(330 days)
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.
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.
The provided document, a 510(k) summary for the Aerotel BP-Tel Trans-Telephonic Blood Pressure Measurement System, offers limited information regarding specific acceptance criteria and the detailed study proving it. However, based on the available text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with EN 60601-1 (Medical electrical equipment safety standard) | "satisfactorily passed all tests" for EN 60601-1. |
| Software Validation | Proper functioning and reliability of the MPM software for receiving, storing, and reporting data. | "undergone extensive validation testing." |
| Clinical Performance (Accuracy of Blood Pressure Measurement) | Equivalent performance to a legally cleared blood pressure device. | "The actual blood-pressure device is a cleared device purchased for this system." |
| System Functionality (Trans-Telephonic Transmission) | Successful transmission of measurements over telephone lines to a central station. | "The entire system has been tested in a clinical test with volunteer subjects." (Implication: transmission and data handling worked as intended). |
| Equivalence to Predicate Devices | Comparable safety and efficacy to specified legally marketed predicate devices. | "The BP-Tel Blood-Pressure trans-telephonic monitoring system is equivalent in safety and efficacy to the legally-marketed predicate devices." |
2. Sample Size and Data Provenance
- Test Set Sample Size: "The entire system has been tested in a clinical test with volunteer subjects." The exact number of volunteer subjects is not specified in the document.
- Data Provenance: The study was a "clinical test." The country of origin is not explicitly stated for the clinical test, but the company is based in Israel, so it's plausible the study was conducted there or in the US (given the FDA submission). It was a prospective study as it involved testing the system in a clinical setting.
3. Number of Experts and Qualifications
- Not applicable / Not specified. The document does not mention the use of experts to establish a ground truth for the clinical test beyond the standard clinical assessment methods that would be used for blood pressure measurement. The core blood pressure device itself was a "cleared device," implying its accuracy was already established.
4. Adjudication Method
- Not applicable / Not specified. Given the nature of a blood pressure measurement device testing, an adjudication method like 2+1 or 3+1 typically applies to subjective interpretations (e.g., radiology images). For quantitative measurements like blood pressure, the ground truth is usually established through a reference standard measurement, not expert consensus on interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned as this device is for measuring and transmitting blood pressure, not for interpretation tasks that involve human readers. The clinical test involved the device's performance, not a comparison of human readers with and without AI assistance.
6. Standalone Performance Study
- Most likely, yes, for a component. The statement "The actual blood-pressure device is a cleared device purchased for this system" implies that the core blood pressure measurement algorithm (which could be considered a standalone algorithm) had undergone its own performance evaluation to achieve clearance. The current submission focuses on the system (measurement + telephonic transmission). The "extensive validation testing" for the MPM software also indicates a standalone assessment of that software component.
7. Type of Ground Truth Used
- Reference Standard Measurement (Inferred): For the blood pressure component, the ground truth would have been established by comparing the device's readings against a recognized standard method for blood pressure measurement (e.g., a mercury sphygmomanometer or another validated oscillometric device).
- System Functionality Verification: For the transmission and data handling aspects, the ground truth would be whether the data was accurately transmitted, stored, and displayed as received from the device's measurements.
8. Sample Size for the Training Set
- Not applicable / Not specified. Blood pressure monitors typically rely on established physiological principles and algorithms rather than machine learning models that require large training sets in the same way an AI diagnostic tool would. While there might be some internal calibration or algorithm development, the document doesn't mention a distinct "training set" in the context of an AI/ML algorithm. The core blood pressure device was "cleared," meaning its underlying algorithms and parameters were already validated.
9. How Ground Truth for Training Set was Established
- Not applicable / Not specified. As mentioned above, a traditional "training set" with ground truth in the AI/ML sense is not indicated for this type of device. The accuracy of the blood pressure measurement component would have been established during its original clearance, likely through comparison to gold-standard manual measurements on a diverse population.
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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 201-727-1703 Fax 201-727-1708
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.
-
- UA 767 Home Blood Pressure System, 8831720
-
- Aerotel Central System for Event Recorders, K930314
-
- 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
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures or profiles facing to the right, resembling a bird in flight. The logo is rendered in black and white.
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 (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" (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 (800) 638-2041 or (301) 443-6597 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)
Beete B Camperle
(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)
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).