system and makes no mention of AI or ML capabilities.
Yes
The device is described as "infusion therapy" which delivers maintenance medications and fluids, indicating a therapeutic function.
No
The device is described as an "Infusion System" designed to provide "infusion therapy" for maintenance medications and fluids. Its purpose is to administer substances, not to diagnose a condition or disease.
No
The device description explicitly states it is comprised of "components" and mentions "casters brakes," indicating it is a physical system with hardware, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for "infusion therapy" to deliver "maintenance medications and fluids" to patients. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical components and operational parameters related to delivering fluids, not analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to administer substances into the body, which is a therapeutic action.
N/A
Intended Use / Indications for Use
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.
Product codes
FRN
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical staff, primarily critical care, emergency room and radiology nursing staff.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
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1
| Parameter | MEDRAD Continuum
MR Compatible Infusion
System - 1.5T | MEDRAD Continuum
MR Compatible Infusion
System - 3.0T |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Classification | Type CF | Same |
| Compatible IV
Administration Set | Standard PVC
Single Use
Y-Site Set
Free Flow Protection | Same |
| 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 |
| Total Infused Volume | Continuous: 1 to 9,999 ml | Same |
| Housing | ABS | Same |
| Microprocessor
Controlled | 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% maximum
battery 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 |
| > Down
Occlusion | Yes | Yes |
| > Pump
Unattended | 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-Weight
Dose | Yes | Yes |
| Integrated Mounting
Clamp for IV Pole | Yes | Yes |
| Built in Free Flow
Protection | Yes | Yes |
| Automatic Bolus Function
(Safety Feature) | Yes | Yes |
| User Selectable Alarm
Volume | Yes | Yes |
| Comprehensive Safety
Features | Yes | Yes |
| Low Battery | Yes | Yes |
| MRI Compatible | Yes | Yes (up to 2000 gauss) |
.
:
2
and the comments of the comments of
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
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.
4
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
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __ MEDRAD Continuum MR Compatible Infusion System (3T Proximity)
Indications For Use:
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.
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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