Who is the manufacturer of CoroFlow Cardiovascular System?

Coroventis Research AB filed the 510(k) submission for CoroFlow Cardiovascular System (K201881).

What is the FDA product code for CoroFlow Cardiovascular System?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CoroFlow Cardiovascular System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CoroFlow Cardiovascular System?

QUANTIENT™ Measurement System (K183099); RadiAnalyzer® Xpress (K092105).

Who can help prepare an FDA 510(k) submission like CoroFlow Cardiovascular System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CoroFlow Cardiovascular System

K201881 · Coroventis Research AB · DQK · Nov 13, 2020 · Cardiovascular

Device Facts

Record ID	K201881
Device Name	CoroFlow Cardiovascular System
Applicant	Coroventis Research AB
Product Code	DQK · Cardiovascular
Decision Date	Nov 13, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2
Attributes	Software as a Medical Device

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.

Device Story

CoroFlow Cardiovascular System is a software-based diagnostic tool for catheterization labs; processes pressure and temperature data from Abbott PressureWire and Wi-box sensors. System receives wireless input via CoroHub Receiver; calculates physiological indices including FFR, Pd/Pa, RFR, IMR, CFR, IMR_Corr, RRR, Absolute Flow/Resistance, dP/dt, and Tau. Software runs on standard Windows PC; displays results on local screen or slaved cathlab monitor. Data stored locally or on network. Used by clinicians to assess coronary lesion severity and micro-circulation; aids in clinical decision-making for cardiovascular disease diagnosis. Benefits include non-invasive-like assessment of coronary physiology using existing pressure/temperature measurement hardware.

Clinical Evidence

No new clinical study was performed. Substantial equivalence was supported by clinical evaluation per FDA guidance 'Medical Device (SaMD): Clinical Evaluation' (Dec 2017), demonstrating valid clinical association, analytical validation, and clinical validation of the SaMD.

Technological Characteristics

Software-based system installed on standard Windows PC. Wireless data reception via USB CoroHub Receiver (2.4 GHz FHSS). Pressure range: -30 to +300 mmHg; Temperature range: 15-42°C. Complies with IEC 62304:2015, IEC 82304-1:2016, IEC 62366:2015, IEC 60601-1, and EN 60601-1-2.

Indications for Use

Indicated for adult patients with cardiovascular diseases to provide hemodynamic information for diagnostic purposes in catheterization and cardiovascular specialty laboratories.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

PressureWire Sensor (K972793)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | |--------------------------------------------------------------------------------------|-----------------------------------------------| |--------------------------------------------------------------------------------------|-----------------------------------------------| ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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. | | | {5}------------------------------------------------ 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. {7}------------------------------------------------ | 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. |…

CoroFlow Cardiovascular System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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CoroFlow Cardiovascular System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

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