(74 days)
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.
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.
The CardioSoft/CASE Cardiac Testing System is described as substantially equivalent to predicate devices based on safety and performance, but specific acceptance criteria and detailed device performance metrics are not explicitly provided in the furnished text.
Here's an breakdown of the information that can be extracted, and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "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." |
2. Sample size used for the test set and the data provenance:
This information is not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided text.
4. Adjudication method for the test set:
This information is not available in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
This information is not available in the provided text.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is an "ECG Analysis Computer" and provides "interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion." It also has "arrhythmia detection provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms." This suggests a standalone component (the algorithm/software) is present, but a formal standalone study proving its performance in isolation is not detailed or explicitly stated. The overall statement is that the system is as safe and effective as the predicate.
7. The type of ground truth used:
This information is not available in the provided text. The submission refers to a "Test Summary" but does not elaborate on the ground truth used for performance evaluation.
8. The sample size for the training set:
This information is not available in the provided text.
9. How the ground truth for the training set was established:
This information is not available in the provided text. The document outlines "quality assurance measures" such as "Requirements specification review," "Code inspections," "Software and hardware testing," "Safety testing," "Environmental testing," and "Final validation," but these do not detail how ground truth was established for any training data.
Summary of the Study Discussed (as per the available text):
The document references a "Test Summary" that states, "The CardioSoft/CASE Cardiac Testing System complies with the voluntary standards as detailed in Section 9 of this submission." It further states, "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 conclusion from these "measurements" (which are not detailed) is that "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 Take away: This 510(k) summary focuses on demonstrating substantial equivalence through a general assertion of safety and effectiveness compared to predicate devices, supported by a list of quality assurance measures. It does not provide the granular detail typically found in a clinical study report regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or ground truth methodologies. This type of submission relies more on demonstrating that the new device uses similar technology, has similar intended use, and has undergone standard development and testing procedures to ensure it is "as safe, as effective, and performs as well" as previously cleared devices.
{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 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 forresting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure andfor recording ECG in real-time with and without arrhythmia detection.The CardioSoft will be offered as a software only package including a frontend for data acquisition. | |
| Intended Use: | The CASE is a turnkey product utilizing the CardioSoft software. The CASEdevice is designed for the US markets. A version designed for the Europeanmarket, the CardioSys, will not be offered for sale in the US.CardioSoft/CASE Cardiac Testing System is intended to be used by trainedoperators under direct supervision of a licensed health care practitioner onadult and pediatric patients. The CardioSoft/CASE Cardiac Testing System isdesigned to acquire process, record, archive, analyze and output (12 and 15lead) ECG data during a period of physiologic stress or during a resting ECGtest, acquire data from ancillary devices (such as Spirometry and AmbulatoryBlood Pressure), provide median morphology recordings and record ECG inreal-time with and without arrhythmia detection. The arrhythmia detectionportion of CardioSoft/CASE Cardiac Testing System is provided to the userfor the convenience of automatic detection of arrhythmias but does not providealarms.CardioSoft/CASE Cardiac Testing System provides the control of externaldevice (typically a treadmill or Ergometer) and communicates with centralized | |
| electronic/digital storage system via network. CardioSoft/CASE CardiacTesting System provides a user selectable option for printouts of prognosticscores on select reports. Vector loops are also available. | ||
| CardioSoft/CASE Cardiac Testing System can be configured in a networkenvironment for multiple CASE and CardioSoft stations allowing the user tocreate a central database of patient demographics and collected patientphysiological 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
§ 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).