(140 days)
Hewlett Packard Pagewriter XLi M1700A
Not Found
No
The document describes a resting ECG analysis program that provides measurements and interpretations, but it does not mention the use of AI or ML technologies in its description or performance studies. The comparison is made against a predicate device using traditional statistical methods.
Yes
The device is described as an "Exercise and Resting Electrocardiograph" for the "acquisition, digitization, display, and recording of conventional diagnostic 12 simultaneous lead ECG waveforms and ECG data," which are used for diagnostic purposes. It also has an optional resting ECG analysis program that "provides interpretation of the ECG waveform," albeit on an advisory basis. These functions clearly indicate its purpose in diagnosing and monitoring health conditions or diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "interpretation of the ECG waveform" and the "Summary of Performance Studies" mentions "diagnostic (interpretive) statements," indicating its use in diagnosing conditions based on ECG analysis.
No
The device description explicitly states that the device is made up of hardware components including the electrocardiograph, optional CRT monitor, cart, integral chart recorder, LCD, keyboard, and patient module. While it includes software for analysis and interpretation, it is not solely software.
Based on the provided information, the Quinton Model Q710 Exercise and Resting Electrocardiograph is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Q710 acquires, digitizes, displays, and records electrical signals from the heart (ECG waveforms) directly from the patient's body using electrodes. It does not analyze specimens taken from the body.
- Intended Use: The intended use is the acquisition and analysis of ECG data from the patient, not the analysis of biological samples.
Therefore, the Quinton Model Q710 falls under the category of a medical device that performs physiological measurements, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended uses of the Quinton Model Q710 Exercise and Resting Electrocardiograph are acquisition, digitization, display, and recording of conventional diagnostic 12 simultaneous lead ECG waveforms and ECG data.
As an option, the Model Q710 has a resting ECG analysis program which makes measurements and provides interpretation of the ECG waveform for both adult and pediatric populations. This analysis program is offered to the physician on an advisory basis only and the physician is asked to overread and validate (or change) the ECG interpretation.
Product codes
870.2340, 870.1425, 870.2300, 870.2370, 870.2600, 870.2810, 870.1025
Device Description
The Q710 Exercise and Resting Electrocardiograph records resting ECG data and provides a variety of user-selectable patient reports. When equipped with the optional exercise monitor, the system can be used for exercise stress testina.
A resting Interpretation option is also available that provides measurement and interpretive statements.
The device is made up of the Q710 electrocardiograph, optional CRT monitor, and cart option with a storage basket. The Q710 electrocardiograph includes an integral chart recorder, liquid crystal display (LCD), keyboard, and patient module which attaches to the patient cable. The electrocardiograph is a selfcontained unit, approximately 15 x 41 x 60cm in size, and housed within a polymeric enclosure.
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 populations
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
Equivalence study:
Sample size: 1047
Data source: ECG cases stored on a floppy disk.
Annotation protocol: Measurements and diagnostic (interpretive) statements were generated for each case by the Q710 and the Pagewriter XLi. These results were ported to a PC and stored. A PC based program compared the measurements and interpretive statements generated by each device for each case and noted any differences.
System study:
Data source: Not explicitly stated, but involves ECG acquisition, identical data input for printed reports, and ECG cases acquired via ECG leads.
Annotation protocol:
- Comparison of ECG acquisition capability of each device.
- Assessment of whether identical data input by the operator and identical ECG data resulted in the same printed reports at each device.
- ECG cases acquired via ECG leads by both devices, processed data resulted in measurements and interpretive statements printed as reports, and compared and analyzed by an overreading physician.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: Made up of two parts, an equivalence study and a system study. Both parts involved side-by-side comparisons of the Q710 and the Pagewriter XLi.
Equivalence study: A randomly selected number of ECG cases having sufficient statistical significance were stored on a floppy disk and ported to the Q710 and to the Pagewriter XLi. Measurements and diagnostic (interpretive) statements were generated for each case by each electrocardiograph. These results were then ported via a floppy disk to a PC and stored on the PC. A PC based program compared the measurements and interpretive statements generated by each device for each case and noted any differences.
Sample size: 1047 test cases.
Key results: All but one case out of 1047 tests cases were shown to produce exact agreement between the Q710 and the Pagewriter XLi for ECG data presented to the software digitally. These results exceed the criteria that was established for statistical equivalence in the equivalence study protocol.
System study: Paired comparisons of outputs from the Q710 and the Pagewriter XLi were made in three areas to demonstrate that as a system both systems perform equivalently with the resting interpretation option.
- One area compared the ECG acquisition capability of each device.
- Another area assessed whether identical data inputed by the operator and identical ECG data resulted in the same printed reports at each device.
- Finally a certain number of ECG cases were acquired via ECG leads by both devices and the data was processed resulting in measurements and interpretive statements that were printed as reports and compared and analyzed by an overreading physician.
Key results: Two minor defects in Q710 system software were found during the system study testing. After correction of these two defects, certain tests were repeated resulting in all system study acceptance criteria being met.
