ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases:

Patients with suspected cardiac abnormalities
Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired.

Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in both ECG waveform and, in the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as Root Mean Square (RMS) values, are compared to the resting values.

ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.

The HyperQ™ Software is intended to be used as an aid to stress ECG test by means of analysis of high frequency components present within the central portion of the QRS complex. The significance of the HF-QRS changes must be determined by a physician.

Device Description

The HyperQ™ System is a compact monitor for measuring, processing, storing, and displaying information derived from the following physiological measurements:

Electrocardiogram (ECG). A twelve lead ECG is acquired and a waveform can be displayed real-time on the LCD screen, recorded or printed. The design of the ECG function is derived directly from the predicate device, the PC ECG 1200 device.
Detection, analyzing and recording of the high frequency components of the QRS complex of standard ECG signals.

AI/ML Overview

The provided text is a 510(k) summary for the HyperQ™ System, which is a physiological patient monitor primarily for ECG and stress testing, including analysis of high-frequency components of the QRS complex (HF-QRS). The document does not contain a dedicated section detailing specific acceptance criteria and a study proving the device meets them with quantitative performance metrics.

However, based on the information provided, we can infer some aspects related to its performance claim, which is primarily substantial equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) nor does it present a table of reported device performance against such criteria. The primary performance claim is related to substantial equivalence to a predicate device and compliance with various voluntary and federal standards.

The document states:

"The HyperQ™ System is substantially equivalent to the PC ECG 1200 device (NORAV MEDICAL LTD.) cleared under K000404 in terms of intended use, technological characteristics, performance and user interface."
"The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing." (No specific accuracy values are provided).
Compliance with various standards: U.S. Federal Performance Standard set forth in 21 CFR 898 for electrode lead wires and Patient Cables; IEC-601-1:1988 and amendments, IEC 60601-1-2:2001, IEC 60601-2-27:1994, IEC60601-2-25:1999 and amendment, IEC 60601-1-4:1996, EC53:1995, EC38:1998 and EC11:1991.

Since no specific performance metrics like sensitivity, specificity, or accuracy are provided for the HyperQ™ System itself, a performance table cannot be constructed with quantitative values for an "AI" component. The document focuses on the functional equivalence and safety aspects relative to the predicate device and established standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document mentions: "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing."

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

For the HyperQ™ software module, it states: "The HyperQ™ System includes a new off-line software module that does not raise new issues of safety or effectiveness based on previous pre-clinical and clinical studies and software validation." This implies some form of testing or validation was performed, but details about the test set are missing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

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:

Not mentioned or implied. The document states the HyperQ™ software is "intended to be used as an aid to stress ECG test" and that "The significance of the HF-QRS changes must be determined by a physician." This suggests a human-in-the-loop scenario, but no comparative effectiveness study with or without the AI aid is described, nor is an effect size reported.

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

The document mentions that "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing." This implies a standalone evaluation of the algorithm's accuracy, but no specific results are provided. The broader HyperQ™ System, including the HF-QRS analysis, is framed as an "aid" to a physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the ST segment algorithm, it states it was "tested for accuracy of the ST segment data." This implies the existence of a reference standard (ground truth) for ST segment changes, likely established by expert interpretation or a highly reliable measurement, but the specific method (e.g., expert consensus with explicit criteria) is not detailed.

8. The sample size for the training set:

Not specified.

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

Not specified.

Summary

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Image /page/0/Picture/0 description: The image shows the text "Ko42981" in a bold, sans-serif font. Below this text, there is a smaller line of text that reads "C / 11". The text appears to be part of a label or identifier, possibly from a document or inventory system.

