CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

K031561 · Ge Medical Systems Information Technologies · DQK · Aug 1, 2003 · Cardiovascular

Device Facts

• Record ID: K031561
• Device Name: CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DQK · Cardiovascular
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

System acquires, processes, records, archives, and outputs 12/15-lead ECG data during resting or stress testing; integrates data from ancillary devices (spirometry, ambulatory blood pressure). Operates via software-only package or turnkey system; controls external devices (treadmills/ergometers). Features include median morphology recording, real-time ECG monitoring, and automatic arrhythmia detection (no alarms). Used in hospitals, clinics, and physician offices by trained operators. Provides interpretive statements on morphology, rhythm, and conduction; physician renders final medical opinion. Supports networked central database for patient demographics and physiological data. Benefits include streamlined cardiac testing workflow and centralized data management.

Clinical Evidence

No clinical data. Bench testing only; system validated through requirements specification review, code inspections, software/hardware testing, safety testing, environmental testing, and final validation.

Technological Characteristics

Programmable diagnostic computer for ECG analysis. Software-based data acquisition and processing. Connectivity via network for centralized storage. Controls external exercise equipment (treadmills/ergometers). Supports 12/15-lead ECG, spirometry, and ambulatory blood pressure inputs.

Indications for Use

Indicated for adult and pediatric patients undergoing resting ECG, stress testing, spirometry, or ambulatory blood pressure monitoring. Used by trained operators under licensed healthcare practitioner supervision. Not for transport, home use, vital signs monitoring, 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 8000 exercise testing system (K991014)
• CardioSoft CardioSys (K951130)
• Twave Alternans (K023380)
• GE Marquette ECG Analysis Program (12SL) (K002209)

Submission Summary (Full Text)

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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: [phone] | |
| | Fax: [phone] | |
| 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 system | K991014 |
| | CardioSoft CardioSys | K951130 |
| | Twave Alternans | K023380 |
| | GE Marquette ECG Analysis Program (12SL) | K002209 |
| Device Description: | The CardioSoft/CASE Cardiac Testing System is designed to be used for<br>resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and<br>for recording ECG in real-time with and without arrhythmia detection.<br>The CardioSoft will be offered as a software only package including a front<br>end for data acquisition. | |
| Intended Use: | The CASE is a turnkey product utilizing the CardioSoft software. The CASE<br>device is designed for the US markets. A version designed for the European<br>market, the CardioSys, will not be offered for sale in the US.<br>CardioSoft/CASE Cardiac Testing System is intended to be used by trained<br>operators under direct supervision of a licensed health care practitioner on<br>adult and pediatric patients. The CardioSoft/CASE Cardiac Testing System is<br>designed to acquire process, record, archive, analyze and output (12 and 15<br>lead) ECG data during a period of physiologic stress or during a resting ECG<br>test, acquire data from ancillary devices (such as Spirometry and Ambulatory<br>Blood Pressure), provide median morphology recordings and record ECG in<br>real-time with and without arrhythmia detection. The arrhythmia detection<br>portion of CardioSoft/CASE Cardiac Testing System is provided to the user<br>for the convenience of automatic detection of arrhythmias but does not provide<br>alarms.<br>CardioSoft/CASE Cardiac Testing System provides the control of external<br>device (typically a treadmill or Ergometer) and communicates with centralized | |
| | electronic/digital storage system via network. CardioSoft/CASE Cardiac<br>Testing System provides a user selectable option for printouts of prognostic<br>scores on select reports. Vector loops are also available. | |
| | CardioSoft/CASE Cardiac Testing System can be configured in a network<br>environment for multiple CASE and CardioSoft stations allowing the user to<br>create a central database of patient demographics and collected patient<br>physiological data. | |

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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

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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

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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### 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