Q-STRESS ECHO BED

K021171 · Medical Positioning, Inc. · DPS · May 8, 2002 · Cardiovascular

Device Facts

• Record ID: K021171
• Device Name: Q-STRESS ECHO BED
• Applicant: Medical Positioning, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: May 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Indications for Use

The Q-Stress Echo™ Bed is intended for use in stress echocardiography examination. The Q-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance. The Q-Stress Echo™ Bed incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients. In addition, the stress echo workstation provides "QRS" complex to a cardiac ultrasound device to be used to capture images (heart beats), either digitally or on videotape, such that each image begins at the time systole begins.

Device Story

Integrated stress echocardiography system combining supine bicycle exercise table with Quinton Q-Stress electrocardiograph; provides programmable, controlled variable resistance for exercise; monitors patient ECG during stress testing; outputs QRS complex signal to external cardiac ultrasound device for gated image capture (systole onset); used in clinical settings by healthcare providers; assists in cardiovascular monitoring and diagnostic imaging; benefits patient by enabling synchronized, high-quality stress echocardiographic assessment.

Clinical Evidence

Bench testing only. Physical performance studies and software evaluation conducted to verify system functionality and intended use.

Technological Characteristics

Integrated supine bicycle exercise source and Quinton Q-Stress electrocardiograph (K001492). Features include height adjustability, Trendelenburg, dual/lateral tilt, and computer controllers. Uses standard patient electrodes/leads. Outputs ECG reports, trends, averages, and ST segments.

Indications for Use

Indicated for patients undergoing stress echocardiography examinations to monitor cardiac electrical activity, detect arrhythmias or rate abnormalities, and synchronize cardiac ultrasound image capture with the onset of systole.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Vertex System (Medical Positioning)

Reference Devices

• Quinton Q-Stress electrocardiograph (K001492)

Submission Summary (Full Text)

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O-Stress Echo™ Bed Special Premarket 510(k) Notification

## Koz 117 |

MAY 0 8 2002

#### DEVICE DESCRIPTION 16.4

The Q-Stress Echo™ Bed is a complete integrated stress echocardiography system. The Q-Stress Echo™ Bed combines the Stress Echo™ Bed / Table with an electrocardiograph. The Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance, while the ECG provides the patient monitoring and recording. Several models of the Stress Echo Bed/Table are available with features that include height adjustability, Trendelenburg, dual, lateral tilt, and computer controllers.

#### SUBSTANTIAL EQUIVALENCE 16.5

The Q-Stress Echo™ Bed is substantially equivalent to the Vertex System in commercial distribution by Medical Positioning. The Q-Stress Echo™ Bed and the predicate device incorporate the same Stress Echo™ Bed and an electrocardiograph. The Q-Stress Echo™ Bed incorporates the Q-Stress electrocardiograph manufactured by Quinton Instruments.

The fundamental technical characteristics of the Q-Stress Echo™ Bed and the Vertex System are equivalent and are listed on the comparison charts provided in this 510(k) submission. The Q-Stress Echo™ Bed and the Vertex System function by providing the user with an integrated exercise source and electrocardiograph for use during cardiovascular monitoring.

#### INTENDED USE 16.6

The O-Stress Echo™ Bed is intended for use in stress echocardiography examination. The Q-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance.

The Q-Stress Echo™ Bed incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients.

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In addition, the Q-Stress Echo™ Bed provides "QRS" complex to a cardiac ultrasound device to be used to capture images (heart beats), either digitally or on videotape, such that each image begins at the time systole begins.

#### TECHNOLOGICAL CHARACTERISTICS 16.7

The technological characteristics of the Q-Stress Echo™ Bed are equivalent to those of the Vertex System. The Q-Stress Echo™ Bed utilizes a supine bicycle for the exercise source. Preprogrammed exercise protocols are run for purposes of electrocardiographic monitoring. The ECG used in the Q-Stress Echo™ Bed is the Quinton Q-Stress electrocardiograph that has been cleared for commercial distribution under K001492. ECG reports, trends, averages and ST segments are printed by the Q-Stress Echo™ Bed. The Q-Stress Echo™ Bed is connected using standard patient electrodes and leads that are not included in the system.

#### 16.8 PERFORMANCE DATA

The Q-Stress Echo™ Bed was subjected to performance bench testing. Physical performance studies and software evaluation were conducted to verify that the Q-Stress Echo™ Bed performed as intended.

#### CONCLUSIONS 16.9

This notification contains all information required by 21 CFR 807.87. The Q-Stress Echo™ Bed was found to perform as intended during verification and validation testing. The Q-Stress Echo™ Bed is substantially equivalent to the current Vertex System in commercial distribution. The Q-Stress Echo™ Bed is intended for use in stress echocardiography examination. The Q-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance.

p.212

15021171

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 8 2002

Medical Positioning, Inc. c/o Ms. Carol Patterson President Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, CA 92630

Re: K021171

Trade Name: Q-Stress Echo™ Bed Regulation Name: Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulatory Class: Class II (two) Product Code: 74 DPS Dated: April 11, 2002 Received: April 12, 2002

Dear Ms. Patterson:

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.

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## Page 2 - Ms. Carol Patterson

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 and additionally 21 CFR Part 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neda Tuh

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Q-Stress Echo™ Bed Special Premarket 510(k) Notification

# INDICATIONS FOR USE

510(k) Number:

KOZ 117 1

Device Name:

Q-Stress EchoTM Bed

Indications for Use:

The Q-Stress Echo™ Bed is intended for use in stress echocardiography examination. The Q-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance.

The Q-Stress Echo™ Bed incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients. In addition, the stress echo workstation provides "QRS" complex to a cardiac ultrasound device to be used to capture images (heart beats), either digitally or on videotape, such that each image begins at the time systole begins.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oelk Tell
Division of Cardiovascular & Respiratory Devices
510(k) Number K021171

OR

Prescription Use \$\checkmark\$

Over-The-

Over-The-Counter Use

(Per 21 CFR 801.109)

CONFIDENTIAL