(14 days)
No
The summary describes a system for transmitting and storing blood pressure data, with no mention of AI or ML algorithms for analysis or interpretation.
No
Explanation: The device is intended for measuring and transmitting blood pressure data, storing it, and preparing reports. It does not provide any treatment or prevention of disease, which are characteristics of a therapeutic device.
Yes
This device measures blood pressure and stores blood pressure data to prepare reports and charts showing the history of systolic, diastolic pressures, and heart rate, which is a diagnostic function.
No
The device description explicitly states the system includes both a "patient unit" and a "central computer program," indicating a hardware component (the patient unit) is part of the system, in addition to the software.
Based on the provided information, the Aerotel Medical Systems (1998) Ltd. MPM-Net system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MPM-Net Function: The MPM-Net system measures blood pressure, which is a physiological parameter measured directly from the body (in vivo), not from a sample taken from the body (in vitro). It then transmits and manages this data.
The system's function is to monitor a physiological parameter (blood pressure) and manage the collected data, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of this device in conjunction with the devices previously cleared is to:
-
- Provide means so that a patient can measure his/her blood pressure at home
- Send the measurement in to central computer 2.
- Provide means so that a physician can monitor progress on the central computer. 3.
The Aerotel Medical Systems (1998) Ltd. MPM-Net 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 system is not intended for patients with defibrillators.
Product codes
DXN
Device Description
The MPM-Net is an option for a modem/dialer system adapted for the purpose of following patients' blood pressures. It operates in conjunction with a cleared home-use blood pressure device. The system includes the computer program at a central station used for receiving data and preparing reports. The option allows reports to be retrieved over the internet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by patients to measure their blood pressure at home. Physician can monitor progress on the central computer.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: The modifications were validated by a validation test for the system.
Clinical Tests: No clinical tests were performed.
Conclusion from these tests is that the MPM-Net is equivalent in safety and efficacy to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BP-Tel K983717, TeleCliniQ Clinical Data Transmission System, K021447
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K030825
page 1 of 2
Page A 2
Aerotel Medical Systems (1998) Ltd. Special 510(k) MPM-Net
MAR 2 8 2003
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements Regulation par. 807.92, effective March 14, 1995.
1. Submitter
Name: Aerotel Medical Systems (1998) Ltd Address: 5 Hazoref St., Holon 58856, Israel Telephone Number: 972-3-5596111 Contact person: Dr. George Myers, 210-787- 1703 Date prepared: April 1, 2002
2. Device
Proprietary name: MPM-Net Common Name: Home blood-pressure measurement device and trans-telephonic transmission system. Monitor, Blood-Pressure, Amplifier and Associated Classification Name: Electronics
3. Predicate Devices
BP-Tel K983717, manufactured by Aerotel TeleCliniQ Clinical Data Transmission System, K021447, manufactured by Aerotel
4. Description
. The MPM-Net is an option for a modem/dialer system adapted for the purpose of following patients' blood pressures. It operates in conjunction with a cleared home-use blood pressure device. The system includes the computer program at a central station used for receiving data and preparing reports. The option allows reports to be retrieved over the internet.
5. Intended Use
The intended use of this device in conjunction with the devices previously cleared is to:
1
-
- Provide means so that a patient can measure his/her blood pressure at home
- Send the measurement in to central computer 2.
- Provide means so that a physician can monitor progress on the central computer. 3.
6. Comparison
The MPM-Net is a modified version of the predicate device. It has basically the same electrical and mechanical characteristics, and the use of the two devices by the patient is equivalent. It permits the reports to be retrieved over the internet.
7. Performance Data
(1) Non-clinical tests
The modifications were validated by a validation test for the system.
(2) Clinical Tests
No clinical tests were performed.
8. Conclusion
The conclusion drawn from these tests is that the MPM-Net is equivalent in safety and efficacy to its predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
MAR 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aerotel Medical Systems (1998) Ltd. c/o Dr. George Myers Medsys Inc. Official Correspondent 377 Rt. 17 Hasbrouck Heights, NJ 07604
Re: K030825 Trade Name: MPM-Net Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: March 13, 2003 Received: March 14, 2003
Dear Dr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Dr. George Myers
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K030825
Indications for Use Form
Device Name: MPM-Net
Indications for Use:
The Aerotel Medical Systems (1998) Ltd. MPM-Net 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 system 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)
Ndelotti
510(k) Number K030825
Prescription Use Only