(279 days)
As with predicate devices indicated in this resubmittal (cardiac output monitors employing impedance plethysmography {DXG and DSB}), the IQ™ System is intended for use by qualified health care practitioners, under direction of a physician, for the non-invasive monitoring and management of cardiac function in a variety of medically accepted clinical applications. The IQ™ System (as well as predicate devices) is especially useful in cases where the invasive monitoring of cardiac output (e.g.: thermodilution) may compromise a given patient, is impractical, or otherwise contraindicated.
"IQ™ System" Cardiac Output Monitor
The provided document is a 510(k) clearance letter from the FDA for the "IQ™ System" Cardiac Output Monitor. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or the study information usually found in a submission or a summary of safety and effectiveness data.
Therefore, I cannot provide the requested information based solely on the provided text. The document is essentially a regulatory approval letter, not a technical report or study summary.
To answer your request thoroughly, I would need to access the full 510(k) submission (K981720) itself, or a summary of safety and effectiveness that would typically accompany such a submission. This document only confirms the device's clearance and its intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB -8 1999
Mr. Philip E. Hamski Vice President of Research and Product Development Renaissance Technology, Inc. 170 Pheasant Run, Suite 200 Newton, PA 18940
Re: K981720/S1 IO System Trade Name: Requlatory Class: II Product Code: DSB Dated: November 17, 1998 Received: November 18, 1998
Dear Mr. Hamski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). 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 misbrandinq and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note:this response to your premarket notification submission does not affect any
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Page 2 - Mr. Philip E. Hamski
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K981720 K922218 __ Previously approved as:
"IQ™ System" Cardiac Output Monitor Device Name:
Indications For Use:
As with predicate devices indicated in this resubmittal (cardiac output monitors employing impedance plethysmography {DXG and DSB}), the IQ™ System is intended for use by qualified health care practitioners, under direction of a physician, for the non-invasive monitoring and management of cardiac function in a variety of medically accepted clinical applications.
The IQ™ System (as well as predicate devices) is especially useful in cases where the invasive monitoring of cardiac output (e.g.: thermodilution) may compromise a given patient, is impractical, or otherwise contraindicated.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Wolf Sapúski
Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
(Optional Format 1-2-96)
510(k) Number _
OR
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.