AVVIGO Guidance System

K201713 · Boston Scientific Corporation · DQK · Jul 23, 2020 · Cardiovascular

Device Facts

• Record ID: K201713
• Device Name: AVVIGO Guidance System
• Applicant: Boston Scientific Corporation
• Product Code: DQK · Cardiovascular
• Decision Date: Jul 23, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

FFR and DFR are 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. FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

Device Story

AVVIGO Guidance System is a tablet-based computer for displaying hemodynamic data. It receives blood pressure measurements (Pa and Pd) wirelessly via Bluetooth from a coronary pressure guidewire and transducer connected to an FFR Link. The system processes these inputs to compute and display physiological parameters, specifically Fractional Flow Reserve (FFR) and Diastolic Pressure Ratio (DFR). Used in catheterization and cardiovascular specialty laboratories by clinicians, the device provides real-time waveforms and calculated values to assist in clinical decision-making during interventional procedures. The system is non-sterile and non-implantable, powered by AC or lithium polymer battery, and features a touchscreen GUI. It benefits patients by providing standardized hemodynamic information to guide diagnosis and treatment.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical performance data, including software, hardware, packaging, and electrical safety verification and validation testing conducted according to international and FDA-recognized consensus standards.

Technological Characteristics

Tablet-based system with touchscreen, lithium polymer battery, and digital pen. Connectivity via Bluetooth to FFR Link. Operates on Windows 10. Complies with ANSI/AAMI ES 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 62304 (software lifecycle). Non-patient contacting. Supports DICOM 3.0 for data management.

Indications for Use

Indicated for patients undergoing measurement of physiological parameters in catheterization and cardiovascular specialty laboratories to provide hemodynamic information for diagnosis and treatment.

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

• iLab Polaris Multi-Modality Guidance System (K201178)

Submission Summary (Full Text)

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July 23, 2020

Boston Scientific Corporation Kevin Catalano Senior Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311

Re: K201713

Trade/Device Name: AVVIGOTM Guidance System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 22, 2020 Received: June 23, 2020

Dear Kevin Catalano:

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,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, & 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) K201713

Device Name AVVIGO™ Guidance System

#### Indications for Use (Describe)

FFR and DFR™ are 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.

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

| Type of Use (Select one or both, as applicable) | <input type="checkbox"/> | <input type="checkbox"/> |
|-------------------------------------------------|--------------------------|--------------------------|
|-------------------------------------------------|--------------------------|--------------------------|

| X | 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 contains the words "Boston Scientific" in a stylized, serif font. The words are stacked on top of each other, with "Boston" on the top line and "Scientific" on the bottom line. The text is a dark blue color. The image appears to be a logo or branding element for the company Boston Scientific.

300 Boston Scientific Way Marlborough, MA 01752-1234 508-683-4000 www.bostonscientific.com

## 510(k) Summary per 21 CFR 807.92

| Sponsor | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, Massachusetts 01752<br>USA |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Kevin Catalano<br>Senior Regulatory Affairs Specialist<br>Three Scimed Place<br>Maple Grove, MN 55311-1566<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | June 22, 2020 |
| Proprietary Name | AVVIGO™ Guidance System |
| Common Name | Computer Diagnostic Programmable<br>Blood Pressure Computer |
| Product Code | DQK<br>DSK |
| Classification | Class II, 21 CFR 870.1425 |
| Predicate Device | iLab™ Polaris Multi -Modality Guidance System<br>K201178, May 29, 2020 |

## Device Description

The AVVIGO Guidance System is a medical device system that consists of a touchscreen tablet with battery, a digital pen, a power supply and cable which can be mounted to a mobile pole via the pole docking station or set on tabletop via the desktop docking station. The tablet is a nonsterile, non-implantable tablet computer controlled by a graphic user interface (GUI) displayed on a touchscreen. The tablet is powered by either AC line power or a lithium polymer battery.

