(259 days)
The intended use of the Quinton Synergy Cardiology Information System (CIS) is the acquisition, storage, and display of electrical signals of biological origin, as ECG data, that are obtained from other devices connected directly to the patient. This display on the CIS would only occur at the cessation of data acquisition by the patient connected equipment. (Hence, the CIS would only operate as non-real time system.) Additionally, the CIS may acquire, store, and display administrative data, as patient demographic information.
Acquired information may be reviewed, edited, abridged, or re-formatted and distributed electronically or printed.
The CIS is a cardiology data management system that encompasses and integrates proprietary software and third party software on a single workstation or networked workstations. The workstation may include ancillary devices as a server, bar cod system, and printer.
The CIS provides a means to establish, maintain, access, review, and edit cardiology patient records that are typically generated from ECG procedures.
The Quinton Synergy Cardiology Information System (CIS) is a cardiology data management system that acquires, stores, and displays electrical signals of biological origin (ECG data) obtained from other connected devices, as well as patient demographic information.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Quinton Synergy Cardiology Information System (CIS) were implicitly demonstrated through performance testing comparing data integrity and visual assessment of ECG and textual information. The reported device performance met these criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Integrity of Digital ECG and Textual Data Transfer (Q710 to CIS): No differences between pre and post-transmitted digital data | Met: "No differences were found in the digital comparison between pre and post transmitted data from the Q710 to the CIS." |
| Integrity of Digital ECG and Textual Data Transfer (HP PageWriter XLi to CIS): Expected differences due to communication protocol | Met: "Only expected differences were found during the digital comparison of pre and post transmitted data from the HP PageWriter XLi to the CIS. These differences are due to the HP communication protocol not transmitting certain fields." |
| Visual Integrity of Printed ECG and Textual Data (Q710 to CIS): No significant differences identified by a cardiologist | Met: "no significant differences were found by the cardiologist when comparing the pretransmission print-outs from the Q710 with the post-transmission print-outs at the CIS." |
| Visual Integrity of Printed ECG and Textual Data (HP PageWriter XLi to CIS via floppy disk): No significant differences identified by a cardiologist | Met: "no significant differences were found in the PageWriter transfer test using a floppy disk." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size for the test set (number of ECG waveforms or textual data transmissions). However, it mentions "randomized ECG waveforms and textual data."
The data provenance is from existing devices for which the CIS is receiving data: the Quinton Model Q710 Exercise and Resting Electrocardiograph and the HP PageWriter XLi. The study appears to be retrospective in the sense that it uses pre-existing data from these devices for transmission testing, rather than prospectively generating new patient data for the purpose of the study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
One expert was used to establish the ground truth for the visual comparison of printed ECG and textual data. This expert was identified as a cardiologist. Specific qualifications (e.g., years of experience) were not provided.
4. Adjudication Method for the Test Set:
For the digital comparisons, the adjudication method was software-based comparison to determine the integrity of the digital transfer. This implies an automated, objective comparison without human adjudication.
For the visual comparisons of printed data, the adjudication method was single expert review, where a cardiologist compared the pre- and post-transmission print-outs. No multi-reader adjudication method (like 2+1 or 3+1) was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This study focuses on the data transfer and display capabilities of the CIS, not on the interpretative accuracy of an AI or human readers, or how AI might assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a form of standalone performance was implicitly done for the digital comparison aspects. Software was used to determine the integrity of the digital transfer, meaning the algorithm (CIS's data handling) was evaluated independently of human interpretation of the raw digital data. However, for the visual integrity of printed reports, a human (cardiologist) was in the loop.
7. The Type of Ground Truth Used:
Two types of ground truth were used:
- Original Digital Data: For the digital transmission integrity tests, the "pre-transmitted information" was considered the ground truth against which the received and stored information at the CIS was compared.
- Original Printed Reports and Expert Visual Comparison: For the visual integrity tests, the "pre-transmission print-outs" from the source devices served as the visual ground truth. The "cardiologist compared the pre- and post-transmissions for significant differences," indicating that expert visual assessment established the ground truth for acceptability.
8. The Sample Size for the Training Set:
The document does not mention a training set. This device is a data management system, not an AI/ML-driven diagnostic algorithm that typically requires a training set. The performance testing described relates to data transfer and display integrity.
9. How the Ground Truth for the Training Set was Established:
As no training set was mentioned or implied, this question is not applicable.