MAR 1 0 2005 510(K) SUMMARY

HYPERQTM SYSTEM

510(k) Number K

Applicant's Name:

Biological Signal Processing Ltd. 2a Habarzel Street Tel-Aviv 69710, Israel Tel.: 972-3-647 4840 Fax: 972-3-647 1498 amir(@bsp.co.il , irit(@bsp.co.il

Contact Person:

Arava HaCohen, RAC A. Stein - Regulatory Affairs Consulting 20 Hata'as St. Kfar Saba 44425 Israel Tel. + 972-9-7670002 Fax. +972-9-7668534 e-mail: ach asra@netvision.net.il

Date Prepared:

October 2004

Trade Name:

HyperQ™ System

Classification Name:

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Establishment Registration No.:

Establishment registration form (Form FDA 2891) has been submitted but no registration number has been assigned yet.

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Classification:

FDA has classified a Monitor, Physiological, Patient (Without Arrhythmia I DA has chassified a neenters s a class II device (product code MWI) and it is reviewed by the Cardiovascular Panel.

Predicate Device:

The HyperQ™ System is substantially equivalent to the PC ECG 1200 device (NORAV MEDICAL LTD.) cleared under K000404 in terms of intended use, (1010) Fire REDIOTE technological characteristics, performance and user interface.

The predicate device is a Class II medical device.

Performance Standards:

The HyperQTM System complies with:

U.S. Federal Performance Standard set forth in 21 CFR 898 for electrode lead wires and Patient Cables.

In addition, the device complies with the voluntary recognized standards: IEC-601-1:1988 and amendments, IEC 60601-1-2:2001, IEC 60601-2-27:1994, IEC60601-2-25:1999 and amendment, IEC 60601-1-4:1996, EC53:1995, EC38:1998 and EC11:1991.

Intended Use / Indication for Use:

ECG

ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases:

Patients with suspected cardiac abnormalities o
Populations of patients at an age or period in which a routine baseline . evaluation of ECG characteristics is desired.

Stress Testing

Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present.

{2}------------------------------------------------

V=4.202

P. 5/4

during patient exercise. Patients exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are decemined by while the LCG is momtored consignals as well as the HF-QRS signals are predenticu protocols. The LCC exginal lecovery phase portions of the exercise recorded for the resulting, enereiss, are compared to the resting protocol. The Changes in both. Desirest, changes in the high frequency of the ECO records. In the Trype Q - Sales - Sales (RMS) values, are compared to the resting values.

Most of the commercial stress test systems control the bicycle or treadmill friost of the conning to the requirements of the chosen protocol, although this is not essential.

The significance of the ST segment changes must be determined by a physician.

HyperOTM

The HyperQ™ Software is intended to be used as an aid to stress ECG test by means of analysis of high frequency components present within the central portion of the QRS complex.

The significance of the HF-QRS changes must be determined by a physician.

Device Description:

The HyperO™ System is a compact monitor for measuring, processing, storing, and displaying information derived from the following physiological measurements:

Electrocardiogram (ECG). A twelve lead ECG is acquired and a waveform . can be displayed real-time on the LCD screen, recorded or printed. The design of the ECG function is derived directly from the predicate device, the PC ECG 1200 device.
Detection, analyzing and recording of the high frequency components of the � QRS complex of standard ECG signals.

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Substantial Equivalence:

There are no unique applications, indications, material or specifications Phore are "ife" and "in "and" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

the HyperQ™ System has the same intended use as its predicate device, ্ত and,
-- 1 ..
the HyperQ™ System has the same technological characteristics, (i.e., o same materials, design, energy source, diagnosis algorithm and principle of operation as the predicate device, and;
The HyperQ™ System includes a new off-line software module that o does not raise new issues of safety or effectiveness based on previous pre-clinical and clinical studies and software validation.

Therefore, we believe that the HyperQ™ System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or abstract figures, possibly representing people or services.

