Cardiovascular Suite 4.2.1

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January 11, 2022 Quipu S.R.L % Dallas Thomas Principal Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 5613 Tiger Way Winter Garden, Florida 34787 Re: K202094 Trade/Device Name: Cardiovascular Suite 4.2.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: December 27, 2021 Received: December 29, 2021 Dear Dallas Thomas: 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. 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Sincerely, LCDR 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) K202094 Device Name Cardiovascular Suite 4.2.1 Indications for Use (Describe) The Cardiovascular Suite 4.2.1 is a software program that is intended to aid trained healthcare in the quantitative analysis of vascular ultrasound images in adults, particularly for the measurement of the diameter and its changes on the brachial artery, the diameter and its changes on the carotid Intima-Media Thickness, and for carotid plaque analysis. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ #### 510(k) Summary #### 5.1 General Information 11 January 2022 Preparation Date: #### Primary Submission Contact Dallas L. Thomas, RAC, MHA, MPA, SSYB Medical Device Regulatory Consultant Thomas Regulatory Resolutions Inc. 5613 Tiger Way Winter Garden, Florida USA 34787 +1 561 898 0260 dallas@thomasregulatory.com #### Manufacturer / Submitter Vincenzo Gemignani President Quipu S.R.L Moruzzi 1 56124 Pisa Italy VAT IT-01995110507 Tel: 39 328 3074229 Email: gemignani@quipu.eu #### 5.2 Regulatory Information | Subject Device Name | Cardiovascular Suite 4.2.1 | |-----------------------|------------------------------------| | Classification Names | Computer, Diagnostic, Programmable | | Device Classification | II | | Common Name | Cardiovascular Suite 4.2.1 | | FDA Product Code | DQK | | CFR References | 870.1425 | | Review Panel | Cardiovascular | {4}------------------------------------------------ #### 5.3 Identification of Predicate Device Quipu regards the Cardiovascular Suite to be substantially equivalent to the predicate K033266, which is the "Vascular Tools 5" consisting of modules: "Brachial Analyzers5", "Carotid Analyzer 5", as commercialized by Medical Imaging Applications LLC. Additionally we are including the reference devices as follows for further consideration for substantial equivalence: Reference Device: M'Ath Std K040686 by Intelligence in Medical Technologies and Reference Device: K090461, the IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 by TOMTEC IMAGING SYSTEMS, GMBH #### 5.4 Subject Device Description The Cardiovascular Suite 4.2.1 is a software indicated for estimating early cardiovascular parameters by identifying and tracking the edges of the arteries by analyzing sequences of ultrasound images or single images of the longitudinal section of the vessel. The software consists of two main functional measurement modules: 1) the FMD-Studio for measuring Flow-Mediated-Dilation (FMD) of the brachial artery, by processing sequences of ultrasound image 2) The Carotid-Studio for measuring, by processing sequences of ultrasound images, the thickness of the carotid intima-media and the instantaneous carotid diameter that, associated with a pressure estimate, can provide arterial elasticity parameters. On single images, the software also provides a tool for Plaque Measurement and Quantification. The system is able to process previously recorded video files or directly process the video output of an ultrasound system in real time. The software is to be used only by trained healthcare professionals, such as laboratory technicians, nurses, doctors and/or ultrasonographers. The use of the system for analyzing people with a distorted anatomy of the examined arterial tract is not recommended. #### ર્સ્ટ Indications for Use Per the current proposed product labeling, the indications for the