(24 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard infusion pump functionalities.
Yes
The device is used for the administration of therapeutic fluids, including drugs and antibiotics, which are used to treat medical conditions.
No
The device is a syringe infusion pump for administering fluids and drugs, not for diagnosing medical conditions. Its indications for use focus on fluid delivery parameters and settings, not on detecting or identifying diseases.
No
The device is described as a "MRI Syringe Infusion Pump," which is inherently a hardware device designed to administer fluids. The description of its intended use and delivery routes further confirms it is a physical pump, not a software-only application.
Based on the provided information, the Medex 3000 Series MRI Syringe Infusion Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use of the Medex 3000 is to administer fluids into the body (arterial, epidural, intravenous, spinal, subcutaneous, and enteral routes).
- The device description and intended use focus on fluid delivery and control within a clinical setting. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
The Medex 3000 is a medical device used for therapeutic purposes (administering fluids and medications), not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows:
- in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
- in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral.
- in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
- in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
- inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla or less.
The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
neonatal and pediatric applications
Intended User / Care Setting
clinician / critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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)
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2004
Ms. Barbara Law Regulatory Affairs Manager Medex, Incorporated 6250 Shier-Rings Road Dublin, Ohio 43016
Re: K040899
Trade/Device Name: Medex 3000 Series MRI Syringe Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 19, 2004 Received: April 6, 2004
Dear Ms. Law:
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 111 (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.
1
Page 2 - Ms. Law
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) 594-46. 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,
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
K040899 510(k) Number (if known):
Device Name:
Medex 3000 series MRI Syringe Infusion Pump
Indications for Use:
The Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows:
- · in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
- · in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral.
- · in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
- in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
- · inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla or less.
The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.
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)
Vick Hubbard for ADW
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of
510(k) Number: K