CARDIOVIEW32 REVIEW MODULE

K083749 · Qrs Diagnostic, LLC · LOS · Mar 10, 2009 · CV

Device Facts

• Record ID: K083749
• Device Name: CARDIOVIEW32 REVIEW MODULE
• Applicant: Qrs Diagnostic, LLC
• Product Code: LOS · CV
• Decision Date: Mar 10, 2009
• Decision: SESE
• Submission Type: Special
• Attributes: Software as a Medical Device

Intended 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.

Device Story

CardioView32 Review Module is a Windows-based software application for hospitals and clinics. It receives, analyzes, displays, stores, and prints standard 12-lead ECG data provided as *.scp files from a host application. The device utilizes the Cardionics ECG algorithm to generate interpretive statements. Physicians review these outputs to render medical opinions. The software facilitates clinical decision-making by providing automated ECG analysis and visualization tools, including adjustable lead ordering, rhythm strip positioning, and multi-lead viewing (2, 3, 6, 9, or 12 leads). It supports PDF report generation with grid overlays. The device is intended for use by healthcare professionals.

Clinical Evidence

Bench testing only. The device was tested for compliance with AAMI EC11-1991 (R/2007) standards for diagnostic electrocardiographic devices. No clinical data was required or provided.

Technological Characteristics

Windows-based software application; 32-bit architecture; C++ (VS2005) framework; utilizes Cardionics ECG algorithm (MMISYS32.dll); supports SCP file format; compliant with AAMI EC11-1991. Connectivity via host application/database integration.

Indications for Use

Indicated for adult male and female patients in hospital and clinic settings. Prescription use only.

Predicate Devices

• CardioView 3000 (K974352)

Submission Summary (Full Text)

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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: [phone] Facsimile: 763-559-2961

Contact: Mary Kay Jensen Phone: [phone] Ext 958 Facsimile: 763-559-2961 e-mail: [e-mail]

#### 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 of<br>Predicate | Manufacturer | Use | 510K) | Date<br>Cleared |
|----------------------|----------------------|--------------|---------|-----------------|
| CardioView<br>3000 | MicroMedical,<br>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
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- 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<br>(CardioView 32<br>Review Module) | Previously Cleared<br>Device<br>CardioView 3000 | Same | Different |
|-----------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------|-----------|
| Indications for Use | | | | | |
| 1 | Patient Population | Male/Female<br>Adult | Male/Female<br>Adult | X | |
| 2 | Environment of Use | Hospital, Clinic,<br>Home Use | Hospital, Clinic, Home<br>Use | X | |
| Fundamental Scientific Technology | | | | | |
| 3 | SCP Files | • Receipt of SCP<br>File from Software<br>• Re-<br>analyze/Interpret<br>• Store<br>• Display<br>• Print | • Acquires/Generates<br>SCP File from<br>Hardware<br>• Receipt from<br>Software<br>• Analyze/Interpret<br>• Stores<br>• Display<br>• Print | | X |
| 4 | Interpretation<br>Algorithm | Cardionics Algorithm | Cardionics Algorithm | X | |
| 5 | Device Components | • Computer with<br>Windows OS<br>• Software | • Computer with<br>Windows OS<br>• 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 computer<br>utilized | N/A | N/A | X | |
| Environmental Specifications | | | | | |
| 9 | Based upon computer<br>utilized | N/A | N/A | X | |
| Performance Standards | | | | | |
| 10 | AAMI EC11-1991 | Meets | Meets | X | |
| # | Area | Modified Device<br>(CardioView 32<br>Review Module) | Previously Cleared<br>Device<br>CardioView 3000 | Same | Different |
| | | AAMI EC11-1991<br>Requirements | AAMI EC11-1991<br>Requirements | | |
| | Algorithms | | | | |
| 11 | ECG Algorithm<br>Executable | Updated to include<br>Japanese Translation<br>MMISYS32.dll | Japanese Translation<br>not available | | X |
| 12 | | Update to eliminate<br>need for user to have<br>"write permission" to<br>C:\ in order to<br>analyze an ECG. | User must have<br>"Write" permission to<br>C:\ in order to analyze<br>an ECG | | X |
| 13 | Cardionics ECG<br>Algorithm DLL<br>(MMISYS32.dll) | Changed writing of<br>the temp file to work<br>with Vista. OS' | ECG Analysis was not<br>supported on Vista OS' | | X |
| 14 | | Recompiled<br>MMISYS32.dll to not<br>include a diagnostic<br>log file. | MMISYS32.dll<br>includes diagnostic log<br>file | | X |
| 15 | | Added Interpretation<br>statement numbers to<br>correlate with<br>Physician's Guide | Interpretation codes<br>listed in Physician's<br>guide not presented to<br>user in software | | X |
| | Software | | | | |
| 16 | Micro Processor | 32 Bit Application | 16 Bit Application | | X |
| 17 | Hosting Program (shell<br>around application) | C++ DLL written in<br>VS2005(ECG.dll) | Based on VB3<br>framework | | X |
| 18 | Review Window | Cardioview32 has<br>three different color<br>choices in review<br>screen | One color scheme | | X |
| 19 | Review Window | Lead order can be<br>changed in<br>Cardioview32 | Lead order cannot be<br>changed | | X |
| 20 | Interpretive Module | SCP file is read<br>through MMISCP.dll,<br>and then the results<br>are sent to<br>MMISYS32.dll | Application wrapper<br>(Analysis.exe) used to<br>read SCP file, and send<br>the results to<br>MMISYS32.dll | | X |
| 21 | Review Window | Rhythm strip can be<br>moved to the bottom<br>of the screen in 12<br>lead view | Rhythm strip always at<br>the top. | | X |
| # | Area | Modified Device (CardioView 32 Review Module) | Previously Cleared Device CardioView 3000 | Same | Different |
| 23 | Review Window | the interpretation codes are available.<br>Review window is launched from a standalone application. | interpretation codes.<br>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<br>(CardioView 32<br>Review Module) | Previously Cleared<br>Device<br>CardioView 3000 | Same | Different |
| 35 | Printed reports | Grid is printed in red | Grid is only available<br>in black. | | X |
| 36 | Printed reports | PDF reports can have<br>minor grids showing | 16 bit software does<br>not allow for minor<br>grids in PDF reports<br>due to quality problems<br>with 16 bit software | | X |
| 37 | Printed reports | This is written in<br>Microsoft Visual C++<br>using microsoft<br>libraries(MMIPRN32<br>dll) | Printed reports part of<br>MMIECG200.vbx | | X |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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