(30 days)
Not Found
No
The summary describes a system for displaying physiological parameters based on direct measurements from sensors, without mentioning any AI/ML components for analysis or interpretation.
No
The device is described as providing hemodynamic information for diagnosis and treatment and displaying patient blood pressure measurements; it does not directly treat a condition or restore function.
Yes
The device is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients.
No
The device description explicitly states the system consists of hardware components including a tablet, digital pen, power supply, and docking stations, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device "computes, and displays various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices." It specifically mentions receiving blood pressure measurements from a coronary pressure guidewire and transducer. This indicates it's measuring physiological parameters in vivo (within the living body) during a procedure, not analyzing samples in vitro (outside the body).
- Intended Use: The intended use is in "catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters." This aligns with real-time monitoring during a medical procedure, not laboratory testing of samples.
Therefore, the AVVIGO Guidance System, as described, is a medical device used for physiological monitoring during cardiovascular procedures, not an in vitro diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DQK, DSK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Catheterization and related cardiovascular specialty laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
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.
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
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,
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
2
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) | ||
|---|---|---|
| ------------------------------------------------- | -------------------------- | -------------------------- |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
|Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Kevin Catalano
Senior Regulatory Affairs Specialist
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2413
Fax: 763-257-6482
e-mail: Kevin.Catalano@bsci.com |
| Date Prepared | June 22, 2020 |
| Proprietary Name | AVVIGO™ Guidance System |
| Common Name | Computer Diagnostic Programmable
Blood Pressure Computer |
| Product Code | DQK
DSK |
| Classification | Class II, 21 CFR 870.1425 |
| Predicate Device | iLab™ Polaris Multi -Modality Guidance System
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.
4
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)
- iLab Polaris Multi-Modality
Guidance System | Proposed Device - AVVIGO
Guidance System | Comment |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use/Intended Use | The IVUS modality of the
iLab™ Polaris Multi-Modality
Guidance System is intended
for ultrasound examinations of
intravascular pathology.
Intravascular ultrasound is
indicated in patients who are
candidates for transluminal
interventional procedures
such as angioplasty and
atherectomy.
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.
The Imaging Catheters
generate ultrasound images
and are intended for
ultrasound examination of
vascular and cardiac
pathology. Boston Scientific
manufactures a wide variety | 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. | Substantially
Equivalent
AVVIGO is not
intended for
IVUS. |
| | | | |
| | of catheters for different
applications. The
recommended use of each of
these catheters may vary
depending on the size and
type of the catheter. Please
refer to the Imaging Catheter
Directions for Use, packaged
with each catheter.
Indications for Auto Pullback
Use (IVUS Only)
Automatic Pullback is
indicated when the following
occurs:
- The physician/operator
wants to standardize the
method in which intravascular
ultrasound images are
obtained and documented:
procedure-to-procedure,
operator-to-operator. - The physician/operator
wants to make linear distance
determinations post-
procedurally, which requires
the imaging core of a catheter
to be pulled back at a known
uniform speed. - Two-dimensional,
longitudinal reconstruction of
the anatomy is desired. | | |
| Overall Design | Two PCs (Acquisition and
Imaging Processors)
One BCM (Bluetooth
Communication Module)
One Imaging Display
One Control Panel
One AC Power Isolation
Transformer
One Rolling Cart Assembly
(includes necessary cabling
internal to the cart)
One Printer | Tablet (with AVVIGO
Software, touchscreen,
Battery, and onboard
Bluetooth)
Power Supply
Digital Pen
Power Cable
Tablet Mobile Pole
Docking Station
Desktop Docking Station
Tablet Mobile Pole (packaged
separately) | Substantially
Equivalent
Both systems
use the same
inputs and
provide the
same outputs to
the user.
