The MI-1000 is used to measure Wavelet Surface Residuan indices at rest and during low level electrical stimulation during the cardiac refractory period. This data is presented in a graphical format for interpretation by a trained physician. The MI-1000 is also used for the measurement of SAECG indices. The MI-1000 should be used only as an adjunct to clinical history and the results of other noninvasive and/or invasive tests.

Device Description

The device consists of an IBM compatible PC, nine skin surface ECG type electrodes, one electronics board, a patient interface module and software. Seven of the electrodes are used for sensing cardiac electrical activity. The remaining two electrodes are used to apply low level current pulses (maximum of 40 milliamps) to the patient. This technology uses noninvasive, externally applied, subthreshold (low amplitude) far-field stimulus while acquiring electrocardiogram data. The MI-1000 system is a tool used to identify heart cells that are significantly less stable than normal or conduct slower than normal and, thus, are an indication of cardiac electrical problems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Micro-Induction 1000 system:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the device's performance (e.g., sensitivity, specificity, accuracy thresholds). Instead, it describes a more general approach to demonstrating substantial equivalence for functional and safety testing.

Acceptance Criteria Category	Acceptance Criteria (as implied)	Reported Device Performance
Functional Performance	Conformance to product specifications under normal usage conditions. The device should "perform as designed" and "meet or exceed all product specifications."	"The results of the examination and testing were successful; the device performed as designed and met or exceeded all product specifications."
Safety Testing	Demonstrate a "low level of risk to the patient." Implied demonstration through clinical studies.	"low level of risk to the patient as demonstrated throughout the clinical studies."
Substantial Equivalence	Demonstrated similarity in functional design, materials, indications for use, and low level of risk compared to predicate devices (Cambridge Heart CH 2000 Cardiac Diagnostic System, Cambridge Heart Micro-V Alternans Sensor, Cambridge Heart Hi-Res ECG Electrode, Zymed Model 2010 Holter Scanner).	The device is "substantially equivalent to the Cambridge Heart CH 2000 Cardiac Diagnostic System... and the Cambridge Heart Micro-V Alternans Sensor... and Cambridge Heart Hi-Res ECG Electrode... [and] substantially equivalent to the Zymed Model 2010 Holter Scanner." This conclusion is based on "similarities in functional design, materials, indications for use and low level of risk to the patient as demonstrated throughout the clinical studies."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): "over 264 patients"
Data Provenance: "two sites in the United States and one site in Europe." (Prospective, as it's a "clinical study" where data was "collected").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. The intended use states that data is "presented in a graphical format for interpretation by a trained physician," but this doesn't specify how ground truth for the study itself was established or adjudicated.

4. Adjudication Method for the Test Set

The document does not provide information on the adjudication method used for the test set (e.g., 2+1, 3+1, none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not explicitly mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance. The study described focuses on the device's functional and safety performance and its substantial equivalence to predicate devices. It's a device that provides data for interpretation by a physician, rather than an AI assisting in the interpretation itself.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The document does not describe a standalone performance study in the context of an algorithm's diagnostic accuracy. The device "is a tool used to identify heart cells," and the data is "presented in a graphical format for interpretation by a trained physician." This implies a human-in-the-loop system where the device provides information for a physician to interpret, rather than making a standalone diagnostic determination. The study focused on the device's ability to "perform as designed" and its "low level of risk."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the clinical study. Given the device's function (measuring Wavelet Surface Residuan indices and SAECG indices to identify unstable heart cells), it's possible ground truth might have involved:

Clinical outcomes (e.g., subsequent cardiac events).
Correlation with findings from other established diagnostic tests.
Expert consensus based on known clinical history and other test results.

However, this is inference, and the document provides no specific details.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This device pre-dates common AI/machine learning paradigms that explicitly use training and test sets in this manner. The "clinical study data" described seems to serve as a general validation/testing dataset rather than a distinct "test set" from a machine learning perspective, and there's no mention of a separate "training set" for an underlying AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, the document does not provide information on how ground truth for a training set was established.

