(90 days)
No
The summary describes a system for transmitting and storing patient data from home monitoring devices. There is no mention of AI or ML in the intended use, device description, or performance studies. The clinical test section explicitly states that clinical tests are not necessary because the device does not use new technology, which would likely be required for a device incorporating AI/ML.
No
The device facilitates the transmission and management of patient data from home monitoring devices. It is not directly involved in treating or diagnosing a condition but rather in the communication of information.
No
The device collects and transmits data from other patient monitoring devices. It does not perform any analysis or interpretation of this data to diagnose a condition. Its function is data management and communication.
No
The device description explicitly states the system comprises a "modem-like device" which is a hardware component, in addition to the central station program.
Based on the provided information, the Aerotel MPM SYSTEM is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect and transmit data from other home patient monitoring devices (blood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) to a central station for reporting. It does not perform any diagnostic testing on biological samples.
- Device Description: The device is described as a modem-like device that connects to measurement devices and a central station program. It facilitates data transfer and reporting, not in vitro analysis.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic interpretation of biological markers
The Aerotel MPM SYSTEM acts as a data collection and transmission system for data generated by other devices, some of which might be IVDs (like a blood glucose meter), but the Aerotel system itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The Aerotel MPM SYSTEM is intended to be used with home patient monitoring devices (blood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.
Product codes
DXN
Device Description
The system comprises a modem-like device that connects to various cleared measurement devices and a ntral station program that keeps the records of the patients, and makes the reports available ... 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
physician and patients / home and central station
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
Non-clinical tests: The system has been tested with all of the compatible measuring units and has satisfactorily passed the tests. The software has been extensively validated.
Clinical tests: Clinical tests are not necessary because the device does not use new technology/
Key Metrics
Not Found
Predicate Device(s)
K020534, K983717, K021447, K030825
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
OCT 6 - 2004
Image /page/0/Picture/3 description: The image shows the alphanumeric string "K041854" in a bold, sans-serif font. Below this string, there is another string "P 1/2" written in a smaller, less defined font. The overall impression is that of a label or identifier, possibly from a document or inventory system.
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: June 3, 2004
(2) Name of Device
Trade Name: MPM System Common Name: Device for transmitting measurement parameters from the home and receiving them at a central station with Internet Access. Classification name: Telephone electrocardiograph transmitter and receiver.
(3) Equivalent legally-marketed devices.
-
- Cybernet Medical Medstar, K020534
-
- Aerotel BPTEL/MPM, K983717
-
- Aerotel TeleCliniQ, K021447
-
- Aerotel MPMP-Net, K030825
(4) Description
1
- 2-1 2-
The system comprises a modem-like device that connects to various cleared measurement devices and a ntral station program that keeps the records of the patients, and makes the reports available ... the internet.
(5) Intended Use
The Aerotel MPM SYSTEM is intended to be used with home patient monitoring devices (b)ood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.
(6) Performance Data
(a) Non-clinical tests
The system has been tested with all of the compatible measuring units and has satisfactorily passed the tests. The software has been extensively validated.
(b) Clinical tests
Clinical tests are not necessary because the device does not use new technology/
(c) Conclusions
The MPM system is equivalent in safety and efficacy to the legally-marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus is composed of three parallel lines that curve and flow together.
OCT 6 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aerotel Medical Systems, Ltd. c/o George H. Myers, Sc.D. Medsys, Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604
Re: K041854
Trade Name: MPM System Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 7, 2004 Received: July 8, 2004
Dear Dr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manatis and the Medical Device American by to de Ford. Four conninered phor to they 2011-03-12) in accordance with the provisions of the Federal Food, DNIg, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic 710 (710) that as not some of in the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls pro reserving 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 rr your device to such additional controls. Existing major regulations affecting your device can may be subject to back adders and Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - George H. Myers, Sc.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA S Issualice of a subside on the requirements of the Act
that FDA has made a determination that your device complies with of acception. Your must that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21) comply with an the Act 3 requirements, merceans, and manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 800); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (overlees) (over device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in 10 I his letter will anow you to ocgin marketing your and equivalence of your device to a legally premarket notification: "The FDA inding of bactualized on 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 If you desire specific advice for your ac 11 594-4648. Also, please note the regulation entitled, and Colliact the Office of Complanou at (501) 37 - 7 - 7 - 7 - 7 807.97). You may obtain " Misoranding of Icierchee to premanter is thirds. In the Act from the Division of Small
other general information on your responsibilities under the Act from the 1990 Call o other general information on your respense 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,
Blimmimo for
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):_____________________________________________________________________________________________________________________________________________________
Indications for Use Form
Device Name: MPM System
Indications for Usc:
The Aerotel MPM SYSTEM is indicated when patients use with home patient monitoring devices (blood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) and wish to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
Use
(Per 21 CFR 810.109)
O
Over-the-Counter
(Optional Format 1-2-96)
Blumuma
lon Slanof Cardlovascular Devices 510fk] Number