KING OF HEARTS EXPRESS + AF MONITOR

K020825 · Card Guard Scientific Survival , Ltd. · DSH · Apr 5, 2002 · Cardiovascular

Device Facts

• Record ID: K020825
• Device Name: KING OF HEARTS EXPRESS + AF MONITOR
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DSH · Cardiovascular
• Decision Date: Apr 5, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, chest pain. The device is contra-indicated for use in combination with an external cardiac defibrillator or high frequency surgical equipment.

Device Story

The King of Hearts Express + AF Monitor is a triggered cardiac event recorder for evaluating transient symptoms. It uses a two-wire single-channel lead set to acquire ECG signals. The device features looping memory to capture ECG data, which triggers automatically upon symptom detection or manually when the patient presses a record button. Physicians can adjust the number of events and the duration of pre- and post-event data acquisition. Stored ECG segments are transmitted as FM-modulated acoustic tones via telephone when the user presses the send button. The device is intended for patient use to record cardiac events for later physician review. It includes an atrial fibrillation (AF) detection feature. The device is a compact, portable unit.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Compact cardiac event recorder (approx. 4" x 2.5" x 0.625"). Uses two-wire single-channel lead set. Data acquisition via looping memory. Transmission via FM-modulated acoustic tone over telephone. Includes atrial fibrillation (AF) detection algorithm. Powered by internal battery.

Indications for Use

Indicated for diagnostic evaluation of patients experiencing transient symptoms including dizziness, palpitations, syncope, and chest pain. Contraindicated for use with external cardiac defibrillators or high-frequency surgical equipment.

Regulatory Classification

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.

Predicate Devices

• King of Hearts Express Monitor (K920984)
• King of Hearts Express II Monitor (K983626)

Submission Summary (Full Text)

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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 [phone]

www.instromedix.com

"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)}.

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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 [phone]

www.instromedix.com

#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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