MAC 7 - Resting ECG Analysis System

K203786 · Ge Medical Systems Information Technologies, Inc. · DPS · Apr 30, 2021 · Cardiovascular

Device Facts

• Record ID: K203786
• Device Name: MAC 7 - Resting ECG Analysis System
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Apr 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Indications for 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.

Device Story

Mobile electrocardiograph; acquires 3, 6, or 12-lead ECG signals via surface electrodes; performs interpretive analysis; displays and prints reports. Used in clinical settings (hospitals, medical facilities) by physicians or trained personnel. Optional trolley for mobility. Connects to network via wired LAN or WiFi; interfaces with cardiology information systems (e.g., GEHC MUSE) for order/demographic download and report transmission. Provides data for physician review; supports clinical decision-making by providing automated interpretation; requires physician overread. Benefits include efficient ECG acquisition, standardized analysis, and integration with clinical information systems.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including risk analysis, design reviews, software development lifecycle, unit-level testing, usability testing, connectivity bench testing, integration testing, and safety/performance verification.

Technological Characteristics

Mobile electrocardiograph; 3, 6, or 12-lead acquisition; wired LAN/WiFi connectivity; optional trolley. Complies with IEC 60601-1 Ed. 3.1. Software-based interpretive analysis. No sterilization required.

Indications for Use

Indicated for adult and pediatric (birth through 21 years) patients to acquire, analyze, display, and print ECGs. Provides data interpretation for physician consideration. Not intended as sole diagnostic means; requires physician overread and consideration of other patient data. Used in clinical settings by physicians or trained personnel under physician orders.

Regulatory Classification

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.

Predicate Devices

• MAC VU360 Resting ECG Analysis System (K173830)

Submission Summary (Full Text)

{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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K203786

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) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

***_****_* and a lot of lines

__ Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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: [phone] Fax: [phone] E-mail: Lee.Bush(@ge.com

Secondary Contact Person:

MANJUNATHA K N Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Telephone: [phone] Fax at [phone] E-mail:Manjunatha.kn(@med.ge.com

## PRODUCT IDENTIFICATION

| Device Trade Name: | MAC 7 Resting ECG Analysis System |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name: | Electrocardiograph |
| Regulation Number -<br>Classification Name(s) | 21 CFR 870.2340 - Electrocardiograph<br>21 CFR 870.1425 – Programmable Diagnostic Computer<br>21 CFR 870.2920 – Telephone electrocardiograph<br>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<br>electrocardiograph designed to acquire, analyze, display, and<br>record ECG signals from surface ECG electrodes. |
| | The MAC 7 can capture 3, 6 or 12 lead electrocardiograms,<br>provide interpretive analysis, and print reports. |
| | The device can connect to a network, either through a wired<br>LAN connection or via wireless WiFi access points. Once on<br>the network, the device can optionally interface with the<br>cardiology information systems such as the GEHC MUSE®<br> |
| | The device provides state-of-the-art information technology<br>security features and a contemporary user interface.<br>Mobility is provided via an optional trolley. |
| Intended Use: | The MAC 7 Resting ECG Analysis System is intended to<br>acquire, analyze, display, and record electrocardiographic<br>information from adult or pediatric populations. Basic<br>system delivers 3, 6, or 12 lead ECG's and interpretive<br>analysis. Transmission and reception of ECG data and other<br>clinical data to and from a central clinical information<br>system is optional. |
| | The MAC 7 Resting ECG Analysis System is intended to be<br>used under the direct supervision of a licensed healthcare<br>practitioner, by trained operators in a hospital, medical<br>professional's facility or wherever ECG testing is performed. |
| Indications for Use | The MAC 7 Resting ECG Analysis System is a non-invasive<br>prescription device.<br>• The device is indicated for use to acquire, analyze, display<br>and print electrocardiograms.<br>• The device is indicated for use to provide interpretation<br>of the data for consideration by a physician.<br>• The device is indicated for use in a clinical setting, by a<br>physician or by trained personnel who are acting on the<br>orders of a licensed physician. It is not intended as a sole<br>means of diagnosis |

{4}------------------------------------------------

{5}------------------------------------------------

| | <ul><li>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.</li></ul> |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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:<br>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: <ul><li>Risk Analysis</li><li>Required Reviews</li><li>Design Reviews</li><li>Software Development Lifecycle</li><li>Testing on unit level</li><li>Usability Testing</li><li>Connectivity Bench Testing</li></ul> |

- Connectivity Bench Testing

{6}------------------------------------------------

- 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.