(189 days)
The intended use of the Q-Tel® Telemetry System v. 6.0 (ST) is the acquisition and transmission of ECG data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change. The intended population are ambulatory adults where cardiac monitoring is prescribed while undergoing exercise rehabilitation.
The Q-Tel® Telemetry System v. 6.0 (ST) consists of a central receiver, transmitter, viewing monitor, keyboard, and accessories. ECG data is received via the transmitter to the central receiver and is displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change.
The provided text describes the Q-Tel® Telemetry System v. 6.0 (ST) and its performance testing. However, it does not explicitly state acceptance criteria in a quantitative table or the specific results to demonstrate direct adherence to such criteria. The document mentions that "Conclusion shows tape-by-tape results that indicate the algorithm's ability to detect events of clinical importance" but does not provide these detailed results or a comparison against predefined numeric thresholds.
Therefore, much of the requested information cannot be definitively extracted from the provided text.
Here's an attempt to answer based on the available information:
Acceptance Criteria and Study Details for Q-Tel® Telemetry System v. 6.0 (ST)
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of explicit, quantitative acceptance criteria with corresponding performance metrics. It generally states that the "Conclusion shows tape-by-tape results that indicate the algorithm's ability to detect events of clinical importance" for both arrhythmia detection and ST algorithm testing.
| Criterion | Acceptance Value | Reported Device Performance |
|---|---|---|
| Arrhythmia Detection | Not explicitly stated (e.g., sensitivity, specificity thresholds for specific arrhythmias) | "tape-by-tape results that indicate the algorithm's ability to detect events of clinical importance" |
| ST Algorithm | Not explicitly stated (e.g., ST segment deviation accuracy, time to detection thresholds) | "tape-by-tape results that indicate the algorithm's ability to detect events of clinical importance" |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "tape-by-tape results," suggesting individual recordings were used, but the total number of tapes or patients is not provided.
- Data Provenance:
- Arrhythmia Detection: Data was tested "in accordance with AAMI recommended practice, Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms." This typically implies standardized arrhythmia databases, which often consist of retrospective recordings. However, the exact source or country of origin is not specified.
- ST Algorithm: Data was "using a test protocol from the European ST-T Database sponsored by the European Society of Cardiology." This indicates the data is from Europe and is likely retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text. The document refers to testing against "AAMI recommended practice" and the "European ST-T Database," but it does not detail how the ground truth within these sources was established or the qualifications of the experts involved.
4. Adjudication method for the test set:
This information is not provided in the text.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not mentioned or described in the provided text. The testing described is focused on the standalone algorithm performance against established industry practices and databases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone algorithm performance study was done. The description focuses entirely on the "arrhythmia detection" and "ST algorithm" functions being tested against established protocols and databases, implying evaluation of the algorithm's performance independent of human-in-the-loop interaction.
7. The type of ground truth used:
- Arrhythmia Detection: The ground truth would have been established within the "AAMI recommended practice" ventricular arrhythmia detection algorithms. This typically involves expert-annotated ECG recordings of various arrhythmias.
- ST Algorithm: The ground truth would have been established within the "European ST-T Database." This database contains expert-annotated ECG recordings with ST segment changes.
8. The sample size for the training set:
The sample size for the training set is not provided in the text. The document focuses on performance testing of the device, not its development or training process.
9. How the ground truth for the training set was established:
This information is not provided in the text. The document does not describe the training phase of the algorithm.
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510(k) SUMMARY
January 19, 2000
| SUBMITTER'S NAME: | Quinton Instrument Company |
|---|---|
| SUBMITTER'S ADDRESS: | 3303 Monte Villa ParkwayBothell, WA 98021USA |
| SUBMITTER'S PHONE NUMBER: | 425-402-2255 |
| SUBMITTER'S FAX NUMBER: | 425-402-2017 |
| CONTACT PERSON: | Karen Browne |
-
- NAME OF DEVICE: Q-Tel® Telemetry System v. 6.0 (ST)
-
- DEVICE COMMON NAME: Cardiac Telemetry Monitor System
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- CLASSIFICATION NAMES: 870.1025 Arrhythmia Detector and Alarm (74DSI) 870.2910 Radiofrequency Physiological Signal Transmitter and Receiver (74DRG)
-
- PREDICATE DEVICE: The legally marketed device for which Quinton is claiming equivalence to is:
K942147 PCI Model 1100
DEVICE DESCRIPTION 5.
The Q-Tel® Telemetry System v. 6.0 (ST) consists of a central receiver, transmitter, viewing monitor, keyboard, and accessories. ECG data is received via the transmitter to the central receiver and is displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change.
INTENDED USE 6.
The intended use of the Q-Tel® Telemetry System v. 6.0 (ST) is the acquisition and transmission of ECG data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change. The intended populations are ambulatory adults where cardiac monitoring is prescribed while undergoing exercise rehabilitation. Multiple central receivers may be used and connected to a local area network.
7. TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO PREDICATE DEVICE
The Q-Tel® Telemetry System v. 6.0 (ST) and PCI Model 1100 are central monitoring stations which acquire data via radio frequency transmitters worn by individuals in a clinical setting. Data is received, viewed, stored and analyzed, with alarms for heart rate, arrhythmia, and ST change. Both central stations may be used and connected to a local area network.
8. PERFORMANCE TESTING AND CONCLUSIONS
Bench testing was performed for the Q-Tel® Telemetry System v. 6.0 (ST) arrhythmia detection and ST algorithm function. Testing for arrhythmia detection was performed in accordance with AAMI recommended practice, Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms. Beat-by-beat and run-by-run comparison as well as ventricular flutter and fibrillation comparisons are performed. Results are compiled in Document #900312, Arrhythmia Detection Performance Results. ST Algorithm testing was done using a test protocol from the European ST-T Database sponsored by the European Society of Cardiology. Both Episodic and ST Level comparisons are performed. Results are compiled in Document # 900419, ST Algorithm Performance Results. Conclusion shows tape-by-tape results that indicate the algorithm's ability to detect events of clinical importance.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AR - 6 2000
Matthew J. Hedlund Ouinton Instrument Co. 3303 Monte Villa Parkway Bothell, WA 98021-8906
K992908/S1 Re: Trade Name: Q-TEL Telemetry system V.6.0 (ST) Cardiac Telemetry Monitor System Regulatory Class: III Product Code: 74 DSI Dated: January 21, 2000 Received: January 27, 2000
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 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 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, the Food and Drug Administration (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. Matthew J. Hedlund
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 at (301) 443-6597.
Sincerely yours,
Steve Norley MD for Mojtaba
Cella M. Witten, Ph.D., M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Q-Tel® Telemetry System v. 6.0 (ST)
Indications for Use:
The intended use of the Q-Tel® Telemetry System v. 6.0 (ST) is the acquisition and transmission of ECG data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change. The intended population are ambulatory adults where cardiac monitoring is prescribed while undergoing exercise rehabilitation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | for Moynahan 3/3/00 |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K992908/51 |
| Prescription Use | |
|---|---|
| OR | Over-The-Counter Use |
(Optional Format 1-2-96)
0000005
§ 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.