(44 days)
Not Found
No
The document describes a standard infusion pump with mechanical and electronic components for controlled fluid delivery. There is no mention of AI, ML, or any data-driven decision-making processes beyond basic pump control.
Yes
The device is described as useful in the administration of various therapeutic fluids and drugs through different delivery routes and modes, which directly supports the delivery of therapy to patients.
No
The device is an infusion pump designed to administer fluids, not to diagnose patients. Its intended use is for therapy (fluid administration) rather than diagnosis.
No
The device description clearly details physical hardware components such as a peristaltic pump channel, motor, controls, display, power supply, battery, processor/memory functions, and infusion sets. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the MRidium 3850 Infusion Pump System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "infuse patients with intra-venous or intra-arterial fluids". This involves administering substances into the patient's body, not analyzing samples from the patient's body.
- Device Description: The description details a pump system designed to deliver fluids, not to perform tests on biological samples.
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing biological specimens (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MRidium 3850 Infusion Pump System's function is therapeutic (delivering fluids), not diagnostic.
N/A
Intended Use / Indications for Use
The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for general hospital or clinical use by medical professionals whenever it is required to infuse intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for general hospital or clinical use by medical professionals when it is required to infuse patients with intra-venous or intra-arterial fluid before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. The specific MRidium 3850 Series MRI Infusion Pump System (including the MRidium 1000 Series of Infusion Sets) indications for use are as follows:
- Useful in the administration of fluids requiring precisely controlled infusions including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
- Useful in the following delivery routes: arterial, intravenous, spinal, subcutaneous, and enteral.
- Useful in the following delivery modes: continuous, intermittent and bolus.
- Although specifically intended for use in the MRI, this product can be useful in critical care, anesthesia, neonatal and pediatric applications or other healthcare environments as long as the pump can be monitored or supervised by a clinician.
- Used inside the MRI room mounted outside the 10,000 Gauss line and with magnets of field strength of 3.0 Tesla or less.
The MRidium 1000 Series Infusion Sets are intended as accessories to the MRidium 3850 Infusion Pump System to aid in the administration of fluids for precisely controlled infusion rates.
The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -150 mm Hg and result in uncontrolled fluid flow.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The MRidium 3850 MRI Infusion Pump System is an MRI compatible IV pump intended for use within the MR Scan room. The device shall operate to full specification in magnetic fields of up to the 10.000 gauss-line of a 3.0 Tcsla MR Scanner, and have RF emissions at the Larmor frequencies up to and including 3.0 Tesla MR scanners such that image signal to noise is not visibly affected with the pump within 1 foot from the MRI bore opening. The magnetic content of the device is minimal so as to avoid any hazard of magnetic attraction.
The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. This integral channel is vertically oriented to the right side of the unit. The main assembly of the pump unit shall contain the controls, display, power supply, battery, and processor/memory functions suitable to meet the complete and expanded system requirements.
The left side of the unit is designed to accommodate attachment of an optional second peristaltic pump channel which is controlled through the main pump assembly's display and controls.
The MRidium 1000 Series Infusion Sets utilize medical-grade PVC tubing with a medical-grade silicone rubber pumping segment that fits into a custom housing within the Pump. These Infusion Sets also contain the necessary flow stop/prevention devices, needle-free access ports, and fluid bottle/bag insertion devices required for safe and effective fluid delivery.
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
medical professionals / general hospital or clinical use
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)
Nonclinical testing has been performed using these standards to establish the device's performance. These include: IEC 60601-1-1; IEC60601-1-2; AAMI/ANSI ID26 (1998); IEC 60601-2-24; and UL2601.
The results of these non-clinical tests allow Iradimed Corporation to conclude that the MRidium™ 3850 MRI Infusion Pump System is substantially equivalent to the Medrad Continuum MRI-Compatible System and Alaris PC-1 Infusion System which are currently being marketed, and that they are as safe and effective as these devices in providing infusion therapy.
