KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II

K983626 · Alaris Medical Systems, Inc. · DXH · Feb 5, 1999 · Cardiovascular

Device Facts

• Record ID: K983626
• Device Name: KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II
• Applicant: Alaris Medical Systems, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Feb 5, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

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.

Device Story

Non-invasive, external ambulatory ECG memory monitors; patient-activated. Inputs: surface ECG signals via leads. Processing: records ECG morphology; detects heart rate changes (bradycardia/tachycardia) and pacemaker pulses. Outputs: stored ECG data transmitted via acoustic FM signal or serial port to clinic/hospital. Used by patients in daily life; operated by patient. Healthcare providers review transmitted ECG to document transient symptoms, diagnose arrhythmias, or assess pacemaker function. Benefits: timely clinical advice for cardiac symptoms; facilitates medical treatment follow-up.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Ambulatory ECG memory monitor; non-invasive. Features: single or multilead ECG recording, pacemaker pulse detection/enhancement, rate-triggered recording. Connectivity: acoustically coupled FM signal for trans-telephonic transmission and serial port for data communication. Class II device.

Indications for Use

Indicated for patients requiring ambulatory ECG monitoring to evaluate transient symptoms including dizziness, palpitations, syncope, and chest pain. Used to visualize arrhythmias, ST segment changes, SVT, heart block, re-entrant phenomena, and p-waves. Supports automatic recording for bradycardia or tachycardia and assessment of pacemaker activity.

Regulatory Classification

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.

Predicate Devices

• Instromedix King of Hearts Express 3X
• Instromedix Prince
• Instromedix 1200
• Instromedix CarryAll
• Braemar ER720
• TZ Medical HeartAide Plus II
• Card Guard CG-6500

Submission Summary (Full Text)

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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 [phone] [phone] 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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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 [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" (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 [phone] or [phone],

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.

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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)