K Number

Device Name

CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM

Manufacturer

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH

Date Cleared

2011-02-16

(62 days)

Product Code

DQK

Regulation Number

870.1425

Intended Use

The CASE Cardiac Testing System and CS Cardiac Testing System are 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 CASE is a turnkey product utilizing the CS software. The CS will be offered as a software only package including o front end for data acquisition. 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. The CASE Cardiac Testing System and CS Cardioc Testing System are 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 recordings and record ECG in real-time without arrhythmia detection. The arrhythmia detection portion 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. 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 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 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 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. 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 Cardiac Testing System and CS 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 or for intracardiac use.

Device Description

The CASE Cardiac Testing System and the CS Cardiac Testing System are 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 CS Cardiac Testing System will be offered as a software only package including a front end for data acquisition. The CASE Cardiac Testing System is a turnkey product utilizing the CS Cardiac Testing software. CASE Cardiac Testing System and the 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. The CASE Cardiac Testing System and the 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. The arrhythmia detection portion of CASE Cardiac Testing System and the CS Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. The CS Cardiac Testing System was formerly named Cardiosoft.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K031561

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard signal processing and analysis for ECG, Spirometry, and Blood Pressure data, including "arrhythmia detection" and "interpretive statements of morphology, rhythm, and conduction." These functions are typically implemented using rule-based algorithms or traditional signal processing techniques, not explicitly AI/ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No.
The device is for diagnostic purposes (acquiring, processing, recording, archiving, and outputting physiological data like ECG, Spirometry, and Blood Pressure) and explicitly states it "offer[s] no diagnostic opinion to the user" and "are not intended to be used as a vital signs physiological monitor." It does not provide treatment or directly impact the patient's condition to bring about a cure or mitigate disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the devices are 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," all of which are diagnostic procedures. While it states the device "offers no diagnostic opinion to the user" and provides "interpretive statements" for the physician to render their own opinion, the collection and processing of such data for clinical evaluation still falls under the umbrella of diagnostic devices.

SaMD (Software as a Medical Device)

Yes

The summary explicitly states that "The CS Cardiac Testing System will be offered as a software only package including a front end for data acquisition." This indicates that one configuration of the device is purely software.

IVD (In Vitro Diagnostic)

Based on the provided text, the CASE Cardiac Testing System and CS 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 description of the CASE and CS systems focuses on acquiring, processing, and analyzing physiological data directly from the patient (ECG, Spirometry, Blood Pressure). There is no mention of analyzing biological samples like blood, urine, or tissue.
The intended use and device description clearly outline the system's function in acquiring and analyzing physiological signals. This is characteristic of in vivo diagnostic devices, not in vitro ones.

Therefore, based on the provided information, these systems fall under the category of in vivo diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

The CASE Cardiac Testing System and CS Cardioc Testing System are 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 recordings and record ECG in real-time without arrhythmia detection. The arrhythmia detection portion 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. 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 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 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 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.

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 Cardiac Testing System and CS 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 or for intracardiac use.

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

DQK

Device Description

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 / 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)

Summary of Non-Clinical Tests:
The CASE Cardioc Testing System and the CS Cardiac Testing System and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis .
Requirements Reviews .
Design Reviews ●
Testing on unit ievel (Module verification) .
Integration testing (System verification)
Performance testing (Verification) .
Safety testing (Verification) .
Simulated use testing (Validation) .

Summary of Clinical Tests:
The subject of this premarket submission. CASE Cardiac Testing System and the CS Cardiac Testing System 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.

K031561

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.

