(123 days)
MAC VU360 Resting ECG Analysis System (K173830)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or methodologies that would indicate the use of AI or ML. The analysis is described as "interpretive analysis," which is a standard function of many ECG devices and does not necessarily imply AI/ML.
No
The device is described as a diagnostic tool used to acquire, analyze, display, and print electrocardiograms, and to provide interpretation for a physician's consideration, not to treat or cure a disease.
Yes
The device is indicated for use to acquire, analyze, display, and print electrocardiograms, and to provide interpretation of the data for consideration by a physician. While it states it is "not intended as a sole means of diagnosis," it clearly aids in the diagnostic process by analyzing data and providing interpretations.
No
The device description explicitly states it is a "mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes," indicating it includes hardware components for signal acquisition and recording, not just software.
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. They are used to examine these samples outside of the body.
- Device Function: The MAC 7 Resting ECG Analysis System acquires, analyzes, displays, and prints electrocardiograms. This involves placing electrodes on the surface of the body to measure electrical activity of the heart. This is a non-invasive procedure performed on the patient, not on a sample taken from the patient.
- Intended Use: The intended use clearly states it's a "non-invasive prescription device" used to acquire and analyze ECGs.
Therefore, the MAC 7 Resting ECG Analysis System falls under the category of a medical device used for physiological measurement and analysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MAC 7 Resting ECG Analysis System is a non-invasive prescription device.
• The device is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.
• It is not intended as a sole means of diagnosis. The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
• The device is indicated for use on adult and pediatric (birth through 21 years of age) populations
Product codes
DPS, DQK, DXH
Device Description
The MAC 7 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.
The MAC 7 can capture 3, 6 or 12 lead electrocardiograms, provide interpretive analysis, and print reports.
The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with the cardiology information systems such as the GEHC MUSE®.
The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.
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 (birth through 21 years of age) populations
Intended User / Care Setting
The MAC 7 Resting ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital, medical professional's facility or wherever ECG testing is performed.
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
Summary of Non-Clinical Tests:
The MAC 7 Resting ECG Analysis System and its applications comply with applicable voluntary standards. It was designed and manufactured under the Quality System Regulations of 21CFR820 and ISO 13485. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Required Reviews
- Design Reviews
- Software Development Lifecycle
- Testing on unit level
- Usability Testing
- Connectivity Bench Testing
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
Summary of Clinical Tests: The subject of this premarket submission, MAC 7 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
MAC VU360 Resting ECG Analysis System (K173830)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 30, 2021
GE Medical Systems Information Technologies, Inc. Lee Bush Director Regulatory Affairs 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K203786
Trade/Device Name: MAC 7 - Resting ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK, DXH Dated: April 2, 2021 Received: April 7, 2021
Dear Lee Bush:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
MAC 7 Resting ECG Analysis System
Indications for Use (Describe)
The MAC 7 Resting ECG Analysis System is a non-invasive prescription device.
· The device is indicated for use to acquire, analyze, display and print electrocardiograms.
- · The device is indicated for use to provide interpretation of the data for consideration by a physician.
· The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.
