BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM

K983717 · Aerotel Medical Systems (1998) , Ltd. · DXN · Sep 16, 1999 · Cardiovascular

Device Facts

• Record ID: K983717
• Device Name: BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
• Applicant: Aerotel Medical Systems (1998) , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Aerotel Medical Systems (1998) Ltd BP-Tel Trans-Telephonic Monitoring system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The BP-Tel is not intended for patients with defibrillators.

Device Story

System comprises home oscillometric blood pressure monitor and central station PC software; patient measures blood pressure at home; data transmitted via telephone lines to central station; central software receives, stores, and generates reports/charts of systolic/diastolic pressure and heart rate; intended for patient self-use; healthcare providers review reports to monitor patient history; facilitates remote clinical oversight of blood pressure trends.

Clinical Evidence

Clinical testing performed with volunteer subjects to validate the entire system, including the blood pressure device and trans-telephonic transmission functionality. Non-clinical testing included compliance with EN 60601-1 and validation of the MPM software.

Technological Characteristics

Oscillometric blood pressure measurement; trans-telephonic data transmission; PC-based central station software for data storage and reporting; system complies with EN 60601-1 safety standards.

Indications for Use

Indicated for patients requiring home blood pressure monitoring and transmission to a central station. Contraindicated for patients with defibrillators.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• UA 767 Home Blood Pressure System (8831720)
• Aerotel Central System for Event Recorders (K930314)
• Aerotel ECG HeartView Cardiac Event recorder (K950004)

Submission Summary (Full Text)

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# רור 1983

Page A4

## Aerotel Medical Systems (1998) Ltd. 510(k) Submission BP-Tel Trans-Telephonic Blood Pressure Measurement System

### 510(k) Summary

### (1) Submitter Information

Name: Aerotel Medical Systems (1998) Ltd.

Address:

5 Hazoref Street 58858 Holon Israel

Telephone Number: 972-3-559-6111

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: October 5, 1998

(2) Name of Device

Trade Name: BP-Tel Trans-telephonic blood pressure measurement system Common Name: Home blood-pressure measurement device and trans-telephonic transmission system. Classification name: Monitor, Blood-Pressure, Amplifier and Associated Electronics, 74 KGJ.

(3) Equivalent legally-marketed devices.

- 1. UA 767 Home Blood Pressure System, 8831720
- 2. Aerotel Central System for Event Recorders, K930314
- 3. Aerotel ECG HeartView Cardiac Event recorder, K950004

(4) Description

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The system includes a home blood-pressure measuring device that makes use of the oscillometric system, a means for sending the measurements over the telephone lines to a central station, and a computer program at the central station for receiving the measurements, storing them in a data base, and preparing reports.

#### (5) Intended Use

The Aerotel BP-Tel Trans-Telephonic Monitoring system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. It is not intended to be used by patients with defibrillators.

(6) Performance Data

(a) Non-clinical tests

The BP-Tel system has been tested by an outside testing laboratory for compliance with EN 60601-1, and satisfactorily passed all tests.

The MPM software has undergone extensive validation testing.

(b) Clinical tests

The actual blood-pressure device is a cleared device purchased for this system. The entire system has been tested in a clinical test with volunteer subjects.

(c) Conclusions

1

The BP-Tel Blood-Pressure trans-telephonic monitoring system is equivalent in safety and efficacy to the legally-marketed predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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## SEP 1 6 1999

Mr. George H. Myers Official Correspondent MEDSYS, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

Re : K983717 Aerotel BP-Tel · Requlatory Class: II (Two) Product Code: 74 DXN Dated: August 10, 1999 Received: Auqust 11, 1999

Dear Mr. Myers:

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 legally marketed predicate 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, labelinq, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 requlation may result in requlatory 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Mr. George H. Myers

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsma/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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510(k) Number (if known): __ 长 98 3717 ___

Indications for Use Form

Device Name: BP-Tel Trans-Telephonic Blood Pressure Measurement System

Indications for Use:

The Aerotel Medical Systems (1998) Ltd BP-Tel Trans-Telephonic Monitoring system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The BP-Tel is not intended for patients with defibrillators.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Beete B Camperle

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(Division Sign-Off)

Division of Cardiovascular, Respiratory,
and Neurological Devices

| 510(k) Number | K 983717 |
|---------------|----------|
|---------------|----------|

| Prescription Use | X | OR | Over-the-Counter |
|------------------|---|----|------------------|
|------------------|---|----|------------------|

Use
(Per 21 CFR 810.109)

(Optional Format 1-2-96)