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Quinton Instrument Company 510k Notification - K964784 Synergy Cardiology Information System
K964784
AUG 1 3 1997
510(k) SUMMARY
| Submitter's Name: | Quinton Instrument Company |
|---|---|
| Submitter's Address: | 3303 Monte Villa ParkwayBothell, 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: | May 14, 1997 |
A. Device Trade Name: Quinton Synergy Cardiology Information System (CIS)
- B. Device Common Name: Electrocardiograph (Accessory)
- C. Device Classification Names
- Electrocardiograph 870.2340
- 870.2450 Medical Cathode-Ray Tube Display
- Programmable Diagnostic Computer 870.1425
- Medical Magnetic Tape Recorder 870.2800
- D. Predicate Device
The legally marketed device to which we claim equivalence is the Model Q710 Exercise and Resting Electrocardiograph. The 510(k) number for this device is K945626.
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C. Device Description
The CIS is a cardiology data management system that encompasses and integrates proprietary software and third party software on a single workstation or networked workstations. The workstation may include ancillary devices as a server, bar cod system, and printer.
The CIS provides a means to establish, maintain, access, review, and edit cardiology patient records that are typically generated from ECG procedures.
D. Intended Use of Device
The intended use of the Quinton Synergy Cardiology Information System (CIS) is the acquisition, storage, and display of electrical signals of biological origin, as ECG data, that are obtained from other devices connected directly to the patient. This display on the CIS would only occur at the cessation of data acquisition by the patient connected equipment. Additionally, the CIS may acquire, store, and display data, as patient demographic information.
Acquired information may be reviewed, edited, abridged, or re-formatted and printed out.
E. Summary of Technological Characteristics Compared with the Predicate Device
Both the Synergy Cardiology Information System and the Quinton Model Q710 record and display 12 lead ECG waveforms and ECG data. Both devices display and allow editing and print-out of patient reports which may include ECG information, demographic information, and interpretive reports. All information contained within the CIS patient reports come only from the ECG device, as the Q710, unless editing occurs. The hardware platform for the CIS is a computer, keyboard, monitor, and peripherals as a laser printer. The Q710, while computer based, is ergonomically designed as a ECG device containing inputs for ECG and a built-in keyboard and printer mounted on a cart.
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Quinton Instrument Company 510k Notification - K964784 Synergy Cardiology Information System
F. Performance Testing and Conclusions
1) Performance Testing
Performance testing was based on transmitting via serial ports randomized ECG waveforms and textual data from the Q710 and the HP PageWriter XLi to the CIS. Pre-transmitted information was compared with information received and stored at the CIS. In one set of tests the comparison was done using software to determine the integrity of the digital transfer. In another test the ECG and textual data was printed out before being transmitted from the Q710 and then printed out again after being received and stored at the CIS. Additionally, data from the HP PageWriter was printed out, transferred to the CIS by floppy disk, and then printed out again. A cardiologist compared the pre- and post transmissions for significant differences in both cases.
2) Conclusions
No differences were found in the digital comparison between pre and post transmitted data from the Q710 to the CIS. Only expected differences were found during the digital comparison of pre and post transmitted data from the HP PageWriter XLi to the CIS. These differences are due to the HP communication protocol not transmitting certain fields. Finally, no signifcant differences were found by the cardiologist when comparing the pretransmission print-outs from the Q710 with the post-transmission print-outs at the CIS. Additionally, no significant differences were found in the PageWriter transfer test using a floppy disk.
Taken together the tests demonstrate that the CIS is substantially equivalent to the Q710 in certain limited areas of recording, displaying, and printing out ECG waveforms and textual information.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr., Matt Hedlund AUG 1 3 1997 : ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ Quinton Instrument Company 3303 Monte Villa Parkway Bothell, Washington 98021-8906
Re: K964784 Synergy Cardiology Information System (CIS) Regulatory Class: II (two) Product Code: 74 DPS Dated: May 15, 1997 Received: May 16, 1997
Dear Mr. Hedlund:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Matt Hedlund
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Number (if known): K964784
nce Name: Synergy Cardiology Information System (CIS)
ications For Use:
The intended use of the Quinton Synergy Cardiology Information System (CIS) is the acquisition, storage, and display of electrical signals of biological origin, as ECG data, that are obtained from other devices connected directly to the patient. This display on the CIS would only occur at the cessation of data acquisition by the patient connected equipment. (Hence, the CIS would only operate as non-real time system.) Additionally, the CIS may acquire, store, and display administrative data, as patient demographic information.
Acquired information may be reviewed, edited, abridged, or re-formatted and distributed electronically or printed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
scription Use r 21 CFR 801.109) OR
Over-The-Counter Use
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).