CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office.

CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.

Patient Population: Male/Female, Adults .
Environment of Use: Hospital and Clinic .
Prescription Device by a Physician ●

Device Description

CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the CardioView 32 Review Module, an ECG interpretive software. The focus of the submission is to demonstrate substantial equivalence to a previously cleared predicate device, the CardioView 3000.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics for diagnostic accuracy (e.g., sensitivity, specificity for specific ECG abnormalities) for the device. Instead, the "Performance Standards" section indicates compliance with a general standard:

Acceptance Criteria	Reported Device Performance
AAMI EC11-1991 Requirements (Diagnostic Electrocardiographic Devices)	Meets AAMI EC11-1991 Requirements

The submission relies on demonstrating that the modified CardioView 32 Review Module is as safe and effective as the unmodified CardioView 3000 predicate device, largely by showing that the fundamental interpretation algorithm (Cardionics Algorithm) remains the same, and that other modifications are related to software functionality, display, and operating system compatibility, rather than core diagnostic performance.

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

The document does not provide any specific information regarding a test set (e.g., ECG recordings used for validation), its sample size, or the provenance of the data (e.g., country of origin, retrospective or prospective). The "Summary of Performance Testing" only states that the device "has been tested or found otherwise to comply with applicable sections of the following standards: AAMI EC11-1991 (R/2007)." This suggests compliance through technical evaluation against the standard's requirements rather than a clinical performance study using a medical dataset.

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

Since no specific test set or clinical performance study is described, there is no information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

Again, given the absence of a described test set or clinical performance study, there is no information regarding an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided document. The submission focuses on substantial equivalence based on technical specifications and adherence to a general standard, rather than a clinical comparison of human readers with and without AI assistance.

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

The document states that the CardioView 32 Review Module "provides interpretive statements for which the physician renders his/her own medical opinion." This indicates that the software is not intended for standalone diagnostic use; it produces interpretations that are reviewed by a physician. While the underlying "Cardionics Algorithm" performs the primary interpretation, the submission does not detail a standalone performance study where the algorithm's output alone was assessed against a ground truth without human review. The claim is that the algorithm itself is the same as the predicate.

7. The Type of Ground Truth Used

As there is no detailed performance study described, there is no explicit mention of the type of ground truth used. If the predicate device's algorithm was validated, it would likely have been against expert consensus or possibly outcomes data, but this submission does not provide those details for the modified device.

8. The Sample Size for the Training Set

The document does not provide any information about the training set sample size. The "Cardionics Algorithm" is a pre-existing component, and no details regarding its development or training are included in this 510(k) summary.

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

Similar to the above, the document does not provide any information on how the ground truth for the algorithm's training set was established, as the algorithm itself pre-dates this submission and is considered a "Same" component as the predicate device.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the letters QRS in a bold, stylized font. The letters are textured with a grainy or speckled pattern, giving them a slightly rough appearance. An oval shape encircles the letters, adding a sense of movement or orbit to the design. The overall impression is a simple yet distinctive logo, possibly for a company or organization with the initials QRS.

MAR 10 2009

510(k) Summary of Safety and Effectiveness

Date:12/09/08

Submitter:

Primary Care Physician Platform LLC, dba QRS Diagnostic Street Address: 14755 27th Ave N. City: Plymouth State: MN Zip Code: 55447 Telephone: 763-559-8492 Facsimile: 763-559-2961

Contact: Mary Kay Jensen Phone: 763-559-8492 Ext 958 Facsimile: 763-559-2961 e-mail: mkjensen@grsdiagnostic.com

Device Name:

Trade Name: CardioView 32 Review Module Common Name: ECG Interpretive Software Classification Name: System, ECG Analysis Classification: Listed as Class III (510(k)) Considered Unclassified Pre-amendment Panel Code: LOS Regulation Number: N/A

Identification of Legally Marketed (Unmodified) Device (Predicate Device):

Name ofPredicate	Manufacturer	Use	510K)	DateCleared
CardioView3000	MicroMedical,Inc	ECG Analysis	K974352	9/8/1998

Device Description:

Indications for Use

CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office.

CardioView32 Review Module receives, analyzes, displays, stores and prints ECG * .scp files generated from a standard 12-lead ECG recording. CardioView 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.

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K083749
p2/5

Patient Population: Male/Female, Adults ●
Environment of Use: Hospital and Clinic
. Prescription Device by a Physician

Technological Comparison to (Unmodified) Predicate Device:

The following summary table of comparisons compares the Modified CardioView 32
11 Cardination of the Reside Chevrol CardioView 3000 Device The following summary table of comparisons comparisons of any and the eview.
Review Module Device to the Previously Cleared CardioView 3000 Device.

