The QRS-Card Cardiology Suite 4.0™ Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming exercise/recreational activities (e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.

The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other associations and medical professional, and not intended for any home use applications.

Device Description

The Cardiology Suite 4.0™ Ambulatory ECG Analysis System is an ambulatory ECG analysis system comprised of a standard computer display, a standard Personal Computer (PC) based system, and hardware used to acquire the ambulatory ECG data (specifically the Braemar DXP1000 data recorder - 510(k) K993618). The Cardiology Suite 4.0TM Ambulatory ECG Analysis System System can provide the retrospective display, storage and recording (or printing) of ambulatory ECG waveform and annotated data that is provided by the Braemar XP 1000 recorder.

The Cardiology Suite 4.0™ Ambulatory ECG Analysis System allows the assessment and review of a patient's recorded ambulatory ECG records, and presents an analysis for the clinician's review and editing. This product performs a high-speed analysis of the data, classify the data into appropriate ECG morphologies, and allow the results to be printed if desired. The Cardiology Suite 4.0™ does not perform any diagnosis of data, but only displays the ECG morphologies, and associated curves calculated form the data but only displays the LCG morphologics, and graphical form. The physician will be able such as heart rate trends and RR variability in graphical form. A PM will provide such as nearl Tate trends and ICC variability in grapped on will provide io roviow, och, as when patient-activated events occurred.

The Cardiology Suite 4.0™ Ambulatory ECG Analysis System provides storage of The Cardionogy Sunte 4.0 - Finouiing various reports. This includes waveform and patient data for atchiving and priming furtous i dpata and assessment. The waveform and parameter data that has been stored in a patient file can be retrieved and reviewed on the display or printed out on a laser printer.

AI/ML Overview

The provided text describes the "Cardiology Suite 4.0™ Ambulatory ECG Analysis System" and outlines its intended use and comparison to predicate devices, but lacks detailed information about specific acceptance criteria and a structured study proving those criteria are met. The document states:

"Tests demonstrating ambulatory ECG testing equivalence with the predicate devices listed above has been performed, and these results show similar performance with these devices."

And, "Conformance to the product development procedures and plans have been assured by the application of the system tests, design reviews, and product verification and validation testing performed prior to product release."

However, it does not provide the quantitative data, detailed methodology, or specific acceptance criteria that would typically be found in a study report. Therefore, I cannot fully complete the requested table and study description as much of the information is not present in the provided text.

Based on the available text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that tests demonstrating equivalence were performed and showed similar performance, but it does not quantify specific acceptance criteria (e.g., sensitivity, specificity, accuracy for arrhythmia detection) or provide exact performance metrics for the Cardiology Suite 4.0™ or its predicate devices. The table below represents the implied acceptance criteria based on intended use and comparison to predicate devices, but the specific numerical targets and results are absent.

Performance Metric/Feature	Acceptance Criteria (Implied)	Reported Device Performance
Arrhythmia Detection	Equivalent to predicate devices in the ability to identify and classify ECG morphologies and arrhythmias.	"Similar performance with these devices"
Ischemic Attack Evaluation	Equivalent to predicate devices in facilitating the evaluation of ischemic attacks.	"Similar performance with these devices"
PQRST Interval Reporting	Equivalent to predicate devices in the ability to report PQRST intervals.	"Similar performance with these devices"
Pacemaker Patient Evaluation	Equivalent to predicate devices for evaluating patients with pacemakers.	"Similar performance with these devices"
Waveform & Data Storage	Ability to store waveform and patient data for archiving and printing.	Device is described to provide "storage of waveform and patient data for archiving and printing various reports."
Retrospective Display & Review	Ability to retrospectively display, review, and edit ambulatory ECG data.	Device is described to provide "retrospective display... of ambulatory ECG waveform and annotated data."
High-Speed Analysis	Performs high-speed analysis of data.	Device "performs a high-speed analysis of the data."
Classification of ECG Morphologies	Classifies data into appropriate ECG morphologies.	Device "classify the data into appropriate ECG morphologies."
Heart Rate & RR Variability Trends	Displays heart rate trends and RR variability in graphical form.	Device "displays the ECG morphologies, and associated curves calculated [from] the data such as heart rate trends and RR variability in graphical form."
Data Printing Capability	Allows results to be printed.	Device allows "the results to be printed if desired."
User Interface & Workflow	Provides assessment and review for clinician's review and editing.	Device "allows the assessment and review of a patient's recorded ambulatory ECG records, and presents an analysis for the clinician's review and editing."
Safety and Effectiveness	Equivalent to legally marketed predicate devices for intended use.	FDA's letter indicates the device was found "substantially equivalent" for the stated indications for use.