The system software displays patient's blood pressure measurements that are received from the coronary pressure guidewire and transducer that is connected to a FFR Link. The FFR Link digitizes and wirelessly streams the data which is displayed on the tablet.

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## Intended Use/Indications for Use

FFR and DFR are 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.

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

#### Comparison of Technological Characteristics

The AVVIGO Guidance System is substantially equivalent to the predicate device, Polaris 2.12 (iLab 3.12) K201178, in intended use, fundamental design technology and FFR/DFR modalities, including DFR Equalization, and performance features.

| Characteristic | Predicate Device (K201178)<br>- iLab Polaris Multi-Modality<br>Guidance System | Proposed Device - AVVIGO<br>Guidance System | Comment |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use/Intended Use | The IVUS modality of the<br>iLab™ Polaris Multi-Modality<br>Guidance System is intended<br>for ultrasound examinations of<br>intravascular pathology.<br>Intravascular ultrasound is<br>indicated in patients who are<br>candidates for transluminal<br>interventional procedures<br>such as angioplasty and<br>atherectomy.<br>FFR and DFR™ are intended<br>for use in catheterization and<br>related cardiovascular<br>specialty laboratories to<br>compute, and display various<br>physiological parameters<br>based on the output from one<br>or more electrodes,<br>transducers, or measuring<br>devices. FFR and DFR are<br>indicated to provide<br>hemodynamic information for<br>use in the diagnosis and<br>treatment of patients that<br>undergo measurement of<br>physiological parameters.<br>The Imaging Catheters<br>generate ultrasound images<br>and are intended for<br>ultrasound examination of<br>vascular and cardiac<br>pathology. Boston Scientific<br>manufactures a wide variety | FFR and DFR are intended for<br>use in catheterization and<br>related cardiovascular<br>specialty laboratories to<br>compute, and display various<br>physiological parameters<br>based on the output from one<br>or more electrodes,<br>transducers, or measuring<br>devices.<br>FFR and DFR are indicated to<br>provide hemodynamic<br>information for use in the<br>diagnosis and treatment of<br>patients that undergo<br>measurement of physiological<br>parameters. | Substantially<br>Equivalent<br><br>AVVIGO is not<br>intended for<br>IVUS. |
| | | | |
| | of catheters for different<br>applications. The<br>recommended use of each of<br>these catheters may vary<br>depending on the size and<br>type of the catheter. Please<br>refer to the Imaging Catheter<br>Directions for Use, packaged<br>with each catheter.<br>Indications for Auto Pullback<br>Use (IVUS Only)<br>Automatic Pullback is<br>indicated when the following<br>occurs:<br>- The physician/operator<br>wants to standardize the<br>method in which intravascular<br>ultrasound images are<br>obtained and documented:<br>procedure-to-procedure,<br>operator-to-operator.<br>- The physician/operator<br>wants to make linear distance<br>determinations post-<br>procedurally, which requires<br>the imaging core of a catheter<br>to be pulled back at a known<br>uniform speed.<br>- Two-dimensional,<br>longitudinal reconstruction of<br>the anatomy is desired. | | |
| Overall Design | Two PCs (Acquisition and<br>Imaging Processors)<br>One BCM (Bluetooth<br>Communication Module)<br>One Imaging Display<br>One Control Panel<br>One AC Power Isolation<br>Transformer<br>One Rolling Cart Assembly<br>(includes necessary cabling<br>internal to the cart)<br>One Printer | Tablet (with AVVIGO<br>Software, touchscreen,<br>Battery, and onboard<br>Bluetooth)<br>Power Supply<br>Digital Pen<br>Power Cable<br>Tablet Mobile Pole<br>Docking Station<br>Desktop Docking Station<br>Tablet Mobile Pole (packaged<br>separately) | Substantially<br>Equivalent<br>Both systems<br>use the same<br>inputs and<br>provide the<br>same outputs to<br>the user.<br>Tablet<br>integrates<br>Bluetooth<br>capability. |
| Connectivity to<br>FFR Link;<br>acquisition of Pd<br>and Pa data | Bluetooth connection | Bluetooth connection | Same |
| Standard<br>Conformity | IEC 62304 Medical device<br>software- Software lifecycle | IEC 62304 Medical device<br>software- Software lifecycle | Same |
| | processes, Edition 1.1 2015-<br>06). FDA/CDRH<br>recognition number 13-79 | processes, Edition 1.1 2015-<br>06). FDA/CDRH<br>recognition number 13-79 | |
| | ANSI AAMI BP-22:1994 (R)<br>2016- Blood Pressure<br>Transducers. FDA recognition<br>number 3-44 | ANSI AAMI BP-22:1994 (R)<br>2016- Blood Pressure<br>Transducers. FDA recognition<br>number 3-44 | |
