(72 days)
The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids intravenously, during an MR procedure. The Continuum is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure, functioning while stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
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I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a medical device (Medrad Continuum MR Compatible Infusion System), along with its intended use and indications for use.
This type of document primarily confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. It defines the device, its intended use, and indicates its regulatory class. However, it does not contain details about specific acceptance criteria for performance, study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies. These details would typically be found in the more comprehensive 510(k) submission itself, which is not provided here.
Therefore, I cannot populate the table or answer the specific questions about the study and acceptance criteria based on this text alone.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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AUG 2 9 2002
Medrad, Incorporated C/O Mr. Robert Mosenkis Responsible Third Party CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K021988
Trade/Device Name: Medrad Continuum MR Compatible Infusion System Regulation Number: 880.5725 and 880.5440 Regulation Name: Infusion Pump and Intravascular Administration Set Regulatory Class: II Product Code: FRN and FPA Dated: August 23, 2002 Received: August 26, 2002
Dear Mr. Mosenkis:
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.
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.
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Page 2 - Mr. Mosenkis
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Timot Direct 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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Intended Use
Indications for Use Statement
510(k) Number:
Device Name:
.
Medrad Continuum MR Compatible Infusion System
Indications for Use:
The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids intravenously, during an MR procedure. The Continuum is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure, functioning while stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cucuriti
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devi
510(k) Number: K621988
• Medrad, Inc. • 510(k) Premarket Submission • Medrad Continuum MR Compatible Infusion System . Response 1 Confidential .
§ 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).