ECG-less Cardiac

K233750 · Ge Medical Systems, LLC · JAK · Apr 2, 2024 · Radiology

Device Facts

• Record ID: K233750
• Device Name: ECG-less Cardiac
• Applicant: Ge Medical Systems, LLC
• Product Code: JAK · Radiology
• Decision Date: Apr 2, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

ECG-less Cardiac streamlines patient preparation by enabling an alternative acquisition of cardiac CT images for general cardiac assessment without the need of a patient-attached ECG monitor. ECG-less Cardiac is for adults only.

Device Story

ECG-less Cardiac is a software-only feature for GE Revolution CT systems that enables cardiac CT image acquisition without patient-attached ECG monitoring. It leverages high-speed gantry rotation (0.23/0.28 s/rot) and wide-detector coverage (120-160 mm) to capture cardiac data. The system integrates with existing SmartPhase and SnapShot Freeze 2 software to reconstruct images suitable for coronary and functional assessment. Used in clinical settings by radiology staff, it streamlines workflow by eliminating electrode attachment and signal verification. By removing the need for ECG gating, it improves access for patients where ECG signal acquisition is difficult or contraindicated, such as trauma cases. Clinicians use the resulting images for diagnostic assessment of cardiac structures and function, providing a workflow-efficient alternative to traditional ECG-gated cardiac CT.

Clinical Evidence

Clinical evidence consisted of a reader study using prospectively collected clinical data. Three board-certified radiologists specializing in cardiac imaging evaluated images across a range of heart rates, patient sizes, and clinical indications using a Likert scale. Images were consistently rated as interpretable without significant motion artifacts, validating diagnostic utility.

Technological Characteristics

Software-only application for GE Revolution CT systems. Utilizes existing CT hardware (gantry, table, DAS). Supports gantry rotation speeds of 0.23 and 0.28 s/rot and collimation of 120, 140, and 160 mm. Operates on the system's operator console computer. Developed under ISO 13485 and 21 CFR 820 quality systems.

Indications for Use

Indicated for adult patients requiring cardiac CT imaging for general cardiac assessment, particularly when ECG monitoring is difficult or impractical (e.g., trauma patients with existing instrumentation or patients with challenging ECG signals).

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Revolution CT Family (K213715)

Reference Devices

• SnapShot Freeze 2 (K183161)

Submission Summary (Full Text)

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April 2, 2024

GE Medical Systems, LLC. % Katelyn Rowley Sr. Lead Specialist - MICT 3000 N Grandview Blvd WAUKESHA. WI 53188

Re: K233750

Trade/Device Name: ECG-less Cardiac Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 28, 2024 Received: February 28, 2024

Dear Katelyn Rowley:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K233750

Device Name ECG-less Cardiac

Indications for Use (Describe)

ECG-less Cardiac streamlines patient preparation by enabling an alternative acquisition of cardiac CT images for general cardiac assessment without the need of a patient-attached ECG monitor. ECG-less Cardiac is for adults only.

| 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)

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Image /page/3/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The color of the logo is a vibrant purple.

# 510(k) SUMMARY OF SAFETY AND EFFECTIVNESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h):

| Date: | November 22, 2022 |
|------------------|---------------------------|
| Submitter: | GE Medical Systems, LLC |
| | 3000 N. Grandview Blvd. |
| | Waukesha, Wisconsin 53188 |
| Primary Contact: | Katelyn Rowley |
| | Sr. Lead Specialist |

Phone: [phone] Email: [e-mail]

| Secondary Contacts: | John Jaeckle | |
|---------------------|-------------------------------------|--|
| | Chief Regulatory Affairs Strategist | |
| | Phone: [phone] | |
| | Email: [e-mail] | |

| Device Trade Name: | ECG-less Cardiac |
|-------------------------------------|--------------------------------------------------------|
| Device Classification | Class II |
| Regulation Number/<br>Product Code: | 21 CFR 892.1750 Computed tomography x-ray system / JAK |

| Predicate Device Information | |
|------------------------------|--------------------------------------------------------|
| Device Name: | Revolution CT Family |
| Manufacturer: | GE Medical Systems, LLC |
| 510(k) Number: | K213715 cleared on December 17, 2021 |
| Regulation Number/ | 21 CFR 892.1750 Computed tomography x-ray system / JAH |

## Device Description

Product Code:

ECG-less Cardiac is a software device that is an additional, optional cardiac scan mode that can be used on the Revolution Apex Elite, Revolution Apex, and Revolution CT with Apex edition systems. There is no change to the predicate device hardware to support the subject device. Currently, the available cardiac scan modes on the Revolution CT Family are Cardiac Axial and Cardiac Helical, which

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makes use of an ECG signal to physiologically trigger the cardiac acquisitions and/or to retrospectively gate the reconstruction.

ECG-less Cardiac is a third cardiac scan mode that introduces the ability to acquire cardiac images without the need of a patient-attached ECG monitor. Hence, an ECG signal from the patient is not utilized for this scan mode. The ECG-less Cardiac workflow leverages the full-heart coverage capability of 160 mm configurations, fast gantry speeds (0.28 and 0.23 s/rot), and existing cardiac software options of SmartPhase and SnapShot Freeze 2 (K183161) to acquire images that are suitable for coronary and cardiac functional assessment.

The ECG-less cardiac feature allows the user to acquire a cardiac CT scan without the need to complete the steps associated with utilizing an ECG monitor, such as attaching ECG electrodes to the patient, checking electrode impedance, and confirming an ECG trace is displayed on the operator console, thus optimizing the workflow.

