(22 days)
No
The description focuses on standard ECG acquisition, analysis (measurement and interpretation with 12SL, which is a known algorithm, not necessarily AI/ML), and reporting features. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets. The "arrhythmia detection" is described as "automatic documentation" for convenience, not as an advanced analytical capability suggesting AI/ML.
No
The device is described as an "ECG acquisition, analysis and recording system," which primarily collects and analyzes diagnostic information rather than providing therapy.
Yes
Explanation: The MAC 800 is described as an "ECG acquisition, analysis and recording system" intended to "acquire, analyze, display and record information" from patients. It provides "ECG measurement and interpretive analysis" and includes an "arrhythmia detection portion." These functions are inherently diagnostic as they support the identification and characterization of medical conditions related to the heart's electrical activity.
No
The device description explicitly mentions integrated hardware components such as a 7" color display, an integrated thermal writer, and options for internal memory, removable storage, barcode reader, and magnetic card scanner.
Based on the provided information, the MAC 800 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- MAC 800 Function: The MAC 800 acquires, analyzes, displays, and records electrical signals from the surface of the body (ECG). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it records ECG signals from surface electrodes.
- Device Description: The description focuses on the acquisition and display of electrical signals, not the analysis of biological samples.
Therefore, the MAC 800 falls under the category of a medical device, specifically an electrocardiograph, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MAC 800 is a portable ECG acquisition, analysis and recording system. The MAC 800 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 MAC 800 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 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.
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 800 is provided to the customer for the convenience of automatic documentation.
The MAC 800 is used under the direct supervision of a licensed healthcare practitioner.
Product codes
DPS, DQK, DXH
Device Description
The MAC 800 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. The MAC 800 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. 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
The MAC 800 delivers multiple leads of ECG on full-size reports and includes an SMS/text message telephone keypad for patient demographics and other data entry with T9 input method, 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 can print the resting ECG report via the external laser printer. The device will have optional internal memory and removable storage to store resting ECG records. The device also can export the resting ECG record to PDF file on SD card as an optional function. An optional barcode reader and magnetic card scanner to enter patient information is available. The MAC 800 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. The MAC 800 is used under the direct supervision of a licensed healthcare practitioner.
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 subject of this premarket submission, MAC 800 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081437, MAC 1600 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).
0
090212
GE Healthcare 510(K) Premarket Notification Submission MAC 800 Resting ECG Analysis System
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | January 26, 2009 | ||
|---|---|---|---|
| Submitter: | Larry Lepley | ||
| Regulatory Affairs - Diagnostic Cardiology | |||
| 9900 Innovation Drive | |||
| Wauwatosa, WI 53226 | |||
| Primary Contact Person: | Larry Lepley | ||
| Regulatory Affairs - Diagnostic Cardiology | |||
| 9900 Innovation Drive | |||
| Wauwatosa, WI 53226 | |||
| T: (414) 721-2593 | |||
| F: (414) 721-3899 | |||
| Secondary Contact Person: | Patricia Taige | ||
| Regulatory Affairs - Diagnostic Cardiology | |||
| 9900 Innovation Drive | |||
| Wauwatosa, WI 53226 | |||
| T: (414) 721-3222 | |||
| F: (414) 721-3899 | |||
| Device: Trade Name: | MAC 800 Resting ECG Analysis System | ||
| Common/Usual Name: | Electrocardiograph | ||
| Classification Names: | 21 CFR | Classification Name | Code |
| Product Code: | 870.2340 | Electrocardiograph | DPS |
| 870.1425 | Programmable Diagnostic Computer | DQK | |
| 870.2920 | Transmitters and Receivers, | ||
| Electrocardiographs, Telephone | DXH | ||
| Predicate Device(s): | K081437, MAC 1600 ECG Analysis System | ||
| Device Description: | The MAC 800 ECG acquisition, analysis and recording system | ||
| can print and display multiple leads of ECG data. The MAC 800 | |||
| 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. 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 |
FR Page 1 OF 3
1
GE Healthcare 510(K) Premarket Notification Submission MAC 800 Resting ECG Analysis System
The MAC 800 delivers multiple leads of ECG on full-size reports and includes an SMS/text message telephone keypad for patient demographics and other data entry with T9 input method, 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 can print the resting ECG report via the external laser printer. The device will have optional internal memory and removable storage to store resting ECG records. The device also can export the resting ECG record to PDF file on SD card as an optional function. An optional barcode reader and magnetic card scanner to enter patient information is available. The MAC 800 can be used as a portable unit.
The MAC 800 is a portable ECG acquisition, analysis and recording Intended Use: system.
The MAC 800 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 MAC 800 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 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.
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 800 is provided to the customer for the convenience of automatic documentation.
The MAC 800 is used under the direct supervision of a licensed healthcare practitioner.
Contraindications:
The MAC 800 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.
E Page 2 of 3
2
GE Healthcare
510(K) Premarket Notification Submission MAC 800 Resting ECG Analysis System
Technology:
The MAC 800 Resting ECG Analysis System employs the same functional scientific technology as its predicate devices.
Determination of Summary of Non-Clinical Tests:
Substantial Equivalence: The MAC 800 Resting ECG Analysis System and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance
measures were applied to the development of the system:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, MAC 800 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the MAC 800 Resting ECG Analysis System to be as safe, as effective, and performance is substantially equivalent to the predicate device.
傍
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three stylized lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2009
GE Medical Systems Information Technologies c/o Mr. Larry Lepley Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226
Re: K090212 -
Trade Name: MAC 800 Resting ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS and DQK Dated: January 26, 2009 Received: January 28, 2009
Dear Mr. Lepley:
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 controll provisions plathe Age melude 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 - Mr. Larry Lepley
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 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 notifications" (21CFR Part 807.97) For questions regarding posimarket 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 (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 yours,
87 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for I levices and Radiological Health
Enclosure
5
GE Healthcare
510(K) Premarket Notification Submission MAC 800 Resting ECG Analysis System
510(k) Number (if known)
510(k) Number (if known): `K090312
Device Name:
MAC 800 Resting ECG Analysis System
Indications for Use:
The MAC 800 is a portable ECG acquisition, analysis and recording system. The MAC 800 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 MAC 800 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 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.
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 800 is provided to the customer for the convenience of automatic documentation.
The MAC 800 is used under the direct supervision of a licensed healthcare practitioner.
Contraindications:
The MAC 800 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 X AND/OR .. Over-The-Counter Use (Port 21 CFR 801 Submart D) (Part 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)
(Division Sign-Off) for Zuckerman
2/20/09
Division of Cardiovascular Devices
510(k) Number K090212
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