Tablet
integrates
Bluetooth
capability. |
| Connectivity to
FFR Link;
acquisition of Pd
and Pa data | Bluetooth connection | Bluetooth connection | Same |
| Standard
Conformity | IEC 62304 Medical device
software- Software lifecycle | IEC 62304 Medical device
software- Software lifecycle | Same |
| | processes, Edition 1.1 2015-
06). FDA/CDRH
recognition number 13-79 | processes, Edition 1.1 2015-
06). FDA/CDRH
recognition number 13-79 | |
| | ANSI AAMI BP-22:1994 (R)
2016- Blood Pressure
Transducers. FDA recognition
number 3-44 | ANSI AAMI BP-22:1994 (R)
2016- Blood Pressure
Transducers. FDA recognition
number 3-44 | |
| | 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 | 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 | IEC 60601-1-2:2014 4th Ed.
Medical electrical equipment -
Part 1-2: General
requirements for basic safety
and essential performance -
Collateral Standard:
Electromagnetic disturbances - Requirements and tests
FDA/CDRH recognition
number 19-8 | |
| Compatible
Accessories | Motordrive Unit, MDU5 Plus
Sterile Bag, Disposable and
Permanent Pullback Sled,
FFR Link, Bluetooth
Communication Module
(BCM)
Pressure Sensitive
Guidewires
• Comet
• Comet II
Intravascular Imaging
Catheters
• OptiCross™
• OptiCross™ 18
• 6OptiCross™ 18
• OptiCross™ HD
• OptiCross™ 6 HD
• Ultra Ice Plus | FFR Link
Pressure Sensitive
Guidewires-
Comet
Comet II | Substantially
Equivalent
AVVIGO is not
intended to
support IVUS
which requires
the use of the
MD5 plus
motordrive and
disposable or
permanent sled
components.
Additionally,
AVVIGO
contains
onboard
Bluetooth
eliminating
need for BCM. |
| Patient Contact | Non-patient contacting | Non-patient contacting | Same |
| Ergonomics of
the User Interface | The iLab User Interface
consists of a console with a
touch screen and Windows | The AVVIGO User Interface
consists of a tablet with a
touch screen and Windows | Substantially
Equivalent
AVVIGO utilizes |
| | based software Graphical
User Interface (GUI). | based software Graphical
User Interface (GUI). | support the
GUI. |
| Software
Technology | The iLab System is a
Windows 7 based device. | The AVVIGO System is a
Windows 10 based device. | Substantially
Equivalent |
| | | | Both Operating
Systems are
Windows based
however, the
Avvigo System
OS has been
updated to
Windows 10. |
| DICOM | DICOM 3.0, Auto-save still
frames & scalable file
compression, Supports
lossless and lossy JPEG
compression. Supports US
Multi-frame Greyscale, (Pixel
Data), US Multi-Frame
Greyscale (Screenshot), Sec
Capture (Screenshot), True
Color Multi Frame Secondary
Capture (Screenshot) | DICOM 3.0, Auto-save still
frames & scalable file
compression, Supports
lossless and lossy JPEG
compression. Supports US
Multi-frame Greyscale, (Pixel
Data), US Multi-Frame
Greyscale (Screenshot), Sec
Capture (Screenshot), True
Color Multi Frame Secondary
Capture (Screenshot) | Same |
| Electromagnetic
Compatibility and
Electrical Safety | In compliance with ANSI/AAMI
ES60601- 1:2005+A2 (R2012)
A1 and other applicable
electrical standards | In compliance with ANSI/AAMI
ES60601- 1:2005+A2 (R2012)
A1 and other applicable
electrical standards | Same |
| Functional
Modality | IVUS and Physiology (FFR/
DFR) | Physiology (FFR/ DFR) | Substantially
Equivalent |
| | | | AVVIGO is not
intended to
support IVUS. |
| Software
Requirements
Related to
Diagnostics | The system shall calculate
and display the FFR value
when the following are met:
● Pd and Pa trend values
are available
● Pa trend value is not 0
● Recording has started
● Display FFR Value in
Record is enabled in
System Profile
● If disabled, value is
calculated but not
displayed. | The system shall calculate
and display the FFR value
when the following are met:
● Pd and Pa trend values
are available
● Pa trend value is not 0
● Recording has started
● Display FFR Value in
Record is enabled in
System Profile
● If disabled, value is
calculated but not
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 |
5
K201713
6
7
8
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.