(54 days)
Not Found
No
The summary describes standard ECG analysis and interpretation features, with no mention of AI or ML technologies. The "hookup advisor" is based on noise measurement, not AI/ML.
No.
The device is described as an ECG acquisition, analysis, and recording system, which is used for diagnosis and monitoring, not for providing therapy or treatment.
Yes
The device is intended to acquire, analyze, display, and record information, and can be upgraded to provide software options such as 12-lead ECG measurement and interpretive analysis, which are diagnostic functions. The "hookup advisor" also provides quality information based on noise measurement, further supporting its role in assessing a patient's physiological state.
No
The device description explicitly mentions hardware components such as an integrated 7" color display, an integrated thermal writer, optional internal memory and removable storage, and an optional barcode reader. It is described as a "system" that includes acquisition and recording, which implies hardware.
Based on the provided information, the MAC1600 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The MAC1600 acquires, analyzes, displays, and records information directly from the patient's body using surface electrodes. It does not process or analyze biological samples like blood, urine, or tissue.
- The intended use and device description clearly state its function is to record and analyze electrical signals from the heart. This is a physiological measurement, not an in vitro diagnostic test.
The MAC1600 is a medical device used for electrocardiography (ECG), which is a non-invasive method of recording the electrical activity of the heart.
N/A
Intended Use / Indications for Use
The MAC1600 is a portable ECG acquisition, analysis and recording system. The MAC1600 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode. The basic systems shall print 6 or 12-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. The basic system shall be upgradeable with a third mode of operation: (3) Exercise mode for exercise stress testing. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is also optional. The arrhythmia detection portion of the MAC 1600 is provided to the customer for the convenience of automatic documentation.
The MAC1600 is used under the direct supervision of a licensed healthcare practitioner.
The MAC 1600 is not designed to provide alarms for arrhythmia detection.
The device is not suitable for intra cardiac application.
It is not intended for use:
As a vital signs physiological monitor; or For use during patient transport.
Product codes (comma separated list FDA assigned to the subject device)
DPS, DQK, DXH
Device Description
The MAC 1600 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. MAC1600 is also capable of acquiring 2 additional ECG leads beyond what is needed for classical 12 lead ECG acquisition. The MAC 1600 will provide, in resting ECG mode, ECG quality information using the hookup advisor. The hookup advisor advises users of poor lead quality based on noise measurement. It can be upgraded to provide options such as ECG measurement and interpretation with 12SL as well as a stress testing option for exercise stress testing. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is also optional. Multiple QT correction formulas including Bazett, Framingham and Fridericia will be available as a user selectable option. Clinical Trials Data Guard and audit trail options are also available to support electronic record requirements.
The MAC 1600 delivers multiple leads of ECG on full-size reports and includes an alphanumeric keyboard for patient demographics and other data entry, an integrated 7" color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non real time reports. The device will have optional internal memory and removable storage to store resting ECG records. An optional barcode reader to enter patient information is available. The MAC 1600 can be used as a portable unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years.
Intended User / Care Setting
trained operators in a hospital or medical professional's facility 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)
Not Found
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.
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
§ 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).
0
KC8/437
p 1/3
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, while the background is white.
