CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.

The CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection.

The arrhythmia detection portion of CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms.

CASE V7.0 Cardiac Testing System and Cardiac Testing System provide the control of external devices (typically a treadmill or bicycle ergometer) and communicate with centralized electronic/digital storage system via data networks.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide a user selectable option for printouts of prognostic scores on selected reports. Vector loops are also available.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System can be configured in a network environment for multiple CASE and CardioSoft stations allowing the user to create a central database of patient demographics and collected patient physiological data.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used primarily in the hospital but can also be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.

CASE V7.0 Cardiac Testing System and Cardiac Testing System offer no diagnostic opinion to the user. Instead, it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.

CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended to be used as a transport device or for home use.

CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended for use as a vital signs physiological monitor.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for intracardiac use.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as an emergency device.

CASE V7.0 Cardiac Testing System and Cardiac Testing System will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use with high frequency surgical units. Disconnect the patient from CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System before using the high frequency surgical unit.

Device Description

The CASE V7.0 Cardiac Testing System and the CardioSoft V7.0 Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometry, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CardioSoft V7.0 Cardiac Testing System will be offered as a software only package including a front end for data acquisition. The CASE V7.0 Cardiac Testing System is a turnkey product utilizing the CardioSoft V7.0 Cardiac Testing software.

AI/ML Overview

This FDA 510(k) summary provides information for the CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System. However, it does not contain specific acceptance criteria, reported device performance metrics tied to those criteria, or a detailed study description with sample sizes, expert qualifications, or ground truth methods related to the device's diagnostic or analytical capabilities.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (CASE Cardiac Testing System, CS Cardiac Testing System (K103678)) by comparing features and functions. It mentions compliance with performance standards but does not detail the results of performance tests in terms of specific metrics for the device itself.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's what can be gathered, addressing the points where information is available or noting its absence:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with corresponding reported device performance metrics for diagnostic accuracy, sensitivity, specificity, or other analytical capabilities. Instead, it compares the proposed device's features and technical specifications to those of the predicate device, asserting "Identical" or "Equivalent" for most technical aspects.

For example, under "ECG Signal Bandwidth", the proposed device has "0.04 to 150 Hz (CC14)" compared to the predicate's "0.01 to 150 Hz (CAM 14)". The explanation notes that the proposed device complies with IEC60601-2-25:2011 requirement of 0.67 Hz to 150 Hz, implying that 0.04 Hz is within acceptable limits for capturing useful ECG data. This is a comparison to a standard, not a specific performance metric of the device against an internal acceptance criterion.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission states, "The subject of this premarket submission, CASE V7.0 and CardioSoft V7.0 did not require clinical studies to support substantial equivalence." This indicates that no new clinical study was conducted for this 510(k) submission to demonstrate performance with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided as no new clinical study (test set evaluation) was detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided as no new clinical study (test set evaluation) was detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed for this submission, as it explicitly states no clinical studies were required. The device provides "interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion," implying human-in-the-loop, but the submission doesn't detail performance with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

A standalone performance study of the algorithm (e.g., for arrhythmia detection or ECG analysis) was not detailed as part of this submission. The "arrhythmia detection portion" is described as being "provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms." The 12SL ECG Analysis Program (V23) is mentioned, which is a previously cleared component (K141963), suggesting its performance was established in its own clearance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided as no new clinical study (test set evaluation) was detailed.

8. The sample size for the training set

This information is not provided. The document describes upgrades to existing software and hardware components and relies on compliance with voluntary standards and substantial equivalence to a predicate device. There is no mention of a new "training set" in the context of machine learning, although software development would involve internal testing.

9. How the ground truth for the training set was established

This information is not provided. As above, there's no mention of a new training set or ground truth establishment. The device incorporates a "12SL ECG Analysis Program (V23) (K141963)" which would have had its own ground truth established during its prior clearance.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

December 13, 2023

GE Medical Systems Information Technologies, Inc. Manjunatha Kn Senior Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, Wisconsin 53226

Re: K231870

Trade/Device Name: CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 15, 2023 Received: November 15, 2023

Dear Manjunatha Kn:

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 (QS) 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 OS 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 medical devices and radiation-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 W. Shih -S

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

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Indications for Use

510(k) Number (if known) K231870

Device Name

CASE V7.0 Cardiac Testing System CardioSoft V7.0 Cardiac Testing System

Indications for Use (Describe)

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide a user selectable option for printouts of prognostic scores on selected reports. Vector loops are also available.

CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended to be used as a transport device or for home use.

CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended for use as a vital signs physiological monitor.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for intracardiac use.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as an emergency device.

CASE V7.0 Cardiac Testing System and Cardiac Testing System will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators.

