(16 days)
K 983717
K 983717
No
The description focuses on data transmission, storage, and reporting of blood pressure measurements, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is described as a data transmission system for blood pressure measurements, not a device that directly treats or diagnoses a medical condition. It facilitates the transfer and storage of data from a separate blood pressure measuring device.
No.
The primary purpose of the device is to transmit blood pressure measurements from a patient's home to a central station, and to store and report this data. While it deals with medical measurements, its stated function is data transmission and management, not to diagnose a condition itself. The blood pressure measuring device is purchased separately and is the diagnostic component, not the Tele-CliniQ system itself.
No
The device description explicitly states the system includes a "home blood-pressure measuring device" and a "means for sending the measurements over the telephone lines," in addition to the computer program. This indicates the system includes hardware components beyond just software.
Based on the provided information, the Aerotel Medical Systems (1998) Ltd Tele-CliniQ Data Transmission 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.
- Tele-CliniQ Function: The Tele-CliniQ system measures blood pressure, which is a physiological parameter measured directly from the patient's body (in vivo), not from a sample taken from the body (in vitro).
- Intended Use: The intended use clearly states it's for patients to measure their blood pressure at home and transmit it. This is a direct measurement of a vital sign.
Therefore, the Tele-CliniQ falls under the category of a medical device for monitoring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aerotel Tele-CliniQ is intended to be used by patients to transmit blood pressure measurements taken at home 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.
The Aerotel Medical Systems (1998) Ltd Tele-CliniQ Data Transmission 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 (purchased separaetly) 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. The Tele-CliniQ is not intended for patients with defibrillators.
Product codes
DXN
Device Description
The system includes a home blood-pressure measuring device that makes use of the oscillometric system (purchased separately), 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.
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
Not Found
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 Tele-CliniQ has been tested by an outside testing laboratory for compliance with EN 60950 electrical safety, and for electromagnetic compatibility, and has satisfactorily passed all tests. The MPM software has undergone extensive validation testing. The UA 767 PC (blood pressure measurement device) has been cleared by the FDA. The entire system has been validated.
Clinical tests: Not required.
Key Metrics
Not Found
Predicate Device(s)
K 983717
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
MAY 2 2 2002
K021447
page 1 of 2
Page A 1
Aerotel Medical Systems (1998) Ltd. Special 510(k) Submission Tele-CliniQ April 26, 2002
510(k) Summary
(1) Submitter Information
Aertotel Tele-CliniQ
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: April 16, 2002
(2) Name of Device
Trade Name: Tele-CliniQ Common Name: Clinical Data Transmission System for Blood Pressure Classification name: Monitor, Blood-Pressure, Amplifier and Associated Electronics, 74 KGJ.
(3) Equivalent legally-marketed devices.
Aerotel BP-Tel, K 983717
(4) Description
The system includes a home blood-pressure measuring device that makes use of the oscillometric system (purchased separately), a means for sending the measurements
1
Aertotel Tele-CliniQ
021447
page 2 of 2
Page A 2
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 Tele-CliniQ is intended to be used by patients to transmit blood pressure measurements taken at home 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 Tele-CliniQ has been tested by an outside testing laboratory for compliance with EN 60950 electrical safety, and for electromagnetic compatibility, and has satisfactorily passed all tests.
The MPM software has undergone extensive validation testing.
The UA 767 PC (blood pressure measurement device) has been cleared by the FDA.
The entire system has been validated.
(b) Clinical tests
Not required.
(c) Conclusions
The Tele-CliniQ is equivalent in safety and efficacy to the legally-marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aerotel Medical Systems Ltd. c/o George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604
Re: K021447
Trade Name: Tele-CliniQ Clinical Data Transmission System Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: May 2, 2002 Received: May 6, 2002
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 way, 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 - George H. Myers, Sc.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I icat 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 Of It Fat 007), adoming (21 (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 prests to redicate 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CF 11 For 2646. 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 Part 807.97). regulation on information on your responsibilities under the Act may be obtained from the O inter general 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,
Denka Tull
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Aerotel Tele-CliniQ
: Page 5
Page
510(k) Number (if known):
Indications for Use Form
Device Name: Tele-ClinQ Clinical Data Transmission System
Indications for Use:
The Aerotel Medical Systems (1998) Ltd Tele-CliniQ Data Transmission 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 (purchased separaetly) 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. The Tele-CliniQ 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)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021447
Prescription Use X