GE Medical Systems
Information Technologies
510(k) Summary 5.0
JUL 1 5 2008
Applicant and Contact Information 5.1
| 5.1.1 Submitter/Manufacturing
Information | GE Medical Systems Information Technologies
9900 Innovation Drive
Wauwatosa, WI 53226 | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.1.2 Establishment Registration
[per 21 CFR 807.87(b)] | Active; Awaiting Assignment of Registration Number | |
| 5.1.3 Contact Person | Primary: | Margaret Mucha
Regulatory Affairs Leader
GE Medical Systems Information Technologies
RP-2122
9900 Innovation Drive
Wauwatosa, WI 53226
Telephone: 414-721-4535
Fax: 414-721-3863
E-mail: margaret.mucha@ge.com |
| | Secondary: | Matthias Buerger
Director QA/RA Diagnostic Cardiology
GE Medical Systems Information Technologies
RP-2122
9900 Innovation Drive
Wauwatosa, WI 53226
Telephone: 414-721-2317
Fax: 414-721-3899
E-mail: Matthias.Buerger@ge.com
Tracey Fox
Regulatory Programs Manager
GE Healthcare
3000 N. Grandview Blvd W-418
Waukesha, WI 53188
Telephone: (262) 513-4061
E-mail: Tracey.Fox@ge.com |
5.2 Basic Device Identification
| 5.2.1 | Device Name | MAC 1600 ECG Analysis System | ||
|---|---|---|---|---|
| 5.2.2 | Device Proprietary Name | |||
| [per 21 CFR 807.87(a)] | MAC 1600 ECG Analysis System | |||
| 5.2.3 | Common/Usual Name | |||
| [per 21 CFR 807.87(a)] | Electrocardiograph | |||
| 5.2.4 Classification | ||||
| Names/Numbers and | ||||
| Code | ||||
| [per 21 CFR807.87(a)] | 21 CFR | Classification Name | Code | |
| 870.2340 | Electrocardiograph | DPS | ||
| 870.1425 | Programmable Diagnostic Computer | DQK | ||
| 870.2920 | Transmitters and Receivers, | |||
| Electrocardiograph, Telephone | DXH | |||
| 5.2.5 | Regulatory Class | |||
| [per 21 CFR 807.87(c)] | II |
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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.
.
GE Medical Systems
Information Technologies
Information Technologies
| 5.2.6 | Prescription Status | Prescription Device |
|---|---|---|
| 5.2.7 | Device/Classification Panel | |
| [per 21 CFR 807.87(c)] | Cardiovascular | |
| 5.2.8 | Predicate Device | CardioSmart ST V1.3 (K973403) and CASE/Cardiosoft (K031561) |
| 5.2.9 | Sterilization Site | Not Applicable, device is sold in a non-sterile condition. |
| 5.2.10 | Sec 514 Performance | |
| Standards | ||
| [per 21 CFR 807.87(d)] | No applicable performance standards have been established under | |
| Section 514 of the Federal Food, Drug and Cosmetic Act for the | ||
| device subject of this submission. The MAC 1600 ECG Analysis | ||
| System complies with the voluntary standards as detailed in Section | ||
| 9 of this submission. | ||
| 5.2.11 | Technology | The technological characteristics of the MAC 1600 have been |
| updated to reflect use of current technology and to incorporate user | ||
| requested features. Data in this submission demonstrate that these | ||
| technological characteristics do not raise new questions of safety or | ||
| effectiveness | ||
| 5.2.12 | Device Description | The MAC 1600 ECG acquisition, analysis and recording system can |
| print and display multiple leads of ECG data. MAC1600 is also | ||
| capable of acquiring 2 additional ECG leads beyond what is needed | ||
| for classical 12 lead ECG acquisition. The MAC 1600 will provide, in | ||
| resting ECG mode, ECG quality information using the hookup | ||
| advisor. The hookup advisor advises users of poor lead quality | ||
| based on noise measurement. It can be upgraded to provide | ||
| options such as ECG measurement and interpretation with 12SL as | ||
| well as a stress testing option for exercise stress testing. | ||
| Transmission and reception of ECG data to and from a central ECG | ||
| cardiovascular information system is also optional. Multiple QT | ||
| correction formulas including Bazett, Framingham and Fridericia will | ||
| be available as a user selectable option. Clinical Trials Data Guard | ||
| and audit trail options are also available to support electronic record | ||
| requirements. | ||
| The MAC 1600 delivers multiple leads of ECG on full-size reports | ||
| and includes an alphanumeric keyboard for patient demographics | ||
| and other data entry, an integrated 7" color display, and an | ||
| integrated thermal writer. The thermal writer will print real time | ||
| continuous waveform, alphanumeric data and non real time reports. | ||
| The device will have optional internal memory and removable | ||
| storage to store resting ECG records. An optional barcode reader to | ||
