CoroFlow is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more measuring devices.

Device Description

CoroFlow Cardiovascular system is used to calculate, display and store physiological parameters based on pressure and temperature measurements from Abbott Medical's PressureWire and Wi-box. Calculated parameters include physiological indices to assess coronary lesion severity (FFR, Pd/Pa, RFR) and indices to assess coronary micro-circulation (IMR, CFR). The system also provides novel indices based on the same raw pressure and temperature measurements (IMR_Corr, RRR, Absolute Flow/Resistance, dP/dt, Tau). CoroFlow™ is installed on a personal computer and receives measurement data wirelessly via the CoroHub™ Receiver. Information is displayed on the computer screen which can optionally be slaved to a monitor inside the coronary cathlab. Data can be stored on a local storage unit or transferred to a network location.

AI/ML Overview

The provided document does not contain details about specific acceptance criteria and a study demonstrating the device meets those criteria. Instead, it describes the CoroFlow™ Cardiovascular System and asserts its substantial equivalence to predicate devices (QUANTIENT™ Measurement System (K183099) and RadiAnalyzer® Xpress (K092105)) based on non-clinical testing and clinical evaluation of Software as a Medical Device (SaMD) principles, rather than a direct clinical study to prove performance against pre-defined acceptance criteria.

The document explicitly states: "No clinical study was performed as a part of either the product development or in support of the substantial equivalence of CoroFlow as the intended use/indications for use and technological characteristics are equivalent to the predicate devices."

Therefore, I cannot provide concrete information for some of your requested points, as a direct clinical study with acceptance criteria and reported performance was not conducted for this specific device clearance.

However, I can extract information related to the device's technical specifications and the general approach to demonstrating substantial equivalence, which serves as an indirect form of meeting performance expectations established by the predicate devices.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of acceptance criteria for specific performance metrics of the CoroFlow™ system, nor does it report specific performance outcomes from a study designed to meet such criteria.
Instead, it highlights that the signal performance specifications (pressure and temperature) of the CoroFlow™ are identical to the predicate devices. This implies that the device is expected to perform at the same level as the predicate devices in these aspects.

Metric (Implied "Acceptance Criteria" based on Predicate)	Reported Device Performance (CoroFlow™)	Notes
Pressure Signal Performance		Identical to Predicate
Range	-30 to +300mmHg	The CoroFlow™ device is designed to measure pressure within this range, matching the predicate device.
Accuracy	± 1 mmHg plus ± 1% of readings (-30 to 50mmHg) ± 3% of reading (50 to 300mmHg)	The CoroFlow™ device is designed to achieve this accuracy, matching the predicate device.
Frequency response	0 – 25Hz	The CoroFlow™ device is designed to have this frequency response, matching the predicate device.
Temperature Signal Performance		Identical to Predicate
Range	15 - 42℃	The CoroFlow™ device is designed to measure temperature within this range, matching the predicate device.
Accuracy	0.05℃ or 10% ΔT (whichever greatest)	The CoroFlow™ device is designed to achieve this accuracy, matching the predicate device.
Calculated Indices (FFR, Pd/Pa, CFR, IMR, RFR, RRR, IMR_Corr, Absolute Flow/Resistance, dP/dt, Tau, PB-CFR)	Yes (calculates these)	The software calculates these indices. For the indices not present in both predicate devices (e.g., IMR_Corr, Absolute Flow, RRR, PB-CFR, Tau), the document references "See clinical testing section below," implying their clinical validity was established through the SaMD clinical evaluation approach.

2. Sample size used for the test set and the data provenance:

Test set sample size: Not applicable for a traditional clinical study with a test set. The substantial equivalence was demonstrated through comparison to predicate devices and a SaMD clinical evaluation. The document does not specify a "test set" in the context of a prospective study with patients.
Data provenance: Not explicitly stated as a separate test set. The clinical evaluation followed FDA guidance for Software as a Medical Device (SaMD), which typically relies on existing clinical data (retrospective) or scientific literature to establish clinical association and validation. The document implies a broad clinical evaluation, not a focused test set from a specific country. However, since the device received clearance in the US, the supporting data would have been reviewed by the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. As no traditional clinical study with a "test set" requiring ground truth establishment by experts was conducted, these details are not relevant to the clearance pathway described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. Again, this is typically relevant for studies involving human readers or expert consensus on a test set, which was not the primary method for this clearance.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device, CoroFlow™, is a "Programmable Diagnostic Computer" for calculating and displaying physiological parameters, not an AI-assisted diagnostic imaging interpretation tool in the context of MRMC studies. It assists human clinicians by computing parameters from measurement devices, rather than directly improving human reader performance in interpreting images or clinical data.

