(83 days)
Not Found
No
The summary describes standard ECG analysis and interpretation software without mentioning AI, ML, or related concepts.
No
The device is a review module for ECG files, used for analysis and display of diagnostic information, not for treatment.
Yes
The device "receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording" and "provides interpretive statements for which the physician renders his/her own medical opinion," indicating it processes and provides insights into physiological data to aid in diagnosis. Additionally, it complies with "AAMI EC11-1991 (R/2007)- Diagnostic Electrocardiographic Devices."
Yes
The device is described as a "Window's based program" that receives, analyzes, displays, stores, and prints ECG files. It does not mention any associated hardware components that are part of the device itself, only that it receives files generated from a "standard 12-lead ECG recording," implying the ECG recording hardware is a separate entity. The description focuses solely on the software's functions.
Based on the provided information, the CardioView32 Review Module is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The CardioView32 Review Module analyzes ECG data, which is a recording of electrical activity of the heart, not a sample taken from the body (like blood, urine, or tissue).
- The intended use is to analyze and interpret ECG data. This falls under the category of medical device software that processes physiological signals, not in vitro samples.
- The device description focuses on processing ECG files. It doesn't mention any interaction with biological samples or reagents.
Therefore, the CardioView32 Review Module is a medical device, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
LOS
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician / Hospital, Clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 . 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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 of
Predicate | Manufacturer | Use | 510K) | Date
Cleared |
|----------------------|----------------------|--------------|---------|-----------------|
| CardioView
3000 | 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.
1
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 32
Review Module) | Previously Cleared
Device
CardioView 3000 | Same | Different |
|-----------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------|-----------|
| Indications for Use | | | | | |
| 1 | Patient Population | Male/Female
Adult | Male/Female
Adult | X | |
| 2 | Environment of Use | Hospital, Clinic,
Home Use | Hospital, Clinic, Home
Use | X | |
| Fundamental Scientific Technology | | | | | |
| 3 | SCP Files | • Receipt of SCP
File from Software
• Re-
analyze/Interpret
• Store
• Display
• Print | • Acquires/Generates
SCP File from
Hardware
• Receipt from
Software
• Analyze/Interpret
• Stores
• Display
• Print | | X |
| 4 | Interpretation
Algorithm | Cardionics Algorithm | Cardionics Algorithm | X | |
| 5 | Device Components | • Computer with
Windows OS
• Software | • Computer with
Windows 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 computer
utilized | N/A | N/A | X | |
| Environmental Specifications | | | | | |
| 9 | Based upon computer
utilized | N/A | N/A | X | |
| Performance Standards | | | | | |
| 10 | AAMI EC11-1991 | Meets | Meets | X | |
| # | Area | Modified Device
(CardioView 32
Review Module) | Previously Cleared
Device
CardioView 3000 | Same | Different |
| | | AAMI EC11-1991
Requirements | AAMI EC11-1991
Requirements | | |
| | Algorithms | | | | |
| 11 | ECG Algorithm
Executable | Updated to include
Japanese Translation
MMISYS32.dll | Japanese Translation
not available | | X |
| 12 | | Update to eliminate
need for user to have
"write permission" to
C:\ in order to
analyze an ECG. | User must have
"Write" permission to
C:\ in order to analyze
an ECG | | X |
| 13 | Cardionics ECG
Algorithm DLL
(MMISYS32.dll) | Changed writing of
the temp file to work
with Vista. OS' | ECG Analysis was not
supported on Vista OS' | | X |
| 14 | | Recompiled
MMISYS32.dll to not
include a diagnostic
log file. | MMISYS32.dll
includes diagnostic log
file | | X |
| 15 | | Added Interpretation
statement numbers to
correlate with
Physician's Guide | Interpretation codes
listed in Physician's
guide not presented to
user in software | | X |
| | Software | | | | |
| 16 | Micro Processor | 32 Bit Application | 16 Bit Application | | X |
| 17 | Hosting Program (shell
around application) | C++ DLL written in
VS2005(ECG.dll) | Based on VB3
framework | | X |
| 18 | Review Window | Cardioview32 has
three different color
choices in review
screen | One color scheme | | X |
| 19 | Review Window | Lead order can be
changed in
Cardioview32 | Lead order cannot be
changed | | X |
| 20 | Interpretive Module | SCP file is read
through MMISCP.dll,
and then the results
are sent to
MMISYS32.dll | Application wrapper
(Analysis.exe) used to
read SCP file, and send
the results to
MMISYS32.dll | | X |
| 21 | Review Window | Rhythm strip can be
moved to the bottom
of the screen in 12
lead view | Rhythm strip always at
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.
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 32
Review Module) | Previously Cleared
Device
CardioView 3000 | Same | Different |
| 35 | Printed reports | Grid is printed in red | Grid is only available
in black. | | X |
| 36 | Printed reports | PDF reports can have
minor grids showing | 16 bit software does
not allow for minor
grids in PDF reports
due to quality problems
with 16 bit software | | X |
| 37 | Printed reports | This is written in
Microsoft Visual C++
using microsoft
libraries(MMIPRN32
dll) | Printed reports part of
MMIECG200.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.
(1) C
2
.
:
3
.
4
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.
5
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.
6
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
7
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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