IQ SYSTEM

K981720 · Renaissance Technology, Inc. · DSB · Feb 8, 1999 · Cardiovascular

Device Facts

• Record ID: K981720
• Device Name: IQ SYSTEM
• Applicant: Renaissance Technology, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended 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.

Device Story

IQ™ System is a non-invasive cardiac output monitor utilizing impedance plethysmography. It serves as an alternative to invasive methods like thermodilution. Operated by qualified healthcare practitioners under physician direction in clinical settings. Device measures thoracic electrical impedance to derive cardiac function parameters. Output assists clinicians in hemodynamic management and decision-making for patients where invasive monitoring is contraindicated or impractical. Benefits include reduced patient risk associated with invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Impedance plethysmography-based cardiac output monitor. Class II device (Product Code DSB).

Indications for Use

Indicated for non-invasive monitoring and management of cardiac function in patients where invasive monitoring (e.g., thermodilution) is contraindicated, impractical, or poses risk. For use by qualified healthcare practitioners under physician direction.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K922218

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a semi-circular fashion around the caduceus.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone],

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