| enter patient information is available. The MAC 1600 can be used as | ||
| a portable unit. | ||
| 5.2.13 | Intended Use | The MAC1600 is a portable ECG acquisition, analysis and recording |
| system. The MAC1600 is intended to acquire, analyze, display and | ||
| record information from adult and pediatric populations. Pediatric | ||
| population is defined as patients between the ages of 0 and 15 | ||
| years. The MAC1600 is intended to be used by trained operators in | ||
| a hospital or medical professional's facility environment to record | ||
| ECG signals from surface electrodes. The basic system shall | ||
| provide 2 modes of operation: (1) Resting ECG mode and (2) | ||
| Arrhythmia mode. The basic systems shall print 6 or 12-leads of | ||
| ECG. The device shall be upgradeable to provide software options | ||
| such as 12-lead ECG measurement and interpretive analysis. The | ||
| basic system shall be upgradeable with a third mode of operation: | ||
| (3) Exercise mode for exercise stress testing. Transmission and | ||
| reception of ECG data to and from a central ECG cardiovascular | ||
| portion of the MAC 1600 is provided to the customer for the convenience of automatic documentation. | ||
| The MAC1600 is used under the direct supervision of a licensed healthcare practitioner. | ||
| The MAC 1600 is not designed to provide alarms for arrhythmia detection. | ||
| The device is not suitable for intra cardiac application. | ||
| It is not intended for use: | ||
| As a vital signs physiological monitor; or For use during patient transport. | ||
| 5.2.14 Conclusion | The MAC 1600 ECG Analysis System is similar to existing CardioSmart ST and CASE/Cardiosoft devices incorporating features that have been previously cleared under different 510(k)'s. This premarket notification submission demonstrates that the MAC 1600 ECG Analysis System is substantially equivalent to the previously cleared devices and differences in technological characteristics do not raise new questions of safety or effectiveness. |
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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white, with the letters and border appearing in black against a white background.
. . . .
GE Medical Systems
Information Technologies
.
:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or flowing fabric. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2008
GE Medical Systems Information Technologies c/o Ms. Margaret Mucha Regulatory Affairs Leader 9900 Innovation Drive, RP-2122 Wauwatosa, WI 53226
Rc: K081437
Trade Name: MAC 1600 ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK, and DXH Dated: May 21, 2008 Received: May 22, 2008
Dear Ms. Mucha:
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
4
Page 2 - Ms. Margaret Mucha
CFR Part 807); 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 clectronic 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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical 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 vours.
elmoe
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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510(k) Number (if known):
Device Name:
MAC 1600 ECG Analysis System
Indications for Use:
The MAC1600 is a portable ECG acquisition, analysis and recording system. The MAC1600 is intended to acquire, analyze, display and record information from adult and pediatic populations. Pediation is defined as patients between the ages of 0 and 15 years. The MAC1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The basic system shall provide 2 modes of operation: (1) Resting ECG mgnae nd (1) Arrhythmia mode. The basic systems shall print 6 or 12-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. The basic system shall be upgradeable with a third mode of operation: (3) Exercise mode for exercise stressing. Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional. The arrhythmia detection portion of the MAC 1600 is provided to the customer for the convenience of automatic documentation.
The MAC1600 is used under the direct supervision of a licensed healthcare practitioner.
Contraindications:
The MAC 1600 is not designed to provide alarms for arrhythmia detection. The device is not suitable for intra cardiac application. It is not intended for use:
- As a vital signs physiological monitor; or .
- . For use during patient transport.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence o of Device Evaluation (ODE)
elopmdQ
iovascular Devices
510(k) Number K081937