(99 days)
Mortara Instrument, Inc.
No
The document mentions an "algorithmic comparison" and a specific algorithm ("VERITAS SERIAL COMPARISON algorithm"), but it does not use terms like AI, ML, or DNN, nor does it describe characteristics typically associated with AI/ML, such as training or test sets. The algorithm appears to be rule-based or deterministic rather than learned.
No
CardioConfirm is a software component that allows clinicians to display, edit, and finalize diagnostic cardiology ECG, Stress, and Holter reports. It aids in the interpretation and management of medical data but does not directly treat or diagnose conditions.
No
CardioConfirm is a software component that helps clinicians finalize cardiology reports by displaying, measuring, and comparing previously acquired ECGs. While it supports algorithmic comparisons and allows editing of automatic comparison statements and interpretations, its primary purpose is "to aid the clinician's interpretation" and "finalize cardiology reports," rather than to make an initial diagnosis itself. It relies on previously acquired diagnostic cardiology tests from other devices.
Yes
The device description explicitly states that CardioConfirm is a "software component" that is embedded or launched as an executable application. It processes data from other devices (Mortara or other vendors) but does not include any hardware components itself. The performance studies section also focuses solely on software verification and validation.
Based on the provided information, CardioConfirm is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CardioConfirm's Function: CardioConfirm's intended use and device description clearly state that it is a software component used by clinicians to display, measure, compare, edit, and finalize reports based on previously acquired ECG, Stress, and Holter data. This data is generated by medical equipment (ECG machines, stress test systems, Holter monitors) that acquire physiological signals from the patient's body.
- No Specimen Examination: CardioConfirm does not involve the collection, preparation, or examination of any specimens taken from the human body. It works with data generated by devices that interact with the body.
In summary, CardioConfirm is a software tool for managing and interpreting data from diagnostic cardiology equipment, not a device that performs tests on biological specimens.
N/A
Intended Use / Indications for Use
CardioConfirm is intended to be used by qualified clinicians to finalize cardiology reports for adult and pediatric patients. To aid the clinician's interpretation of resting ECGs, CardioConfirm supports the display and onscreen measurement of ECG waveforms. CardioConfirm also supports the algorithmic comparison of serial adult ECGs and allows the user to edit the automatic comparison statements.
CardioConfirm is intended to be controlled by a host application that manages user authentication, user permissions, and secure persistent storage of the tests.
Product codes
DPS
Device Description
CardioConfirm is a software component that is embedded into a host application (e.g. EMR) as a Dynamic Link Library (DLL) or launched as an executable application. CardioConfirm allows the user to display, edit and finalize diagnostic cardiology ECG, Stress and Holter reports. A Clinician can open a diaqnostic cardiology test from a workstation application and pass it to CardioConfirm as a DICOM object for viewing or editing. CardioConfirm is able to open and edit diagnostic cardiology ECG, Stress and Holter reports from Mortara Instrument, Inc. devices and offers an optional version which can edit diagnostic cardiology ECG, Stress and Holter reports from multiple diagnostic cardiology equipment vendors.
CardioConfirm allows the clinician the ability to view, measure, and compare previously acquired resting ECGs as well as perform visual and textual serial comparison of acquired ECGs. With visual serial comparison, the clinician can view current and previous ECG's simultaneously superimposed on the screen. Textual serial comparison allows the clinician to enter or edit text that describes the significant differences between the ECG's. For adult ECG's the initial text can be generated by the VERITAS SERIAL COMPARISON algorithm. The algorithm generates comparative statements automatically on the basis of the VERITAS INTERPRETATION statements originally made by the Mortara acquiring devices, measurements and the ECG waveforms. The clinician can edit the patient demographics, previous measurements and interpretations and the serial comparison statements, and then sign final ECG reports.