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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/4/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized version of the letters "GE" inside a circle. The text "GE HealthCare" is written in a clean, sans-serif font.

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	01-June-2023
Submitter:	GE Medical Systems Information Technologies, Inc.
	9900 Innovation Drive
	Wauwatosa, WI 53226
Primary Contact Person:	Manjunatha K N
	Senior Regulatory Affairs Leader
	GE Medical Systems Information Technologies, Inc.
	Phone: +91 (98453) 58045
Secondary Contact Person:	Shlomi Deler
	Regulatory Affairs Director
	GE Medical Systems Information Technologies, Inc.
	Phone: +(972) 544301056
Device Trade Name:	CASE V7.0 Cardiac Testing System
	CardioSoft V7.0 Cardiac Testing System
Common/Usual Name:	CASE V 7.0 / Cardiosoft V7.0
Classification Names:	Computer, diagnostic, programmable
Product Code:	DQK 21CFR.870.1425
Predicate Device(s):	CASE Cardiac Testing System, CS Cardiac Testing System (K103678)

Device Description:	The CASE V7.0 Cardiac Testing System and the CardioSoft V7.0Cardiac Testing System are designed to be used for resting ECG,stress test ECG, Spirometry, Ambulatory Blood Pressure and forrecording ECG in real-time with and without arrhythmia detection.The CardioSoft V7.0 Cardiac Testing System will be offered as asoftware only package including a front end for data acquisition. The

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Image /page/5/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circle with the letters "GE" inside, followed by the words "GE HealthCare" in purple. The logo is simple and modern, and it is likely used to represent the company's brand.

CASE V7.0 Cardiac Testing System is a turnkey product utilizing the CardioSoft V7.0 Cardiac Testing software.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Indications for Use: Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.

The CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection.

The arrhythmia detection portion of CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide the control of external devices (typically a treadmill or bicycle ergometer) and communicate with centralized electronic/digital storage system via data networks.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide a user selectable option for printouts of prognostic scores on selected reports. Vector loops are also available.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System offer no diagnostic opinion to the user. Instead, it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.

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Image /page/6/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circle with a stylized "GE" inside. To the right of the circle is the text "GE HealthCare" in purple. The text is in a sans-serif font.

	CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended to be used as a transport device or for home use.
	CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as a vital signs physiological monitor.
	CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for intracardiac use.
	CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as an emergency device.
	CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators.
	CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use with high frequency surgical units. Disconnect the patient from CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System before using the high frequency surgical unit.
Technology:	CASE V7.0 Cardiac Testing System and the CardioSoft V7.0 Cardiac Testing System employ the same fundamental scientific technology, basic design, construction, materials, energy source, control mechanism, and operating principles as the predicate device CASE / CS Cardiac Testing System (K103678) to acquire, process, record, archive, analyze, and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings, and record ECG in real-time with and without arrhythmia detection.
Determination of Substantial Equivalence:	CASE V7.0 Cardiac Testing System and the CardioSoft V7.0 Cardiac Testing System is substantially equivalent to predicate device CASE / CS Cardiac Testing System (K103678) as described in the table below

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac

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Image /page/7/Picture/0 description: The image shows the alphanumeric string "K231870" in a bold, sans-serif font. The string is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, creating a clear and legible sequence.

Image /page/7/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a circular emblem with a stylized "GE" monogram inside, followed by the text "GE HealthCare" in a simple, sans-serif font. The emblem and text are both in a matching shade of purple.

Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
Classification /Product Code	21CFR.870.1425/DQK	21CFR.870.1425/ DQK	Identical
Intended UseStatement	CASE Cardiac Testing System andCS Cardiac Testing System areintended to be used by trainedoperators under direct supervisionof a licensed health carepractitioner on adult and pediatricpatients.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM are intended to beused by trained operators underdirect supervision of a licensed healthcare practitioner on adult andpediatric patients.	Equivalent:The CardioSoft CardiacTesting System wasformerly named CSCardiac Testing System.
	The CASE Cardiac Testing Systemand CS Cardiac Testing System aredesigned to acquire, process,record, archive, analyze and output(12 and 15 lead) ECG data during aperiod of physiologic stress orduring a resting ECG test, acquiredata from ancillary devices (such asSpirometry and Ambulatory BloodPressure), provide medianmorphology recordings and recordECG in real-time with and withoutarrhythmia detection.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM are designed toacquire, process, record, archive,analyze and output (12 and 15 lead)ECG data during a period ofphysiologic stress or during a restingECG test, acquire data from ancillarydevices (such as Spirometry andAmbulatory Blood Pressure), providemedian morphology recordings andrecord ECG in real-time with andwithout arrhythmia detection.
	The arrhythmia detection algorithmof CASE Cardiac Testing System andCS Cardiac Testing System areprovided to the user for theconvenience of automatic detectionof arrhythmias but does not providealarms.	The arrhythmia detection algorithmof CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM are provided to theuser for the convenience of automaticdetection of arrhythmias but do notprovide alarms.
	CASE Cardiac Testing System andCS Cardiac Testing System providethe control of external devices(typically a treadmill or Ergometer)and communicate with centralizedelectronic/digital storage systemvia data network.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM provide the controlof external devices (typically atreadmill or Ergometer) andcommunicate with centralizedelectronic/digital storage system viadata network.
	CASE Cardiac Testing System andCS Cardiac Testing System providea user selectable option forprintouts of prognostic scores onselect reports. Vector loops are alsoavailable.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM provide a userselectable option for printouts ofprognostic scores on select reports.Vector loops are also available.
	CASE Cardiac Testing System andCS Cardiac Testing System can beconfigured in a networkenvironment for multiple CASEstations and CS stations allowingthe user to create a centraldatabase of patient demographicsand collected patient physiologicaldata.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM can be configured ina network environment for multipleCASE and CardioSoft stationsallowing the user to create a centraldatabase of patient demographicsand collected patient physiologicaldata.
Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
	CASE Cardiac Testing System andCS Cardiac Testing System areintended to be used primarily in thehospital but can be used in clinics,physician offices, outreach centersor wherever exercise, stress testing,ECG, Spirometry or ambulatoryblood pressure testing isperformed.	TESTING SYSTEM intended to be usedprimarily in the hospital but can beused in clinics, physician offices,outreach centers or whereverexercise, stress testing, ECG,Spirometry or ambulatory bloodpressure testing is performed.
	CASE Cardiac Testing System andCS Cardiac Testing System offer nodiagnostic opinion to the user.Instead, it provides interpretivestatements of morphology, rhythm,and conduction for which thephysician renders his/her ownmedical opinion.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM offer no diagnosticopinion to the user. Instead, itprovides interpretive statements ofmorphology, rhythm, and conductionfor which the physician rendershis/her own medical opinion.
	CASE Cardiac Testing System andCS Cardiac Testing System are notintended to be used as a transportdevice or for home use.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM are not intended tobe used as a transport device or forhome use.
	CASE Cardiac Testing System andCS Cardiac Testing System are notintended for the use as a vital signsphysiological monitor.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM are not intended foruse as a vital signs physiologicalmonitor.
	CASE Cardiac Testing System andCS Cardiac Testing System are notintended for intracardiac use.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM are not intended forintracardiac use.
	CASE Cardiac Testing System andCS Cardiac Testing System are notintended for the use as anemergency device.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM are not intended foruse as an emergency device.
	CASE Cardiac Testing System andCS Cardiac Testing System will notcause abnormal operation of apatient's cardiac pacemaker orother electronic stimulators.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM will not causeabnormal operation of a patient'scardiac pacemaker or other electronicstimulators.
	CASE Cardiac Testing System andCS Cardiac Testing System are notintended for use with highfrequency surgical units. Disconnectthe patient from CASE CardiacTesting System and CS CardiacTesting System before using thehigh frequency surgical unit.	CASE V7.0 CARDIAC TESTINGSYSTEM, CARDIOSOFT V7.0 CARDIACTESTING SYSTEM are not intended foruse with high frequency surgical units.Disconnect the patient from CASEV7.0 CARDIAC TESTING SYSTEM,CARDIOSOFT V7.0 CARDIAC TESTINGSYSTEM before using the highfrequency surgical unit
