K Number
K031561
Device Name
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
Date Cleared
2003-08-01

(74 days)

Product Code
Regulation Number
870.1425
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CardioSoft/CASE Cardiac Testing System is intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CardioSoft/CASE Cardiac Testing System is 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 CardioSoft/CASE Cardiac Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. CardioSoft/CASE Cardiac Testing System provides the control of external device (typically a treadmill or Ergometer) and communicates with centralized electronic/digital storage system via network. CardioSoft/CASE Cardiac Testing System provides a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available. CardioSoft/CASE 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. CardioSoft/CASE Cardiac Testing System is 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. CardioSoft/CASE Cardiac Testing System offers 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. CardioSoft/CASE Cardiac Testing System is not intended to be used as a transport device or for home use. CardioSoft/CASE Cardiac Testing System is not intended for the use as a vital signs physiological monitor or for intracardiac use.
Device Description
The CardioSoft/CASE Cardiac Testing System is designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CardioSoft will be offered as a software only package including a front end for data acquisition. The CASE is a turnkey product utilizing the CardioSoft software. The CASE device is designed for the US markets. A version designed for the European market, the CardioSys, will not be offered for sale in the US.
More Information

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard signal processing and data management functionalities.

No.
The device is strictly for acquiring, processing, and analyzing physiological data. It explicitly states that it "offers no diagnostic opinion" and does not provide therapy or treatment.

Yes

The device is designed to acquire, process, record, archive, analyze, and output physiological data (ECG, Spirometry, Ambulatory Blood Pressure) for the purpose of testing during stress or rest, which is integral to the diagnostic process performed by a healthcare practitioner. While it states it "offers no diagnostic opinion," it provides interpretive statements and data that assist the physician in rendering their medical opinion, thus serving as a diagnostic tool.

No

The device description explicitly states that the CardioSoft will be offered as a software-only package, but the CASE is described as a "turnkey product utilizing the CardioSoft software," implying it includes hardware. Furthermore, the performance studies mention "Software and hardware testing," confirming the existence of hardware components in at least one configuration of the system.

Based on the provided text, the CardioSoft/CASE Cardiac Testing System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
  • CardioSoft/CASE Function: The description clearly states that the CardioSoft/CASE system is designed to acquire, process, and analyze ECG data during stress or resting tests, and data from ancillary devices like Spirometry and Ambulatory Blood Pressure. These are measurements taken directly from the patient's body, not from specimens taken from the body.
  • No Mention of Specimen Analysis: The text does not mention the analysis of any biological specimens.

Therefore, the CardioSoft/CASE Cardiac Testing System falls under the category of a medical device used for physiological monitoring and testing, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The CardioSoft/CASE Cardiac Testing System is intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CardioSoft/CASE Cardiac Testing System is 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 CardioSoft/CASE Cardiac Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.
CardioSoft/CASE Cardiac Testing System provides the control of external device (typically a treadmill or Ergometer) and communicates with centralized electronic/digital storage system via network. CardioSoft/CASE Cardiac Testing System provides a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available.
CardioSoft/CASE 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.
CardioSoft/CASE Cardiac Testing System is 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.
CardioSoft/CASE Cardiac Testing System offers 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.
CardioSoft/CASE Cardiac Testing System is not intended to be used as a transport device or for home use. CardioSoft/CASE Cardiac Testing System is not intended for the use as a vital signs physiological monitor or for intracardiac use.

Product codes

MHX

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

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 on adult and pediatric patients.
The CardioSoft/CASE Cardiac Testing System is 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.

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)

The CardioSoft/CASE Cardiac Testing System complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:

  • Requirements specification review
  • Code inspections .
  • Software and hardware testing ●
  • Safety testing ●
  • Environmental testing .
  • Final validation .
    The results of these measurements demonstrated that the CardioSoft/CASE Cardiac Testing System is as safe, as effective, and performs as well as the predicate device.