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

Yes, implicitly. The "clinical evaluation" described for this SaMD involved establishing "clinical association, analytical validation and clinical validation of the SaMD" as per FDA guidance. This typically involves demonstrating that the algorithm (CoroFlow™ calculating parameters from raw pressure/temperature data) accurately computes these parameters correctly and that these parameters are clinically meaningful, similar to how predicate devices compute and display them. The device's "raison d'être" is the standalone calculation and display of these physiological parameters.

7. The type of ground truth used:

The document states that the substantial equivalence was evaluated by following FDA guidance for Software as a Medical Device (SaMD): "the performed clinical evaluation showed a valid clinical association, analytical validation and clinical validation of the SaMD."
- Analytical Validation: Likely involved comparing the device's computed parameters against established reference methods or highly accurate physical models, ensuring the calculations are correct.
- Clinical Validation: Involved demonstrating that the calculated parameters (e.g., FFR, CFR, IMR) are clinically meaningful and correlate with patient outcomes or established diagnostic thresholds as widely accepted in cardiology. This would rely on existing clinical data and scientific literature that supports the utility of these physiological indices, rather than generating new ground truth from a dedicated prospective study.
- For indices not present in the primary predicate (e.g., IMR_Corr, Absolute Flow, RRR, PB-CFR, Tau), the "clinical testing section below" (which refers back to the general SaMD clinical evaluation statement) would have addressed their clinical validation by leveraging scientific literature and existing clinical evidence for these emerging parameters.

8. The sample size for the training set:

This information is not provided. The CoroFlow™ device is described as a software for calculating physiological parameters based on direct measurements, implying rule-based algorithms rather than a machine learning model that requires a "training set" in the conventional sense of AI/ML. The analytical and clinical validation would be sufficient for such a device.

9. How the ground truth for the training set was established:

Not applicable, as there's no explicitly mentioned "training set" in the context of machine learning. The "ground truth" for the device's functionality would be the scientifically established physiological formulas for the calculated indices and the accurate measurements from the input sensing devices (Abbott PressureWire and Wi-box).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 13, 2020

Coroventis Research AB Johan Svanerud CEO Ulls Vag 29A Uppsala, Uppsala Lan 75651 Sweden

Re: K201881

Trade/Device Name: CoroFlow Cardiovascular System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 2, 2020 Received: November 5, 2020

Dear Johan Svanerud:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201881

Device Name CoroFlow™ Cardiovascular System

Indications for Use (Describe)

CoroFlow is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases.

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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Image /page/3/Picture/1 description: The image shows the logo for Coroventis. The logo consists of the word "Coroventis" in a bold, sans-serif font, with a blue diamond shape above the "v". Below the word "Coroventis" is the tagline "Turning ideas into reality" in a smaller, lighter font. The logo is simple and modern, and the blue diamond shape adds a touch of visual interest.

510(k) Summary Per 21 CFR §807.92

510(k) number:	K201881
Date prepared:	24 September 2020
Submitter name:	Coroventis Research AB
Submitter address:	Ulls väg 29ASE-756 51 UppsalaSweden
Name of officialcorrespondent /Contact person:	Johan Svanerud, CEOPhone: +46 70-970 31 00Fax: -Email: jsvanerund@coroventis.se
Proprietary/TradeName:	CoroFlow™ Cardiovascular system
Common/Usualname:	CoroFlow™
Deviceclassification code:	DQK (Programmable Diagnostic Computer)
Regulation numberand name:	21 CFR 870.1425, Programmable diagnostic computer
Deviceclassification:	II
Predicate device(s):	Primary: QUANTIENT™ Measurement System (K183099) with Software Version1.12.1, cleared 28 February 2019.Secondary: RadiAnalyzer® Xpress (K092105) with accessory softwareRadiView® and Physiomon™, cleared 9 October 2009.
Device description:	CoroFlow Cardiovascular system is used to calculate, display and storephysiological parameters based on pressure and temperature measurements fromAbbott Medical's PressureWire and Wi-box.Calculated parameters include physiological indices to assess coronary lesionseverity (FFR, Pd/Pa, RFR) and indices to assess coronary micro-circulation(IMR, CFR).

