(97 days)
Not Found
K#895520, K#935772
No
The document describes standard signal processing algorithms and filtering for ECG analysis, not AI or ML. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No.
The device is a diagnostic tool, used to measure the heart's response to exertion and help detect coronary artery disease. It does not provide therapy or treatment.
Yes
The intended use explicitly states, "This type of diagnostic tool can assist a physician in two important ways." Additionally, the device description refers to it as "a basic, easy-to-use diagnostic system." The system's purpose of detecting coronary artery disease and evaluating cardiac conditions through ECG changes clearly points to a diagnostic function.
No
The device description explicitly states that the system consists of a personal computer running software, but also includes a cardiograph (hardware for signal acquisition and printing) and an isolation transformer. While the software is a principal component, the system is not solely software.
Based on the provided text, the M2488A HP StressWriter Exercise Testing System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the system is a "diagnostic tool" used to "help detect coronary artery disease" and "assist a physician" in evaluating ECG changes and assessing exercise capacity. These are diagnostic purposes.
- Device Description: The device is described as a "basic, easy-to-use diagnostic system" that provides "exercise ECG test performance capability." It measures "ST level and slope during a stress test" and provides "measurements of the heart's response to exertion." These are all related to obtaining diagnostic information from the patient.
- Physician Use: The information is used by a physician "in conjunction with other clinical information to diagnose and provide treatment." This confirms its role in the diagnostic process.
While the device itself doesn't directly analyze biological samples in vitro in the traditional sense (like blood or urine), the FDA's definition of an IVD includes devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. In this case, the "specimen" is the electrical activity of the heart (ECG signals) derived from the patient's body. The system processes and analyzes this data to provide diagnostic information to the physician.
Therefore, the M2488A HP StressWriter Exercise Testing System fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the M2488A HP StressWriter Exercise Testing System is to produce accurate measurements of the heart's response to exertion.
Exercise electrocardiography is a commonly used non-invasive technique used to help detect coronary artery disease. This type of diagnostic tool can assist a physician in two important ways:
- Report ECG changes which may indicate whether coronary circulation is able to increase the oxygen supply to muscle tissue in response to increased demand.
- Assess the patient's overall exercise capacity.
Typical applications of exercise electrocardiography could include the following:
- Evaluating patients with symptoms suggestive of coronary disease
- Determining the prognosis and severity of coronary disease
- Evaluating the effects of medical and surgical therapy
- Screening for latent coronary disease
- Evaluating patients with stable congestive heart failure
- Evaluating patients with arrhythmias
- Evaluating the patient's functional capacity, and developing exercise prescriptions
- Evaluating patients with congenital heart disease
- Evaluating patients with exertional shortness of breath, dizziness, or syncope
- Evaluating cardiac rehabilitation
- Evaluating patients with rate-responsive pacemakers
- Evaluating sports medicine patients
Physicians typically evaluate the electrocardiogram for ST segment depression or elevation and or QRS alterations. This information is used by a physician in conjunction with other clinical information to diagnose and provide treatment.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The M2488A HP StressWriter Exercise Testing System is a basic, easy-to-use diagnostic system which provides the physician with exercise ECG test performance capability. The system is principally a stress ECG software application running on a personal computer which uses a cardiograph for signal acquisition and printing. The system provides an interface with an exercise device, either a treadmill or bicycle ergometer.
The system consists of a PageWriter cardiograph (models M1700A or M1770A or M1771A or M1772A), a high performance personal computer including a high resolution Ultra VGA display, and an isolation transformer. Exercise devices and cart are not part of the M2488A system and must be purchased separately.
The system provides measurements of the ST level and slope during a stress test. The automatic execution of the routine stress test activities allow the physician to pay more direct attention to the patient and the patient's condition. The system incorporates algorithms and a filtering system to discriminate between useful ECG signals and artifacts. The filtering system helps ensure an effective stability of the ECG signal.
System features:
SuperTrace baseline wander filter ST segment measurements in all 12 leads Data acquisition from 12 simultaneous leads Digital patient module minimizes cable noise Periodic 12 lead reports in various formats Rhythm strips in 3 or 6 channel format Various summary reports plus signature-ready final report High resolution screen displays:
Patient name Heart rate Blood pressure Phase and stage time Treadmill speed and grade Ergometer workload Reference averaged complexes
Current averaged complexes ST level and slope Protocol selected 3 channels of ECG rhythm Variety of exercise protocols Conforms to applicable IEC, UL, and AAMI standards
The M1700A PageWriter XLi cardiograph and the M177XA series cardiographs are currently marketed (K#895520 and K#935772 respectively). The cardiographs have been modified for use in this application by the addition of communication circuitry. The cardiograph software has been revised to accommodate communication with the personal computer. The hardware and software modifications to the cardiographs do not interfere in any way with the intended use of the cardiograph as previously cleared for market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Not Found
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.
M2488A StressWriter Exercise Testing System
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.