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

Not Found

Predicate Device(s)

K991014, K951130, K023380, K002209

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

K031561
p. 1/2

510(k) Summary of Safety and Effectiveness

Date:May 15, 2003
Submitter:GE Medical Systems Information Technologies
8200 West Tower Avenue
Milwaukee, WI 53223 USA
Contact Person:David Wahlig
Sr. Regulatory Affairs Specialist
GE Medical Systems Information Technologies
Phone: (262) 293-1705
Fax: (414) 918-8112
Device:Trade Name:CardioSoft/CASE Cardiac Testing System
Common/Usual Name:ECG Analysis Computer
Classification Names:21 CFR 870.1425 Programmable diagnostic computer
21 CFR 870.2920 Transmitters and Receivers, Electrocardiograph, Telephone
21 CFR 870.2340 Electrocardiograph
21 CFR 870.2340 System, ECG Analysis
21 CFR 870.1025 Detector and Alarm, Arrhythmia
Predicate Devices:CASE 8000 exercise testing systemK991014
CardioSoft CardioSysK951130
Twave AlternansK023380
GE Marquette ECG Analysis Program (12SL)K002209
Device Description:The CardioSoft/CASE Cardiac Testing System is designed to be used for
resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and
for recording ECG in real-time with and without arrhythmia detection.
The CardioSoft will be offered as a software only package including a front
end for data acquisition.
Intended Use:The CASE is a turnkey product utilizing the CardioSoft software. The CASE
device is designed for the US markets. A version designed for the European
market, the CardioSys, will not be offered for sale in the US.
CardioSoft/CASE Cardiac Testing System is intended to be used by trained
operators under direct supervision of a licensed health care practitioner on
adult and pediatric patients. The CardioSoft/CASE Cardiac Testing System is
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 CardioSoft/CASE Cardiac Testing System is provided to the user
for the convenience of automatic detection of arrhythmias but does not provide
alarms.
CardioSoft/CASE Cardiac Testing System provides the control of external
device (typically a treadmill or Ergometer) and communicates with centralized
electronic/digital storage system via network. CardioSoft/CASE Cardiac
Testing System provides a user selectable option for printouts of prognostic
scores on select reports. Vector loops are also available.
CardioSoft/CASE 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.

1

CardioSoft/CASE Cardiac Testing System is 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.

CardioSoft/CASE Cardiac Testing System offers 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.

CardioSoft/CASE Cardiac Testing System is not intended to be used as a transport device or for home use. CardioSoft/CASE Cardiac Testing System is not intended for the use as a vital signs physiological monitor or for intracardiac use.

Technology:

The proposed CardioSoft/CASE Cardiac Testing System employs the same technology as the predicate device.

Test Summary:

The CardioSoft/CASE Cardiac Testing System complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:

  • Requirements specification review
  • Code inspections .
  • Software and hardware testing ●
  • Safety testing ●
  • Environmental testing .
  • Final validation .

Conclusion:

The results of these measurements demonstrated that the CardioSoft/CASE Cardiac Testing System is as safe, as effective, and performs as well as the predicate device.

212

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or energy.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

GE Medical Systems Information Technologies c/o Mr. David Wahlig Senior Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee. WI 53223

Re: K031561

Trade Name: CardioSoft/CASE Cardiac Testing Systems Regulation Number: 21 CFR $870.1025 Regulation Name: Patient Physiological Monitor with arrhythmia detection and alarms Regulatory Class: Class III (three) Product Code: MHX Dated: May 15, 2003 Received: May 19, 2003

Dear Mr. Wahlig:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

3

Page 2 - Mr. David Wahlig

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dele Tum

U-Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

510(k) Number (if known):

CardioSoft/CASE Cardiac Testing System Device Name:

Indications For Use:

CardioSoft/CASE Cardiac Testing System is intended to be used by trained operators under of a licensed health care practitioner on adult and pediatic patients. The Cardiac Testing System is designed to acquire process, record, archive, 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 record ECG in real-time with and without arrhythmia detection. The arrhythmia detection portion of Cardiac Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.

CardioSoft/CASE Cardiac Testing System provides the control of external device (typically a treadmill or Ergoneter) and communicates with centralized electronic/digital storage system via network. Cardiac Testing System provides a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available.

CardioSoft/CASE 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.

CardioSoft/CASE Cardiac Testing System is 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.

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

CardioSoft/CASE Cardiac Testing System is not intended to be used as a transport device or for home use, CardioSoft/CASE Cardiac Testing System is not intended for the use as a vital signs physiological monitor or for intracardiac use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

N.Qetta

510(k) Number K03156