(26 days)
Not Found
No
The summary describes a system for stress echocardiography that combines an exercise bed and an electrocardiograph. It mentions capturing images and ECG data but does not describe any analytical or interpretive functions that would typically involve AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used to facilitate stress echocardiography examinations by providing an exercise source and monitoring the heart's electrical activity. This information is used to diagnose or assess cardiac health, which aligns with the definition of a therapeutic device designed for diagnosis, treatment, or prevention of disease.
Yes
The device is described as incorporating an electrocardiograph that records normal conditions or patterns of arrhythmia and/or rate abnormalities, and provides "QRS" complex to a cardiac ultrasound device to capture images. This information, along with the stress echocardiography examination, directly points to the device being used to identify or analyze physiological states (arrhythmia, rate abnormalities, and heart function under stress), which is characteristic of a diagnostic device.
No
The device description explicitly states it is a "complete integrated stress echocardiography system" that "combines the Stress Echo™ Bed / Table with an electrocardiograph." This indicates the device includes significant hardware components (bed/table and ECG hardware) in addition to any software.
Based on the provided information, the Q-Stress Echo™ Bed is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Q-Stress Echo™ Bed function: The Q-Stress Echo™ Bed is a medical device used for stress echocardiography. This involves exercising a patient and monitoring their heart's electrical activity (ECG) and structure/function (ultrasound imaging) in real-time. It is a diagnostic procedure performed on the patient's body, not on a sample taken from the body.
- No mention of samples: The description focuses on the bed as an exercise source, an electrocardiograph for monitoring, and integration with an ultrasound device for imaging. There is no mention of analyzing biological samples.
Therefore, the Q-Stress Echo™ Bed falls under the category of in vivo diagnostic devices or therapeutic devices used in a diagnostic context, rather than in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
74 DPS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The Q-Stress Echo™ Bed was found to perform as intended during verification and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
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.
1
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
2
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.
3
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 (301) 594-4646. 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,
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
4
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