(22 days)
This device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; Dizziness, Palpitations, Syncope, Chest pain.
The King of Hearts® Express + AF Monitor is an triggered cardiac event recorder designed for auto diagnostic evaluation of transient symptoms. The device uses a two-wire single channel lead set for event recording. Using looping memory, the device captures ECG data; auto triggering after the patient experiences a cardiac symptom or manually after the patient pushes the RECORD button. The number of Events can be physician adjusted according to the programmed lengths of Before and After data acquisition duration for each recording. These segments of stored ECG can then be transmitted later in the form of an FM-modulated acoustic tone, when the SEND button is manually depressed. The device is configured in the same compact sized case approximately 4 inches long, 2 % inches wide and 5/8 " thick as the predicate devices. The two wire lead set is the same as is used in the predicate device [King of Hearts Express Monitor (K920984)}.
The provided text describes the "King of Hearts® Express + AF Monitor," and its 510(k) submission for FDA clearance. However, it does not contain specific acceptance criteria, details of a study proving the device meets acceptance criteria, sample sizes for testing or training, ground truth establishment, or multi-reader multi-case study information.
The document primarily focuses on:
- Identifying the device and its intended use.
- Stating its equivalence to predicate devices.
- Highlighting the addition of atrial fibrillation (AF) detection as a key modification.
- Confirming that the modifications do not impact safety and effectiveness.
Therefore, I cannot fulfill the request for a detailed table and study description based on the provided input. The document explicitly states: "The King of Hearts Express + AF Monitor is Safety and Effectiveness: considered safe and effective for use when used in accordance with the instructions provided in the Owners Manual which accompanies each device. This device is a modification of previously cleared products currently manufactured by Instromedix. The only modifications are stated above. Based on these minor changes, there is no impact on safety and effectiveness." This indicates that extensive new studies for safety and effectiveness, beyond demonstrating the new AF detection feature, were likely not required for this 510(k) given the device's predicate status and the nature of the modification.
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Image /page/0/Picture/0 description: The image shows the word "Instromedix" in a stylized font. There is a curved line above the word. A registered trademark symbol is to the right of the word.
A Card Guard Company
Today's Telemedicine Solutions
APR = 5 2002
K020825
p.1/2
6779 Mesa Ridge Road, Suite 200 San Diego, CA 92121-2909
main 858.450.1750 fax 858.450.9718
"510(k) Summary" As Required By Section 807.92(c)
Contact Person: Alden Kay Ja
Date
March 11, 2002
Trade Name:
King of Hearts® Express + AF Monitor or TBD
Telephone Electrocardiograph Recorder and Transmitter Common Name:
Classification Name: Telephone Electrocardiograph Transmitter and Receiver (Per 21 CFR section 870.2920)
King of Hearts® Express Monitor (K920984) and King of Predicate Devices: Hearts® Express II Monitor (K983626) [Instromedix]
[21 CFR 807.92(a)(3)]
The King of Hearts Express + AF Monitor is equivalent to our predicate devices in that this device is a looping recorder utilizing ECG data acquisition for The FSK (Frequency Shift recording and playback. Keying), Center Frequency, and Transmission Protocol are the same as that of our predicate device. The fundamental scientific technology of the device has not been altered with this modification of our predicate devices.
Device Description Summary
The King of Hearts® Express + AF Monitor is an [21 CFR 807.92(a)(4)] triggered cardiac event recorder designed for auto diagnostic evaluation of transient symptoms. The device uses a two-wire single channel lead set for event recording. Using looping memory, the device captures ECG data; auto triggering after the patient experiences a cardiac symptom or manually after the patient pushes the RECORD button. The number of Events can be physician adjusted according to the programmed lengths of Before and After data acquisition duration for each recording. These segments of stored ECG can then be transmitted later in the form of an FM-modulated acoustic tone, when the SEND button is manually depressed. The device is configured in the same compact sized case approximately 4 inches long, 2 % inches wide and 5/8 " thick as the predicate devices. The two wire lead set is the same as is used in the predicate device [King of Hearts Express Monitor (K920984)}.
Page 8 of 175
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Image /page/1/Picture/1 description: The image shows the logo for Instromedix, a Card Guard Company. The word "Instromedix" is in a bold, sans-serif font, with a curved line above it. Below the company name is the text "A Card Guard Company" in a smaller, serif font. The logo is simple and professional, and it clearly identifies the company.
Today's Telemedicine Solutions
6779 Mesa Ridge Road, Suite 200 San Diego, CA 92121-2909
main 858.450.1750 fax 858.450.9718
Device Intended Use: [21CFR 807.92(a)(5)]
The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, chest pain.
is contra-indicated for The device use in combination with an external cardiac defibrillator or high frequency surgical equipment.
The INDICATION/INTENDED USE and CONTRA-INDICATIONS of the modified device HAS NOT CHANGED.
Similarities to Predicate Device:
This device has the same basic technological [21CFR 807.92(a)(6)] characteristics as the predicate devices. The differences are a) Addition of atrial fibrillation (AF) detection, b) Modified total ECG recording time.
The King of Hearts Express + AF Monitor is Safety and Effectiveness: considered safe and effective for use when used in accordance with the instructions provided in the Owners Manual which accompanies each device. This device is a modification of previously cleared products currently manufactured by Instromedix. The only modifications are stated above. Based on these minor changes, there is no impact on safety and effectiveness.
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ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
APR - 5 2002
Mr. Alden Kay Director, Quality Card Guard Scientific Survival Ltd Instromedix 6779 Mesa Ridge Road, Suite 200 San Diego, CA 92121-2909
Re: K020825
Trade Name: King of Hearts® Express + AF Monitor Regulation Name: Medical Magnetic Tape Recorder Regulation Number: 21 CFR 870.2800 Regulatory Class: Class II (two) Product Code: DSH Dated: March 13, 2002 Received: March 14, 2002
Dear Mr. Kay:
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. Iisting 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.
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Page 2 - Mr. Alden Kay
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,
h
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_
1102002 510(k) Number (if known):
Device Name: King of Hearts® Express + AF Monitor
Indications for Use
This device is indicated for diagnostic evaluation of patients who experience transient symptoms such as;
- Dizziness
- Palpitations
- Syncope
- Chest pain
Contra-Indications for Use
Warning:
This device is contra-indicated for use in combination with external cardiac defibrillators or high frequency surgical equipment. Disconnect the patient leads from the electrodes prior to performing external defibrillation or using electro surgical equipment.
There are no known safety hazards connected with the use and operation of a cardiac pacemaker or any electrical cardiac stimulator and the King of Hearts® Express + AF monitor.
(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) |
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020525
Page 11 of 175
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).