(201 days)
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.
The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals.
The provided text is an FDA 510(k) clearance letter for the CardioPAL (Model PM20) Event/Loop Recorder. This letter approves the marketing of the device based on its substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain information about specific acceptance criteria or a study proving the device meets those criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. It typically relies on comparison to a predicate device, sometimes supported by performance data, but it does not usually include a detailed report of a study establishing new acceptance criteria or proving performance against them in the way described in your request.
Therefore, I cannot extract the requested information as it is not present in the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the device's performance against specific metrics.
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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.
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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
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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
§ 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).