(14 days)
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.
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.
The provided K030825 document is a 510(k) summary for the "MPM-Net" device. It is essentially an administrative filing to demonstrate equivalence to a predicate device, not a report of a scientific study designed to establish new performance criteria. Therefore, the document explicitly states there were no clinical tests performed for this specific submission to demonstrate accuracy or performance.
Here's a breakdown based on the information provided and the absence of certain elements:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
- Explanation: The document does not define specific performance acceptance criteria (e.g., accuracy, precision) for blood pressure measurement, nor does it report numerical device performance metrics for the MPM-Net itself. It relies on demonstrating equivalence to predicate devices which would have undergone such testing.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 0 (No clinical tests were performed for this submission).
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, an MRMC study was not done. The device is a blood pressure monitor and transmission system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of this 510(k) submission. The device is a system that includes a home blood pressure monitor and a transmission system, not a standalone algorithm for diagnostic interpretation. The emphasis is on the transmission and reporting capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable for this submission as no clinical tests were performed. For the predicate blood pressure monitors, the ground truth would typically be established through comparison with a reference standard validated blood pressure measurement device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The document does not describe a machine learning algorithm or a "training set" in the context of its development. The validation mentioned was for the system itself (software validation, electrical/mechanical characteristics), not the training of an AI model.
9. How the ground truth for the training set was established
- How Ground Truth was Established: Not applicable.
Summary of the Study (as described in K030825):
The document explicitly states: "No clinical tests were performed."
Instead, the study to demonstrate the device meets acceptance criteria (which are implicitly tied to the predicate devices) relied on:
- Non-clinical tests: "The modifications were validated by a validation test for the system." This likely refers to engineering, software, and functional testing to ensure the modifications (primarily the internet retrieval of reports) work as intended and do not negatively impact the core functionality, which is the transmission of blood pressure data.
- Comparison to Predicate Devices: The primary argument for safety and effectiveness is that 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." The predicate devices (BP-Tel K983717 and TeleCliniQ K021447) would have undergone their own clinical testing to establish accuracy and performance. This 510(k) relies on the established safety and effectiveness of those predicates, asserting that the new modification (internet reporting) does not alter the fundamental performance or safety.
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K030825
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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:
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- 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.
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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.
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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
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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
§ 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).