The clinician can also view and edit stress and Holter reports that includes editing patient demographics, summary statistics and physician conclusions. The clinician can electronically sign both stress and Holter final reports in CardioConfirm and print final reports or generate PDF copies to store in the host application. If a physician wants to amend a previously finalized report with additional information, CardioConfirm has an option to perform amendments to final reports and store the updated test in the host application.
CardioConfirm is available in two versions. The standard version is intended to be used with tests generated by Mortara equipment. The professional version is intended to be used with tests generated by any equipment that produces DICOM 12-lead ECG Waveform and Encapsulated PDF objects.
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
Adult and pediatric patients.
Intended User / Care Setting
Qualified clinicians. Control by a host application that manages user authentication, user permissions, and secure persistent storage of the tests.
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
Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices" and "Off-the-Shelf Software Use in Medical Devices." Software code reviews and unit testing were conducted as part of our overall design control process for software development and subsequent verification and validation.
The subject of this premarket notification did not require clinical data to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Public Health Service
September 3, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mortara Instrument, Inc. Margaret Mucha Director of Global Regulatory Affairs 7865 North 86th Street Milwaukee. Wisconsin 53224
Re: K161465
Trade/Device Name: CardioConfirm Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: August 1, 2016 Received: August 2, 2016
Dear Margaret Mucha:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K161465
Device Name CardioConfirm
Indications for Use (Describe)
CardioConfirm is intended to be used by qualified clinicians to finalize cardiology reports for adult and pediatric patients. To aid the clinician's interpretation of resting ECGs, CardioConfirm supports the display and onscreen measurement of ECG waveforms. CardioConfirm also supports the algorithmic comparison of serial adult ECGs and allows the user to edit the automatic comparison statements.
Cardio Confirm is intended to be controlled by a host application that manages user authentication, user permissions, and secure persistent storage of the tests.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5
510(k) Summary Statement
1. Submitter
Primary Contact Mortara Instrument, Inc. 7865 North 86th Street Margaret Mucha Milwaukee, WI 53224 Director of Global Requlatory Affairs Meg.mucha@mortara.com Telephone 414-354-1600 Secondary Contact Fax 414-354-4760 Sarah Weber Senior Regulatory Affairs Manager sarah.weber@mortara.com
2. Product Names
CardioConfirm Device Trade Name
Common/ Usual Name
Classification
Electrocardiograph
870.2340 DPS Electrocardiograph 870.1425 DQK Computer, diagnostic, programmable Cardiovascular
Note: There are no previous submissions for this device
3. Predicate Devices to which this is Substantially Equivalent
| E-Scribe (primary) | K930558 |
|---|---|
| Pyramis ECG Management System | K032038 |
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Image /page/4/Picture/0 description: The image shows a logo with a heart shape at the top. Below the logo, the text "Traditional 510(k) Notification" is displayed. The number "K161465" is printed below the notification text. The logo and text are centered on a white background.
These predicate devices have not been subject to a design-related recall
4. Device Description
CardioConfirm is a software component that is embedded into a host application (e.g. EMR) as a Dynamic Link Library (DLL) or launched as an executable application. CardioConfirm allows the user to display, edit and finalize diagnostic cardiology ECG, Stress and Holter reports. A Clinician can open a diaqnostic cardiology test from a workstation application and pass it to CardioConfirm as a DICOM object for viewing or editing. CardioConfirm is able to open and edit diagnostic cardiology ECG, Stress and Holter reports from Mortara Instrument, Inc. devices and offers an optional version which can edit diagnostic cardiology ECG, Stress and Holter reports from multiple diagnostic cardiology equipment vendors.
CardioConfirm allows the clinician the ability to view, measure, and compare previously acquired resting ECGs as well as perform visual and textual serial comparison of acquired ECGs. With visual serial comparison, the clinician can view current and previous ECG's simultaneously superimposed on the screen. Textual serial comparison allows the clinician to enter or edit text that describes the significant differences between the ECG's. For adult ECG's the initial text can be generated by the VERITAS SERIAL COMPARISON algorithm. The algorithm generates comparative statements automatically on the basis of the VERITAS INTERPRETATION statements originally made by the Mortara acquiring devices, measurements and the ECG waveforms. The clinician can edit the patient demographics, previous measurements and interpretations and the serial comparison statements, and then sign final ECG reports.