Study Proving Device Meets Acceptance Criteria

The provided text only briefly mentions "Summary of Performance Testing" without detailing a specific study.

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

Not explicitly stated. The document mentions "tests demonstrating ambulatory ECG testing equivalence," but does not provide details on the sample size of the test set, number of recordings, patient demographics, or data provenance (e.g., country of origin, retrospective/prospective nature).

2. 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 explicitly stated. The document refers to analysis for "clinician's review and editing" and intended use by "medical professionals" and "trained physician or health care professional," but does not specify the number or qualifications of experts involved in establishing ground truth for any testing.

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

Not explicitly stated. The document does not describe any specific adjudication methods used for the test set.

4. 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 explicitly stated. The document discusses the device as an "Ambulatory ECG Analysis System" that aids clinicians in reviewing and editing data. It doesn't present itself as an "AI assistance" device in the modern sense or detail an MRMC study comparing human performance with and without its aid. The focus is on its function as an analysis and display system for existing ECG data.

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

Not explicitly stated. The device is described as providing "an analysis for the clinician's review and editing," indicating a human-in-the-loop design. A standalone performance evaluation is not mentioned.

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

Not explicitly stated. Given the nature of ECG analysis, ground truth for arrhythmias would typically be established by expert cardiologists reviewing the raw ECG tracings manually, possibly through expert consensus, but the document does not specify this.

7. The sample size for the training set:

Not applicable / Not explicitly stated. The document does not describe a machine learning or AI model that would require a distinct "training set." It refers to "software" for data analysis, which might involve rule-based systems or traditional signal processing algorithms rather than trainable models with specific training data.

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

Not applicable / Not explicitly stated. As there's no mention of a training set, the method for establishing its ground truth is also not mentioned.

Summary of Device and its Claimed Performance:

The Cardiology Suite 4.0™ Ambulatory ECG Analysis System is a software and hardware system designed for the retrospective display, storage, and analysis of ambulatory ECG data acquired from a Braemar DXP1000 recorder. It performs high-speed analysis, classifies ECG morphologies, and displays trends like heart rate and RR variability. The system's purpose is to assist medical professionals in the review and editing of patient ECG records, enabling evaluation of arrhythmias, ischemic attacks, and other cardiac conditions.

The manufacturer claims that "Tests demonstrating ambulatory ECG testing equivalence with the predicate devices listed above has been performed, and these results show similar performance with these devices." The FDA's 510(k) clearance indicates that the device was found "substantially equivalent" to predicate devices, implying that its performance is considered acceptable for its intended use, although the specific metrics and study details are not provided in this summary.

Summary

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OCT 2 2 2004

K042799
page 1 of 2

510(k) Summary of Safety and Effectiveness

Submitter Information:

Pulse Biomedical Inc. 935 South Trooper Rd. Norristown, PA 19403 Phone: 610-666-5510 Contact: Saleem Hasan, President FAX: 610 666-5630 Product Name:

Cardiology Suite 4.0™ Ambulatory ECG Analysis System Proprietary: Programmable Diagnostic Computer and Software. Common: Classification: Class II (see 21 CFR - 870.1425).

Predicate Devices:

The predicate device(s) are the following:

1. Northeast Monitoring Inc. Holter for Windows System (510(k) K930564).
1. Caird Technology Holter 2000 System. (510(k) K012686).
1. Advanced BioSensor ABS Holter (formerly Micro SI Ambulatory ECG Monitor) System (510(k) K881905).
1. Oxford Scientific Medilog Excel 2 System. (510(k) K002544).
1. Biomed Systems Inc. WinPV Holter System. (510(k) K8841524).

These predicate devices have the same performance specifications as the Cardiology Suite 4.0TM Ambulatory ECG Analysis System

Device Description:

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but only displays the ECG morphologies, and associated curves calculated form the data but only displays the LCG morphologics, and graphical form. The physician will be able
such as heart rate trends and RR variability in graphical form. A PM will provide such as nearl Tate trends and ICC variability in grapped on will provide io roviow, och, as when patient-activated events occurred.