Device Type	ECG recording system	ECG recording system	Identical
Modalities	Resting ECGExercise TestSpirometryAmbulatory Blood Pressure	Resting ECGExercise TestSpirometryAmbulatory Blood Pressure	EquivalentErgospirometrymeasurement in theExercise testing, will not
Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
	Exercise Test andergospirometry/metabolictest)		be offered for sale withthe subject device in US.
DeviceDescription	CASE is a medical cartincluding a thermal writer.The system cart is based onan embedded PC with CAM14 acquisition module. Theapplication software is pre-installed. CASE can beconfigured to maintain alocal database or use ashared database on a server.Additional devices liketreadmills, ergometersambulatory blood pressuredevices and spirometerdevices can be connected.CS utilizes a customer-provided PC and consists ofthe application software andthe CAM USB acquisitionmodule (CAM14 and CAM-USB Interface), whichconnects to the PC's USBport. CS can be configured tomaintain a local database oruse a shared database on aserver. There are a numberof peripheral devices andaccessories that can beconnected.	CASE is a medical cartincluding a thermal writer. Thesystem cart is based on anembedded PC with wiredacquisition module CAMConnect 14 (CC14) and GEHECG 1200 wireless acquisitionmodule. The applicationsoftware is pre-installed.CASE can be configured tomaintain a local database oruse a shared database on aserver. Additional devices liketreadmills, ergometersambulatory blood pressuredevices and spirometerdevices can be connected.CardioSoft utilizes acustomer-provided PC andconsists of the applicationsoftware and acquisitionmodules (CAM Connect 14,CAM-USB interface, and GEHECG 1200), which connects tothe PC's USB port. CardioSoftcan be configured to maintaina local database or use ashared database on a server.There are a number ofperipheral devices andaccessories that can beconnected.	EquivalentThe proposed devicesupport both wired (CC-14) and wireless (GEHECG 1200) ECGacquisition moduleswhich don't impact safetyand effectiveness of thedevice. Refer to section18 for Performance data
OperatingSystem	CASE:Windows XP embeddedCS:Windows XP,Windows XP Pro,Windows Vista HomePremium, Windows VistaBusiness,	CASE:Windows 10 IoT Enterprise 64bitCardioSoft:Windows 10 Professional (64bit)Windows 10 Enterprise (64bit).Windows Server 2016 (64 bit).	EquivalentRemoved old WindowsOS due to obsolescenceand added currentWindows OS to takeadvantage of currenttechnology operatingsystem.
Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
DataManagement	MUSE InterfaceInterface to the MUSECardiology InformationSystem.Patient Demographics andOrders are imported fromMUSE. Exercise Tests,	MUSE InterfaceInterface to the MUSECardiology InformationSystem.Patient Demographics andOrders are imported fromMUSE. Exercise Tests, Resting	Equivalent
	Resting ECGs are exportedto MUSE.BDT/GDT InterfaceProtocol for system-independent data transfer ofmedical data defined byQMS (Quality association formedical software, Germany)	ECGs are exported to MUSE.BDT/GDT InterfaceProtocol for system-independent data transfer ofmedical data defined by QMS(Quality association formedical software, Germany)	Introduced DICOM withEncryption (TLS Ver 1.2)DCAR CommunicationProtocol (DCP withencryption) is added toimprove the efficiency ofcommunication for MUSEinterface and EMRgateway.
	HIS: HL7 EMR interfaceInterface to Centricity EMR(formally known as Logician)has been added forcustomer convenience toenter demographic dataonce and to provide aURL/link to the specificpatient record in theCASE/CardioSoft database.Demographic and clinicaldata import and export to anElectronic Medical RecordEMR.EMR GatewayConfigurable HL7 Interfaceoutbound only.Demographic and clinicaldata export to EMRproviders based on PDF andXML export.	DICOM InterfaceProtocol for querying andretrieving a DICOM ModalityWorklist from a WorklistService Control Provider(SCP), sending test status to aDICOM Modality PerformedProcedure Step SCP, sendingstorage commitment requests(and receiving replies) to aDICOM Storage CommitmentSCP, exporting DICOMComposite Instances (ECGWaveforms for Exercise testsand Final report as DICOMEncapsulated PDF for all typesof tests) as Storage ServiceControl User (SCU) andDICOM verification (as SCP &SCU).	HL7 EMR Communicationis not supported with theproposed device.
	DICOM InterfaceProtocol for querying andretrieving a DICOM ModalityWorklist from a WorklistService Control Provider(SCP), sending test status toa DICOM ModalityPerformed Procedure StepSCP, sending storagecommitment requests (andreceiving replies) to aDICOM Storage	Introduced DICOM withEncryption (TLS Ver 1.2)DCAR CommunicationProtocol (DCP withEncryption)Communication with MUSEand EMR Gateway.Database is updated fromBtrieve to Microsoft SQLServer
Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
	Commitment SCP, exportingDICOM Composite Instances(ECG Waveforms forExercise tests and Finalreport as DICOMEncapsulated PDF for alltypes of tests) as StorageService Control User (SCU)and DICOM verification (asSCP & SCU).
Export Formats	Word, Excel, PDF, XML	Word, Excel, PDF, XML	Identical
Archiving	All test data can be storedelectronically on hard drive,network server, floppy disk,CD-RW or can be printed out	All test data can be storedelectronically on hard drive,network server, externalmedia or can be printed out	EquivalentRemoved obsoletestorage media (floppydisk,) compared topredicate,