#	Area	Modified Device(CardioView 32Review Module)	Previously ClearedDeviceCardioView 3000	Same	Different
Indications for Use
1	Patient Population	Male/FemaleAdult	Male/FemaleAdult	X
2	Environment of Use	Hospital, Clinic,Home Use	Hospital, Clinic, HomeUse	X
Fundamental Scientific Technology
3	SCP Files	• Receipt of SCPFile from Software• Re-analyze/Interpret• Store• Display• Print	• Acquires/GeneratesSCP File fromHardware• Receipt fromSoftware• Analyze/Interpret• Stores• Display• Print		X
4	InterpretationAlgorithm	Cardionics Algorithm	Cardionics Algorithm	X
5	Device Components	• Computer withWindows OS• Software	• Computer withWindows OS• Software	X
Contraindications
6	Contraindications	No contraindications	No contraindications	X
Sterility/Expiration Dating
7	N/A	N/A	N/A	X
Energy Type
8	Based upon computerutilized	N/A	N/A	X
Environmental Specifications
9	Based upon computerutilized	N/A	N/A	X
Performance Standards
10	AAMI EC11-1991	Meets	Meets	X
#	Area	Modified Device(CardioView 32Review Module)	Previously ClearedDeviceCardioView 3000	Same	Different
		AAMI EC11-1991Requirements	AAMI EC11-1991Requirements
	Algorithms
11	ECG AlgorithmExecutable	Updated to includeJapanese TranslationMMISYS32.dll	Japanese Translationnot available		X
12		Update to eliminateneed for user to have"write permission" toC:\ in order toanalyze an ECG.	User must have"Write" permission toC:\ in order to analyzean ECG		X
13	Cardionics ECGAlgorithm DLL(MMISYS32.dll)	Changed writing ofthe temp file to workwith Vista. OS'	ECG Analysis was notsupported on Vista OS'		X
14		RecompiledMMISYS32.dll to notinclude a diagnosticlog file.	MMISYS32.dllincludes diagnostic logfile		X
15		Added Interpretationstatement numbers tocorrelate withPhysician's Guide	Interpretation codeslisted in Physician'sguide not presented touser in software		X
	Software
16	Micro Processor	32 Bit Application	16 Bit Application		X
17	Hosting Program (shellaround application)	C++ DLL written inVS2005(ECG.dll)	Based on VB3framework		X
18	Review Window	Cardioview32 hasthree different colorchoices in reviewscreen	One color scheme		X
19	Review Window	Lead order can bechanged inCardioview32	Lead order cannot bechanged		X
20	Interpretive Module	SCP file is readthrough MMISCP.dll,and then the resultsare sent toMMISYS32.dll	Application wrapper(Analysis.exe) used toread SCP file, and sendthe results toMMISYS32.dll		X
21	Review Window	Rhythm strip can bemoved to the bottomof the screen in 12lead view	Rhythm strip always atthe top.		X
#	Area	Modified Device (CardioView 32 Review Module)	Previously Cleared Device CardioView 3000	Same	Different
23	Review Window	the interpretation codes are available.Review window is launched from a standalone application.	interpretation codes.Review window is launched within Office Medic		X
24	Review Window	Print preview is available	No print preview		X
25	Review Window	Interpretation/measurements can be viewed on the main review screen	Interpretation and measurements are on a new window.		X
26	Review Window	Patient details can be viewed on the main review screen	Patient details come up on a new window.		X
27	Review Window	Menus and toolbars have a different order.			X
28	Review Window	Print to file is available inside of the review window	Print to file is initiated from Shell Application		X
29	Review Window	Strips view can show 2,3, 6, 9, and 12 leads at a time	Strips view only shows 3 leads at a time.		X
31	Review Window	X axis and Y axis controlled by radio buttons on the right	X axis and Y axis are controlled by buttons below the traces.		X
31	Review Window	The icon in the upper left is a heart	The icon is a picture of a computer with an ECG trace.		X
32	ECG Trace viewing module	This is written in Microsoft Visual C++ using microsoft libraries(MMIECG32.ocx)	This is written using a 1995 compiler, Borland C.(MMIECG200.VBX)		X
33	SCP File reading and writing module	This is written in Microsoft Visual C++ using microsoft libraries(MMISCP32.ocx)	This is written using a 1995 compiler, Borland C.(MMSCP200.dll)		X
		Strings are only in English	Strings are translated into French, German,		X
#	Area	Modified Device(CardioView 32Review Module)	Previously ClearedDeviceCardioView 3000	Same	Different
35	Printed reports	Grid is printed in red	Grid is only availablein black.		X
36	Printed reports	PDF reports can haveminor grids showing	16 bit software doesnot allow for minorgrids in PDF reportsdue to quality problemswith 16 bit software		X
37	Printed reports	This is written inMicrosoft Visual C++using microsoftlibraries(MMIPRN32dll)	Printed reports part ofMMIECG200.vbx		X

Image /page/1/Picture/8 description: The image shows a black and white image of what appears to be a leaf. The leaf is dark in color and has a distinct shape. The background is white, which helps to highlight the leaf. The image is simple, but it effectively captures the details of the leaf.

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Summary of Performance Testing:

The modified CardioView 32 Review Module has been tested or found otherwise to comply with applicable sections of the following standards:

AAMI EC11-1991 (R/2007)- Diagnostic Electrocardiographic Devices .

Conclusions:

The results of the tests discussed above, indicate that the modified QRS Diagnostic CardioView 32 Review Module is as safe, as effective, and performs as well as or better than the non-modified device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2009

Primary Care Physician Platform, LLC dba QRS Diagnostic, LLC c/o Ms. Amy Ptak Operations Manager 14755 27th Avenue North Plymouth, MN 55447

Re: K083749

Trade Name: Cardioview32 Review Module Regulation Number: Unclassified Regulation Name: ECG Analysis System Product Code: LOS Dated: February 3, 2009 Received: February 13, 2009

Dear Ms. Ptak:

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.

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Page 2 - Ms. Amy Ptak

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 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), 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.

Ateh W. Stine

27 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): To be determined

Device Name: CardioVew 32 Review Module

Indications for Use:

CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a hospital or in a Physician's Office. CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.

Patient Population: Male/Female, Adults .
Environment of Use: Hospital and Clinic .
Prescription Device by a Physician ●

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thielstet B Zuckerman

(Division Sign-Off) 3/01/09 Division of Cardiovascular Devices 510(k) Number K083749

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Regulation Number and Section

N/A