(99 days)
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.
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 The algorithm generates comparative statements automatically on the basis of the VERITAS INTERPRETATION statements originally made by the Mortara acquiring devices, measurements and the ECG waveforms.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.
I will provide the information based on the text provided, which focuses on the regulatory submission and comparison to predicate devices, rather than a detailed study protocol for performance. The document primarily describes the device and asserts its substantial equivalence based on non-clinical data. It explicitly states that clinical data was not required.
Here's the breakdown of the information you requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not list specific numeric acceptance criteria for device performance or corresponding reported performance metrics in the format typically used for studies determining efficacy or accuracy (e.g., sensitivity, specificity, F1-score). Instead, it implicitly defines "performance" through a comparison of technological characteristics with predicate devices and emphasizes software verification and validation. The "reported device performance" is framed as performing "as intended" and demonstrating "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device E-Scribe (K930558) | CardioConfirm employs the same functional scientific technology. |
| Functional equivalence to predicate device Pyramis ECG Management System (K032038) | CardioConfirm employs the same functional scientific technology. |
| Ability to display, edit, and finalize diagnostic cardiology reports (ECG, Stress, Holter) | Device allows the user to display, edit, and finalize these reports. |
| Support for algorithmic comparison of serial adult ECGs | Device supports algorithmic comparison and allows user editingstatements. |
| Compliance with 21 CFR Part 820 | CardioConfirm was designed and manufactured according to 21 CFR Part 820. |
| Software Verification & Validation | Conducted as recommended by FDA guidance; code reviews and unit testing performed. |
| Safety of the device | Non-clinical data supports the safety of this device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document makes no mention of a "test set" in the context of clinical or performance data for the device. The "non-clinical data" and "software verification and validation" (Section 7) refer to engineering and software testing, not a dataset of patient cases used to evaluate the diagnostic or comparison algorithm's performance against human experts or ground truth. Therefore, sample size, data provenance, retrospective/prospective nature are not applicable or provided.
3. 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 applicable, as no clinical test set for evaluating diagnostic performance or algorithmic comparison accuracy is described in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set is described.
5. 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
No MRMC study was done. The document explicitly states: "The subject of this premarket notification did not require clinical data to support substantial equivalence." (Section 7)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as providing "algorithmic comparison of serial adult ECGs" and mentions "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." (Section 4). However, it does not provide performance metrics for this algorithm in a standalone capacity (e.g., sensitivity, specificity for identifying changes). It also states that users can "edit the automatic comparison statements" and "edit previously-signed interpretations," indicating that the device is intended for human-in-the-loop use. No standalone performance study as such is detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "VERITAS SERIAL COMPARISON algorithm" mentioned (which generates initial comparative statements), the ground truth for its development or internal validation is not explicitly stated. Given the context, it would likely be based on consensus interpretations by cardiologists or a similar expert review of ECG changes, but this is not specified in the document. For the overall device, the "ground truth" for its acceptance criteria revolved around demonstrating functional equivalence to existing devices and proper software engineering practices, rather than diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
The document does not mention a "training set" in the context of a machine learning or AI model that would typically require one for statistical performance evaluation. The "VERITAS SERIAL COMPARISON algorithm" implicitly refers to an algorithmic component, but details on its development data (training set) are not provided.
9. How the ground truth for the training set was established
Not applicable, as no "training set" is documented, nor is the establishment of its ground truth described.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
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.
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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
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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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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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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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- 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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| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | Changeexplanation | |
|---|---|---|---|---|---|
| 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 tobe used by qualifiedclinicians to finalizecardiology reports for adultand pediatric patients. Toaid the clinician'sinterpretation of restingECGs, CardioConfirmsupports the display andonscreen measurement ofECG waveforms.CardioConfirm also supportsthe algorithmic comparisonof serial adult ECGs andallows the user to edit theautomatic comparisonstatements.CardioConfirm is intended tobe controlled by a hostapplication that managesuser authentication, userpermissions, and secure | This system is designed tobe used as a storagesystem for ECG data inhospitals and largemedical clinics. The E-Scribe allows the user tostore, edit and retrievepatient ECG information | The Pyramis ECGManagement System is anECG data managementand information system.Its primary function is tostore records of biologicorigin such as ECG,Stress and Holter recordsreceived from thoserespective recordingdevices in a database andsubsequently allow theuser to select, view, edit,print/fax/email and export(distribute) those records | Equivalent | |