MAR I U 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BSP Ltd. c/o Arava HaCohen, RAC A. Stein Regulatory Consulting 20 Hata'as St. Kfar Saba 44425 ISRAEL

Re: K042981 Trade Name: HyperQ System Regulation Number: 21 CFR 870.2300 Regulation Number: 21 CFR 870.2500
Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MWI Dated: October 24, 2004 Received: October 29, 2004

Dear Mr. HaCohen:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainted in the may better the indications
referenced above and have determined the device is substantial in interstate referenced above and have determined the arrest of the Madical Devices marketed in interstate for use stated in the enclosure) to regally manced promotions of the Federal Food Drug commerce prior to May 28, 1970, the charger and other conveyel and the Federal Food, Drug,
devices that have been reclassified in accordance with the provision application (P devices that have been reclassified in accordance with the previous approval applications of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the generation, listing You may, merelore, market the devreet, belyer to the general controls provisions of the Feet mortal sequilibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it c If your device is classified (sec above) mo existing major regulations affecting your devices. EDA may may be subject to such additional controls. Existing thing of the 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 septem be found in the Code of Pederal Regarders
publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 -- Arava HaCohen, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated of a but course with other requirements of the Act
that FDA has made a determination that your device complies with of manages. You must that FDA has made a determination administered by other Federal agencies. You must a or any Federal statutes and regulations daminities or registration and listing (21 l
comply with all the Act's requirements, including, but not limited to requirements as set comply with all the Act s requirements, mercessed in the practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as s CFR Part 807); labeling (21 CFR Part 800); good and frapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1950 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); vary Section > product radiation control provisions (Dections of Section in your Section 10(k)
This letter will allow you to begin marketing your device of your davice to a legal This letter will anow you to begin maketing your averal equivalence of your device to a legally premarket notification. The PDA inding of subscribed on 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), please
rs the results of the counter and 100 and 11 and manages the roculation ent If you desire specific advice for your ac not on one of the regulation entitled, and the regulation Contact the Office of Complanes as (21) = 1) = 1 = (21 Part 807.97). You may obtain " Misoranding by reference to premanteries.its in the Act from the Division of Small other general Information on your responsion in toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the bitcomment btral Manufacturers, International and Octess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dana R. Wehner

Image /page/5/Picture/5 description: The image contains a handwritten symbol that resembles a cursive letter 'G' or a simplified drawing of a crescent moon with a small loop at the bottom. The symbol is drawn with a thick line, and it appears to be isolated against a white background. The image is simple and focuses solely on the single, stylized character.

( A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K042981 HyperQTM System Device Name: Indications for Use:

ECG

ECG is intended to disclose either normal condition or patterns of arthythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases:

Patients with suspected cardiac abnormalities �
I attents with basebased and . characteristics is desired.

Stress Testing

Stress Pesting Angina pectors (chest pain) is a chilical syndrome results necessariogram may
indicative of reduced blood supply to the cardiac muscle. The economic of indicative of Treduced "Diood" supply" to "the "carateristic changes are present. "
establish the diagnosis of ischemic heart disease if characteristic changes are present.

Stress testing is the most widely used method to decide whether this chest pain is related to Stress testing is the most when ascree arery disease. In stress testing, the contractile myocardial ischemia, and thus to colonal y atent execuse. Patient exercise. Patients exercise. Patients by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise by bicycle, treadmin, by predefined protocols. The ECG signals as well as the ORS signals are recorded for the resting, exercise, and recovery phase portions of the exercise signals are recorded for the resting, exercise, and records') po the resting ECG records. Incomes colousted protocol. The changes in both LCO warolohio are componey of the mid QRS complex, calculated the HyperQ -- stress test, changes in re compared to the resting values.

as too the commercial stress test systems control the bicycle or readmill automatically Most of the requirements of the chosen protocol, although this is not essential.

ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in ST segment monitoring is michael as an are in the ST segment algorithm has been patients with Known of suspected coronary artery and adatabase is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.

HyperQ™M

The HyperQTM Software is intended to be used as an aid to stress ECG test by means of The HyperQ™ Software is michied to oo asser as an in in the central portion of the QRS complex.

The significance of the HF-QRS changes must be determined by a physician.

Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimmar

n Sian-I vision of Cardlov 10(k) Number k

Page 1 of 1

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).