Additionally, tests demonstrating consideration and mitigation of the identified potential hazards for this device have been completed, along with the design reviews, prior to product release.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Ko50 30
MAR 2 4 2005
(P. 1 of 3)
510(k) Summary of Safety and Effectiveness
Submitter Information:
Iradimed Corporation 7457 Aloma Ave. Suite 201 Winter Park, FL 32792
Phone: 407-677-8020 407-677-5037 Fax: Contact: Mr. Francis Casey
Date Prepared: January 31, 2005
Product Name:
| Trade Name: | MRidium™ 3850 Infusion Pump System |
|---|---|
| Common Name: | Infusion Pump and Infusion Sets. |
| Classification Name & Class: | Infusion Pump - Class II (see 21 CFR - 880.5725) |
Predicate Devices:
The predicate device(s) are: the Medrad Continuum Infusion Pump System (510(k) numbers K032771 and K021988); Alaris PC-1 Infusion Pump System (510(k) number K012383); and their respective infusion sets. These predicate devices have similar performance specifications as the MRidium 3850 Infusion Pump System.
Device Description:
The MRidium 3850 MRI Infusion Pump System is an MRI compatible IV pump intended for use within the MR Scan room. The device shall operate to full specification in magnetic fields of up to the 10.000 gauss-line of a 3.0 Tcsla MR Scanner, and have RF emissions at the Larmor frequencies up to and including 3.0 Tesla MR scanners such that image signal to noise is not visibly affected with the pump within 1 foot from the MR1 bore opening. The magnetic content of the device is minimal so as to avoid any hazard of magnetic attraction.
The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. This integral channel is vertically oriented to the right side of the unit. The main assembly of the pump unit shall contain the controls, display, power supply, battery, and processor/memory functions suitable to meet the complete and expanded system requirements.
The left side of the unit is designed to accommodate attachment of an optional second peristaltic pump channel which is controlled through the main pump assembly's display and controls.
The MRidium 1000 Series Infusion Sets utilize medical-grade PVC tubing with a medical-grade silicone rubber pumping segment that fits into a custom housing within the Pump. These Infusion Sets also contain the necessary flow stop/prevention devices,
1
K454341(42 or 43)
needle-free access ports, and fluid bottle/bag insertion devices required for safe and effective fluid delivery.
Intended Uses:
The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for general hospital or clinical use by medical professionals whenever it is required to infuse geduction nooplar of enous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile resomation . This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
Technological Comparison to Predicate Device(s):
The MRidium™ 3850 MRI Infusion Pump System (including the MRidium 1000 Series Infusion Sets) is functionally identical and substantially equivalent to the Medrad Continuum MRI-Compatible System and Alaris PC-1 Infusion System (and their respective infusion sets) which are currently being marketed.
They are functionally equivalent in the following areas:
-
- Fluid Overpressure Limit System 1. Patient Infusion Sets
-
- AC/Battery Power Systems
-
- Alarm Detection System 7. Keypad/ Information Display System
-
- Pump Drive and Control System
- Air Bubble Detection System
-
- Communication System
The only notable difference in the technology is the use of a piezo-electric/ultrasonic motor, which is functionally identical to the commonly-used drive motors, but possesses inherent MRI-compatibility due to its immunity to the influence of magnetic fields.
- Communication System
The Iradimed Corporation MRIDIUM 3850 Infusion Pump System uses similar types of technology that are found in the predicate devices listed above. A detailed comparison of these similarities and differences has been performed, and demonstrates equivalence with the predicate devices.
Summary of Performance Testing:
The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System (including the MRidium 1000 Series Infusion Sets) conforms with national and available international product safety standards for infusion therapy, electrical safety, and electromagnetic compatibility. Nonclinical testing has been performed using these standards to establish the device's performance. These include: IEC 60601-1-1; IEC60601-1-2; AAMI/ANSI ID26 (1998); IEC 60601-2-24; and UL2601.
The results of these non-clinical tests allow Iradimed Corporation to conclude that the MRidium™ 3850 MRI Infusion Pump System is substantially equivalent to the Medrad Continuum MRI-Compatible System and Alaris PC-1 Infusion System which are currently being marketed, and that they are as safe and effective as these devices in providing infusion therapy.
