(132 days)
No
The summary describes a software feature that leverages existing hardware and software capabilities (full-heart coverage, fast gantry speeds, SmartPhase, SnapShot Freeze 2) to acquire cardiac images without an ECG signal. It focuses on workflow optimization and increased access for certain patients. There is no mention of AI or ML being used for image acquisition, processing, or analysis. The performance studies described are a reader study and engineering bench testing, which do not indicate the use of AI/ML algorithms.
No
The device is a software for alternative acquisition of cardiac CT images for general cardiac assessment and does not directly provide therapy.
Yes
The device produces images that are used for "general cardiac assessment" and the clinical testing stated that "ECG-less Cardiac acquisitions are of diagnostic utility."
No
The device is described as a software device that is an additional, optional cardiac scan mode that can be used on specific Revolution CT systems. While it is software, it is inextricably linked to and operates as a mode on a hardware medical device (the CT scanner). It is not a standalone software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that ECG-less Cardiac is a software device that is an additional scan mode for a CT system. It modifies how the CT system acquires images of the heart.
- Intended Use: The intended use is to enable an alternative acquisition of cardiac CT images for general cardiac assessment. This is a method of imaging, not a test performed on a biological sample.
- Input: The input is from a Computed Tomography X-Ray System, which is an imaging modality, not a biological sample.
The device is a software modification to an imaging system, designed to improve the workflow and accessibility of cardiac CT scans. It does not perform any tests on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Cardiac
Indicated Patient Age Range
Adults only.
Intended User / Care Setting
Not Found
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Non-Clinical Testing: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Revolution CT Family (K213715)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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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: 262-309-5888 Email: Katelyn.Rowley@ge.com
| Secondary Contacts: | John Jaeckle | |
|---|---|---|
| Chief Regulatory Affairs Strategist | ||
| Phone: 262-424-9547 | ||
| Email: John.Jaeckle@med.ge.com |
| Device Trade Name: | ECG-less Cardiac |
|---|---|
| Device Classification | Class II |
| Regulation Number/ | |
| 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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Image /page/4/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a circular emblem with a stylized "GE" monogram in the center. The monogram is surrounded by a decorative, swirling pattern. The logo is colored in a shade of purple.
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/
Attribute | Revolution CT Family
(Predicate Device, K213715) | ECG-less Cardiac
on the Revolution CT Family
(Proposed Device) |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Cardiac Scan
Modes | Cardiac Axial with ECG gating
Cardiac Helical with ECG gating | New ECG-less Cardiac scan mode to the
predicate device in addition to the
existing Cardiac Axial and Cardiac Helical
modes with ECG gating |
| CT Hardware | Revolution CT Family System including
CT Gantry, Patient Table, Data
Acquisition System, and operator
console computer | Same as predicate.
(ECG-less Cardiac is a software only
application implemented into operator
console computer) |
| Compatible
Cardiac
Rotation
Speeds | 0.23, 0.28, and 0.35 s/rot | ECG-less Cardiac: 0.23 and 0.28 s/rot |
| Supported
Cardiac
Collimation | Cardiac Axial: 40, 80, 100, 120, 140, 160 mm
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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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.