(113 days)
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No
The summary describes a standard cardiac event recorder with automatic recording based on heart rate, but there is no mention of AI or ML algorithms for analysis or interpretation.
No
This device is a diagnostic tool used to record ECG data for the evaluation of transient symptoms and potential arrhythmias. It does not actively treat or provide therapy to the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for diagnostic evaluation of transient symptoms such as dizziness, palpitations, syncope and chest pain."
No
The device description explicitly states "These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors" and mentions hardware components like a serial port and acoustically coupled FM signal, indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The King of Hearts Express® II cardiac event recorder is a non-invasive device that records electrical activity on the surface of the body (ECG).
- The intended use is for diagnostic evaluation of transient symptoms by recording ECG. This is a physiological measurement, not an analysis of a biological sample.
Therefore, the device falls under the category of a medical device, specifically an electrocardiograph or cardiac event recorder, but not an IVD.
N/A
Intended Use / Indications for Use
The King of Hearts Express® II cardiac event recorder is a patient-activated device designed for diagnostic evaluation of transient symptoms such as dizziness, palpitations, syncope and chest pain. The recorder provides single lead or multiple lead ECG morphology, which may be used to visualize arrhythmias, ST segment changes, SVT, heart block, re-entrant phenomena, and p-waves. The recorder may also provide automatic recording for detected bradycardia or tachycardia rhythms. The recorder may be used with pacemaker patients to assess pacemaker activity.
Product codes
74 DXH
Device Description
These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment follow-up, where such symptoms may be present. The new devices are capable of recording one or more leads of surface ECG. The additional features options permit automatic recording of ECG based upon measured heart rate or changes in heart rate, and/or pacemaker pulse detection and enhancement. A serial port connection is available for data communication, in addition to the standard acoustically coupled FM signal provided for trans-telephonic communications of the ECG.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
These devices are intended for use by patients who need to record their ECG during daily activities for subsequent transmission to a clinic, service, or hospital. These patients may have been instructed by their physician to record their ECG for the purpose of documenting transient symptoms which may suggest cardiac arrhythmia.
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
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Key Metrics
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Predicate Device(s)
Instromedix King of Hearts Express 3X, Prince, and 1200, the Instromedix CarryAll, the Braemar ER720, the TZ Medical HeartAide Plus II, and the Card Guard CG-6500.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 Alaris Medical Systems, specifically the Instrumedix Division. The logo features a stylized star-like symbol on the left, followed by the word "ALARIS" in bold, sans-serif font. Below "ALARIS" are the words "MEDICAL SYSTEMS" and "INSTRUMEDIX DIVISION", stacked on top of each other in a smaller font size.
7431 NW Evergreen Parkway Hillsboro, Oregon USA 97124 (503) 681-9000 (503) 681-8230 fax
510(k) Summary October. 1998 K983626 Gary N. Mills
Trade name - King of Hearts Express® II King of Hearts Express® EZ II Common name - ambulatory event recorder Classification name - telephone electrocardiograph transmitter and receiver (per 21 CFR 870.2920)
These devices are intended for use by patients who need to record their ECG during daily activities for subsequent transmission to a clinic, service, or hospital. These patients may have been instructed by their physician to record their ECG for the purpose of documenting transient symptoms which may suggest cardiac arrhythmia. The telephonic use of these devices allows the patient to receive advice based on their ECG and symptoms in a timely manner.
These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment follow-up, where such symptoms may be present.
Features and functions are identical to identified predicate devices which include the Instromedix King of Hearts Express 3X, Prince, and 1200, the Instromedix CarryAll, the Braemar ER720, the TZ Medical HeartAide Plus II, and the Card Guard CG-6500.
The new devices are capable of recording one or more leads of surface ECG. The additional features options permit automatic recording of ECG based upon measured heart rate or changes in heart rate, and/or pacemaker pulse detection and enhancement. A serial port connection is available for data communication, in addition to the standard acoustically coupled FM signal provided for trans-telephonic communications of the ECG.
The safety and effectiveness of these devices is substantially equivalent to the predicate devices. There are no known contraindications for use of this type of device. The multilead ECG, pacemaker pulse enhancement, rate-triggered recording, and other features in one or both of these devices present a non-significant risk to the host. These devices are categorized as Class II, non-significant risk devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 5 1999
Alaris Medical Systems c/o Gary N. Mills 7431 NW Evergreen Parkway Hillsboro, OR 97124
Re: K983626/SI Trade Name: King of Hearts Express® II and King of Hearts Express® EZ II Regulatory Class: II Product Code: 74 DXH Dated: January 14, 1999 Received: January 19, 1999
Dear Mr. Mills:
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, Drug, 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 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 (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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 regulation 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 regulations.
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.
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Page -2- Mr. Gary Mills
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) 594-4613. 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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. Callahon
Thomas J. Caller Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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K983626 510(k) Number (if known):
King of Hearts Express® II Device Name:
Indications For Use:
The King of Hearts Express® II cardiac event recorder is a patient-activated device designed for diagnostic evaluation of transient symptoms such as dizziness, palpitations, syncope and chest pain. The recorder provides single lead or multiple lead ECG morphology, which may be used to visualize arrhythmias, ST segment changes, SVT, heart block, re-entrant phenomena, and p-waves. The recorder may also provide automatic recording for detected bradycardia or tachycardia rhythms. The recorder may be used with pacemaker patients to assess pacemaker activity.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vak Mellk
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K983626 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)