What is the regulatory pathway for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Q: Who is the manufacturer of CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

Ge Medical Systems Information Technologies, Inc. filed the 510(k) submission for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (K231870).

Q: What is the FDA product code for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

Q: Does CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System use AI or machine learning?

Yes. CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (K231870) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Q: Can an AI/ML device like CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

K231870 · Ge Medical Systems Information Technologies, Inc. · DQK · Dec 13, 2023 · Cardiovascular

Device Facts

Record ID	K231870
Device Name	CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
Applicant	Ge Medical Systems Information Technologies, Inc.
Product Code	DQK · Cardiovascular
Decision Date	Dec 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

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 Story

System acquires, processes, records, archives, and analyzes 12/15-lead ECG data during resting or physiologic stress tests; integrates ancillary data from spirometry and ambulatory blood pressure devices. Operates via medical cart (CASE) or customer-provided PC (CardioSoft) using wired (CC14) or wireless (GEH ECG 1200) acquisition modules. Controls external exercise equipment (treadmills/ergometers). Provides arrhythmia detection (no alarms), prognostic scores, and vector loops. Used in hospitals, clinics, and physician offices by trained operators. Outputs interpretive statements for physician review; does not provide diagnostic opinions. Facilitates network-based central database management of patient demographics and physiological data. Benefits include standardized cardiac testing, automated data acquisition, and streamlined clinical workflow through EMR/MUSE integration.

Clinical Evidence

No clinical studies required. Substantial equivalence supported by bench testing, risk analysis, requirements reviews, verification testing, and EMI-EMC/safety testing per IEC 60601-2-25 and ANSI/AAMI ES60601-1 standards.

Technological Characteristics

System uses wired (CC14) or wireless (GEH ECG 1200) acquisition modules. Connectivity via network (DICOM, TLS 1.2, DCP). Software runs on Windows 10 IoT/Professional/Server. Database migrated to Microsoft SQL Server. Complies with ANSI/AAMI ES60601-1 and IEC 60601-2-25. ECG bandwidth 0.04-150 Hz. Sample rate 500 Hz.

Indications for Use

Indicated for adult and pediatric patients requiring resting ECG, stress test ECG, spirometry, or ambulatory blood pressure monitoring. Used by trained operators under licensed healthcare practitioner supervision. Not for home, transport, emergency, or intracardiac use.

Regulatory Classification

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.

Predicate Devices

CASE Cardiac Testing System, CS Cardiac Testing System (K103678)

Reference Devices

SpiroSoft (K031194)
EasyOne-CS (K993921)
Spiro-SP TrueFlow Sensor at Easy on-PC (K090034)
Tonoport V (K012647)
Tonoport VI (K170966)
MAC VU 360 (K173830)
12SL ECG Analysis Program (V21) (K060833)
12SL ECG Analysis Program (V23) (K141963)
HEART exercise (K091594)
ACI-Tipi Diagnosis (K9974199)

