(57 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as an "algorithm library" without mentioning any AI/ML specific terms or methodologies.
No
The device is described as an algorithm library for assessing exercise test results and provides measurements, prognostic scores, and interpretive statements, but it does not offer a diagnostic opinion or directly treat a condition. Its primary function is analysis, not therapy.
No
The device description explicitly states, "HEART-Exercise does not offer a diagnostic opinion to the user." While it provides measurements, prognostic scores, and interpretive statements, it emphasizes that the physician renders their own opinion and it is used in conjunction with other diagnostic tests and clinical judgment.
No
The device is described as an "algorithm library for exercise testing systems" and processes ECGs. While it is software, it is explicitly stated to be part of a larger "exercise testing system," implying it is a component of a hardware-based system that acquires the ECG data. The predicate device is also a "Cardiac Testing System," further suggesting a hardware component is involved.
Based on the provided information, the HEART-Exercise device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- HEART-Exercise analyzes ECG signals: The device processes electrocardiogram (ECG) signals, which are electrical recordings of heart activity. While related to the body, this is a physiological measurement, not the analysis of a biological sample.
- The intended use focuses on exercise test results: The primary function is to process and interpret data from an exercise stress test, which involves monitoring the heart's response to physical exertion.
Therefore, HEART-Exercise falls under the category of a medical device that analyzes physiological signals, rather than an IVD.
N/A
Intended Use / Indications for Use
The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results.
The results of HEART-Exercise are intended to be used by qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.
HEART-Exercise provides measurements, prognostic scores, and interpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diagnostic opinion to the user.
The Exercise Test Interpretation (XTI) is restricted to adults (age >= 18 years). The measurements apply to adults and children able to accomplish an exercise test.
Product codes (comma separated list FDA assigned to the subject device)
DOK, MHX, DQK, DXH, DPS
Device Description
HEART-Exercise is an algorithm library for exercise testina systems. It is able to process up to 15 lead ECGs with a high noise and artifact level and provides real-time and retrospective computerized analysis of stress test ECGs for evaluation by the user.
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
The Exercise Test Interpretation (XTI) is restricted to adults (age >= 18 years). The measurements apply to adults and children able to accomplish an exercise test.
Intended User / Care Setting
hospital, doctor's office, or clinical environment by competent healthcare professionals
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 subject of this premarket submission, HEART-Exercise, 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.
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
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JUL 2 9 2009
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: May 29, 2009
Submitter: GE Healthcare, GE Medical Systems Information Technologies GmbH Munzinger Str. 3 79111 Freiburg, Germany
Primary Contact Person:
Patricia Taige Requlatory Affairs - Diagnostic Cardiology GE Healthcare, GE Medical Systems Information Technologies 9900 Innovation Drive Wauwatosa, WI 53226 Phone: (414) 721-3222 Fax: (414) 721-3863
Secondary Contact
Person:
RA Director - Patient Monitoring
GE Healthcare, GE Medical Systems Information Technologies 8200 West Tower Avenue
Milwaukee, WI 53223 Phone: (262) 510-9997
Fax: (414) 918-8112
David Wahlig
Trade Name: HEART-Exercise
ECG Analysis Computer, Programmable Diagnostic Computer
Classification Names: 21 CFR 870.1425 Product Code: DOK
Intended Use:
Predicate Device(s): Device Description:
Common/Usual Name:
Device:
CardioSoft/CASE Cardiac Testing System (K031561)
HEART-Exercise is an algorithm library for exercise testina systems. It is able to process up to 15 lead ECGs with a high noise and artifact level and provides real-time and retrospective computerized analysis of stress test ECGs for evaluation by the user.
The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results.
The results of HEART-Exercise are intended to be used by
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and surrounded by a circular border. There are three decorative swirls or flourishes evenly spaced around the outside of the circle. The logo is black and white.
(091594 キ2/2 GE Healthcare
510(k) Premarket Notification Submission
qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.
HEART-Exercise provides measurements, prognostic scores, and interpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diagnostic opinion to the user.
The Exercise Test Interpretation (XTI) is restricted to adults (age ≥ 18 years). The measurements apply to adults and children able to accomplish an exercise test
The proposed HEART-Exercise algorithm library employs the same fundamental scientific technology as the HEART-Exercise algorithm library currently cleared as part of the predicate device CardioSoft/CASE Cardiac Testing System (K031561)
Summary of Non-Clinical Tests: Determination of
The HEART-Exercise algorithm library and its applications comply with voluntary standards as detailed in Section 9 and 16 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 level (Module verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, HEART-Exercise, did not require clinical studies to support substantial equivalence.
Conclusion:
Technology:
Substantial Equivalence:
GE Healthcare considers the HEART-Exercise algorithm library to be as safe, as effective, and performance is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 2009
GE Healthcare, GE Medical Systems Information Technologies GmbH c/o Ms. Patricia Taige Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226
K091594 Re:
HEART - Exercise
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhytmia detector and alarm (including ST- segment measurement and alarm)
Regulatory Class: Class II (two) Product Code: MHX, (DQK, DXH, DPS) Dated: May 29, 2009 Received: June 02, 2009
Dear Ms. Taige: .
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 confrols 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.
3
Page 2 - Ms. Patricia Taige
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K09/594
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GE Healthcare
510(k) Premarket Notification Submission
510(k) Number (if known):
HEART-Exercise Device Name:
Indications for Use:
The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results.
The results of HEART-Exercise are intended to be used by qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judament.
HEART-Exercise provides measurements, prognostic scores, and interpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diaqnostic opinion to the user.
The Exercise Test Interpretation (XTI) is restricted to adults (age ≥ 18 years). The measurements apply to adults and children able to accomplish an exercise test.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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)
(Division Sign-Off)
B Zuckerman
7/29/09
Division of Cardiovascular Devices 1091594 510(k) Number