Media StorageDevice	• CD Drive R/W• SD Card Reader• Internal storage(Integrated in CASE;available as peripheral forCS)	• CD Drive R/W• SD Card Reader• External storage throughUSB port• internal storage(available as peripheral forCARDIOSOFT)	EquivalentRemoved obsoletestorage media (floppydisk,)External storage throughUSB Port is added
Analog / TTLoutput ports tointerface	• Echocardiographic Devices• Nuclear Cameras	• Echocardiographic Devices• Nuclear Cameras	Identical
Serial I/O portsUSB Ports	• Treadmill(Serial)• Ergometer(Serial)• Automated BloodPressure Units(Serial)• Metabolic Systems• Pulse Oximeters• Spirometer• Ambulatory BloodPressure Device	• Treadmill(Serial/USB)• Ergometer(Serial/USB)• Automated Blood PressureUnits (Serial/USB)• Metabolic Systems• Pulse Oximeters• Spirometer• Ambulatory Blood PressureDevice	Equivalent:Added support for USBports to take advantageof current technology.
ECG Modality
ECG AcquisitionModule	CS: CAM-USB acquisitionmodule(CAM14 and CAM-USBInterface)CAM-USB A/TCASE: CAM14	CardioSoft : CAM Connect 14(CC14), and GEH ECG 1200wireless acquisition module (cleared under K080141)CASE: CAM Connect 14(CC14)and GEH ECG 1200	Equivalent:The proposed device willhave both wired andwireless acquisitionmodules.
Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
		Wireless acquisition module(Cleared under K080141).
BP Devices	Measurement is triggered,systolic and diastolic BPvalue read from device.	Measurement is triggered,systolic and diastolic BP valueread from device.	Identical
SPO2 Devices(exercise testonly)	SPO2 value is read from thedevic	SPO2 value is read from thedevice	Identical
Ergometers(exercise testonly)	Load value is sent toergometerActual load value andrevolutions are read fromergometer	Load value is sent toergometerActual load value andrevolutions are read fromergometer	Identical
Treadmills(exercise testonly)	Treadmill is started andstopped.Speed and Grade value issent to Treadmill.Actual Speed and Gradevalue is read from treadmill.	Treadmill is started andstopped.Speed and Grade value is sentto Treadmill.Actual Speed and Grade valueis read from treadmill.	Identical
SpirometryModule	SpiroSoft (K031194) andEasyOne-CS (K993921)	Spiro-SP TrueFlow Sensor atEasy on-PC (K090034)	EquivalentThe proposed device willsupport cleared moduleSpiro-SP TrueFlow Sensorat Easy on-PC (K090034)
ABP Module	Tonoport V(K012647)	Tonoport V (K012647)Tonoport VI (K170966)	EquivalentThe proposed device willsupport a cleared moduleTonoport VI (K170966)
ECG SystemPerformance
Leads/ChannelsResting ECG	12, 15	12, 15	Identical
Leads/ChannelsStress Test	3, 6, 12, 15	3, 6, 12, 15	Identical
Paper speed -Thermal Writer	25, 50 mm/s +/- 2%5, 12.5 mm/s +/- 10%	25, 50 mm/s +/- 2%5, 12.5 mm/s +/- 10%	Identical
FrequencyResponse	3dB, display and writer	3dB, display and writer	Identical
ECG SignalBandwidth	0.01 to 150 Hz (CAM 14)	0.04 to 150 Hz (CC14).Note: CC 14 is cleared with MACVU 360 (K173830)	EquivalentECG Bandwidth as per theIEC60601-2-25 standardis 0.67 Hz to 150 Hz whichis well within thebandwidth of 0.04 Hz.
Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
			of ECG Data even if thebandwidth is 0.04 Hz
Sensitivity	2.5/5/10/20 mm/mV	2.5/5/10/20 mm/mV	Identical
Online ECG (Fulldisclosure)	In the operation mode"stress test" the ECG can bestored electronically.Alternatively selectedsegments of the ECG can beprinted out.Online ECG (full disclosure)for "resting ECG"	In the operation mode "stresstest" the ECG can be storedelectronically. Alternativelyselected segments of the ECGcan be printed out.Online ECG (full disclosure) for"resting ECG"	Identical
Sample Rate	Sample rate at point ofanalysis is 500 Hz.	Sample rate at point ofanalysis is 500 Hz.	Identical
Noise	< 15uV p-p RTI<2.5uV RMS IEC/AHArecommendation	< 15uV p-p RTI<2.5uV RMS IEC/AHArecommendation	Identical
ECG SignalInput forResting andStress ECG
Electrodeconnections	IEC: R, L, F, N, C1-C6AHA: RL, RA, LL, LA, V1-V6Supported also:- V3r, V4r, V5r, V7-V9, A1-A4- CMH, CML, NEHB electrodesets- Option to acquireadditional 4 uni-polar leadssimultaneously	IEC: R, L, F, N, C1-C6AHA: RL, RA, LL, LA, V1-V6Supported also:- V3r, V4r, V5r, V7-V9, A1-A4- CMH, CML, NEHB electrodesets- Option to acquire additional4 uni-polar leadssimultaneously	Identical
Electrodesmonitored fordisconnection	Every electrode except RL	Every electrode except RL	Identical
Detection ofpacemaker pulse	CAM 14:>750 uV @ 50 uS	CC14:Duration: 0.1 ms to 2.2 msAmplitude: 2 mV to 700 mVSeparation: 1 ms or greater	EquivalentCC 14 complies to theclause no 201.12.4.109 ofIEC 60601-2-25 :2011.CC 14 is cleared with MACVU 360 (K173830)
Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
Input impedancefor differentialsignals at 10 Hz	CAM14:>10 M Ohm	CC14:>2.5M Ohm	EquivalentIEC 60601-2-25:2011 requirement is that theInput impedance isminimum 2.5 M Ohms. CC14 complies to thisrequirement.CC 14 is cleared underK173830
Input impedancefor common-mode signals at60Hz	>50 M Ohm	>50 M Ohm	Identical
Common moderejection ratio	> 140 dB> 123 dB with AC filterenabled	> 140 dB> 123 dB with AC filterenabled	Identical
Dynamic range atAC voltage	+/- 320 mV +/- 10 mV	+/- 300 mV +/- 5 mV	EquivalentIEC 60601-2-25:2011requirement is that Offsetshall be +/- 300mV DCand AC DifferentialVoltage as +/- 5 mV
Patient leakagecurrent	< 5uA normal conditions<10uA single fault condition	< 10 uA normal conditions< 50uA single fault condition	EquivalentIEC 60601-2-25:2011requirement is thatPatient leakage currentshall be less than 10 uA inNormal Condition andLess than 50 uA in SingleFault Condition
Line Filter	50 or 60Hz notch filter(selectable)	50 or 60Hz notch filter(selectable)	Identical
High Pass Filter	CAM14:.01 Hz (or .05Hz special use)with DC offset control	CC14: 0.04 Hz	Equivalent:As per IEC 60601-2-25:2011. the frequencybandwidth shall be 0.67Hz T0 150 HZ. Having a
Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
			bandwidth of 0.04 Hz to150 HZ will accommodateall the useful informationof ECG.
Inputs: PatientDemographics,Non-ECG Data
Stress Protocols	Treadmill:BRUCE,MODBRUCE,NAUGHTON,ELLESTAD,MODBALKE,USAFSAM,SLOWUSAFSAM,CORNELL,BALKEWARE,MODBALKEWARE,ADENOSIN,DOBUTAMINE,PERSANTINE,User definedErgometer:WHO,WHO50,WHO75,HOLLMANN,BAL,STD. FRANCE,MODWHO,CONCONI,User defined	Treadmill:BRUCE,MODBRUCE,NAUGHTON,ELLESTAD,MODBALKE,USAFSAM,SLOWUSAFSAM,CORNELL,BALKEWARE,MODBALKEWARE,ADENOSIN,DOBUTAMINE,PERSANTINE,User definedErgometer:WHO,WHO50,WHO75,HOLLMANN,BAL,STD. FRANCE,MODWHO,CONCONI,User defined	Identical
Exerciseparameters	Time: phase, stage, clocksTreadmill:Speed(mph,km/h), gradePharma stress: Drug/dosage,Bike: weight (kg), load(Watts)Metabolic EquivalentMeasurement (METs)Other derivatives: exercisetime, workload	Time: phase, stage, clocksTreadmill: Speed(mph,km/h),gradePharma stress: Drug/dosage,Bike: weight (kg), load (Watts)Metabolic EquivalentMeasurement (METs)Other derivatives: exercisetime, workload	Identical
Blood Pressure	Systolic / Diastolic (mmHg,kPa) is manually entered orautomatically acquired bythe proposed device	Systolic / Diastolic (mmHg,kPa) is manually entered orautomatically acquired by theproposed device	Identical
Feature/Function	Predicate DeviceCASE V6.6 and CS V6.6(K103678)	Proposed DeviceCASE V7.0 and CardioSoft V7.0	Explanation of Differences
Patientdemographics	Yes	Yes.Visit number and SecondaryPatient ID is added	Equivalent.Visit number andSecondary Patient IDDemographics fieldsare added based oncustomer request.
Indication ofDetectedPacemakerpulses	Pacemaker activityidentified by ECG acquisitionhardware. Leveraging newertechnology for pacemakerdetection improvements	Pacemaker activity identifiedby ECG acquisition hardware.Leveraging newer technologyfor pacemaker detectionimprovements	Identical
ECG -ArrhythmiaFeatures
ArrhythmiaDetection duringexercise test	Yes	Yes	Identical
Arrhythmiadetection inResting RCG/ Fulldisclosure	Yes	Yes	Identical
ArrhythmiaAnnotation	ASYSTO,CPLT,ESC,L,PAU1,PAU2,PCAP,PERR,QRSL,RUN,SVPB,VBIG,VIFB,VPB,VTAC	ASYSTO,CPLT,ESC,L,PAU1,PAU2,PCAP,PERR,QRSL,RUN,SVPB,VBIG,VIFB,VPB,VTAC	Identical
HEART exercise /ECGinterpretation	HEART exercise (K091594)	HEART exercise (K091594)	Identical
Resting ECG -Processing Data
ECG Analysis/Interpretation(12SL)	12SL ECG Analysis Program(V21) (K060833)	12SL ECG Analysis Program(V23) (K141963)	EquivalentImplementing 12SL v23cleared under K141963
Resting ECG Re-analysis	Manual setting ofmeasurement points	Manual setting ofmeasurement points	Identical
Automaticbaselinecorrection	Yes	Yes	Identical
Resting ECG -MeasuredParameters
Intervals	12SL global: PR, QRS, QT,QTC, P, RR, PP12SL lead dep.: QD, RD, SD,RPDHEART global: PR, QRS, QT,QTC, P, RR, PP, QTD, QTcBDHEART lead dep.: Q, R, S, Rp,QT	12SL global: PR, QRS, QT, QTC,P, RR, PP12SL lead dep.: QD, RD, SD,RPDHEART global: PR, QRS, QT,QTC, P, RR, PP, QTD, QTcBDHEART lead dep.: Q, R, S, Rp,QT	Identical
Amplitudes	12SL lead dep: PA, PPA QA,RA, SA, RPA TA TPAHEART lead dep.: P, Q, R, S,R', S', J, ST, T	12SL lead dep: PA, PPA QA,RA, SA, RPA TA TPAHEART lead dep.: P, Q, R, S, R',S', J, ST, T	Identical
hers	P-R-T axesHeart RateST slope	P-R-T axesHeart RateST slope	Identical
Interpretation	12SL DiagnosisHEART DiagnosisACI-Tipi Diagnosis(K9974199)	12SL DiagnosisHEART DiagnosisACI-Tipi Diagnosis (K9974199)	Identical
Resting ECG -Display
ECG Traces	12 or 15	12 or 15	Identical
ECG Speed	25/50 mm/sec.	25/50 mm/sec.	Identical
ECG Display	Test Summary (PatientInformation, GlobalMeasurement Results, Testinformation, Interpretation)	Test Summary (PatientInformation, GlobalMeasurement Results, Testinformation, Interpretation)	Identical
	ECG Traces	ECG Traces
	Medians	Medians
	Lead dependent	Lead dependent
	Measurement Results	Measurement Results
	Arrhythmia Review	Arrhythmia Review
	Vector Loops	Vector Loops
	Full Disclosure ECG	Full Disclosure ECG
Print Formats	Configured Reports	Configured Reports	Identical
	Standard Reports	Standard Reports
	Medians	Medians
	Vector Loops	Vector Loops
	Full Disclosure ECG	Full Disclosure ECG
	Rhythm Report	Rhythm Report
Colored Reports	YES	YES	Identical
Previous Test	Simultaneous previous	Simultaneous previous report	Identical
Report Retrieval	report review capability in	review capability in post test
	post test review mode	review mode
Manual ECG	Yes, paper and on screen	Yes, paper and on screen	Identical
measurement
Exercise ECG -
Display
ECG Traces	Maximum 15 traces in one	Maximum 15 traces in one	Identical
	screen	screen
Exercise Test	Visual Assessment of ECG	Visual Assessment of ECG	Identical
Assessment	Traces	Traces
	CS: Audio Assessment of	CardioSoft: Audio Assessment
	ECG Traces	of ECG Traces
Sweep Speed	25/50 mm/sec.	25/50 mm/sec.	Identical
Display Data	Heart Rate (HR)	Heart Rate (HR)	Identical
	Target HR	Target HR
	Max predicted HR	Max predicted HR
	Clocks (stress test)	Clocks (stress test)
	Blood Pressure (BP	Blood Pressure (BP
	[mmHg,kPa])	[mmHg,kPa])
	Rate Pressure Product (RPP)	Rate Pressure Product (RPP)
	Avg. beat w/ST fiducial	Avg. beat w/ST fiducial points
	points	Protocol Stage
	Protocol Stage	Protocol Phase
	Protocol Phase	Protocol Name
	Protocol Name	Treadmill Speed and Grade
	Treadmill Speed and Grade	METS display
	METS display	Spirometer measurement
	Spirometer measurement	SpO2
	SpO2	Target Load
	Target Load	Ergometer Load/RPM
	Ergometer Load/RPMQuantitative Lead Prep.	Quantitative Lead Prep.
	Measurements	Measurements
	Arrhythmia Display	Arrhythmia Display
	HR recovery	HR recovery
	HR reserved used	HR reserved used
	FVE recovery	FVE recovery
Trends	Heart rate	Heart rate	Identical