· It is not intended as a sole means of diagnosis. The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
· The device is indicated for use on adult and pediatric (birth through 21 years of age) populations
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
_**_ and a lot of lines
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h):
DATE: December 22, 2020
SUBMITTER
GE MEDICAL SYSTEMS Information Technologies, Inc. 9900 Innovation Drive Milwaukee County Research Park Wauwatosa, Wisconsin 53226-4856
Primary Contact Person:
Lee Bush Regulatory Affairs Manager GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Milwaukee County Research Park Wauwatosa, Wisconsin 53226-4856 Phone: +1 (262) 309-9429 Fax: +1 (414) 721-3864 E-mail: Lee.Bush(@ge.com
Secondary Contact Person:
MANJUNATHA K N Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Telephone: +91 80 40887193 Fax at +919901233442 E-mail:Manjunatha.kn(@med.ge.com
PRODUCT IDENTIFICATION
| Device Trade Name: | MAC 7 Resting ECG Analysis System |
|---|---|
| Common / Usual Name: | Electrocardiograph |
| Regulation Number - | |
| Classification Name(s) | 21 CFR 870.2340 - Electrocardiograph |
| 21 CFR 870.1425 – Programmable Diagnostic Computer | |
| 21 CFR 870.2920 – Telephone electrocardiograph | |
| Transmitter and Receiver | |
| Device Classification: | Class II |
| Product Code(s): | DPS, DQK, DXH |
| Predicate Device(s): | MAC VU360 Resting ECG Analysis System (K173830) |
| Device Description: | The MAC 7 Resting ECG Analysis System is a mobile |
| electrocardiograph designed to acquire, analyze, display, and | |
| record ECG signals from surface ECG electrodes. | |
| The MAC 7 can capture 3, 6 or 12 lead electrocardiograms, | |
| provide interpretive analysis, and print reports. | |
| The device can connect to a network, either through a wired | |
| LAN connection or via wireless WiFi access points. Once on | |
| the network, the device can optionally interface with the | |
| cardiology information systems such as the GEHC MUSE® |
|
| | The device provides state-of-the-art information technology
security features and a contemporary user interface.
Mobility is provided via an optional trolley. |
| Intended Use: | The MAC 7 Resting ECG Analysis System is intended to
acquire, analyze, display, and record electrocardiographic
information from adult or pediatric populations. Basic
system delivers 3, 6, or 12 lead ECG's and interpretive
analysis. Transmission and reception of ECG data and other
clinical data to and from a central clinical information
system is optional. |
| | The MAC 7 Resting ECG Analysis System is intended to be
used under the direct supervision of a licensed healthcare
practitioner, by trained operators in a hospital, medical
professional's facility or wherever ECG testing is performed. |
| Indications for Use | The MAC 7 Resting ECG Analysis System is a non-invasive
prescription device.
• The device is indicated for use to acquire, analyze, display
and print electrocardiograms.
• The device is indicated for use to provide interpretation
of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a
physician or by trained personnel who are acting on the
orders of a licensed physician. It is not intended as a sole
means of diagnosis |
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5
| The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. | |
|---|---|
| Technology: | The MAC 7 employs the same fundamental scientific technology, basic design, construction, materials, energy source, control mechanism, operating principles as the predicate device MAC VU360 in acquiring, analyzing, recording, displaying and printing ECG data for both adult and pediatric populations. |
| The basic system prints 3, 6 or 12 leads of ECG and provides optional transmission and reception of ECG data to and from a central ECG cardiovascular information system. The system can be upgraded with software options, similar to the predicate device. | |
| The MAC 7 is similar to the MAC VU360 Resting ECG Analysis System, K173830, in the technology of downloading orders and patient demographics from a central ECG cardiovascular information system (e.g. MUSE) as well as supporting ECG reports in PDF. Both are able to use WiFi communication. | |
| Performance Standards: | The MAC 7 Resting ECG Analysis System has completed testing and demonstrated compliance with IEC 60601-1 Ed. 3.1 and it associated collateral and particular standards. |
| Sterilization: | The MAC 7 Resting ECG Analysis System does not require sterilization. |
| Determination of Substantial Equivalence: | Summary of Non-Clinical Tests: |
| The MAC 7 Resting ECG Analysis System and its applications comply with applicable voluntary standards. It was designed and manufactured under the Quality System Regulations of 21CFR820 and ISO 13485. The following quality assurance measures were applied to the development of the system: Risk AnalysisRequired ReviewsDesign ReviewsSoftware Development LifecycleTesting on unit levelUsability TestingConnectivity Bench Testing |
- Connectivity Bench Testing
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- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Summary of Clinical Tests: The subject of this premarket submission, MAC 7 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the MAC 7 Resting ECG Analysis Conclusion: System to be as safe, and as effective, and performance is substantially equivalent to the predicate device, MAC VU360 Resting ECG Analysis System.