The clinician can also view and edit stress and Holter reports that includes editing patient demographics, summary statistics and physician conclusions. The clinician can electronically sign both stress and Holter final reports in CardioConfirm and print final reports or generate PDF copies to store in the host application. If a physician wants to amend a previously finalized report with additional information, CardioConfirm has an option to perform amendments to final reports and store the updated test in the host application.
CardioConfirm is available in two versions. The standard version is intended to be used with tests generated by Mortara equipment. The professional version is intended to be used with tests generated by any
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Image /page/5/Picture/0 description: The image shows a logo above the text "Traditional 510(k) Notification K161465". The logo is a blue shape that resembles a heart. The text is in a simple, sans-serif font and is centered below the logo. The text "K161465" is on the line below the notification.
equipment that produces DICOM 12-lead ECG Waveform and Encapsulated PDF objects.
5. Intended Use
CardioConfirm is intended to be used by qualified clinicians to finalize cardiology reports for adult and pediatric patients. To aid the clinician's interpretation of resting ECGs, CardioConfirm supports the display and onscreen measurement of ECG waveforms. CardioConfirm also supports the algorithmic comparison of serial adult ECGs and allows the user to edit the automatic comparison statements.
CardioConfirm is intended to be controlled by a host application that manages user authentication, user permissions, and secure persistent storage of the tests.
6. Technological characteristics
CardioConfirm employs the same functional scientific technology as its predicate device E-Scribe (K930558) and Pyramis ECG Management System (K032038). At a high level, all three devices employ a Windows based tool to transfer electrocardiographic data from resting ECGs, stress, and Holter exams to further process and analyze the data, prepare final reports, and archive the data and reports.
CardioConfirm was designed and manufactured by Mortara Instrument according to 21 CFR Part 820. CardioConfirm is substantially equivalent to E-Scribe (Predicate K930558) and Pyramis ECG Management System (Predicate K032038) with the following technological differences:
- CardioConfirm is imbedded as a DLL in a host application such as an ● EMR or EHR
- CardioConfirm can be made available as a Windows executable file . that can be controlled by a host application
- CardioConfirm can print reports and waveforms ●
- CardioConfirm can accept demographic updates outside of ● CardioConfirm
- For Resting ECG Reports: .
- o CardioConfirm reads DICOM 12-Lead ECG waveform objects
- o CardioConfirm allows the user to edit previously-signed interpretations
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Image /page/6/Picture/0 description: The image shows a logo with a white heart shape inside a blue square. Below the logo, the text "Traditional 510(k) Notification" is displayed, followed by the code "K161465" on the next line. The text and code appear to be related to a regulatory notification process, possibly in the medical field.
- CardioConfirm provides an onscreen magnifying loupe for Resting o ECG waveforms
- o CardioConfirm allows the user to edit the statement prediction in reports
- For Stress and Holter Reports: .
- o CardioConfirm will read DICOM Encapsulated PDF objects
- o CardioConfirm will write DICOM Encapsulated PDF objects
- o CardioConfirm will allow the user to use conclusion templates
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Image /page/7/Picture/0 description: The image shows a logo with a white heart shape inside a blue square. Below the logo, the text "Traditional 510(k) Notification" is displayed, followed by the code "K161465" on the next line. The text is in a simple, sans-serif font and is centered below the logo.
| Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System | Change
explanation | |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------|
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| Intended Use | CardioConfirm is intended to
be used by qualified
clinicians to finalize
cardiology reports for adult
and pediatric patients. To
aid the clinician's
interpretation of resting
ECGs, CardioConfirm
supports the display and
onscreen measurement of
ECG waveforms.
