(28 days)
Not Found
No
The description focuses on receiving, recording, and displaying ECG signals for physician analysis, with no mention of automated analysis, pattern recognition, or learning algorithms.
No
Explanation: The device is for monitoring and analysis of ECG signals, not for treatment or therapy.
Yes.
Explanation: The device receives ECG signals, records them, and displays them for "physicians analysis and comment," which directly relates to diagnosis.
Yes
The device description explicitly states, "The HRS is basically a software system, and operates on commercial personal computers." While it receives signals from patient-operated transmitters (hardware), the Heartline device itself, as described, is the receiving and display system which is software-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device receives ECG signals from a patient-operated transmitter and displays them for physician analysis. This is a direct measurement of a physiological signal from the patient's body.
- Device Description: The description reinforces that it's an ECG monitoring device that receives signals over telephone lines.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, or tissue. IVDs are designed to examine these types of samples to provide diagnostic information.
Therefore, the Heartline is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Heartline Receiving Station is indicated for use when patients transmit electrocardiographic signals from remote cardiac ECG event recorders to a central station.
"The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters when decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment. "
Product codes
DXH
Device Description
The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters. When decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment. The HRS is basically a software system, and operates on commercial personal computers. The device is compatible with all Aerotel monitors, all of which have been cleared by the FDA.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: The programs for the Heartline Receiving Station have been thoroughly verified and validated. The recommended computers meet international standards for electrical safety and electronic emissions. The entire system has been validated.
Clinical tests: Not required.
Conclusions: The Heartline Receiving Station is equivalent in safety and efficacy to the legally-marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aerotel Heartline receiving Console, K930314
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
Aerotel Medical Systems (1998) Ltd. Special 510(k) Submission Heartline Receiving Station
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 19, 2002
(2) Name of Device
Trade Name: Heartline Receiving Station Common Name: Electrocardiographic Telephone Event Receiver/Transmitter Classification name: Transmitters and Receivers, Electrocardiograph, Telephone 74 KGJ.
(3) Equivalent legally-marketed devices.
Aerotel Heartline receiving Console, K930314
(4) Description
The Heartline is an ECG monitoring device intended to receive ECG signals
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Aerotel Heartline
Page A2
over standard telephone lines from patient operated transmitters. When decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment. The HRS is basically a software system, and operates on commercial personal computers. The device is compatible with all Aerotel monitors, all of which have been cleared by the FDA.
(5) Intended Use
The Heartline Receiving Station is indicated for use when patients transmit electrocardiographic signals from remote cardiac ECG event recorders to a central station.
(6) Performance Data
(a) Non-clinical tests
The programs for the Heartline Receiving Station have been thoroughly verified and validated. The recommended computers meet international standards for electrical safety and electronic emissions.
The entire system has been validated.
(b) Clinical tests
Not required.
(c) Conclusions
The Heartline Receiving Station is equivalent in safety and efficacy to the legallymarketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Public Health Service
JUL 2 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aerotel Medical Systems c/o George H. Myers, Sc.D. President Medsys Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
Re: K022073
Trade Name: Heartline Receiving Station Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulation Number: 21 CFR 870.2920 Regulatory Class: Class II (two) Product Code: DXH Dated: June 24, 2002 Received: June 26, 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 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 - George S. Myers, Sc.D.
ース アドリア アイディース イベント (イン) イベント) ヘルドアーター (1) (1) ) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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). Other general information on your responsibilities under the Act may be obtained 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.
Della Till
onna-Bea 7 illman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Aerotel Heartline
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Indications for Use Form
Device Name: Heartline Receiving Station
Indications for Use:
"The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters when decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment. "
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Cardiovascular and Respiratory Device
510(k) Number.