	Speed	Speed
	Grade	Grade
	ST-level	ST-level
	ST-slope.	ST-slope.
	User definable, also	User definable, also including
	including double product:	double product:
	RPP	RPP
	ST Integral	ST Integral
	Pulse Rate	Pulse Rate
	Respiratory Rate	Respiratory Rate
	Tidal Volume	Tidal Volume
	ST-HR Loops	ST-HR Loops
	PVC/min	PVC/min
	Exertion Scale	Exertion Scale
	Exercise Time	Exercise Time
	Workload	Workload
	J Level	J Level
	J+20 Level	J+20 Level
	J+60 Level	J+60 Level
	ST/HR slope	ST/HR slope
	ST/HR index (ST vs. HR)	ST/HR index (ST vs. HR)
	SpO2	SpO2
	V O2	V O2
	VC O2	VC O2
	ETC O2	ETC O2
	Cardiac Output	Cardiac Output
	TWA	TWA
	METS	METS
	VE/min	VE/min
	ST/HR hysteresis	ST/HR hysteresis
ECGDisplay/PrintFormats	Medians	Medians	Equivalent
	Linked Medians	Linked Medians
	Recall Reports	Recall Reports	Full disclosure was
	Tabular Summary Reports	Tabular Summary Reports	available in Post test and
	Sample cardiac cycle reports	Sample cardiac cycle reports	is now available during
	3/6/12/15-Lead reports	3/6/12/15-Lead reports	acquisition and in Posttest
	Graded exercise summaryreport	Graded exercise summaryreport
	Waterfall display	Waterfall display
	TWA medians	TWA medians
	Trends Reports	TWA full disclosure
	12SL Report	Trends Reports
	Vector Loops	12SL Report
	Rhythm Report	Vector Loops
	Full disclosure (in Post test)	Rhythm Report
Previous TestReport Retrieval	Simultaneous previousreport review capabilityduring current test.	Simultaneous previous reportreview capability duringcurrent test.	Identical
Manual ECG	Yes, paper and on screen	Yes, paper and on screen	Identical

