Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on calculating physiological parameters based on pressure and temperature measurements using established formulas and indices. There is no mention of AI, ML, or any learning-based algorithms.

Therapeutic

No

Explanation: The device is indicated for diagnosis and provides hemodynamic information. It does not provide any form of treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that CoroFlow is "indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases." This directly implies its role in the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description explicitly states that CoroFlow receives measurement data wirelessly via the CoroHub™ Receiver and is based on pressure and temperature measurements from Abbott Medical's PressureWire and Wi-box. These are hardware components, making the system more than just software.

IVD (In Vitro Diagnostic)

Based on the provided information, CoroFlow 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, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
CoroFlow's Function: CoroFlow directly measures physiological parameters in vivo (within the living body) using pressure and temperature sensors placed inside the coronary arteries via a catheter. It processes this real-time data to calculate hemodynamic indices.
Lack of Specimen Handling: The description does not mention the collection, preparation, or analysis of any biological specimens from the patient.

Instead, CoroFlow is a physiological monitoring and analysis system used in a clinical setting (catheterization lab) to provide real-time information about the cardiovascular system. It's a medical device, but not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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.

Product codes

DQK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary

Indicated Patient Age Range

adult patients

Intended User / Care Setting

catheterization and related cardiovascular specialty laboratories

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)

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.
However, the substantial equivalence of CoroFlow and the indices it calculates was demonstrated as per FDA guidance document Medical Device (SAMD): Clinical Evaluation issued on Dec 8, 2017). As per the guidance, the performed clinical evaluation showed a valid clinical association, analytical validation and clinical validation of the SaMD.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

QUANTIENT™ Measurement System (K183099), RadiAnalyzer® Xpress (K092105)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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

1

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.

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.

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 29A
SE-756 51 Uppsala
Sweden
Name of official
correspondent /
Contact person:	Johan Svanerud, CEO
Phone: +46 70-970 31 00
Fax: -
Email: jsvanerund@coroventis.se
Proprietary/Trade
Name:	CoroFlow™ Cardiovascular system
Common/Usual
name:	CoroFlow™
Device
classification code:	DQK (Programmable Diagnostic Computer)
Regulation number
and name:	21 CFR 870.1425, Programmable diagnostic computer
Device
classification:	II
Predicate device(s):	Primary: QUANTIENT™ Measurement System (K183099) with Software Version
1.12.1, cleared 28 February 2019.

Secondary: RadiAnalyzer® Xpress (K092105) with accessory software
RadiView® and Physiomon™, cleared 9 October 2009. |
| 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). |

4

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 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.
Indications for Use/
Intended Use:	CoroFlow™ is indicated to provide hemodynamic information for use in the
diagnosis of patients with cardiovascular diseases.
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.
Contraindication(s):	The system has no patient alarm functions. Do not use for cardiac/vital signs
monitoring.
Patient
category/population:	CoroFlow™ is intended to be used with adult patients with cardiovascular
diseases
Comparison of
subject device to
predicate devices	Feature/
Characteristic	QUANTIEN™
(Predicate Device) K183099	CoroFlow™
(Subject Device) K201881
	Intended use /
Indications for
use statements	The QUANTIEN™ system 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 electrodes, transducers or
measuring devices.	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.
		The QUANTIEN Measurement
System is indicated to provide
hemodynamic information for use
in the diagnosis and treatment of
coronary or peripheral artery
disease.	CoroFlow™ is indicated to provide
hemodynamic information for use in
the diagnosis of patients with
cardiovascular diseases.
		The intended use/indications for use statements of the subject device is
identical to the predicate device. Except that the predicate device
specifically identifies electrodes, transducers as input data sources and
specifically identifies coronary or peripheral artery disease. However, the
general purpose of the subject device is the same as the for the predicate
device.