Cardiovascular Suite 4.2.1 are quoted as follows: #### Indications for Use The Cardiovascular Suite 4.2.1 is a software program that is intended to aid trained healthcare practitioners in the quantitative analysis of vascular ultrasound images in adults, particularly for the measurement of the diameter and its changes on the brachial artery, the diameter and its changes on the carotid artery, the Carotid Intima-Media Thickness, and for carotid plaque analysis. {5}------------------------------------------------ #### Contraindications The Cardiovascular Suite 4.2.1 device is not intended for use as a test that provides a direct diagnosis of any cardiovascular disease. It is intended to supplement, not substitute, the physician's decision-making process for diagnosis and treatment. It should be used in conjunction with knowledge of the patient's history and other clinical findings. It is not intended for use in pediatric population. Please note that the above indication is slightly reworded compared to the already cleared indications for the predicate Vascular Tools 5 and updated accordingly per current FDA Guidance. The indications for use statement also provides further clarification that is complementary to the cleared predicate indications for use. {6}------------------------------------------------ #### Substantial Equivalence Discussion 5.6 Any modifications between the predicate device are provided in while the table below. The review of the indications for use and comparison characteristics provided in Error! Reference source not found. demonstrate that 4.2.1 is substantially equivalent o the predicate device, Vascular Tools 5. A reference device was also included. #### Table 1. Substantial Equivalence Discussion Please note a number of published article references are provided in this table. | Item<br>No. | Device<br>Characteristic. | Proposed Device<br>Cardiovascular Suite | Primary Predicate<br>Device Vascular<br>Tools 5 | Reference Device:<br>M'Ath Std. | Reference Device:<br>K090461, the IMAGE-<br>ARENA 4.0 AND IA<br>APPLICATIONS 2D<br>CARDIAC<br>PERFORMANCE<br>ANALYSIS 1.0 by<br>TOMTEC IMAGING<br>SYSTEMS, GMBH | Comparison<br>Analysis: Identical<br>/ Substantially<br>Equivalent /<br>Modified / Cannot<br>Be Determined /<br>Not Applicable | Rationale as to why<br>Modification or<br>Difference from Predicate<br>to Subject Device Does<br>Not Impact Safety and<br>Effectiveness. | 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| 1 | 510 (k)<br>Number | K202094 | K033266 | K040686 | K090461 | N/A | Difference in 510k numbers do not<br>impact safety or efficacy of the<br>product. | | 2 | Device Name,<br>Model | Cardiovascular Suite | Vascular Tools 5 | M'Ath® Std | IMAGE-ARENA 4.0<br>AND IA APPLICATIONS<br>2D CARDIAC<br>PERFORMANCE<br>ANALYSIS 1.0 | N/A | Difference in Names do not impact<br>safety or efficacy of the product. | | Item<br>No. | Device<br>Characteristic. | Proposed Device<br>Cardiovascular Suite | Primary Predicate<br>Device Vascular<br>Tools 5 | Reference Device:<br>M'Ath Std. | Reference Device:<br>K090461, the IMAGE-<br>ARENA 4.0 AND IA<br>APPLICATIONS 2D<br>CARDIAC<br>PERFORMANCE<br>ANALYSIS 1.0 by<br>TOMTEC IMAGING<br>SYSTEMS, GMBH | Comparison<br>Analysis: Identical<br>/ Substantially<br>Equivalent /<br>Modified / Cannot<br>Be Determined /<br>Not Applicable | Rationale as to why<br>Modification or<br>Difference from Predicate<br>to Subject Device Does<br>Not Impact Safety and<br>Effectiveness. | | 3 | Manufacturer | QUIPU SRL | MEDICAL<br>IMAGING<br>APPLICATIONS<br>LLC | Intelligence in<br>Medical<br>Technologies | TOMTEC IMAGING<br>SYSTEMS, GMBH | N/A | Differences do not impact safety or<br>efficacy. | | 4 | CFR Reference | 870.1425 | 870.1425 | CFR 892.2050 | 892.2050 | N/A | Differences do not impact safety or<br>efficacy. | | 5 | FDA Review<br>Panel | Cardiovascular | Cardiovascular | Radiology | Radiology | N/A | Differences do