Predicate Devices

Reference Devices

K080141, K090034, K012647, K170966, K091594, K141963, K9974199

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, deep learning, neural networks, or any related terms. The analysis described (morphology, rhythm, conduction, arrhythmia detection) is typical of traditional ECG analysis algorithms.

Therapeutic

No.
The device is described as a "Cardiac Testing System" intended for acquiring, processing, recording, archiving, analyzing, and outputting ECG data during stress tests or resting ECGs. It provides no diagnostic opinion or therapeutic function, and explicitly states it is "not intended for use as a vital signs physiological monitor" or "as an emergency device." Its purpose is for testing and data analysis, not treatment.

Diagnostic

Yes
Explanation: The device is described as a "Cardiac Testing System" designed to acquire, process, record, archive, analyze, and output ECG data. It also mentions providing "interpretive statements of morphology, rhythm, and conduction," which are used by a physician to render a medical opinion, indicating its role in providing information for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that 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 described as a "turnkey product utilizing the CardioSoft V7.0 Cardiac Testing software," implying it includes hardware components. Furthermore, the summary of non-clinical tests mentions "EMI-EMC & Safety Testing," which are typically performed on hardware components.

IVD (In Vitro Diagnostic)

Based on the provided text, the CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not IVD (In Vitro Diagnostic) devices.

Here's why:

IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this system acquires and processes ECG data directly from the patient during stress or resting tests. It also acquires data from ancillary devices like Spirometry and Ambulatory Blood Pressure, which are also direct measurements from the patient.
The system does not analyze biological samples. There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or substance.
The focus is on physiological measurements. The system is designed to acquire, process, and analyze physiological signals (ECG, spirometry, blood pressure) from the patient.

Therefore, based on the provided information, this device falls under the category of a medical device for physiological monitoring and testing, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

DQK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ECG

Anatomical Site

Not Found

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

trained operators under direct supervision of a licensed health care practitioner / 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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests: 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
Clinical Tests: The subject of this premarket submission, CASE V7.0 and CardioSoft V7.0 did not require clinical studies to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K103678

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K080141, K090034, K012647, K170966, K091594, K141963, K9974199

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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)