(16 days)
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.
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.
The provided document does not contain information about specific acceptance criteria, a detailed study proving the device meets acceptance criteria, or most of the requested study parameters. The submission is a 510(k) summary for a Special 510(k), which typically relies on equivalence to a predicate device rather than extensive new clinical trials.
Here's a breakdown of the available information and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "The Tele-CliniQ is equivalent in safety and efficacy to the legally-marketed predicate devices." |
| Compliance with EN 60950 electrical safety | "satisfactorily passed all tests" |
| Electromagnetic compatibility | "satisfactorily passed all tests" |
| MPM software validation | "has undergone extensive validation testing" |
| UA 767 PC (blood pressure measurement device) clearance | "has been cleared by the FDA" |
| Entire system validation | "has been validated" |
Missing Information: Specific numerical or qualitative acceptance criteria for clinical performance (e.g., accuracy against a gold standard for blood pressure measurement, data transmission success rate, software reliability metrics, user interface usability guidelines).
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical tests: Not required." This indicates that a specific test set, in the sense of a clinical study cohort, was not used for this 510(k) submission. The FDA clearance is based on the device's technical specifications, validation of its software, and the prior clearance of its associated blood pressure measurement device (UA 767 PC), along with equivalence to a predicate device (Aerotel BP-Tel, K 983717).
Missing Information: Since clinical tests were not required, there is no information on sample size, country of origin, or retrospective/prospective nature of a test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Missing Information: As clinical tests were "not required," no experts were explicitly used to establish ground truth in a clinical study context for this submission.
4. Adjudication Method
Missing Information: No adjudication method is mentioned, as no clinical study with expert review was performed or required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Missing Information: No MRMC study was done, as this refers to comparative studies involving human readers, which are not relevant for a blood pressure data transmission system that aims to digitize and transmit measurements from an already cleared device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a "Clinical Data Transmission System for Blood Pressure." Its primary function is to transmit data. The "algorithm" here would largely pertain to the data transmission and storage functionalities.
- Non-clinical tests: The MPM (presumably "Medical Patient Monitoring" or similar) software "has undergone extensive validation testing." This would be the closest analogue to a standalone evaluation of the software's data handling capabilities. However, specific performance metrics or a detailed study of this validation are not provided.
- The FDA-cleared UA 767 PC blood pressure monitor itself would have undergone standalone performance evaluation for blood pressure accuracy prior to its clearance.
Missing Information: Specific details of the "extensive validation testing" for the MPM software, including metrics, methodologies, and results that would demonstrate standalone performance.
7. Type of Ground Truth Used
- For the electrical safety and EMC testing, the "ground truth" would be compliance with the respective EN 60950 and electromagnetic compatibility standards.
- For the MPM software validation, the "ground truth" would likely involve software engineering best practices, data integrity tests, and functional requirements to ensure accurate data transmission, storage, and reporting.
- For the blood pressure measurements themselves, the "ground truth" would have been established during the clearance of the UA 767 PC device, likely against invasively measured blood pressure or highly accurate reference non-invasive devices.
Missing Information: Specific details on how ground truth was established for the software validation in terms of what constitutes "accurate" data transmission and storage.
8. Sample Size for the Training Set
Missing Information: The document does not mention a training set, as this type of device (a data transmission system) does not typically involve machine learning or AI models that require a "training set" in the conventional sense. The "training" here would be the development and testing of robust software code.
9. How the Ground Truth for the Training Set Was Established
Missing Information: Not applicable, as there is no mention of a training set.
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K021447
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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
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Aertotel Tele-CliniQ
021447
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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.
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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.
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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
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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
§ 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).