Related Devices

K031561 — CARDIOSOFT/CASE CARDIAC TESTING SYSTEM · Ge Medical Systems Information Technologies · Aug 1, 2003
K103678 — CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM · Ge Medical Systems Information Technologies GmbH · Feb 16, 2011
K991014 — CASE 8000 EXERCISE TESTING SYSTEM · General Electric Medical Systems Information Techn · Oct 20, 1999
K152427 — PC ECG · Edan Instruments, Inc. · Feb 5, 2016
K093211 — CARECENTER MD · Cardiac Science Corporation · Jun 3, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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 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. {3}------------------------------------------------ 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. | 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 V7.0 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 | {5}------------------------------------------------ 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 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 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ 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 Device CASE V6.6 and CS V6.6 (K103678) | Proposed Device CASE V7.0 and CardioSoft V7.0 | Explanation of Differences | |---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification / Product Code | 21CFR.870.1425 /DQK | 21CFR.870.1425 / DQK | Identical | | Intended Use Statement | CASE Cardiac Testing System and CS 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. | CASE V7.0 CARDIAC TESTING SYSTEM, 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. | Equivalent: The CardioSoft Cardiac Testing System was formerly named CS Cardiac Testing System. | | | The CASE Cardiac Testing System and CS 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. | CASE V7.0 CARDIAC TESTING SYSTEM, 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 algorithm of CASE Cardiac Testing System and CS Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. | The arrhythmia detection algorithm of CASE V7.0 CARDIAC TESTING SYSTEM, 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 Cardiac Testing System and CS Cardiac Testing System provide the control of external devices (typically a treadmill or Ergometer) and communicate with centralized electronic/digital storage system via data network. | CASE V7.0 CARDIAC TESTING SYSTEM, CARDIOSOFT V7.0 CARDIAC TESTING SYSTEM provide the control of external devices (typically a treadmill or Ergometer) and communicate with centralized electronic/digital storage system via data network. | | | | CASE Cardiac Testing System and CS Cardiac Testing System provide a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available. | CASE V7.0 CARDIAC TESTING SYSTEM, CARDIOSOFT V7.0 CARDIAC TESTING SYSTEM provide a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available. | | | | CASE Cardiac Testing System and CS Cardiac Testing System can be configured in a network environment for multiple CASE stations and CS stations allowing the user to create a central database of patient demographics and collected patient physiological data. | CASE V7.0 CARDIAC TESTING SYSTEM, 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. | | | Feature/Function | Predicate Device CASE V6.6 and CS V6.6 (K103678) | Proposed Device CASE V7.0 and CardioSoft V7.0 | Explanation of Differences | | | CASE Cardiac Testing System and CS Cardiac Testing System are intended to be used primarily in the hospital but can be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed. | TESTING SYSTEM intended to be used primarily in the hospital but can be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed. | | | | CASE Cardiac Testing System and CS 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, 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. | | | | CASE Cardiac Testing System and CS Cardiac Testing System are not intended to be used as a transport device or for home use. | CASE V7.0 CARDIAC TESTING SYSTEM, CARDIOSOFT V7.0 CARDIAC TESTING SYSTEM are not intended to be used as a transport device or for home use. | | | | CASE Cardiac Testing System and CS Cardiac Testing System are not intended for the use as a vital signs physiological monitor. | CASE V7.0 CARDIAC TESTING SYSTEM, CARDIOSOFT V7.0 CARDIAC TESTING SYSTEM are not intended for use as a vital signs physiological monitor. | | | | CASE Cardiac Testing System and CS Cardiac Testing System are not intended for intracardiac use. | CASE V7.0 CARDIAC TESTING SYSTEM, CARDIOSOFT V7.0 CARDIAC TESTING SYSTEM are not intended for intracardiac use. | | | | CASE Cardiac Testing System and CS Cardiac Testing System are not intended for the use as an emergency device. | CASE V7.0 CARDIAC TESTING SYSTEM, CARDIOSOFT V7.0 CARDIAC TESTING SYSTEM are not intended for use as an emergency device. | | | | CASE Cardiac Testing System and CS Cardiac Testing System will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators. | CASE V7.0 CARDIAC TESTING SYSTEM, CARDIOSOFT V7.0 CARDIAC TESTING SYSTEM will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators. | | | | CASE Cardiac Testing System and CS Cardiac Testing System are not intended for use with high frequency surgical units. Disconnect the patient from CASE Cardiac Testing System and CS Cardiac Testing System before using the high frequency surgical unit. | CASE V7.0 CARDIAC TESTING SYSTEM, 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, CARDIOSOFT V7.0 CARDIAC TESTING SYSTEM before using the high frequency surgical unit | | | Device Type | ECG recording system | ECG recording system | Identical | | Modalities | Resting ECG Exercise Test Spirometry Ambulatory Blood Pressure | Resting ECG Exercise Test Spirometry Ambulatory Blood Pressure | Equivalent Ergospirometry measurement in the Exercise testing, will not | | Feature/Function | Predicate Device CASE V6.6 and CS V6.6 (K103678) | Proposed Device CASE V7.0 and CardioSoft V7.0 | Explanation of Differences | | | Exercise Test and ergospirometry/metabolic test) | | be offered for sale with the subject device in US. | | Device Description | CASE is a medical cart including a thermal writer. The system cart is based on an embedded PC with CAM 14 acquisition module. The application software is pre- installed. CASE can be configured to maintain a local database or use a shared database on a server. Additional devices like treadmills, ergometers ambulatory blood pressure devices and spirometer devices can be connected. CS utilizes a customer- provided PC and consists of the application software and the CAM USB acquisition module (CAM14 and CAM- USB Interface), which connects to the PC's USB port. CS can be configured to maintain a local database or use a shared database on a server. There are a number of peripheral devices and accessories that can be connected. | CASE is a medical cart including a thermal writer. The system cart is based on an embedded PC with wired acquisition module CAM Connect 14 (CC14) and GEH ECG 1200 wireless acquisition module. The application software is pre-installed. CASE can be configured to maintain a local database or use a shared database on a server. Additional devices like treadmills, ergometers ambulatory blood pressure devices and spirometer devices can be connected. CardioSoft utilizes a customer-provided PC and consists of the application software and acquisition modules (CAM Connect 14, CAM-USB interface, and GEH ECG 1200), which connects to the PC's USB port. CardioSoft can be configured to maintain a local database or use a shared database on a server. There are a number of peripheral devices and accessories that can be connected. | Equivalent The proposed device support both wired (CC- 14) and wireless (GEH ECG 1200) ECG acquisition modules which don't impact safety and effectiveness of the device. Refer to section 18 for Performance data | | Operating System | CASE: Windows XP embedded CS: Windows XP, Windows XP Pro, Windows Vista Home Premium, Windows Vista Business, | CASE: Windows 10 IoT Enterprise 64 bit CardioSoft: Windows 10 Professional (64 bit) Windows 10 Enterprise (64 bit). Windows Server 2016 (64 bit).…

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

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

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

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Welcome

Check your email

Welcome!