Cardiovascular Suite 4.2.1

K202094 · Quipu S.R.L · DQK · Jan 11, 2022 · Cardiovascular

Device Facts

• Record ID: K202094
• Device Name: Cardiovascular Suite 4.2.1
• Applicant: Quipu S.R.L
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Software for quantitative analysis of vascular ultrasound images; processes B-mode or Duplex (B-mode + Doppler) sequences/single images of longitudinal vessel sections. Two modules: FMD-Studio (brachial artery Flow-Mediated-Dilation) and Carotid-Studio (carotid IMT, diameter, elasticity parameters, plaque quantification). Used by trained healthcare professionals (technicians, nurses, doctors, ultrasonographers) in clinical settings. Inputs: real-time video output from ultrasound systems (via frame grabber) or previously recorded video files. Outputs: diameter charts, shear rate charts, IMT measurements, elasticity parameters. Supplements physician decision-making; not for direct diagnosis. Benefits: provides standardized, reproducible cardiovascular biomarkers for risk stratification.

Clinical Evidence

Bench testing and clinical evaluation. Precision assessed in 135 healthy volunteers (FMD-Studio) and 10 volunteers (Carotid-Studio). Accuracy validated against manual expert gold-standard measurements across 15 different ultrasound devices. Results showed excellent agreement in vessel edge location and diameter evaluation. Precision (coefficient of variation) for FMD-Studio was 10-13%; Carotid-Studio precision was <12% for most parameters.

Technological Characteristics

Software-only device; no patient-contacting materials. Operates on PC/laptop (Windows/Mac OS X). Uses contour tracking algorithm based on edge detection operator and pattern recognition. Connectivity via USB/frame grabber. Complies with IEC 62304 (software lifecycle), IEC 62366 (usability), and ISO 14971 (risk management).

Indications for Use

Indicated for quantitative analysis of vascular ultrasound images in adults to measure brachial artery diameter/changes, carotid artery diameter/changes, Carotid Intima-Media Thickness (IMT), and carotid plaque analysis. Not for pediatric use. Not for direct diagnosis of cardiovascular disease.

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

• Vascular Tools 5 (K033266)

Reference Devices

• M'Ath Std (K040686)
• IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 (K090461)

Submission Summary (Full Text)

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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. 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 ([e-mail]) or phone [phone] or 301-796-7100).

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

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#### 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> |

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#### 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 [phone]

[e-mail]

#### Manufacturer / Submitter

Vincenzo Gemignani

President

Quipu S.R.L Moruzzi 1 56124 Pisa Italy VAT IT-01995110507 Tel: [phone] Email: [e-mail]

#### 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 |

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#### 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.

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#### 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.

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#### 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. |
|-------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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…