KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II by ALARIS MEDICAL SYSTEMS, INC.

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.

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.

AI/ML Overview

This 510(k) summary for the King of Hearts Express® II and King of Hearts Express® EZ II ambulatory event recorders does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Here's why and what information is provided:

Key Takeaways from the Provided Document:

Substantial Equivalence: The primary claim for this device is "substantial equivalence" to previously marketed predicate devices (Instromedix King of Hearts Express 3X, Prince, 1200, CarryAll; Braemar ER720; TZ Medical HeartAide Plus II; Card Guard CG-6500). This indicates that the regulatory approval was based on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than requiring extensive de novo clinical trials with specific acceptance criteria.
"Non-Significant Risk": The devices are categorized as Class II, "non-significant risk devices." This classification often influences the type and extent of data required for regulatory submission, usually leaning away from large-scale clinical trials with pre-defined acceptance criteria for novel performance.
Identical Features and Functions (to predicates): The document explicitly states: "Features and functions are identical to identified predicate devices." This is a crucial point for substantial equivalence.
No Mention of Performance Metrics or Studies: There is no discussion of sensitivity, specificity, accuracy, or any other quantitative performance metrics, nor is there any mention of a specific study designed to "prove" the device meets such metrics.

What is Missing (and why it's likely not in this type of 510(k) submission):

The sections of your request (acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) are typically found in submissions for novel devices or devices where substantial equivalence cannot be merely demonstrated by comparison to existing predicate devices. For a 510(k) focused on substantial equivalence to multiple already approved predicate devices with "identical features and functions," the FDA often relies on the established safety and effectiveness of those predicates.

Attempting to Fill the Table Based on the Provided Information (with significant caveats):

Given the lack of specific performance studies, I can only state what the submission implies about performance based on substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Implied by Substantial Equivalence)
Functional Equivalence	Device functions (ECG recording, lead types, automatic recording, pacemaker detection, data communication) must be identical or substantially equivalent to predicate devices.	The King of Hearts Express® II and EZ II are described as having "identical" features and functions to the predicate devices (Instromedix King of Hearts Express 3X, Prince, 1200, CarryAll; Braemar ER720; TZ Medical HeartAide Plus II; Card Guard CG-6500). This implies these functions meet the established performance of the predicates.
Safety	Device must pose "non-significant risk" and be as safe as predicate devices.	The devices are categorized as Class II, non-significant risk devices, and the submission states: "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."
Effectiveness (Clinical Purpose)	Device must be effective for its intended use (diagnostic evaluation of transient symptoms, ECG morphology visualization, arrhythmia detection) as predicate devices.	The submission claims "The safety and effectiveness of these devices is substantially equivalent to the predicate devices." It also lists the Indications For Use, which align with the function of similar ambulatory event recorders.
Technical Performance (e.g., Signal Quality)	(Not explicitly stated, but implied by functional equivalence) ECG signal quality and recording reliability expected to be equivalent to predicate devices.	"Multilead ECG, pacemaker pulse enhancement, rate-triggered recording, and other features...present a non-significant risk." This implies these technical aspects are performing as expected and are comparable to predicate devices. No specific quantitative metrics are provided.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. It is highly likely that no specific, independent "test set" with a defined sample size for performance evaluation was used in the manner of a clinical trial. The submission relies on the established performance of predicate devices.
Data Provenance: Not applicable, as performance data (in the sense of a test set) is not presented. The basis for comparison is the design and function of existing, legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No "ground truth" establishment by experts on a test set is mentioned or implied, as the submission does not present performance data from a novel study.

4. Adjudication method for the test set:

Not applicable. No test set requiring expert adjudication for ground truth is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done (or at least none is reported in this summary). This device is an ambulatory ECG recorder, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of an algorithm's diagnostic performance. The device records ECG data for human interpretation. Its "standalone" performance would relate to its ability to accurately record and transmit ECG signals, which is implied to be equivalent to predicates.

7. The type of ground truth used:

Not applicable. No ground truth for an analytical or clinical performance study is reported. The "truth" for this submission is based on the regulatory precedent set by the predicate devices.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that would require a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

In summary: This 510(k) submission is for a device seeking approval based on substantial equivalence to existing devices, meaning it is considered as safe and effective as those already on the market because its features and functions are "identical." Therefore, it does not contain the detailed performance metrics, study designs, or expert adjudications that would be present in a submission for a novel device requiring a de novo performance study.

Summary

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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.

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 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 (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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Page 1 of

K983626 510(k) Number (if known):

King of Hearts Express® II Device Name:

Indications For Use:

(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)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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).