not impact safety or<br>efficacy. | | 6 | FDA Device<br>Name | Computer, Diagnostic,<br>Programmable | Programmable<br>diagnostic computer | System, Image<br>processing,<br>Radiological | Ultrasonic pulsed doppler<br>imaging system | N/A | Differences do not impact safety or<br>efficacy. | | 7 | FDA Product<br>Code | DQK | DQK | LLZ | LLZ, DQK | N/A | Differences do not impact safety or<br>efficacy. | | 8 | Class | II | II | II | II | Identical | N/A | | Item<br>No. | Device<br>Characteristic. | Proposed Device<br>Cardiovascular Suite | Primary Predicate<br>Device Vascular<br>Tools 5 | Reference Device:<br>M' Ath Std. | Reference Device:<br>K090461, the IMAGE-<br>ARENA 4.0 AND IA<br>APPLICATIONS 2D<br>CARDIAC<br>PERFORMANCE<br>ANALYSIS 1.0 by<br>TOMTEC IMAGING<br>SYSTEMS, GMBH | Comparison<br>Analysis: Identical<br>/ Substantially<br>Equivalent /<br>Modified / Cannot<br>Be Determined /<br>Not Applicable | Rationale as to why<br>Modification or<br>Difference from Predicate<br>to Subject Device Does<br>Not Impact Safety and<br>Effectiveness. | | 9 | Indications for<br>use | The Cardiovascular Suite is a<br>software program for the<br>quantitative analysis of<br>vascular ultrasound images,<br>particularly for the<br>measurement of the diameter<br>and its changes on the<br>brachial artery, the diameter<br>and its changes on the carotid<br>artery, the Carotid Intima-<br>Media Thickness, and for<br>carotid plaque analysis | Vascular Tools 5"<br>software program<br>has been developed<br>to aid in quantitative<br>analysis of<br>longitudinal<br>vascular ultrasound<br>images, particularly<br>to determine<br>vascular diameter<br>and intima-media<br>thickness, as well as<br>their changes as<br>depicted in brachial<br>and carotid arterial<br>ultrasound images. | M'Ath Std<br>software is a<br>Windows-based<br>application<br>program running<br>on a personal<br>computer that is<br>intended to aid the<br>physician in the<br>organization of<br>patient data<br>relating to the<br>ultrasound images<br>or video acquired<br>during echo-<br>cardiology exams<br>of the<br>cardiovascular<br>system, including<br>the patient's | The Image-Arena Platform<br>Software is intended to<br>serve as a data<br>management platform for<br>clinical application<br>packages. It provides<br>information that is used for<br>clinical diagnosis<br>purposes. The software is<br>suited for stand-alone<br>workstations as well as for<br>networked multisystem<br>installations and therefore<br>is an image management<br>system for research and<br>routine use in both<br>physician practices and<br>hospitals. It is intended as<br>a general purpose digital<br>medical image processing | Substantially Equivalent | Differences do not impact safety or<br>efficacy. | | Item<br>No. | Device<br>Characteristic. | Proposed Device<br>Cardiovascular Suite | Primary Predicate<br>Device Vascular<br>Tools 5 | Reference Device:<br>M'Ath Std. | Reference Device:<br>K090461, the IMAGE-<br>ARENA 4.0 AND IA<br>APPLICATIONS 2D<br>CARDIAC<br>PERFORMANCE<br>ANALYSIS 1.0 by<br>TOMTEC IMAGING<br>SYSTEMS, GMBH | Comparison<br>Analysis: Identical<br>/ Substantially<br>Equivalent /<br>Modified / Cannot<br>Be Determined /<br>Not Applicable | Rationale as to why<br>Modification or<br>Difference from Predicate<br>to Subject Device Does<br>Not Impact Safety and<br>Effectiveness. | | | | | | characteristics.