Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)

K992908 · Quinton, Inc. · DSI · Mar 6, 2000 · Cardiovascular

Device Facts

• Record ID: K992908
• Device Name: Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
• Applicant: Quinton, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Mar 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended 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 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.

Device Story

Q-Tel® Telemetry System v. 6.0 (ST) is a cardiac monitoring system consisting of a radio-frequency (RF) transmitter, central receiver, viewing monitor, and keyboard. The system acquires ECG signals from ambulatory adult patients via the transmitter; data is transmitted to a central station for real-time display, storage, and analysis. The system provides automated alarms for heart rate, arrhythmia, and ST-segment changes. Used in hospital or clinical environments, the system is operated by healthcare professionals to monitor patients undergoing exercise rehabilitation. Output is viewed on a central monitor to assist clinicians in identifying cardiac events, facilitating clinical decision-making regarding patient status and intervention. The system supports connectivity to local area networks for multi-receiver configurations.

Clinical Evidence

Bench testing only. Arrhythmia detection performance evaluated per AAMI recommended practice (beat-by-beat, run-by-run, ventricular flutter/fibrillation comparisons). ST algorithm performance evaluated using the European ST-T Database (episodic and ST level comparisons). Results documented in internal reports #900312 and #900419, demonstrating the algorithm's ability to detect clinically important events.

Technological Characteristics

Central monitoring station; RF signal transmission; ECG data acquisition; local area network connectivity. Software-based arrhythmia and ST-segment analysis algorithms. System components include transmitter, receiver, monitor, and keyboard.

Indications for Use

Indicated for ambulatory adults requiring cardiac monitoring during exercise rehabilitation in hospital or clinical settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PCI Model 1100 (K942147)

Submission Summary (Full Text)

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# 510(k) SUMMARY

January 19, 2000

| SUBMITTER'S NAME: | Quinton Instrument Company |
|---------------------------|------------------------------------------------------|
| SUBMITTER'S ADDRESS: | 3303 Monte Villa Parkway<br>Bothell, WA 98021<br>USA |
| SUBMITTER'S PHONE NUMBER: | 425-402-2255 |
| SUBMITTER'S FAX NUMBER: | 425-402-2017 |
| CONTACT PERSON: | Karen Browne |

- 1. NAME OF DEVICE: Q-Tel® Telemetry System v. 6.0 (ST)
- 2. DEVICE COMMON NAME: Cardiac Telemetry Monitor System
- 3. CLASSIFICATION NAMES: 870.1025 Arrhythmia Detector and Alarm (74DSI) 870.2910 Radiofrequency Physiological Signal Transmitter and Receiver (74DRG)
- 4. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone].

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.

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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)

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