CardioConfirm also supports
the algorithmic comparison
of serial adult ECGs and
allows the user to edit the
automatic comparison
statements.
CardioConfirm is intended to
be controlled by a host
application that manages
user authentication, user
permissions, and secure | This system is designed to
be used as a storage
system for ECG data in
hospitals and large
medical clinics. The E-
Scribe allows the user to
store, edit and retrieve
patient ECG information | The Pyramis ECG
Management System is an
ECG data management
and information system.
Its primary function is to
store records of biologic
origin such as ECG,
Stress and Holter records
received from those
respective recording
devices in a database and
subsequently allow the
user to select, view, edit,
print/fax/email and export
(distribute) those records | Equivalent | |
| | persistent storage of the | | (distribute) those records | | |
| Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System | Change
explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application
tests. | K930558 | K032038 | | |
| Operating
System | Windows 7, Windows 8.1, etc. | Windows 2008 R2, Windows 7 | Windows 2008, Windows 7 | Equivalent | |
| Form: DLL for
embedding in a
host application | Yes | Not applicable | Not applicable | New feature | |
| Form: executable
controlled by a
host application | Yes | Not applicable | Not applicable | New feature | |
| IO: option to limit
to Mortara device
data only | Yes | Yes | Yes | Equivalent | |
| IO: offline PDF
generation of
reports | Yes | Yes | Yes | Equivalent | |
| IO: report printing | Yes | Yes | Yes | Equivalent | |
| Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System | Change
explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| User
Permissions:
view only | Yes | Yes | Yes | Equivalent | |
| | User
Permissions:
view and save | Yes | Yes | Yes | Equivalent |
| | | User
Permissions:
view and
electronically
sign | Yes | Yes | Yes |
| User
Permissions: edit
demographics | | | Yes | Yes | Yes |
| | User
Permissions: edit
measurements | | Yes | Yes | Yes |
| | | Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System |
| BRAND | | Mortara | Mortara | Quinton | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| View: patient
identity always
visible | Yes | Yes | Yes | Equivalent | |
| View: pan and
zoom | Yes | Yes | Yes | Equivalent | |
| Edit: patient
demographics | Yes | Yes | Yes | Equivalent | |
| Edit: accepts
demographic
updates outside
of CardioConfirm | Yes | Not applicable | Not applicable | New feature | |
| Sign:
electronically
sign | Yes | Yes | Yes | Equivalent | |
| Resting ECG | | | | | |
| IO: option to
support non- | Yes for professional | No | Yes | Equivalent to | |
| Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System | Change
explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| Mortara device
data | version | | | Pyramis | |
| IO: reads DICOM
12-Lead ECG
Waveform
objects | Yes | Not applicable | Not applicable | Equivalent to
Pyramis | |
| IO: writes DICOM
12-lead ECG
Waveform
objects | Yes | Yes | No | Equivalent to E-
Scribe | |
| User
Permissions: edit
interpretation
including serial
comparison and
conclusion | Yes | Yes | Yes | Equivalent | |
| View: waveform
zoom | Optimizes for display of
full 10s waveforms over a | Fit page, Fit width, 75%,
100%, 150%, 200%, | Fit width, Fit height, 25%,
50%, 75%, 100%, 125%, | Equivalent | |
| Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System | Change
explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| | wide range of screen
resolutions | 300%, 400% | 150%, 200%, 400%,
600%, 800% | | |
| View: local
magnification | Onscreen magnifying
loupe | No | No | New feature,
allows closer
inspection of beat
details in context
of full ECG | |
| View: channel
layout | 3x4, 3x4+1, 3x4+3, 6x2,
12x1, 3x5, 3x5+1, 3x5+3 | 3x4, 3x4+1, 3x4+3, 6x2,
12x1 | 15x1, 12x1, 6x2, 3x4,
3x4+1, 6x2 | Equivalent | |
| View: median
beat layout | 3x4, overlay | 3x4, overlay | 3x4 | Equivalent | |
| View: frequency
filter | 40 Hz, 150 Hz, None | 40 Hz, 150 Hz, None | None | Equivalent to E-
Scribe | |
| View: waveform
gain | 5, 10, 20 mm/mV | 5, 10, 20 mm/mV | None | Equivalent to E-
Scribe | |