Design principle	Plastic enclosure with screen
display. Modular processing and
input hardware modules for input
and output signals. Including Radio
Receiving capabilities for wireless
reception of digital data from
measurement devices

Subject device is a software while predicate device has dedicated hardware.
CoroFlow is installed on a stand-alone standard Windows PC outside the
patient environment. | Software to be installed on a stand-
alone standard Windows PC. USB
Radio Receiving device for wireless
reception of digital data from
measurement devices. | |
| Operating
principle | Pressure and temperature
measurement data received from
Abbott PressureWire and Aortic
pressure transducer (through Wi-
Box). Parameters calculated and
displayed on a screen. | Pressure and temperature
measurement data received from
Abbott PressureWire and Aortic
pressure transducer (through Wi-
Box). Parameters calculated and
displayed on a screen. | |
| | Identical | | |
| Signal input | Wireless and /or cable data input
from Abbott PressureWire Certus,
Aeris, X

Wireless (aortic pressure) data
input from external pressure
transducer via Abbott Wi-Box.

Cable (aortic pressure) data input
from Catlab recording system | Wireless data input from Abbott
PressureWire Aeris, X

Wireless (aortic pressure) data input
from external pressure transducer
via Abbott Wi-Box. | |
| | The signal input for the subject device is identical compared to the
predicate device, except that the predicate device can receive input via
physical cables. | | |
| Signal
performance
specifications | Pressure
Range: 30 to +300mmHg
Accuracy: ± 1 mmHg plus ± 1% of
readings (over the pressure range -
30 to 50mmHg), ± 3% of reading
(over the range 50 to 300mmHg)
Frequency response: 0 – 25Hz

Temperature
Range: 15 - 42℃
Accuracy: 0.05℃ or 10% ΔT
whichever greatest | Pressure
Range: 30 to +300mmHg
Accuracy: ± 1 mmHg plus ± 1% of
readings (over the pressure range -
30 to 50mmHg), ± 3% of reading
(over the range 50 to 300mmHg)
Frequency response: 0 – 25Hz

Temperature
Range: 15 - 42℃
Accuracy: 0.05℃ or 10% ΔT
whichever greatest | |
| | Identical | | |
| Wireless data
communication | 2.4 GHz point to point
radio communication.
FHSS frequency hopping | 2.4 GHz point to point
radio communication.
FHSS frequency hopping | |
| | spread spectrum protocol

Checksum controlled | spread spectrum protocol
Checksum controlled | |
| | Identical | | |
| Calculated
indices - FFR | Yes | Yes | |
| Calculated
indices - Pd/Pa | Yes | Yes | |
| Calculated
indices - CFR | Yes | Yes | |
| Calculated
indices - IMR | No (Refer to secondary predicate
device) | Yes | |
| Calculated
indices -
IMR_Corr | See clinical testing section below. | | |
| Calculated
indices -
Absolute Flow | No | Yes | |
| | See clinical testing section below. | | |
| Calculated
indices - RFR | Yes | Yes | |
| Calculated
indices - RRR | No | Yes | |
| | See clinical testing section below. | | |
| Calculated
indices - PB-CFR | No | Yes | |
| | See clinical testing section below. | | |
| Calculated
indices - dP/dt | No (Refer to secondary predicate
device) | Yes | |
| Calculated
indices - 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

6

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 for
use statements | RadiAnalyzer® Xpress 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 electrodes,
transducers or measuring devices.

RadiAnalyzer® Xpress is indicated
to provide hemodynamic
information for use in the diagnosis
and treatment of patients that
undergo measurement of
physiological parameters with
PressureWire.

The intended use/indications for use statements of the subject device is
identical to the predicate device. Except that the predicate device
specifically identifies electrodes, transducers as input data sources and
specifically identifies patients that undergo measurement of physiological
parameters with PressureWire. The general purpose of the subject device is
the same as the for the predicate device. | 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.