| | ANSI AAMI ES 60601-1:<br>2005/(R)2012 and A1:2012-<br>Medical Electrical Equipment-<br>Part1: General requirements<br>for Basic Safety and Essential<br>Performance. FDA<br>recognition number-19-4 | ANSI AAMI ES 60601-1:<br>2005/(R)2012 and A1:2012-<br>Medical Electrical Equipment-<br>Part1: General requirements<br>for Basic Safety and Essential<br>Performance. FDA recognition<br>number-19-4 | |
| | IEC 60601-1-2 Edition 3:<br>2007-03 - Medical Electrical<br>Equipment - Part 1-2: General<br>Requirements for Basic<br>Safety and Essential<br>Performance - Collateral<br>Standard: Electromagnetic<br>Compatibility – Requirements<br>and Tests- FDA recognition<br>number-19-1 | IEC 60601-1-2:2014 4th Ed.<br>Medical electrical equipment -<br>Part 1-2: General<br>requirements for basic safety<br>and essential performance -<br>Collateral Standard:<br>Electromagnetic disturbances<br>- Requirements and tests<br>FDA/CDRH recognition<br>number 19-8 | |
| Compatible<br>Accessories | Motordrive Unit, MDU5 Plus<br>Sterile Bag, Disposable and<br>Permanent Pullback Sled,<br>FFR Link, Bluetooth<br>Communication Module<br>(BCM)<br>Pressure Sensitive<br>Guidewires<br>• Comet<br>• Comet II<br>Intravascular Imaging<br>Catheters<br>• OptiCross™<br>• OptiCross™ 18<br>• 6OptiCross™ 18<br>• OptiCross™ HD<br>• OptiCross™ 6 HD<br>• Ultra Ice Plus | FFR Link<br>Pressure Sensitive<br>Guidewires-<br>Comet<br>Comet II | Substantially<br>Equivalent<br>AVVIGO is not<br>intended to<br>support IVUS<br>which requires<br>the use of the<br>MD5 plus<br>motordrive and<br>disposable or<br>permanent sled<br>components.<br>Additionally,<br>AVVIGO<br>contains<br>onboard<br>Bluetooth<br>eliminating<br>need for BCM. |
| Patient Contact | Non-patient contacting | Non-patient contacting | Same |
| Ergonomics of<br>the User Interface | The iLab User Interface<br>consists of a console with a<br>touch screen and Windows | The AVVIGO User Interface<br>consists of a tablet with a<br>touch screen and Windows | Substantially<br>Equivalent<br>AVVIGO utilizes |
| | based software Graphical<br>User Interface (GUI). | based software Graphical<br>User Interface (GUI). | support the<br>GUI. |
| Software<br>Technology | The iLab System is a<br>Windows 7 based device. | The AVVIGO System is a<br>Windows 10 based device. | Substantially<br>Equivalent |
| | | | Both Operating<br>Systems are<br>Windows based<br>however, the<br>Avvigo System<br>OS has been<br>updated to<br>Windows 10. |
| DICOM | DICOM 3.0, Auto-save still<br>frames & scalable file<br>compression, Supports<br>lossless and lossy JPEG<br>compression. Supports US<br>Multi-frame Greyscale, (Pixel<br>Data), US Multi-Frame<br>Greyscale (Screenshot), Sec<br>Capture (Screenshot), True<br>Color Multi Frame Secondary<br>Capture (Screenshot) | DICOM 3.0, Auto-save still<br>frames & scalable file<br>compression, Supports<br>lossless and lossy JPEG<br>compression. Supports US<br>Multi-frame Greyscale, (Pixel<br>Data), US Multi-Frame<br>Greyscale (Screenshot), Sec<br>Capture (Screenshot), True<br>Color Multi Frame Secondary<br>Capture (Screenshot) | Same |
| Electromagnetic<br>Compatibility and<br>Electrical Safety | In compliance with ANSI/AAMI<br>ES60601- 1:2005+A2 (R2012)<br>A1 and other applicable<br>electrical standards | In compliance with ANSI/AAMI<br>ES60601- 1:2005+A2 (R2012)<br>A1 and other applicable<br>electrical standards | Same |
| Functional<br>Modality | IVUS and Physiology (FFR/<br>DFR) | Physiology (FFR/ DFR) | Substantially<br>Equivalent |
| | | | AVVIGO is not<br>intended to<br>support IVUS. |
| Software<br>Requirements<br>Related to<br>Diagnostics | The system shall calculate<br>and display the FFR value<br>when the following are met:<br>● Pd and Pa trend values<br>are available<br>● Pa trend value is not 0<br>● Recording has started<br>● Display FFR Value in<br>Record is enabled in<br>System Profile<br>● If disabled, value is<br>calculated but not<br>displayed. | The system shall calculate<br>and display the FFR value<br>when the following are met:<br>● Pd and Pa trend values<br>are available<br>● Pa trend value is not 0<br>● Recording has started<br>● Display FFR Value in<br>Record is enabled in<br>System Profile<br>● If disabled, value is<br>calculated but not<br>displayed. | Same |
| | The system shall display the following during DFR run recording Pa waveform Pd waveform Pa and Pd DFR windows Recorded time | The system shall display the following during DFR run recording Pa waveform Pd waveform Pa and Pd DFR windows Recorded time | Same |