| View: waveform | 1mm, 5mm, None | 1mm, 5mm, None | 1mm, 5mm | Equivalent to E- | |
| Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System | Change
explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| grid | | | | Scribe | |
| View: compare
ECGs in side-by-
side display | Yes | Yes | Yes | Equivalent | |
| Edit: global
measurements | Yes | Yes | Yes | Equivalent | |
| Edit: statement
acronyms | Yes | Yes | Yes | Equivalent | |
| Edit: option to
protect
previously-signed
interpretation | Yes | No | No | New feature,
allows host
applications to
amend previously-
signed ECGs. | |
| Edit: statement
prediction | Yes | No | No | New feature,
predicts
statements after
entering a few | |
| Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System | Change
explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| | | | | characters | |
| Measure:
onscreen calipers | Time, Voltage, Periodicity | Time, Voltage | Time, Voltage | Equivalent | |
| Analyze: Veritas
comparison
algorithm
generates
comparison
statements for
Mortara ECGs | Yes | Yes | No | Equivalent to E-
Scribe | |
| Stress and
Holter | | | | | |
| IO: reads DICOM
Encapsulated
PDF objects | Yes | Not applicable | Not applicable | New feature,
predicates do not
accept DICOM
data | |
| Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System | Change
explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| IO: writes DICOM
Encapsulated
PDF objects | Yes | Not applicable | No | New feature,
predicates do not
export stress and
Holter DICOM
reports | |
| User
Permissions: edit
conclusions | Yes | Not applicable | Yes | Equivalent to
Pyramis | |
| User
Permissions: edit
summary
statistics | Yes | Not applicable | Yes | Equivalent to
Pyramis | |
| Edit: summary
statistics | Yes | Not applicable | Yes | Equivalent to
Pyramis | |
| Edit: free-text
conclusions | Yes | Not applicable | Yes | Equivalent to
Pyramis | |
| Edit: use
conclusion | Yes | Not applicable | No | New feature,
beyond free-text | |
| Data
Management
System | CardioConfirm | E-scribe (Primary) | Pyramis ECG
Management System | Change
explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| templates | | | | conclusions | |
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Image /page/12/Picture/0 description: The image shows a logo with a white heart shape inside a blue square. Below the logo, the text "Traditional 510(k) Notification" is displayed, followed by the code "K161465" on the next line. The text and code are in a simple, sans-serif font and are centrally aligned below the logo.
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Image /page/16/Picture/0 description: The image shows a logo with a heart shape in a blue square at the top. Below the logo, the text "Traditional 510(k) Notification" is written. The number "K161465" is written below the text.
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Image /page/17/Picture/0 description: The image shows a logo above the text "Traditional 510(k) Notification K161465". The logo is a blue heart shape with a white heart shape cut out of the middle. The text is black and centered below the logo. The text indicates that this is a traditional 510(k) notification, which is a type of premarket submission to the FDA to demonstrate that a medical device is safe and effective.
7. Determination of Substantial Equivalence - Non-clinical
Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices" and "Off-the-Shelf Software Use in Medical Devices." Software code reviews and unit testing were conducted as part of our overall design control process for software development and subsequent verification and validation.
Determination of Substantial Equivalence – Clinical
The subject of this premarket notification did not require clinical data to support substantial equivalence.
8. Conclusion
The non-clinical data that supports the safety of this device as well as the software verification and validation that have been completed at the time of this submission demonstrate that CardioConfirm performs as intended. As a result of completed verification and validation activities to date, Mortara has determined the CardioConfirm is substantially equivalent to the predicate device.