(201 days)
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Not Found
No
The summary describes a device for recording and transmitting ECG signals, but there is no mention of AI, ML, or any related technologies for analysis or interpretation.
No
The device is used to record and transmit ECG signals for diagnostic purposes, not to treat a condition.
Yes
The device is described as recording and transmitting ambulatory ECG signals from patients experiencing symptoms. This process of collecting physiological data to assess a patient's condition falls under the umbrella of diagnostic activities, even if it doesn't provide a direct diagnosis itself, it provides data that aids in diagnosis.
No
The device description explicitly states it is a "pager-sized, handheld or patient-worn device" designed to record and transmit ECG signals, indicating it is a physical hardware device, not software only.
Based on the provided information, the CardioPAL device 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.
- CardioPAL Function: The description clearly states that the CardioPAL is designed to "record and transmit ambulatory ECG signals." ECG (Electrocardiogram) is a measurement of the electrical activity of the heart, which is a physiological signal, not a sample taken from the body for analysis.
Therefore, the CardioPAL falls under the category of a medical device that monitors physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature. Since the CardioPAL is patient-activated, the device is not intended for use by patients who are unable to activate the Record switch when they are experiencing a symptom.
Product codes
74 DXH
Device Description
The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
patient-worn device
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a three-lined wave-like design. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1998
Mr. Josephus Riffe Medicomp, Inc. 7845 Ellis Road Melbourne, FL 32904
Re : K981119 CardioPAL (Model PM20) Event/Loop Recorder Regulatory Class: II (two) Product Code: 74 DXH Dated: July 22, 1998 Received: July 23, 1998
Dear Mr. Riffe:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 (Premarket Approval), 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 o 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2 - Mr. Josephus Riffe
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number: K981119
Device Name: CardioPAL Model PM20
Indications for Use:
The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature. Since the CardioPAL is patient-activated, the device is not intended for use by patients who are unable to activate the Record switch when they are experiencing a symptom.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) .... ...................................................................
10/14/98
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
07/17/98