ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION

K974199 · Marquette Medical Systems, Inc. · LOS · Feb 6, 1998 · CV

Device Facts

• Record ID: K974199
• Device Name: ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
• Applicant: Marquette Medical Systems, Inc.
• Product Code: LOS · CV
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional

Intended Use

Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals . TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitue for the physician's decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings. ACI-TIPI is intended for adult patient populations.

Device Story

Software option for Marquette MAC-series electrocardiographs; processes patient age, gender, chest pain status, and ECG features; calculates numerical score representing probability of acute cardiac ischemia; used by clinicians in hospital/clinic settings; supplements physician decision-making; intended to aid in chest pain assessment; does not replace clinical judgment; requires integration with patient history, physical exam, and ECG tracing.

Clinical Evidence

Bench testing only. Quality assurance measures included requirements specification review, software testing, and field tests of the ACI-TIPI analysis.

Technological Characteristics

Software option for Marquette MAC-series electrocardiographs. Uses same technology as predicate device. Operates on recorded ECG data combined with patient demographic and clinical inputs.

Indications for Use

Indicated for adult patients presenting with chest pain in hospital or clinic settings to assist physicians in assessing the probability of acute cardiac ischemia (unstable angina pectoris or acute myocardial infarction).

Predicate Devices

• Hewlett-Packard Model 1791A ACI-TIPI

Submission Summary (Full Text)

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# K974199

# SECTION 2 - SUMMARY AND CERTIFICATION

FEB 6 1998

## -2.1 510(k) Summary of Safety and Effectiveness

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter: | Marquette Medical Systems, Inc.<br>8200 W. Tower Avenue<br>Milwaukee, WI 53223<br>Telephone: [phone]<br>FAX: [phone] |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristin Pabst |
| Device: | Trade Name: Acute Cardiac Ischemia Time-Insensitive Predictive<br>Instrument (ACI-TIPI) Option<br>Classification Name: Computer, diagnostic, programmable<br>Detector and Alarm, Arrhythmia |
| Predicate Device: | Hewlett-Packard Model 1791A ACI-TIPI |
| Device Description: | Acute Cardiac Ischemia Time-Insensitive Predictive Instrument<br>(ACI-TIPI ) Option is a software option for Marquette MAC-series<br>electrocardiographs to aid the physician's decision-making process in<br>a chest pain setting by using patient age, gender, chest pain status<br>and ECG features to provide the predicted probability of acute cardiac<br>ischemia (which includes unstable angina pectoris and acute<br>myocardial infarction). |
| Intended Use: | Acute Cardiac Ischemia Time-Insensitive Predictive Instrument<br>(ACI-TIPI ) Option is intended to be used in a hospital or clinic<br>environment by competent health professionals utilizing recorded<br>ECG data to produce a numerical score which is the predicted<br>probability of acute cardiac ischemia. Like any computer-assisted ECG<br>interpretation program, the Marquette ACI-TIPI evaluation and<br>probability score is intended to supplement, not substitute for the<br>physician's decision process. It should be used in conjunction with<br>knowledge of the patient's history, the results of a physical<br>examination, the ECG tracing, and other clinical findings.<br>ACI-TIPI is intended for adult patient populations. |
| Technology: | ACI-TIPI option employs the same technology as the predicate<br>device. |
| Performance: | The following quality assurance measures were applied to the<br>development of ACI-TIPI. |
| | Requirements specification review, software testing and field tests of<br>the ACI-TIPI analysis. |

510(k) Notification "ACI-TIPI" November 7, 1997
66

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The results of these measurements demonstrated that ACI-TIPI analysis is as safe, as effective, and performs as well as the predicate device, Hewlett-Packard Model 1791A ACI-TIPI.

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31

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Rockville MD 20857

#### FEB 6 1998

Ms. Kristin Pabst Regulatory Affairs Manager Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223

K974199 Re : Acute Cardiac Ischemia Time-Intensive Predictive Instrument (ACI-TIPI) Option Regulatory Class: III (three) Product Code: 74 LOS Dated: November 7, 1997 Received: November 10, 1997 -------

Dear Ms. Pabst:

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 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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 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 requlations.

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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 requlation (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 regulation 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. Callahan

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

Enclosure

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#### 6 1998 FEB

### SECTION 11 - INTENDED USE STATEMENT

Unknown - 510(k) filed August 29, 1997 510(k) Number (if known):

Device Name: Acute Cardiac Ischemia Time-Insensitive Instrument (ACI-TIPI)

Indications For Use:

Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals . TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitue for the physician's decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings.

ACI-TIPI is intended for adult patient populations.

M. Puye
(Division Sign-Off)

and Seurolog 510(k) Num

12

23