Conclusions: Taken together, the results of the equivalence study and the system study demonstrate that the Quinton Q710 with the resting interpretation option is substantially equivalent to the Hewlett Packard Pagewriter XLi.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hewlett Packard Pagewriter XLi M1700A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JUL 31 1996
510(k) SUMMARY
| Submitter's Name: | Quinton Instrument Company |
|---|---|
| Submitter's Address: | 3303 Monte Villa Parkway |
| Bothell, Washington 98021-8906 | |
| Submitter's Phone Number: | (US) 206-402-2000 |
| Submitter's Fax Number: | (US) 206-402-2017 |
| Contact Person: | Matt Hedlund |
| Date Summary Prepared: | June 3, 1996 |
A. Device Name and Classification
-
Device Trade Name Quinton Model Q710 Exercise and Resting Electrocardiograph
-
Device Common Name Electrocardiograph and ECG Analysis System
| 3) Device Classification Names | |
|---|---|
| 870.2340 | Electrocardiograph |
| 870.1425 | Programmable Diagnostic Computer |
| 870.2300 | Cardiac Monitor |
| 870.2370 | ECG Surface Electrode System |
| 870.2600 | Signal Isolation System |
| 870.2810 | Paper Chart Recorder |
| 870.1025 | Arrhythmia Detector and Alarm (Resting Interpretation Option) |
B. Predicate Device
The legally marketed device to which we claim equivalence is the Hewlett Packard Pagewriter XLi M1700A.
1
C. Device Description
The Q710 Exercise and Resting Electrocardiograph records resting ECG data and provides a variety of user-selectable patient reports. When equipped with the optional exercise monitor, the system can be used for exercise stress testina.
A resting Interpretation option is also available that provides measurement and interpretive statements.
The device is made up of the Q710 electrocardiograph, optional CRT monitor, and cart option with a storage basket. The Q710 electrocardiograph includes an integral chart recorder, liquid crystal display (LCD), keyboard, and patient module which attaches to the patient cable. The electrocardiograph is a selfcontained unit, approximately 15 x 41 x 60cm in size, and housed within a polymeric enclosure.
D. Intended Use of Device
The intended uses of the Quinton Model Q710 Exercise and Resting Electrocardiograph are acquisition, digitization, display, and recording of conventional diagnostic 12 simultaneous lead ECG waveforms and ECG data.
As an option, the Model Q710 has a resting ECG analysis program which makes measurements and provides interpretation of the ECG waveform for both adult and pediatric populations. This analysis program is offered to the physician on an advisory basis only and the physician is asked to overread and validate (or change) the ECG interpretation.
E. Summary of Technological Characteristics Compared with the Predicate Device
Both the Quinton Model Q710 and the Hewlett Packard Pagewriter XLi acquire. digitize, display, and record conventional diagnostic 12 simultaneous lead resting ECG waveforms and ECG data. As an option both devices have a resting ECG analysis and interpretation program covering adult and pediatric populations. The physical characteristics for both devices are approximately the same as each electrocardiograph has a built-in chart recorder, keyboard, and display panel contained within a unifed polymeric enclosure. Each device has rechargeable batteries for use when line power is not available. Optional carts are available for transporting the electrocardiographs.
2
E. Summary of Technological Characteristics Compared with the Predicate Device (Continued)
Differences between the devices include Pagewriter XLi's optional feature of displaying and/or recording signal averaginy ECG (SAECG) waveforms and data. Additionally, the Pagewriter XLi has a modem feature that the Q710 does not. The Q710 has a stress test option not available on the Pagewriter XLi that allows one to control exercise devices and employ specific exercise protocols from the Q710 while simultaneously recording 12 lead ECG data and displaying such data in a variety of reports. A CRT monitor is included in this option.
LI Performance Testing and Conclusions
-
- Performance Testing
Performance testing was made up of two parts, an equivalence study, and a system study. Both parts involved side-by-side comparisons of the Q710 and the Pagewriter XLi. In the equivalence study, a randomly selected number of ECG cases having sufficient statistical significance were stored on a floppy disk and ported to the Q710 and to the Pagewriter XLi. Measurements and diagnostic (interpretive) statements were generaled for each case by each electrocardiograph. These results were then ported via a floppy disk to a PC and stored on the PC. A PC based program compared the measurements and interpretive statements generated by each device for each case and noted any differences. In the system study paired comparisons of outputs from the Q710 and the Pagewriter XLi were made in three areas to demonstrate that as a system both systems perform equivalently with the resting interpretation option. One area compared the ECG acquisition capability of each device. Another area assessed whether identical data inputed by the operator and identical ECG data resulted in the same printed reports at each device. Finally a certain number of ECG cases were acquired via ECG leads by both devices and the data was processed resulting in measurements and interpretive statements that were printed as reports and compared and analyzed by an overreading physician.
- Performance Testing
3
F. Performance Testing and Conclusions (Continued)
2) Conclusions
All but one case out of 1047 tests cases in the equivalence study were shown to produce exact agreement between the Q710 and the Pagewriter XLi for ECG data presented to the software digitally. These results exceed the criteria that was established for statistical equivalence in the equivalence study protocol.
Two minor defects in Q710 system software were found during the system study testing. Neither defect was associated with the Q710 resting interpretation option software. After correction of these two defects certain tests were repeated rosulting in all system study acceptance criteria being met.
Taken together, the results of the equivalence study and the system study demonstrate that the Quinton Q710 with the resting interpretation option is substantially equivalent to the Hewlett Packard Pagewriter XLi.