PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM

K972255 · Pulse Biomedical, Inc. · LOS · Jul 7, 1998 · CV

Device Facts

• Record ID: K972255
• Device Name: PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
• Applicant: Pulse Biomedical, Inc.
• Product Code: LOS · CV
• Decision Date: Jul 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Attributes: Pediatric

Intended Use

This device is intended for use as a patient monitor for any patient undergoing ECG ST Segment Analysis and/or ECG Stress Analysis during resting or exercise. Exercise can be performed during treadmill or bicycle ergometer use. This device is capable of performing automatic computerized ECG Interpretation during resting condition. This device does not support automatic ECG Interpretation for neonatal use. The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

Device Story

QRS Card™ S-T Segment Analysis Patient Monitoring System III monitors ECG signals during rest or exercise. Device inputs include ECG data; processes signals to perform ST segment analysis and automatic computerized ECG interpretation (excluding neonates). Used in hospitals, physician offices, and rehabilitation facilities by clinicians. Output provides diagnostic ECG data to assist physicians in clinical decision-making regarding cardiac status. System facilitates patient monitoring during treadmill or bicycle ergometer stress testing.

Technological Characteristics

ECG monitoring system for ST segment and stress analysis. Features automatic computerized ECG interpretation capabilities. Designed for clinical/hospital environments. Not for home use.

Indications for Use

Indicated for patients undergoing ECG ST Segment Analysis and/or ECG Stress Analysis during rest or exercise (treadmill/bicycle). Not indicated for neonatal automatic ECG interpretation. For use by or on order of physician/qualified healthcare professional in clinical/hospital settings.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three profiles, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 7 1998

Mr. Saleem Hasan Pulse Biomedical, Inc. 935 S. Trooper Road Norristown, PA 19403

Re: K972255 The QRS Card™ S-T Segment Analysis Patient Monitoring System III (three) Requlatory Class: Product Code: 74 LOS May 4, 1998 Dated: Received: May 6, 1998

Dear Mr. Hasan:

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 (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). 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 (Premarket Approval), 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 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any 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.

{1}------------------------------------------------

## Page 2 - Mr. Saleem Hasan

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/dsmamain.html".

Sincerely yours,

## Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

RE: K972255

## INDICATION FOR USE

This device is intended for use as a patient monitor for any patient undergoing ECG ST Segment Analysis and/or ECG Stress Analysis during resting or exercise. Exercise can be performed during treadmill or bicycle ergometer use.

This device is capable of performing automatic computerized ECG Interpretation during resting condition. This device does not support automatic ECG Interpretation for neonatal use.

The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

Prescription Use \$\checkmark\$

Mark Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number