(30 days)
No
The document describes "interpretive analysis" and "software analysis options such as high resolution signal averaging," which are standard signal processing techniques for ECGs and do not inherently indicate the use of AI or ML. There is no mention of AI, ML, or related terms like neural networks or deep learning.
No.
The device is intended to acquire, analyze, display, and record electrocardiographic information, which is diagnostic, not therapeutic.
Yes
The device is intended to "acquire, analyze, display, and record electrocardiographic information," including "interpretive analysis," which indicates it is used to diagnose conditions based on ECG signals.
No
The device description explicitly states it consists of two basic components: the processing unit and the patient acquisition module, and mentions hardware like a keyboard, display, thermal writer, and removable data storage.
Based on the provided information, the MAC 5500 ECG Analysis System 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.
- MAC 5500 function: The MAC 5500 acquires, analyzes, displays, and records electrocardiographic information from the patient's body surface using electrodes. This is a non-invasive procedure that measures electrical activity of the heart.
- No sample analysis: The device does not analyze samples taken from the body. It directly measures a physiological signal from the body.
Therefore, the MAC 5500 falls under the category of a medical device that performs a physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The MAC 5500 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG’s, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
Product codes
DPS, DQK, DHX
Device Description
The MAC 5500 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device consists of two basic components: the processing unit and the patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment. The MAC 5500 can deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5500 system acquires ECG data using the CAM14 patient data acquisition module. By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5500 delivers 12 or 15 lead ECG's on full-size reports. The MAC 5500 incorporates a alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, an integrated thermal writer and removable data storage. Additionally, the MAC 5500 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop 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
Intended User / Care Setting
The MAC 5500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
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)
K042177 MAC 5500 ECG Analysis System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the logo for GE Healthcare. The logo consists of the GE monogram on the left and the words "GE Healthcare" on the right. The GE monogram is a circular design with the letters "GE" intertwined.
December 21, 2007
JAN 25 2008
| 2. | 510(k) Summary | |||
|---|---|---|---|---|
| Date: | 12/17/2007 | |||
| Submitter: | GE Medical Systems Information Technologies 9900 Innovation Drive | |||
| Wauwatosa, WI 53226 USA | ||||
| Primary Contact: | Margaret Mucha | |||
| Regulatory Affairs Leader | ||||
| GE Medical Systems Information Technologies | ||||
| Phone: 414-416-2716 | ||||
| Fax: 414-721-3863 | ||||
| Secondary Contact: | Matthias Buerger | |||
| Global Director QA/RA, | ||||
| Diagnostic Cardiology | ||||
| GE Medical Systems Information Technologies | ||||
| Phone: 414-416-2317 | ||||
| Fax: 414-721-3863 | ||||
| Device: | Trade Name: MAC 5500 ECG Analysis System | |||
| Common/Usual Name: | Electrocardiograph | |||
| Classification Names1: | 21 CFR 870.2340 | Electrocardiograph | DPS | |
| 21 CFR 870.1425 | Programmable Diagnostic Computer | DQK | ||
| 21 CFR 870.2920 | Transmitters and Receivers, | |||
| Electrocardiograph, Telephone | DHX | |||
| Predicate Device: | K042177 MAC 5500 ECG Analysis System | |||
| Device Description: | The MAC 5500 ECG Analysis System is designed to acquire, analyze, | |||
| display, and record ECG signals from surface ECG electrodes. The | ||||
| device consists of two basic components: the processing unit and the | ||||
| patient acquisition module. Models provide rechargeable battery | ||||
| operation and/or optional trolley for transporting the equipment. |
The Classification Names/Numbers and Code assigned during the clearance of the MAC 5500 ECC Analysis System for K042777 was MHX - Detector Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) (870.1025). GE Medical Systems Information Technologies formally requested on 12/14/07 that the MAC 5500 ECG be reclassified as DPS – Electrocardiograph (870.2340) as this code more accurately reflects the intended use of this device as this device is not intended to detect an arrhythmia and alarm or produce an audible signal when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation ocurs, which is the Identification statement contained in Code MHX (Section 870.1025). The intended use more closely matches the Identification statement for Section 870.2340 Electrocardiograph, which states that an Electrocarding 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. This submission is reflective of this requested code change to DPS for the MAC 5500.
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Page 20 of 727
Image /page/1/Picture/1 description: The image shows the GE Healthcare logo. The logo consists of the GE monogram in a circle on the left, followed by the words "GE Healthcare" in a simple, sans-serif font. The text is aligned horizontally with the monogram.
December 21, 2007
Device Description: (continued) The MAC 5500 can deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The MAC 5500 system acquires ECG data using the CAM14 patient data acquisition module. By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5500 delivers 12 or 15 lead ECG's on full-size reports. The MAC 5500 incorporates a alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, an integrated thermal writer and removable data storage.
Additionally, the MAC 5500 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop unit.
Indications for Use
The MAC 5500 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The MAC 5500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
Technology The MAC 5500 ECG Analysis System employs the same functional technology as the predicate devices.
Conclusion: The results of these measurements demonstrated that the MAC 5500 ECG Analysis System is as safe, as effective, and performs as well as the predicate devices.
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services, USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Ms. Margaret Mucha Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, WI 53226
Re: K073625
Trade/Device Name: MAC 5500 Resting ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS, DQK, DHX Dated: December 21, 2007 Received: December 26, 2007
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.
3
Page 2 – Ms. Margaret Mucha
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 of device adverse events (Medical 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.
Bfsimima fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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December 21, 2007
- Intended Use
510(k) Number (if known):
Page 1 of 1
Device Name:
MAC 5500 ECG Analysis System
Intended Use:
The MAC 5500 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The MAC 5500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
Prescription Use X (Per 21 CFR 801.109 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Brammer
Division of Cardiovascular Devices
510(k) Number K073625