(25 days)
The device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device may interface with external devices, including a treadmill or ergometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device is intended for adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.
Q-Stress and HeartStride are diagnostic devices capable of ECG monitoring; ST analysis and ventricular ectopic beat detection; generation, review, and storage of stress reports; and treadmill or ergometer control. These devices consist of a patient cable, preamplifier, PC, display, mouse, printer, keyboard, and isolation power supply. Approved serial devices such as non-invasive blood pressure measurement may be supported by these devices. Electrocardiographic data is obtained by the preamplifier and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.
The provided text is a 510(k) summary for the Cardiac Science Corporation's Q-Stress and HeartStride devices. It describes the devices, their intended use, and their substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies.
The document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device (K001492, Q-Stress). In such submissions, extensive clinical studies with detailed performance metrics are often not required if the new device shares the same intended use, technological characteristics, and fundamental principles of operation as a legally marketed predicate device. The FDA typically relies on the established safety and effectiveness of the predicate.
Therefore, I cannot provide the requested information based on the input text. The table and other details you asked for are not present in this 510(k) summary.
{0}------------------------------------------------
Cardiac Science Corporation Bothell, WA Special 510K July 30, 2008
AUG 2 6 2008
11. 510(k) Summary
Name of Device A.
Trade name: Q-Stress and HeartStride Common name: Stress system Classification name: Electrocardiograph
B. Predicate Devices
| Device Name | Premarket Notification |
|---|---|
| Q-Stress | K001492 |
C. Device description
Q-Stress and HeartStride are diagnostic devices capable of ECG monitoring; ST analysis and ventricular ectopic beat detection; generation, review, and storage of stress reports; and treadmill or ergometer control. These devices consist of a patient cable, preamplifier, PC, display, mouse, printer, keyboard, and isolation power supply. Approved serial devices such as non-invasive blood pressure measurement may be supported by these devices. Electrocardiographic data is obtained by the preamplifier and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.
The differences between the Q-Stress and HeartStride are as follows:
-
- System Specifications/ Firmware
- a. HeartStride system specifications are the same as the Q-Stress. HeartStride could also be available as a software only product. The PC, monitor, mouse, and printer may be supplied by the customer, however, they must meet Cardiac Science Corporation (CSC) specifications.
- b. Q-Stress reports can be printed using chart recorder or laser printer. However, HeartStride reports can only be printed using laser printer.
1 3
Page of 40
Confidential
{1}------------------------------------------------
- c. Remote keypad and external hard drive are available with Q-Stress, but not with HeartStride.
-
- Software
- a. HeartStride has a different toolbar and provides a testing wizard.
- b. Different options are available with the Q-Stress and the HeartStride device.
Q-Stress:
- Network
- Q-Exchange (includes Q-Exchange+)
- Full Disclosure -
- Freeze Frame
- Risk Scoring
- Re-analysis
- Ramped Protocol Generator
- Custom Reports
- SpO2
- Interface to TMX425
HeartStride:
- Network
- -Q-Exchange (does not include Q-Exchange+)
- QRS sync and Analog outs
- Interface to TMX425
D. Intended use
The device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device may interface with external devices, including a treadmill or ergometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device is intended for use in adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.
Confidential
{2}------------------------------------------------
E. Summary
The intended use, indication for use, and principle of operation are substantially equivalent to the predicate devices. We believe that the modifications to the device do not raise any new questions of safety and/or effectiveness.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2008
Cardiac Sciences Corporation c/o Ms. Beverly Magrane Senior Manager RA/RC 3303 Monte Villa Parkway Bothell, WA 98201-8969
Re: K082173
Trade/Device Name: Q-Stress and HeartStride Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: July 30, 2008 Received: August 1, 2008
Dear Ms. Magrane:
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807);
{4}------------------------------------------------
Page 2 - Ms. Beverly Magrane
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillaree at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
{5}------------------------------------------------
Cardiac Science Corporation Bothell, WA Special 510K July 30, 2008
l. Indications for Use Statement
510(k) Number: TBD
Device Name: Q-Stress and HeartStride
Indications for Use:
The device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device may interface with external devices, including a treadmill or ergometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device is intended for adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use X (Per 21 CFR 801.109)
| Over-The Counter Use | |
|---|---|
| - Real Property |
ion of Cardiovascular Devices
Confidential
KORZI73 510(k) Number
OR
Page 3 of 40
§ 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).