<br>Additionally, the<br>software allows the<br>physician to make<br>measurements to<br>determine the<br>intima-media<br>thickness of the<br>carotid artery from<br>the acquired<br>images and stores<br>them with the<br>patient file. | tool for cardiology. As the<br>Image-Arena Applications<br>software tool package is<br>modular structured,<br>clinical applications<br>packages with different<br>indications for use can be<br>connected. Echo-Com<br>software is intended to<br>serve as a versatile<br>solution for Stress Echo<br>examinations in patients<br>who may not be receiving<br>enough blood or oxygen<br>because of blocked<br>arteries. Image-Corn<br>software is intended for<br>reviewing, measuring and<br>reporting of DICOM dBta<br>of thi batdiah rodadlities. | | | | Item<br>No. | Device<br>Characteristic. | Proposed Device<br>Cardiovascular Suite | Primary Predicate<br>Device Vascular<br>Tools 5 | Reference Device:<br>M'Ath Std. | Reference Device:<br>K090461, the IMAGE-<br>ARENA 4.0 AND IA<br>APPLICATIONS 2D<br>CARDIAC<br>PERFORMANCE<br>ANALYSIS 1.0 by<br>TOMTEC IMAGING<br>SYSTEMS, GMBH | Comparison<br>Analysis: Identical<br>/ Substantially<br>Equivalent /<br>Modified / Cannot<br>Be Determined /<br>Not Applicable | Rationale as to why<br>Modification or<br>Difference from Predicate<br>to Subject Device Does<br>Not Impact Safety and<br>Effectiveness. | | | | | | | US and XA. -It can be'<br>driven by Image;Arena or<br>other third party platforms<br>and is intended to launch<br>other clinical applications.<br>The clinical application<br>package 2D Cardiac<br>Performance Analysis is<br>indicated for cardiac<br>quantification based on<br>echocardiographic data. It<br>provides measurements of<br>myocardial function<br>(displacement, velocity<br>and strain) that is used for<br>clinical diagnosis purposes<br>of patients with suspected<br>heart disease. | | | | Item<br>No. | Device<br>Characteristic. | Proposed Device<br>Cardiovascular Suite | Primary Predicate<br>Device Vascular<br>Tools 5 | Reference Device:<br>M'Ath Std. | Reference Device:<br>K090461, the IMAGE-<br>ARENA 4.0 AND IA<br>APPLICATIONS 2D<br>CARDIAC<br>PERFORMANCE<br>ANALYSIS 1.0 by<br>TOMTEC IMAGING<br>SYSTEMS, GMBH | Comparison<br>Analysis: Identical<br>/ Substantially<br>Equivalent /<br>Modified / Cannot<br>Be Determined /<br>Not Applicable | Rationale as to why<br>Modification or<br>Difference from Predicate<br>to Subject Device Does<br>Not Impact Safety and<br>Effectiveness. | | 10 | Anatomical<br>structure of use | Carotid and brachial artery | Same | Cardio vascular<br>bed | Cardiovascular Bed | Identical to Predicate | N/A - Cardiovascular Suite analyzes<br>carotid and brachial artery. These<br>sites are included in the predicate's<br>anatomical structure of use. | | 11 | Cardiovascular<br>Plaque<br>Measurement<br>function<br>included | Yes | No | Yes | No | Identical to Reference<br>Device | N/A-Cardiovascular Suite' tool for<br>carotid plaque includes geometrical<br>and density measurements<br>substantially equivalent to those of<br>the reference device | | 12 | Flow-Mediated<br>Dilatation<br>(FMD)<br>function<br>included | Yes | Yes | No | No | Identical to Predicate | N/A | | 13 | IMT - Intima<br>Media<br>Thickness | Yes | Yes | Yes | Yes | Identical to Predicate and<br>Reference Devices | N/A | | Item<br>No. | Device<br>Characteristic. | Proposed Device<br>Cardiovascular Suite | Primary Predicate<br>Device Vascular<br>Tools 5 | Reference Device:<br>M'Ath Std. | Reference Device:<br>K090461, the IMAGE-<br>ARENA 4.0 AND IA<br>APPLICATIONS 2D<br>CARDIAC<br>PERFORMANCE<br>ANALYSIS 1.0 by<br>TOMTEC IMAGING<br>SYSTEMS, GMBH | Comparison<br>Analysis: Identical<br>/ Substantially<br>Equivalent /<br>Modified / Cannot<br>Be Determined /<br>Not Applicable | Rationale as to why<br>Modification or<br>Difference from Predicate<br>to Subject Device Does<br>Not Impact Safety and<br>Effectiveness. | | | function<br>included | | | | | | | | 14 | Hardware<br>requirements | Laptop or PC running<br>Mac OS X, Microsoft<br>Windows<br>Operating System (OS) | Laptop or PC<br>running Microsoft<br>Windows<br>Operating System<br>(OS) | Microsoft<br>Windows<br>operating system | Microsoft Windows<br>operating system on a<br>laptop or PC | Modified | Differences do not impact safety or<br>efficacy. Cardiovascular Suite can be<br>used on Laptop or PC running<br>Microsoft Windows Operating<br>System (OS) as the predicate.<br>Cardiovascular Suite can be used<br>also on Ma…