Intended Uses:

. .

The Cardiology Suite 4.0™ Ambulatory ECG Analysis System is intended for general The Cardionoly Barto by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) professional, and maring personory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and of armythmias; foonemas, evaluation of a patients response after resuming chicemore/four recreational activities(e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.

The need to record, review, edit and archive these ambulatory ECG data is most The need to recorntered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other associations and medical professional, and not intended for any home use applications.

Technological Comparison to Predicate Device(s):

The Cardiology Suite 4.0™ Ambulatory ECG Analysis System uses the same type of technology (i.e. personal computers and Microsoft Windows-based data analysis software) that is found in the predicate devices listed above.

Summary of Performance Testing:

Tests demonstrating ambulatory ECG testing equivalence with the predicate devices listed I vote has been performed, and these results show similar performance with these devices.

Conformance to the product development procedures and plans have been assured by the application of the system tests, design reviews, and product verification and validation testing performed prior to product release.

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Public Health Service

Image /page/2/Picture/2 description: The image is a seal or logo. It features a circular design with text around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

Pulse Biomedical, Inc. c/o Mr Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K042799

Trade Name: QRS-Card Cardiology Suite 4.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DQK Dated: October 06, 2004 Received: October 08, 2004

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications felerenced above and nave decembers and and and and and one incessare of interstate for use stated in the encrosule) to regally manacted proad to fice Americal Device American For to American Drug commerce prior to May 28, 1970, the enastment assist of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the reliesting (RMA) devices that have been recatismed in accee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appen the general controls provisions of the Act. The You may, merciole, market the devices, courses, courtements for annual registration, listing of general controls provisions of the Act mortals comments.
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 II your device is classified (500 above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional bontroller in the 21, Parts 800 to 898. In addition, FDA may be found in the Ouc of I cases oncerning your device in the Federal Register.

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Page 2 – Mr Robert Mosenkis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substanter equires with other requirements of the Act
that FDA has made a determination that your device and other requirements that FDA has made a determination that your ac-res by other Federal agencies. You must
or any Federal statutes and regulations administered by registration and listing or any Federal statutes and regulations and limited to: registration and listing (2)
comply with all the Act's requirements, including, but not limited to: registerents as se comply with all the Act s requirements, including, barufacturing pracice requirements as set
CFR Part 807); labeling (21 CFR Part 81) ; good manufacturing practice the electr CFR Part 807); labeling (21 CFR Patl 601); good manatanaga; and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 1 CFF) 1000-1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation confor provisions (Sections 95 12 42 420))
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin harketing your article equivalence of your device to a legally premarket notification. The PDA Inding of substantial equivalians 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), please
rs the latest of the may on to tall (16 (11 (11 (11 ) and see mate the regu If you desire specific advice for your de need on one note the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please note the regulation contact the Orice of Compliance at (2017) of CFR Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Parts the obtained from the " Misbranding by release to premarket housiness ander the Act may be obtained from the Other general information on your responsional 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,

B.Brimsmotor for

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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(042799

Indication for Use

510(k) Number (if known):_

Device: Name: QRS-Card Cardiology Suite 4.0

Indication for Use:

The QRS-Card Cardiology Suite 4.0™ Ambulatory ECG Analysis System is intended for essess The QRS-Card Cardiology Sulte 4.6 - 1 milionfessionals whenever it is required to assess
general hospital or clinical use by medical professionals whence whencision or health a patient's ambulatory ECG data. This product allows a trained physician or health care
a patient's ambulatory ECG data. This product allows alostracerdiograph (FGCG) a patient's amounatory LCC data. This product as continuous electrocardiograph (ECG) protessional, alter having periormed a long term to download and analyze the data recording on a digital frash memory fronter reports. This will enable the evaluation
from the recorder, review it and produce printed reports. This will end If in the recorder, fevior it and proporting of PQRST intervals, clinical and of arthyllinias, ischentle anables, reportable of a patients response affer epidemological research staties, ties (e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.

The need to record, review, edit and archive these ambulatory ECG data is most I he need to record, review, can and also areas of the hospital during cardiac patient commonly encountered in the Cardiotogy areast of a physician or other assessment. This device is a wallable for sale sincended for any home use applications.

Prescription Use: (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE A IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Anima

in Sian-O on of Cardlov 510(k) Number

Page

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).