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The color of the logo is a vibrant purple, which contrasts with the white background. The logo is simple, yet recognizable.

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Image /page/9/Picture/0 description: The image shows a purple and white logo. The logo is a circle with a stylized "GE" in the center. The "GE" is written in a cursive font and is surrounded by a swirling design. The logo is likely for General Electric.

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Image /page/10/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram enclosed in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The color of the logo is purple.

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Image /page/11/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" monogram on the left, and the text "GE HealthCare" on the right. The emblem and text are both in a purple color.

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Image /page/12/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The color of the logo is purple.

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Image /page/13/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside. To the right of the emblem is the text "GE HealthCare" in a matching purple color.

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Image /page/14/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside. To the right of the emblem is the text "GE HealthCare" in purple.

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Image /page/15/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, swirling design in purple, and the text is also in purple.

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Image /page/16/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The color of the logo is purple.

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Image /page/17/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, circular design with intricate details, while the text is in a clean, sans-serif font.

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Image /page/18/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized version of the GE monogram, and the text is in a sans-serif font. The logo is purple.

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Image /page/19/Picture/0 description: The image contains the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized design. The text is also purple and uses a sans-serif font.

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Image /page/20/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circle with a white GE monogram inside. To the right of the circle is the text "GE HealthCare" in purple.

The CASE V7.0 and CardioSoft V7.0 complies with the Performance standards: voluntary consensus standard ANSI/AAMI ES60601-1:2005/(R)2012 and its relevant collateral and particular standards. Determination of Summary of Non-Clinical Tests Substantial Equivalence: The CASE V7.0 & Cardiosoft V7.0 program was designed and tested for compliance with applicable clauses of the following voluntary standard: IEC 60601-2-25 : 2011- Medical Electrical Equipment – Part 2-25 Particular requirements for the Basic Safety and Essential performance of Electrocardiographs The following quality assurance measures were applied to the development of the system: Risk Analysis -Requirements Reviews --Verification Testing -Performance testing -EMI-EMC & Safety Testing -Summary of Clinical Tests: Summary of Clinical Tests: The subject of this premarket submission, CASE V7.0 and CardioSoft V7.0 did not require clinical studies to support substantial equivalence. Conclusion: The CASE V7.0 and CardioSoft V7.0 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

K231870

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).