(29 days)
No
The summary describes a basic ECG event recorder and transmitter. There is no mention of any analytical capabilities beyond recording and transmitting the ECG signal, nor any terms associated with AI/ML.
No
This device is an electrocardiogram monitor and event recorder, used for diagnosis and monitoring of cardiac symptoms, not for treating a disease or condition.
Yes
The device is described as an "electrocardiogram monitor" and an "ECG event recorder and transmitter" that records and sends ECGs for "long-term cardiac out-patient management" and when a patient "feels symptoms". This information is then sent to a physician, implying its use in diagnosing cardiac conditions related to patient symptoms.
No
The device description explicitly states it is a "battery-powered ECG event recorder and transmitter," indicating it includes hardware components beyond just software.
Based on the provided information, the Heart 2006 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Heart 2006 Function: The Heart 2006 records and transmits electrocardiograms (ECG). An ECG is a recording of the electrical activity of the heart, which is a physiological measurement taken directly from the body, not from a specimen taken from the body.
The Heart 2006 is a physiological monitoring device used for cardiac assessment based on electrical signals from the heart.
N/A
Intended Use / Indications for Use
The Heart 2006 is a long-term portable electrocardiogram monitor intended to be used for long-term cardiac out-patient management. The unit records a period of electrocardiogram whenever the patient feels symptoms, as indicated to him by a physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone.
The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.
Product codes
DXH
Device Description
The Heart 2006 is a battery-powered ECG event recorder and transmitter that is capable of storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station. It records a portion of the ECG both before and after a "Record" button is depressed.
The H2006 is a battery powered ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as Aerotel's Heartline Receiving Station (FDA # K022073) or equivalent. It records portions of the ECG both before and after the Record button is depressed.
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)
(1) Non-clinical tests
The modifications were validated by repeating IEC 601-1 and IEC 601-1-2 tests (electrical safety and electromagnetic compatibility) and the electrical characteristic tests of standard EC38.
(2) Clinical Tests
No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
, P
OCT 03 2003
Image /page/0/Picture/2 description: The image shows the text "K032736 page 1 of 2 Page A 2". The text appears to be handwritten, with the exception of "Page A 2". The text is black and is set against a white background. The image is likely a page from a document.
Aerotel Medical Systems (1998) Ltd. Special 510(k) Heart 2006 Cardiac Event Recorder
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: March 7, 2000
2. Device
Proprietary name: Heart 2006 Common Name: Electrocardiograph Event Recorder and Telephonic Transmitter Classification Name: Transmitters and Receivers, electrocardiograph, telephone
The Heart 2006 is a battery-powered ECG event recorder and transmitter that is capable of storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station. It records a portion of the ECG both before and after a "Record" button is depressed.
- Predicate Device
Heart 2005. K000775. manufactured by Aerotel Medical Systems (1998) Ltd..
- Description
The H2006 is a battery powered ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as Aerotel's Heartline Receiving Station (FDA # K022073) or equivalent. It records portions of the ECG both before and after the Record button is depressed.
- Intended Use
The Heart 2006 is a long-term portable electrocardiogram monitor intended to be used for long-term cardiac out-patient management. The unit records a period of electrocardiogram whenever the patient feels symptoms, as indicated to him by a
1
Aerotel H2006
physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone.
The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.
- Comparison
The Heart 2006 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.
- Performance Data
(1) Non-clinical tests
The modifications were validated by repeating IEC 601-1 and IEC 601-1-2 tests (electrical safety and electromagnetic compatibility) and the electrical characteristic tests of standard EC38.
(2) Clinical Tests
No clinical tests were performed.
8. Conclusion
The conclusion drawn from these tests is that the Heart 2006 is equivalent in safety and efficacy to its predicate device.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 03 2003
Aerotel Medical Systems (1998) Ltd. c/o George H. Myers, Sc.D. President Medsys Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
Re: K032736
Trade Name: Heart 2006 Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: September 2, 2003 Received: September 4, 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.
3
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.
V. Valenti
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Aerotel H2006 Recorder
Page 3
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Indications for Use Form
Device Name: Heart 2005
Indications for Use:
The Heart 2006 is a long-term portable electrocardiogram monitor intended to be used for long-term cardiac out-patient management. The unit records a period of electrocardiogram whenever the patient feels symptoms, as indicated to him by a physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone.
The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| Use | |
| (Per 21 CFR 810.109) |
OR
Over-the-Counter
(Optional Format 1-2-96)
OaheTm
510(k) Number