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Image /page/4/Picture/1 description: The image shows the logo for Coroventis. The logo consists of the word "Coroventis" in a sans-serif font, with a blue diamond shape above the "v". Below the word "Coroventis" is the tagline "Turning ideas into reality" in a smaller, lighter font. The logo is simple and modern, and the blue diamond shape adds a touch of visual interest.

The system also provides novel indices based on the same raw pressure andtemperature measurements (IMR_Corr, RRR, Absolute Flow/Resistance, dP/dt,Tau).CoroFlow™ is installed on a personal computer and receives measurement datawirelessly via the CoroHub™ Receiver. Information is displayed on the computerscreen which can optionally be slaved to a monitor inside the coronary cathlab.Data can be stored on a local storage unit or transferred to a network location.
Indications for Use/Intended Use:	CoroFlow™ is indicated to provide hemodynamic information for use in thediagnosis of patients with cardiovascular diseases.CoroFlow™ is intended for use in catheterization and related cardiovascularspecialty laboratories to compute and display various physiological parametersbased on the output from one or more measuring devices.
Contraindication(s):	The system has no patient alarm functions. Do not use for cardiac/vital signsmonitoring.
Patientcategory/population:	CoroFlow™ is intended to be used with adult patients with cardiovasculardiseases
Comparison ofsubject device topredicate devices	Feature/Characteristic	QUANTIEN™(Predicate Device) K183099	CoroFlow™(Subject Device) K201881
	Intended use /Indications foruse statements	The QUANTIEN™ system isintended for use in catheterizationand related cardiovascular specialtylaboratories to compute and displayvarious physiological parametersbased on the output from one ormore electrodes, transducers ormeasuring devices.	CoroFlow™ is intended for use incatheterization and relatedcardiovascular specialty laboratoriesto compute and display variousphysiological parameters based onthe output from one or moremeasuring devices.
		The QUANTIEN MeasurementSystem is indicated to providehemodynamic information for usein the diagnosis and treatment ofcoronary or peripheral arterydisease.	CoroFlow™ is indicated to providehemodynamic information for use inthe diagnosis of patients withcardiovascular diseases.
		The intended use/indications for use statements of the subject device isidentical to the predicate device. Except that the predicate devicespecifically identifies electrodes, transducers as input data sources andspecifically identifies coronary or peripheral artery disease. However, thegeneral purpose of the subject device is the same as the for the predicatedevice.

Design principle	Plastic enclosure with screendisplay. Modular processing andinput hardware modules for inputand output signals. Including RadioReceiving capabilities for wirelessreception of digital data frommeasurement devicesSubject device is a software while predicate device has dedicated hardware.CoroFlow is installed on a stand-alone standard Windows PC outside thepatient environment.	Software to be installed on a stand-alone standard Windows PC. USBRadio Receiving device for wirelessreception of digital data frommeasurement devices.
Operatingprinciple	Pressure and temperaturemeasurement data received fromAbbott PressureWire and Aorticpressure transducer (through Wi-Box). Parameters calculated anddisplayed on a screen.	Pressure and temperaturemeasurement data received fromAbbott PressureWire and Aorticpressure transducer (through Wi-Box). Parameters calculated anddisplayed on a screen.
	Identical
Signal input	Wireless and /or cable data inputfrom Abbott PressureWire Certus,Aeris, XWireless (aortic pressure) datainput from external pressuretransducer via Abbott Wi-Box.Cable (aortic pressure) data inputfrom Catlab recording system	Wireless data input from AbbottPressureWire Aeris, XWireless (aortic pressure) data inputfrom external pressure transducervia Abbott Wi-Box.
	The signal input for the subject device is identical compared to thepredicate device, except that the predicate device can receive input viaphysical cables.
Signalperformancespecifications	PressureRange: 30 to +300mmHgAccuracy: ± 1 mmHg plus ± 1% ofreadings (over the pressure range -30 to 50mmHg), ± 3% of reading(over the range 50 to 300mmHg)Frequency response: 0 – 25HzTemperatureRange: 15 - 42℃Accuracy: 0.05℃ or 10% ΔTwhichever greatest	PressureRange: 30 to +300mmHgAccuracy: ± 1 mmHg plus ± 1% ofreadings (over the pressure range -30 to 50mmHg), ± 3% of reading(over the range 50 to 300mmHg)Frequency response: 0 – 25HzTemperatureRange: 15 - 42℃Accuracy: 0.05℃ or 10% ΔTwhichever greatest
	Identical
Wireless datacommunication	2.4 GHz point to pointradio communication.FHSS frequency hopping	2.4 GHz point to pointradio communication.FHSS frequency hopping
	spread spectrum protocol- Checksum controlled	spread spectrum protocol- Checksum controlled
	Identical
Calculatedindices - FFR	Yes	Yes
Calculatedindices - Pd/Pa	Yes	Yes
Calculatedindices - CFR	Yes	Yes
Calculatedindices - IMR	No (Refer to secondary predicatedevice)	Yes
Calculatedindices -IMR_Corr	See clinical testing section below.
Calculatedindices -Absolute Flow	No	Yes
	See clinical testing section below.
Calculatedindices - RFR	Yes	Yes
Calculatedindices - RRR	No	Yes
	See clinical testing section below.
Calculatedindices - PB-CFR	No	Yes
	See clinical testing section below.
Calculatedindices - dP/dt	No (Refer to secondary predicatedevice)	Yes
Calculatedindices - Tau	No	Yes
	See clinical testing section below.