CoroFlow™ is indicated to provide
hemodynamic information for use in
the diagnosis of patients with
cardiovascular diseases. |
| Design principle | Plastic enclosure with screen
display. Modular processing and
input hardware modules for input
and output signals. Including Radio
Receiving capabilities for wireless
reception of digital data from
measurement devices

Subject device is a software while predicate device has dedicated hardware.
CoroFlow is installed on a stand-alone standard Windows PC outside the
patient environment. | Software to be installed on a stand-
alone standard Windows PC. USB
Radio Receiving device for wireless
reception of digital data from
measurement devices. |
| Operating
principle | Pressure and temperature
measurement data received from
Abbott PressureWire and Aortic
pressure transducer. | Pressure and temperature
measurement data received from
Abbott PressureWire and Aortic
pressure transducer (through Wi-
Box). Parameters calculated and
displayed on a screen. |
| | Identical, except that the predicate device receives data via cable
connection and the subject device receives data via wireless links. | |
| Signal input | Cable connection data input from
Abbott PressureWire Certus

Cable connection (aortic pressure) | Wireless data input from Abbott
PressureWire Aeris, X

Wireless (aortic pressure) data input |
| | data input from external pressure
transducer. | from external pressure transducer
via Abbott Wi-Box. |
| | Input from same PressureWire Sensor (K972793), except that the predicate
device receives data via cable connection and the subject device receives
data via wireless links. | |
| Signal
performance
specifications | Pressure
Range: 30 to +300mmHg
Accuracy: ± 1 mmHg plus ± 1% of
readings (over the pressure range –
30 to 50mmHg), ± 3% of reading
(over the range 50 to 300mmHg)
Frequency response: 0 – 25Hz | Pressure
Range: 30 to +300mmHg
Accuracy: ± 1 mmHg plus ± 1% of
readings (over the pressure range –
30 to 50mmHg), ± 3% of reading
(over the range 50 to 300mmHg)
Frequency response: 0 – 25Hz |
| | Temperature
Range: 15 - 42°C
Accuracy: 0.05°C or 10% AΤ
whichever greatest
Identical | Temperature
Range: 15 - 42°C
Accuracy: 0.05°C or 10% AΤ
whichever greatest |
| Wireless data
communication | NA | - 2.4 GHz point to point
radio communication.

FHSS frequency hopping
spread spectrum protocol
Checksum controlled |
| | Predicate device receives data exclusively via cable connection. | |
| Calculated
indices - FFR | Yes | Yes |
| Calculated
indices - Pd/Pa | Yes | Yes |
| Calculated
indices - CFR | Yes | Yes |
| Calculated
indices – IMR | Yes | Yes |
| Calculated
indices –
IMR_Corr | No
See clinical testing section below. | Yes |
| Calculated
indices -
Absolute Flow | No
See clinical testing section below. | Yes |
| Calculated
indices – RFR | No (refer to primary predicate
device) | Yes |
| Calculated
indices – RRR | No
See clinical testing section below. | Yes |
| Calculated
indices - PB-
CFR | No
See clinical testing section below. | Yes |
| Calculated
indices – dP/dt | Yes | Yes |
| Calculated
indices – Tau | No
See clinical testing section below. | Yes |
| Non-clinical testing | Verification and Validation testing were completed to demonstrate
substantial equivalence and ensure that the subject device performs as
intended. Design verification and validation included the following:
Verification - performed to ensure that the subject device meets specified
system requirements and functions as intended. The software was
validated in accordance with IEC 62304:2015.
Validation/Usability Engineering – performed to ensure that the subject
device meets user requirements and to identify, evaluate and eliminate or
reduce 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 in
support of the substantial equivalence of CoroFlow as the intended
use/indications for use and technological characteristics are equivalent to the
predicate devices.
However, the substantial equivalence of CoroFlow and the indices it calculates
was demonstrated as per FDA guidance document Medical Device (SAMD):
Clinical Evaluation issued on Dec 8, 2017). As per the guidance, the performed
clinical evaluation showed a valid clinical association, analytical validation and
clinical 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

9

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.