Summary

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MAY 2 9 2002

SECTION 2. SUMMARY AND CERTIFICATION

A. 510(k) Summary

Submitter:	Harbinger Medical, Inc.
Contact Person:	Harold Hoium6466 City West ParkwayEden Prairie, MN 55344Ph: 952-943-1684Fax: 952-943-1686
Date Prepared:	May 24, 2002
Trade Name:	Micro-Induction 1000 system
Classification Name and Number:	ElectrocardiographClass II, 21 CFR 870.2340
	Electrode ElectrocardiographClass II, 21 CFR 870.2360
Product Code:	DPS
	DRX
Predicate Device(s):	The Micro-Induction 1000 system is substantiallyequivalent to the Cambridge Heart CH 2000 CardiacDiagnostic System (K950018 - K983102 - K001034), andthe Cambridge Heart Micro-V Alternans Sensor (K002230)and Cambridge Heart Hi-Res ECG Electrode (K962115) allmanufactured by Cambridge Heart, Inc. HarbingerMedical also considers the MI 1000 to be substantiallyequivalent to the Zymed Model 2010 Holter Scanner(K955015), manufactured by Zymed, Inc., and othersimilar devices made by other manufacturers.
Device Description:	The device consists of an IBM compatible PC, nine skinsurface ECG type electrodes, one electronics board, apatient interface module and software. Seven of theelectrodes are used for sensing cardiac electrical activity.The remaining two electrodes are used to apply low levelcurrent pulses (maximum of 40 milliamps) to the patient.This technology uses noninvasive, externally applied,subthreshold (low amplitude) far-field stimulus whileacquiring electrocardiogram data.The MI-1000 system is a tool used to identify heart cellsthat are significantly less stable than normal or conductslower than normal and, thus, are an indication of cardiacelectrical problems.

K013615

: :

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(013615

Intended Use:

The MI-1000 is used to measure Wavelet Surface Residuan indices at rest and during low level electrical stimulation during the cardiac refractory period. This data is presented in a granhical format for interpretation by a trained physician. The MI-1000 is also used for the measurement of SAECG indices. The MI-1000 should be used only as an adjunct to clinical history and the results of other noninvasive and/or invasive tests.

Functional and Safety Testing:

Conclusion:

Functional and safety testing of the Micro-Induction 1000 system consisted of bench and human clinical testing, Examination of device function was done under conditions similar to those found in normal usage to ensure conformance to product specifications. The results of the examination and testing were successful; the device performed as designed and met or exceeded all product specifications. Human clinical study data was collected on over 264 patients at two sites in the United States and one site in Europe.

The Micro-Induction 1000 system is substantially equivalent to the Cambridge Heart CH 2000 Cardiac Diagnostic System (K950018 - K983102 - K001034) and the Cambridge Heart Micro-V Alternans Sensor (K002230) and Cambridge Heart Hi-Res ECG Electrode (K962115) all manufactured by Cambridge Heart, Inc. Harbinger Modical also considers the MI 1000 system to be substantially equivalent to the Zymed Model 2010 Holter Scanner (K955015), manufactured by Zymed, Inc. and other similar devices made by other manufacturers. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and low level of cisk to the patient as demonstrated throughout the clinical studies.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2002

Mr. Harold Hoium Harbinger Medical, Inc. 12086 Oxbow Drive Eden Prairie, MN 55347

Re: K013615

Trade Name: Micro-Induction (MI) 1000 System Regulation Name: Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulatory Class: Class II (two) Product Code: DPS Dated: February 27, 2002 Received: March 1, 2002

Dear Mr. Hoium:

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, 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 (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.

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

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Page 2 - Mr. Harold Hoium

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,

Dale Tiller

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K013612 |21

Indications for use Page

Device Name: Micro-Induction 1000 system

Indications for Use:

The MI-1000 is used to measure Wavelet Surface Residunn indices at rest and during low level clecatical stimalation during the cardiac refractory period. This data is presented in a graphical for and interpretation by a trained physician. The MI-1000 is also used for the measurement of SAECG indices. interpreading of a anned yayans an adjunct to clinical history and the results of other nouncies ive and or invasive tests.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013615

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).