2
Additionally, tests demonstrating consideration and mitigation of the identified potential Auditionally, tests demonstrating completed, along with the design reviews, product hazards for this device au vo oting performed prior to product release.
・・
:
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2005
Iradimed Corporation C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K050301
K020201
Trade/Device Name: MRidium 3850 Series MRI Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 7, 2005 Received: February 8, 2005
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becarer bed the device is substantially equivalent (for the referenced above and nave acternillioure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisere prior to fray ave been reclassified in accordance with the provisions of Amendinents, or to devroes and Cosmetic Act (Act) that do not require approval of a premarket the rederal I vod, Drug, and Ocomens , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the rior ston, 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 (1 Mr), it may be subject to Back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the be announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Mosenkis
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s issualled of a busefalles with other requirements
mean that FDA has made a determination that your device Federal accepaires mean that FDA has made a decommanent until Jose administered by other Federal agencies. of the Act of ally rederal statutes and regaranents, including, but not limited to: registration You must comply with an the Act 3 requirements) at 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Bart 800); and and listing (21 CFR Pat 607), laceming (21 CFR Pat 820) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820 requirements as set form in the quality of storms (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) This letter will anow you to begin mailering , bastantial equivalence of your device to a premarket notification. The PDA midml of basilinal of 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), If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation please contact the Office of Occipitalism premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general micrimational and Consumer Assistance at its toll-free Division of Birman (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Quitte Michie MD.
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
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Indications for Use
510(k) Number (if known): Unknown
Device Name: Iradimed Corporation MRidium 3850 series MRI Infusion Pump
Indications For Use:
The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for The Iradimed Corporation's MKU/LDM 3830 Inniston I tis required to interest it is required to infuse
general hospital or clinical use by medical fluid-hefore, during or after general hospital or cimical use by incores protested, during, or after Magnetic patients with intra-venous of mucharing while either in a stationary or mobile
Resonance Imaging (MR) scans, functioning while either in a stationary of mobile Resonance Imaging (MKI) Scans, Iunchoning MRI offision Pump System (including the
position. The specific MRidium 2850 Series MRI Infinitions for as follows: position. The specific MRusion 5650 Series Mr. 4.
MRidium 1000 Series of Infusion Sets) indications for use are as follows:
-
- Useful in the administration of fluids requiring precisely controlled infusions and Useful in the administration of nulus requiring proclession.
including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
- Useful in the administration of fluids requiring precisely controlled infusions and Useful in the administration of nulus requiring proclession.
- other therapeutic nulus.
- Useful in the following delivery routes: arterial, intravenous, spinal,
- subcutaneous, and enteral. subcutaneous, and enteral.
- Useful in the following delivery modes: continuous, intermittent and bolus.
-
- Useful in the following denvely modes. Somators, this product can be useful in
- Although specifically intended for use in the MRI, this product of the liberare
- Although specifically intended for use in are headlications or other healthcare
critical care, anesthesia, neonatal and pediatric applications or other healthcared or critical care, anesthesia, neonatur and pourines of promp can be monitored or supervised by a clinician. - supervised by a cimician.
- Used inside the MRI room mounted outside the 10,000 Gauss line and with Osta misto magnets of field strength of 3.0 Tesla or less.
The MRidium 1000 Series Infusion Sets are intended as accessories to the The MKidlum 1000 Senes Infusion Bow are more in the administration of fluids for precisely controlled infusion rates.
The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater Membrane Oxygenation (ECMO) systems where and result in uncontrolled fluid flow.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(Please do not write below this line-continue on another PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1 --
A.K. m
mi Diro-Oli) ring of Anashesiology, General Hospital, Control. Control. Dental Devices
My Number: K9542341
PACE 11/21 RCVD AT 1/31/2005 7:17:17 PM [Eastern Standard Time] - CSID:407677607 * DURATION (mm-s):08-10