K#895520, K#935772
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
§ 870.1425 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
JUN 17 1996
Hewlett-Packard StressWriter Modification 510(k) Notification
Image /page/0/Picture/2 description: The image shows a handwritten text that reads "UK961009" on the top line and "3/8/96" on the second line. The text is written in black ink on a white background. The handwriting is somewhat stylized, with the letters having a distinct and recognizable form. The date "3/8/96" is written in a more standard format, with the month, day, and year separated by slashes.
Attachment I: 510(k) Summary of Safety and Effectiveness
General Information
Device Generic Name: Stress Exercise Testing System
Device Trade Name: M2488A StressWriter Exercise Testing System
Legally marketed predicate device: M2488A StressWriter Exercise Testing System
Applicant:
Hewlett-Packard Diagnostic Cardiology Division 1700 South Baker Street McMinnville, Oregon 97128
Indications for Use:
The intended use of the M2488A HP StressWriter Exercise Testing System is to produce accurate measurements of the heart's response to exertion.
Exercise electrocardiography is a commonly used non-invasive technique used to help detect coronary artery disease. This type of diagnostic tool can assist a physician in two important ways:
- Report ECG changes which may indicate whether coronary circulation is able to increase the oxygen supply to muscle tissue in response to increased demand.
- Assess the patient's overall exercise capacity.
Typical applications of exercise electrocardiography could include the following:
- Evaluating patients with symptoms suggestive of coronary disease
- Determining the prognosis and severity of coronary disease
- Evaluating the effects of medical and surgical therapy
- Screening for latent coronary disease
- Evaluating patients with stable congestive heart failure
- Evaluating patients with arrhythmias
- Evaluating the patient's functional capacity, and developing exercise prescriptions
- Evaluating patients with congenital heart disease
- Evaluating patients with exertional shortness of breath, dizziness, or syncope
1: 510(k) Summary of Safety and Effectiveness
| - 1
1
- Evaluating cardiac rehabilitation
- Evaluating patients with rate-responsive pacemakers
- Evaluating sports medicine patients
Physicians typically evaluate the electrocardiogram for ST segment depression or elevation and or QRS alterations. This information is used by a physician in conjunction with other clinical information to diagnose and provide treatment.
Device Description:
The M2488A HP StressWriter Exercise Testing System is a basic, easy-to-use diagnostic system which provides the physician with exercise ECG test performance capability. The system is principally a stress ECG software application running on a personal computer which uses a cardiograph for signal acquisition and printing. The system provides an interface with an exercise device, either a treadmill or bicycle ergometer.
The system consists of a PageWriter cardiograph (models M1700A or M1770A or M1771A or M1772A), a high performance personal computer including a high resolution Ultra VGA display, and an isolation transformer. Exercise devices and cart are not part of the M2488A system and must be purchased separately.
The system provides measurements of the ST level and slope during a stress test. The automatic execution of the routine stress test activities allow the physician to pay more direct attention to the patient and the patient's condition. The system incorporates algorithms and a filtering system to discriminate between useful ECG signals and artifacts. The filtering system helps ensure an effective stability of the ECG signal.
System features:
SuperTrace baseline wander filter ST segment measurements in all 12 leads Data acquisition from 12 simultaneous leads Digital patient module minimizes cable noise Periodic 12 lead reports in various formats Rhythm strips in 3 or 6 channel format Various summary reports plus signature-ready final report High resolution screen displays:
Patient name Heart rate Blood pressure Phase and stage time Treadmill speed and grade Ergometer workload Reference averaged complexes
I: 510(k) Summary of Safety and Effectiveness
1 - 2
2
Current averaged complexes ST level and slope Protocol selected 3 channels of ECG rhythm Variety of exercise protocols Conforms to applicable IEC, UL, and AAMI standards
The M1700A PageWriter XLi cardiograph and the M177XA series cardiographs are currently marketed (K#895520 and K#935772 respectively). The cardiographs have been modified for use in this application by the addition of communication circuitry. The cardiograph software has been revised to accommodate communication with the personal computer. The hardware and software modifications to the cardiographs do not interfere in any way with the intended use of the cardiograph as previously cleared for market.
Marketing History
The M2488A StressWriter Exercise Testing system is not currently sold in the US. or foreign markets.
Adverse Effects of the Device on Health
All exercise ECG testing has an inherent risk due to the stress placed on the patient during the test. Beyond the inherent risk of a stress test procedure is risk associated with the proper function and control of the exercise device. If the exercise device control failed the exercise device could injure the patient. The level of concern associated with exercise device control software module has been determined to be moderate.
The level of concern is minor regarding direct risks to the patient as a result of the stress ECG measurement software. In many years of experience, there has been no reported instance of a patient suffering acute adverse effects; much less death, irreversible illness or permanent injury, as a consequence of the use of the stress ECG measurement software. There is no known case of stress ECG management software failure which would result in direct injury or death to the patient.
Clearly, the risk of not using the system is the lack of diagnostic information which may affect the physician's assessment of the patient and treatment decisions.