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Image /page/5/Picture/1 description: The image shows the logo for Coroventis. The logo consists of the word "Coroventis" in a sans-serif font, with a blue diamond shape above the "v". Below the word "Coroventis" is the tagline "Turning ideas into reality" in a smaller font.

CoroFlow™ Cardiovascular System

Traditional 510(k) Premarket Notification Attachment 6 – 510(k) Summary

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Image /page/6/Picture/1 description: The image shows the logo for Coroventis. The logo consists of the word "Coroventis" in a sans-serif font, with a blue diamond shape above the "v". Below the word "Coroventis" is the tagline "Turning ideas into reality" in a smaller font. The logo is simple and modern, and the blue diamond shape adds a touch of visual interest.

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Feature/Characteristic	RadiAnalyzer® Xpress(Predicate Device) K092105	CoroFlow™(Subject Device) K201881
Intended use /Indications foruse statements	RadiAnalyzer® Xpress is intendedfor use in catheterization andrelated cardiovascular specialtylaboratories to compute, anddisplay various physiologicalparameters based on the outputfrom one or more electrodes,transducers or measuring devices.RadiAnalyzer® Xpress is indicatedto provide hemodynamicinformation for use in the diagnosisand treatment of patients thatundergo measurement ofphysiological parameters withPressureWire.The intended use/indications for use statements of the subject device isidentical to the predicate device. Except that the predicate devicespecifically identifies electrodes, transducers as input data sources andspecifically identifies patients that undergo measurement of physiologicalparameters with PressureWire. The general purpose of the subject device isthe same as the for the predicate device.	CoroFlow™ is intended for use incatheterization and relatedcardiovascular specialty laboratoriesto compute and display variousphysiological parameters based onthe output from one or moremeasuring devices.CoroFlow™ is indicated to providehemodynamic information for use inthe diagnosis of patients withcardiovascular diseases.
Design principle	Plastic enclosure with screendisplay. Modular processing andinput hardware modules for inputand output signals. Including RadioReceiving capabilities for wirelessreception of digital data frommeasurement devicesSubject device is a software while predicate device has dedicated hardware.CoroFlow is installed on a stand-alone standard Windows PC outside thepatient environment.	Software to be installed on a stand-alone standard Windows PC. USBRadio Receiving device for wirelessreception of digital data frommeasurement devices.
Operatingprinciple	Pressure and temperaturemeasurement data received fromAbbott PressureWire and Aorticpressure transducer.	Pressure and temperaturemeasurement data received fromAbbott PressureWire and Aorticpressure transducer (through Wi-Box). Parameters calculated anddisplayed on a screen.
	Identical, except that the predicate device receives data via cableconnection and the subject device receives data via wireless links.
Signal input	Cable connection data input fromAbbott PressureWire CertusCable connection (aortic pressure)	Wireless data input from AbbottPressureWire Aeris, XWireless (aortic pressure) data input
	data input from external pressuretransducer.	from external pressure transducervia Abbott Wi-Box.
	Input from same PressureWire Sensor (K972793), except that the predicatedevice receives data via cable connection and the subject device receivesdata via wireless links.
