(89 days)
Not Found
Not Found
No
The description mentions using ECG data, patient demographics, and chest pain status to produce a numerical score, which is a common approach in traditional statistical modeling or rule-based systems, not necessarily AI/ML. There is no mention of AI, ML, or related terms like neural networks or deep learning. The performance studies compare it to a predicate device from the same era, which is unlikely to have incorporated AI/ML.
No
The device aids in diagnosis by predicting the probability of acute cardiac ischemia; it does not directly treat or provide therapy to the patient.
Yes
The device is described as aiding the physician's decision-making process by providing a "predicted probability of acute cardiac ischemia," which directly relates to diagnosing a condition. It uses ECG data and patient information to produce a numerical score for diagnostic purposes.
No
The device is described as a "software option for Marquette MAC-series electrocardiographs," indicating it is integrated into existing hardware (electrocardiographs) and is not a standalone software product.
Based on the provided information, this device 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.
- Device function: The ACI-TIPI device analyzes recorded ECG data along with patient demographic and chest pain status. ECG data is a measurement of electrical activity of the heart, not a sample taken from the body for analysis of its components.
- Intended Use: The intended use clearly states it utilizes "recorded ECG data" and patient information to produce a score.
Therefore, while it's a medical device used in a clinical setting to aid in diagnosis, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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 utilizing recorded ECG data 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 substitute 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.
Product codes (comma separated list FDA assigned to the subject device)
GXZ
74 LOS
Device Description
Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is a software option for Marquette MAC-series electrocardiographs to aid the physician's decision-making process in a chest pain setting by using patient age, gender, chest pain status and ECG features to provide the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ECG data
Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
competent health professionals, hospital or clinic environment
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 following quality assurance measures were applied to the development of ACI-TIPI.
Requirements specification review, software testing and field tests of the ACI-TIPI analysis. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hewlett- Packard Model 1791A ACI-TIPI
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Antony R. H. Fender · Official FDA Correspondent Jack's Electrodes, Inc. 2227 East Crescent Drive Altadena, California 91001
JAN 28 1998
Re: K974119 Disposable Needle Electrode (ALM and DLM) Trade Name: Regulatory Class: II Product Code: GXZ Dated: September 4, 1997 Received: October 31, 1997
Dear Mr. Fender:
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 The general controls provisions of the Act 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. ನ್ನ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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. Antony R. H. Fender
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
FEB 6 1998
f
SECTION 2 - SUMMARY AND CERTIFICATION
510(k) Summary of Safety and Effectiveness
് This Summary of 810(k) 590 and 21 CFR 807.92.
| Submitter: | Marquette Medical Systems, Inc.
8200 W. Tower Avenue
Milwaukee, WI 53223
Telephone: (414) 355-5000
FAX: (414) 362-3553 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristin Pabst |
| Device: | Trade Name: Acute Cardiac Ischemia Time-Insensitive Predictive
Instrument (ACI-TIPI) Option
Classification Name: Computer, diagnostic, programmable
Detector and Alarm, Arrhythmia |
| Predicate Device: | Hewlett- Packard Model 1791A ACI-TIPI |
| Device Description: | Acute Cardiac Ischemia Time-Insensitive Predictive Instrument
(ACI-TIPI ) Option is a software option for Marquette MAC-series
electrocardiographs to aid the physician's decision-making process in
a chest pain setting by using patient age, gender, chest pain status
and ECG features to provide the predicted probability of acute cardiac
ischemia (which includes unstable angina pectoris and acute
myocardial infarction). |
| 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 utilizing recorded
ECG data 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 substitute 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. |
| Technology: | ACI-TIPI option employs the same technology as the predicate
device. |
| Performance: | The following quality assurance measures were applied to the
development of ACI-TIPI.
Requirements specification review, software testing and field tests of
the ACI-TIPI analysis. |
Image /page/2/Picture/7 description: The image shows a sequence of six symbols. The first five symbols appear to be the number zero, each represented in a similar outlined style. The sixth symbol is a stylized image of a horse head, possibly representing a chess piece, rendered in solid black.
3
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.
. එ
1255
4
Image /page/4/Picture/10 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Rockville MD 20857
FEB 6 1998
Ms. Kristin Pabst Regulatory Affairs Manager Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223
Re : K974199 Acute Cardiac Ischemia Time-Intensive Predictive Instrument (ACI-TIPI) Option Requlatory Class: III (three) Product Code: 74 LOS November 7, 1997 Dated: 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (Q&) 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 regulations.
5
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 (301) 594-4648. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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 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-TIP! is intended for adult patient populations.
M. Puye
510(k) Num