Not Found

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

FEB 16 2011

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: March 30, 2010

| Submitter: | GE Healthcare, GE Medical Systems Information Technologies GmbH
Munzinger Strasse 5
79111 Freiburg , Germany |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Albrecht Malkmus
Regulatory Affairs - Diagnostic Cardiology
GE Healthcare, GE Medical Systems Information
Technologies GmbH
Munzinger Strasse 5
79111 Freiburg, Germany
Phone: +49-761-4543-481
Fax: +49-761-4543-391 |
| Secondary Contact Person: | Doug Kentz
Regulatory Affairs - Diagnostic Cardiology
GE Healthcare, GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, WI 53223
Phone: (414) 581-8987
Fax: (414) 362-2585 |
| Trade Name: | CASE Cardiac Testing System
CS Cardiac Testing System |
| Common/Usual Name: | ECG Analysis Computer |
| Classification Names: | 2 1 CFR 870.1425 Programmable diagnostic computer |
| Product Code: | DQK |
| Predicate Device(s): | CardioSoft / CASE Cardiac Testing System
K031561 |
| Device Description: | The CASE Cardiac Testing System and the CS Cardiac Testing System
are 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 CS Cardiac |

Image /page/0/Picture/8 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and connected, forming a single, recognizable symbol. The border is also decorative, with a repeating pattern that surrounds the letters.

GE Healthcare 510(k) Premarket Notification Submission

Testing System will be offered as a software only package including a front end for data acquisition. The CASE Cardiac Testing System is a turnkey product utilizing the CS Cardiac Testing software. CASE Cardiac Testing System and the 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. The CASE Cardiac Testing System and the 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. The arrhythmia detection portion of CASE Cardiac Testing System and the CS Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. The CS Cardiac Testing System was formerly named Cardiosoft.

Intended Use:

CASE Cardiac Testing System and the 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. The CASE Cardiac Testing System and the 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. The arrhythmia detection portion of CASE Cardiac Testing System and the CS Cardiac Testina System are provided to the user for the convenience of automatic detection of arrhythmias but does not provide alorms. CASE Cardiac Testing System and the CS Cardiac Testing System provide the control of external devices (typically a treadmill or Ergometer) and communicate with centralized electronic/digital storage system via network. CASE Cardiac Testing System and the CS 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 the CS Cardiac Testing System can be configured in a network environment for multiple CASE or CS stations allowing the user to create a central database of patient demographics and collected patient physiological data. CASE Cardiac Testing System and the 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

Image /page/2/Picture/21 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular border. The border has a textured appearance, and the letters 'GE' are stylized with curved lines.

3/3

103678

is performed.

CASE Cardiac Testing System and the 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 /CS Cardiac Testing System is not intended to be used as a transport device or for home use. CASE Cardiac Testing System and the CS Cardiac Testing System are not intended for the use as a vital signs physiological monitor or for intracardiac use. The CS Cardiac Testing System was formerly named Cardiosoft.

The proposed CASE Cardiac Testing System and the CS Cardiac Technology: Testing System employ the same technology as the predicate device CardioSoft /CASE Cardiac Testing System (K031561)

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The CASE Cardioc Testing System and the CS Cardiac Testing System and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis .
Requirements Reviews .
Design Reviews ●
Testing on unit ievel (Module verification) .
- Integration testing (System verification)
Performance testing (Verification) .
Safety testing (Verification) .
Simulated use testing (Validation) .

Summary of Clinical Tests:

The subject of this premarket submission. CASE Cardiac Testing System and the CS Cardiac Testing System did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the CASE Cardiac Testing System and the CS Cardiac Testina System to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is a stylized symbol that resembles an abstract bird or human figure with three wing-like or arm-like extensions.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

GE Medical Systems Information Technologies c/o Mr. Albrecht Malkmus Regulatory Affairs Leader 3200 N Grandview Boulevard Waukesha, WI 51388

FEB 16 201

Re: K103678

Trade/Device Name: CASE V6.6 and CS V6.6 Cardiac Testing Systems Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer. Regulatory Class: Class II (two) Product Code: DQK Dated: March 30, 2010 Received: December 16, 2010

Dear Mr. Malkmus:

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 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.

Page 2 - Mr. Albrecht Malkmus

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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

Enclosure

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known):

Device Names:

CASE Cardiac Testing System CS Cardiac Testing System

Indications for Use:

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 Cardiac Testing System and CS 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 or for intracardiac use.

IFU K10 3678

ವ/ಸ

Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The logo is in black and white.

GE Healthcare 510(k) Premarket Notification Submission

Prescription Use_X____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.

(Division Sign-Off) (Division of Cardiovascular Devices 510(k) Number