(90 days)
No
The document describes a system for monitoring and recording cardiovascular data using standard signal processing and data acquisition techniques. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is strictly for monitoring, calculating, and recording cardiovascular data for diagnostic and procedural guidance during cardiac catheterization. It does not provide any therapeutic intervention.
Yes
The device is used to monitor, calculate, and record cardiovascular data, including ECG waveforms, heart rate, hemodynamics, and blood pressure. These measurements are used to assess the patient's physiological state and can indicate the presence of a disease or condition, which is a diagnostic function.
No
The device description explicitly states that the MAC-LAB System includes hardware components such as the TRAM module housed in a Remote Acquisition Unit (RAU), computer processors, display monitors, power supply, thermal printer, keyboard, and optional IECG module.
Based on the provided information, the MAC-LAB System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used to "monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization." This involves collecting data directly from the patient's body (ECG, blood pressure, etc.) during a medical procedure.
- Device Description: The description details how the system acquires and processes physiological signals from the patient via modules and cables connected to the body or catheters.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The MAC-LAB System does not perform any analysis on such specimens.
The MAC-LAB System is a physiological monitoring and data acquisition system used in a clinical setting for real-time patient assessment during cardiac procedures.
N/A
Intended Use / Indications for Use
The MAC-LAB Systems are intended for use under the direct supervision of a licensed healthcare practitioner. The device is intended to monitor and/or calculate and/or record cardiovascular data from patients as they undergo catheterization of the heart and circulatory system. Data includes: ECG waveforms, heart rate, pulse oximetry, respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems.
The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Marquette TRAM modules (K921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO-), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG).
Product codes (comma separated list FDA assigned to the subject device)
74-DQK
Device Description
The MAC-LAB Systems ioin together the TRAM module which is housed in a Remote Acquisition Unit (RAU) with computer processors, software, high resolution display monitors, power supply, thermal printer and a keyboard. Data acquisition modules, depending upon application, are inserted into the RAU and then digital data is transmitted, via cable, to the computers for processing. An optional IECG module (K935394) enables electrophysiological investigations of the heart to be performed. The IECG module consists of electronic amplifiers and other signal processing devices. An IECG cable connects an intracardiac catheter (not covered by this submission) to the IECG system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart and circulatory system
Indicated Patient Age Range
Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization
Intended User / Care Setting
Intended for use in catheterization and related cardiovascular specialty labs.
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 MAC-LAB complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the MAC-LAB System: . Requirements specification review, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final validation. The results of these measurements demonstrated that the MAC-LAB system is as safe, as effective, and performs as well as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Devic
Cor
GE Marquette Medical Systems, Inc.
Section 2: 510(k) Summary of Safety and Effectiveness
| Date: August 28, 1999 | |
|---|---|
| Submitter: | GE Marquette Medical Systems |
| 100 Marquette Drive | |
| Jupiter, FL USA | |
| Contact Person: | Maria Vitug Fouts |
| Sr. Regulatory Compliance Specialist | |
| GE Marquette Medical Systems | |
| Phone: (410) 573-6294 | |
| Fax: (410) 897 - 6294 | |
| Trade Name: | MAC-LAB System |
| Common/Usual Name: | MAC-LAB, MAC-LAB System EX |
| Classification Names: | 21 CFR 870.1425 Programmable Diagnostic Computer |
| Predicate Devices: | MAC-LAB Cardiac System, |
| K895801, SE date: 04 April 1990 |
MAC-LAB Electrophysiology (IECG)Option, K935394, SE date: 20 October 1994
- Device Description: The MAC-LAB Systems ioin together the TRAM module which is housed in a Remote Acquisition Unit (RAU) with computer processors, software, high resolution display monitors, power supply, thermal printer and a keyboard. Data acquisition modules, depending upon application, are inserted into the RAU and then digital data is transmitted, via cable, to the computers for An optional IECG module (K935394) processing. enables electrophysiological investigations of the heart to be performed. The IECG module consists of electronic amplifiers and other signal processing devices. An IECG cable connects an intracardiac catheter (not covered by this submission) to the IECG system.
- The MAC-LAB Systems are intended for use under the direct supervision of Intended Use: a licensed healthcare practitioner. The device is intended to monitor and/or calculate and/or record cardiovascular data from patients as they undergo catheterization of the heart and circulatory system. Data includes: ECG waveforms, heart rate, pulse oximetry, respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems.
Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization
Intended for use in catheterization and related cardiovascular specialty labs.
1
GE Marquette Medical Systems, Inc.
Section 2: 510(k) Summary of Safety and Effectiveness, continued
The proposed MAC-LAB Cardiac Catheterization Laboratory System Technology: employs the same functional technology as the predicate devices.
- Test Summary: The MAC-LAB complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the MAC-LAB System:
- . Requirements specification review
- Code inspections .
- . Software and hardware testing
- . Safety testing
- Environmental testing .
- Final validation .
- Conclusion: The results of these measurements demonstrated that the MAC-LAB system is as safe, as effective, and performs as well as the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 1999
Ms. Maria Vitug Fouts Senior Requlatory Compliance Specialist GE Marquette Medical Systems A GE Medical Systems Company 200 Harry S. Truman Parkway, Suite 220 Annapolis, Maryland 21401
Re: K992948 Trade Name: MAC-LAB System Version 18A Requlatory Class: 2 Product Code: 74-DQK Dated: August 28, 1999 Received: August 31, 1999
Dear Ms. Fouts:
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, Druq, 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 reqistration, 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 Requlations, 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
3
Page 2 - Ms. Maria Vitug Fouts
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4645. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "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/dsma/dsmamain.html".
Sincerely yours,
Dank Miller
lia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
MAC-LAB System Device Name:
Indications For Use:
The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Marquette TRAM modules (K921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO-), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG).
Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization
Intended for use in catheterization and related cardiovascular specialty labs
Note: Catheterization devices are not provided or offered for use with the MAC-LAB system.
*To be assigned by FDA upon receipt of 510(k) submission
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division 3)
Division of Cardiovascular, Respiratory,
and Neurological Devices,
510(k) Number K992948
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)