ECG-less Cardiac may be best utilized in examinations where excluding the ECG connection would streamline the patient examination, including and unloading of the patient. This may result in an improved workflow for certain clinical presentations. ECG-less Cardiac may also increase access to cardiac assessment for patients that are difficult to receive an ECG signal from. Circumstances where the subject device is expected to increase cardiac access includes scenarios where trauma patient has a diagnostic ECG attached and/or other instrumentation, such that there is added difficulty of attaching ECG leads for a gated scan, and situations where it is challenging to get an ECG signal from a patient such as a patient's t-wave triggering the scan or R-peak being difficult to detect.

## Indications for Use

ECG-less Cardiac streamlines patient preparation by enabling an alternative acquisition of cardiac CT images for general cardiac assessment without the need of a patient-attached ECG monitor. ECG-less Cardiac is for adults only.

## Comparisons

ECG-less Cardiac on the Revolution CT Family is substantially equivalent to the predicate device Revolution Apex (K213715). ECG-less Cardiac largely utilizes existing CT system scan technology. The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device. The changes described below do not change the fundamental technology of the predicate and do not raise any issues of safety and effectiveness.

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# GE HealthCare 510(k) Premarket Notification Submission – ECG-less Cardiac

| Specification/<br>Attribute | Revolution CT Family<br>(Predicate Device, K213715) | ECG-less Cardiac<br>on the Revolution CT Family<br>(Proposed Device) |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Cardiac Scan<br>Modes | Cardiac Axial with ECG gating<br>Cardiac Helical with ECG gating | New ECG-less Cardiac scan mode to the<br>predicate device in addition to the<br>existing Cardiac Axial and Cardiac Helical<br>modes with ECG gating |
| CT Hardware | Revolution CT Family System including<br>CT Gantry, Patient Table, Data<br>Acquisition System, and operator<br>console computer | Same as predicate.<br>(ECG-less Cardiac is a software only<br>application implemented into operator<br>console computer) |
| Compatible<br>Cardiac<br>Rotation<br>Speeds | 0.23, 0.28, and 0.35 s/rot | ECG-less Cardiac: 0.23 and 0.28 s/rot |
| Supported<br>Cardiac<br>Collimation | Cardiac Axial: 40, 80, 100, 120, 140, 160 mm<br>Cardiac Helical: 40 mm | ECG-less Cardiac: 120, 140, and 160 mm |

## Determination of Substantial Equivalence

## Summary of Non-Clinical Testing

ECG-less Cardiac has successfully completed the design control activities including risk management, verification and validation testing per our quality system. No additional hazards were identified, and no unexpected test results were observed. ECG-less Cardiac was designed under GE HealthCare's QMS per the Quality System Regulations of 21CFR 820 and ISO 13485.

The following quality assurance measures have been applied to the development of the system:

- Requirement Definition
- Risk Analysis and Control
- Technical Design Reviews
- Formal Design Reviews
- Software Development Lifecycle
- o Code Review
- Software Unit Implementation O
- Software Integrations and Integration Testing O
- System Testing
- Safety Testing (Verification) O
- Image Performance Testing (Verification) O

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K233750

# GE HealthCare

Image /page/6/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a circular shape with a stylized "GE" monogram in the center. The monogram is surrounded by a swirling pattern. The logo is purple.

# 510(k) Premarket Notification Submission – ECG-less Cardiac

- Simulating Use Testing (Validation) O
- Software Release

The testing and results did not raise different questions of safety and effectiveness than associated with predicate device. We consider the proposed device is substantially equivalent to the predicate device, the Revolution CT Family.

The non-clinical testing also included engineering bench testing that was carried out to assess how simulated ECG-less Cardiac scan conditions performed against an ECG-gated "ground truth" nominal phase location. This testing included a variety of cases that are representative of the clinical scenarios where ECG-less Cardiac is intended to be used. Non-clinical testing also concluded the dose level of ECGless Cardiac acquisition is comparable to Cardiac Helical and single peak mA, full heart cycle Cardiac Axial as commonly used for functional assessment. The result of the engineering bench testing showed that ECG-less Cardiac scan acquisitions can produce images that are equivalent to an ECG-gated "ground truth" nominal phase location and is safe and effective for its intended use.

# Clinical Testing

The clinical testing was carried out in the form of a reader study of sample clinical data. The reader study included prospectively collected clinical data from patients undergoing a routine cardiac exam that represented a broad variety of technical scan parameters and patient characteristics, such as their clinical indication, heart rate, age, and size. Each image was read by three board certified radiologists who specialize in cardiac imaging who provided an assessment of image quality related to motion artifact and diagnostic use according to a Likert scale. These images generated from ECG-less Cardiac acquisitions were consistently rated as interpretable without a significant motion artifact penalty. Thus, the result of this reader study validated that ECG-less Cardiac acquisitions are of diagnostic utility and is safe and effective for its intended use.

# Substantial Equivalence

The changes associated with ECG-less Cardiac do not change the Intended Use from the predicate and represent equivalent technology.

ECG-less Cardiac was developed under GE Healthcare's quality system. Design verification, along with bench testing and the clinical reader study provided in this submission demonstrates that ECG-less Cardiac is substantially equivalent and hence as safe and as effective as the legally marketed predicate device. GE's quality system's design, verification, and risk management processes did not identify any unexpected results, or adverse effects stemming from the changes to the predicate.

GE Healthcare believes that ECG-less Cardiac is substantially equivalent to the predicate device and hence is safe and effective for its intended use.