Signalperformancespecifications	PressureRange: 30 to +300mmHgAccuracy: ± 1 mmHg plus ± 1% ofreadings (over the pressure range –30 to 50mmHg), ± 3% of reading(over the range 50 to 300mmHg)Frequency response: 0 – 25Hz	PressureRange: 30 to +300mmHgAccuracy: ± 1 mmHg plus ± 1% ofreadings (over the pressure range –30 to 50mmHg), ± 3% of reading(over the range 50 to 300mmHg)Frequency response: 0 – 25Hz
	TemperatureRange: 15 - 42°CAccuracy: 0.05°C or 10% AΤwhichever greatestIdentical	TemperatureRange: 15 - 42°CAccuracy: 0.05°C or 10% AΤwhichever greatest
Wireless datacommunication	NA	- 2.4 GHz point to pointradio communication.- FHSS frequency hoppingspread spectrum protocol- Checksum controlled
	Predicate device receives data exclusively via cable connection.
Calculatedindices - FFR	Yes	Yes
Calculatedindices - Pd/Pa	Yes	Yes
Calculatedindices - CFR	Yes	Yes
Calculatedindices – IMR	Yes	Yes
Calculatedindices –IMR_Corr	NoSee clinical testing section below.	Yes
Calculatedindices -Absolute Flow	NoSee clinical testing section below.	Yes
Calculatedindices – RFR	No (refer to primary predicatedevice)	Yes
Calculatedindices – RRR	NoSee clinical testing section below.	Yes
Calculatedindices - PB-CFR	NoSee clinical testing section below.	Yes
Calculatedindices – dP/dt	Yes	Yes
Calculatedindices – Tau	NoSee clinical testing section below.	Yes
Non-clinical testing	Verification and Validation testing were completed to demonstratesubstantial equivalence and ensure that the subject device performs asintended. Design verification and validation included the following:- Verification - performed to ensure that the subject device meets specifiedsystem requirements and functions as intended. The software wasvalidated in accordance with IEC 62304:2015.- Validation/Usability Engineering – performed to ensure that the subjectdevice meets user requirements and to identify, evaluate and eliminate orreduce use errors.
Applied standards	- IEC 62304:2015- IEC 82304-1:2016- EN ISO 15223-1:2016- EN ISO 14971:2012- IEC 62366:2015- IEC 60601-1-1:2006/AMD1:2012- EN 60601-1-2:2014- IEC 60950-1:2005- CISPR11:2009- SS-EN 55302:2015- FCC Part 15B- IEC 60529:2013- EN 300 328 V2.1.1:2017- AAMI TIR 69:2017- ANSI C63.27:2017- ASTM D4169-16
Clinical testing	No clinical study was performed as a part of either the product development or insupport of the substantial equivalence of CoroFlow as the intendeduse/indications for use and technological characteristics are equivalent to thepredicate devices.However, the substantial equivalence of CoroFlow and the indices it calculateswas demonstrated as per FDA guidance document Medical Device (SAMD):Clinical Evaluation issued on Dec 8, 2017). As per the guidance, the performedclinical evaluation showed a valid clinical association, analytical validation andclinical validation of the SaMD.

CoroFlow™ Cardiovascular System

Traditional 510(k) Premarket Notification Attachment 6 – 510(k) Summary

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Image /page/8/Picture/1 description: The image shows the logo for Coroventis. The logo consists of the word "Coroventis" in a sans-serif font, with a blue diamond shape above the "v". Below the word "Coroventis" is the tagline "Turning ideas into reality" in a smaller, lighter font. The logo is simple and modern, and the blue diamond shape adds a touch of visual interest.

CoroFlow™ Cardiovascular System

Traditional 510(k) Premarket Notification Attachment 6 – 510(k) Summary

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K201881 Page 7 of 7

Conclusion on substantial equivalence

The CoroFlow™ Cardiovascular system is equivalent to QUANTIEN™ Measurement System (K183099) in terms of intended use and the non-clinical data support substantial equivalence in terms of technological and performance characteristics. The verification, validation and usability activities demonstrate that CoroFlow™ is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).