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# K201713

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### Non-clinical Performance

Determination of substantial equivalence is based on an assessment of non-clinical performance data which includes software, hardware, packaging and electrical safety verification and validation carried out on the AVVIGO Guidance System. Testing was conducted according to applicable international standards, FDA recognized consensus standards, and the same wellestablished test methods and criteria applied to the predicate device. The following standards and guidance are applicable in demonstration of substantial equivalence related to software:

- . IEC 62304 Medical Device Software - Software Lifecycle Processes, (edition 1.1 2015-06) FDA recognition: 13-79.
- FDA Guidance for Industry, Issued May 11, 2005, Guidance for the Content of Premarket ● Submissions for Software Contained in Medical Devices.

The following standards and guidance are applicable in demonstration of substantial equivalence related to Hardware:

- FDA Guidance for Industry, Issued August 14, 2013, Radio Frequency Wireless ● Technology in Medical Devices.
- ANSI AAMI ES 60601-1: 2005/(R)2012 and A1:2012- Medical Electrical Equipment-. Part1: General requirements for Basic Safety and Essential Performance. FDA recognition number-19-4
- . IEC 60601-1-2 Edition 3: 2007-03 – Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests- FDA recognition number-19-1

#### Clinical Performance Data

Not applicable. A determination of Substantial Equivalence for this modification is not based on clinical data. Substantial Equivalence is based on non-clinical performance data.

#### Conclusion

Based on a comparison of intended use, fundamental design technology, FFR/DFR modalities, including DFR Equalization and performance features, the AVVIGO Guidance System is substantially equivalent to the predicate device. A comparison of the modified and predicate devices, along with verification and validation testing applicable to the modified device, supports a conclusion of substantial equivalence and raise no new issues of safety and effectiveness.