| persistent storage of the | (distribute) those records | ||||
| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | Changeexplanation | |
| BRAND | Mortara | Mortara | Quinton | ||
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | ||
| 510 (K) Number | Present Applicationtests. | K930558 | K032038 | ||
| OperatingSystem | Windows 7, Windows 8.1, etc. | Windows 2008 R2, Windows 7 | Windows 2008, Windows 7 | Equivalent | |
| Form: DLL forembedding in ahost application | Yes | Not applicable | Not applicable | New feature | |
| Form: executablecontrolled by ahost application | Yes | Not applicable | Not applicable | New feature | |
| IO: option to limitto Mortara devicedata only | Yes | Yes | Yes | Equivalent | |
| IO: offline PDFgeneration ofreports | Yes | Yes | Yes | Equivalent | |
| IO: report printing | Yes | Yes | Yes | Equivalent | |
| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | Changeexplanation | |
| BRAND | Mortara | Mortara | Quinton | ||
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | ||
| 510 (K) Number | Present Application | K930558 | K032038 | ||
| UserPermissions:view only | Yes | Yes | Yes | Equivalent | |
| UserPermissions:view and save | Yes | Yes | Yes | Equivalent | |
| UserPermissions:view andelectronicallysign | Yes | Yes | Yes | ||
| UserPermissions: editdemographics | Yes | Yes | Yes | ||
| UserPermissions: editmeasurements | Yes | Yes | Yes | ||
| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | ||
| BRAND | Mortara | Mortara | Quinton | ||
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | ||
| 510 (K) Number | Present Application | K930558 | K032038 | ||
| View: patientidentity alwaysvisible | Yes | Yes | Yes | Equivalent | |
| View: pan andzoom | Yes | Yes | Yes | Equivalent | |
| Edit: patientdemographics | Yes | Yes | Yes | Equivalent | |
| Edit: acceptsdemographicupdates outsideof CardioConfirm | Yes | Not applicable | Not applicable | New feature | |
| Sign:electronicallysign | Yes | Yes | Yes | Equivalent | |
| Resting ECG | |||||
| IO: option tosupport non- | Yes for professional | No | Yes | Equivalent to | |
| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | Changeexplanation | |
| BRAND | Mortara | Mortara | Quinton | ||
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | ||
| 510 (K) Number | Present Application | K930558 | K032038 | ||
| Mortara devicedata | version | Pyramis | |||
| IO: reads DICOM12-Lead ECGWaveformobjects | Yes | Not applicable | Not applicable | Equivalent toPyramis | |
| IO: writes DICOM12-lead ECGWaveformobjects | Yes | Yes | No | Equivalent to E-Scribe | |
| UserPermissions: editinterpretationincluding serialcomparison andconclusion | Yes | Yes | Yes | Equivalent | |
| View: waveformzoom | Optimizes for display offull 10s waveforms over a | Fit page, Fit width, 75%,100%, 150%, 200%, | Fit width, Fit height, 25%,50%, 75%, 100%, 125%, | Equivalent | |
| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | Changeexplanation | |
| BRAND | Mortara | Mortara | Quinton | ||
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | ||
| 510 (K) Number | Present Application | K930558 | K032038 | ||
| wide range of screenresolutions | 300%, 400% | 150%, 200%, 400%,600%, 800% | |||
| View: localmagnification | Onscreen magnifyingloupe | No | No | New feature,allows closerinspection of beatdetails in contextof full ECG | |
| View: channellayout | 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: medianbeat layout | 3x4, overlay | 3x4, overlay | 3x4 | Equivalent | |
| View: frequencyfilter | 40 Hz, 150 Hz, None | 40 Hz, 150 Hz, None | None | Equivalent to E-Scribe | |
| View: waveformgain | 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- | |
| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | Changeexplanation | |
| BRAND | Mortara | Mortara | Quinton | ||
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | ||
| 510 (K) Number | Present Application | K930558 | K032038 | ||
| grid | Scribe | ||||
| View: compareECGs in side-by-side display | Yes | Yes | Yes | Equivalent | |
| Edit: globalmeasurements | Yes | Yes | Yes | Equivalent | |
| Edit: statementacronyms | Yes | Yes | Yes | Equivalent | |
| Edit: option toprotectpreviously-signedinterpretation | Yes | No | No | New feature,allows hostapplications toamend previously-signed ECGs. | |
| Edit: statementprediction | Yes | No | No | New feature,predictsstatements afterentering a few | |
| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | Changeexplanation | |
| 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: Veritascomparisonalgorithmgeneratescomparisonstatements forMortara ECGs | Yes | Yes | No | Equivalent to E-Scribe | |
| Stress andHolter | |||||
| IO: reads DICOMEncapsulatedPDF objects | Yes | Not applicable | Not applicable | New feature,predicates do notaccept DICOMdata | |
| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | Changeexplanation | |
| BRAND | Mortara | Mortara | Quinton | ||
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | ||
| 510 (K) Number | Present Application | K930558 | K032038 | ||
| IO: writes DICOMEncapsulatedPDF objects | Yes | Not applicable | No | New feature,predicates do notexport stress andHolter DICOMreports | |
| UserPermissions: editconclusions | Yes | Not applicable | Yes | Equivalent toPyramis | |
| UserPermissions: editsummarystatistics | Yes | Not applicable | Yes | Equivalent toPyramis | |
| Edit: summarystatistics | Yes | Not applicable | Yes | Equivalent toPyramis | |
| Edit: free-textconclusions | Yes | Not applicable | Yes | Equivalent toPyramis | |
| Edit: useconclusion | Yes | Not applicable | No | New feature,beyond free-text | |
| DataManagementSystem | CardioConfirm | E-scribe (Primary) | Pyramis ECGManagement System | Changeexplanation | |
| 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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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.
§ 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).