(77 days)
No
The summary describes standard signal processing and comparison of physiological parameters (FFR, DFR, iFR) with no mention of AI or ML algorithms being used for analysis or interpretation. The performance studies focus on the equivalence of DFR to iFR and FFR, which are established physiological indices, not AI/ML outputs.
No
The device is intended for diagnostic purposes (ultrasound examinations, physiological parameter computation for diagnosis and treatment), not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that FFR and DFR are "indicated to provide hemodynamic information for use in the diagnosis and treatment of patients." Additionally, the IVUS modality is intended for "ultrasound examinations of intravascular pathology," which is a diagnostic purpose.
No
The device description explicitly states that the iLab™ Polaris Multi-Modality Guidance System consists of both hardware and software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The iLab™ Polaris Multi-Modality Guidance System uses Intravascular Ultrasound (IVUS) to image inside blood vessels and measures physiological parameters (FFR and DFR) directly within the body using catheters and pressure wires.
- Lack of Specimen Analysis: The device does not analyze specimens taken from the body. It interacts directly with the body to gather information.
Therefore, while it is a diagnostic device used in a clinical setting, it falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes
DOK, DSK, IYO, ITX
Device Description
iLab™ Polaris Multi-Modality Guidance System consists of hardware and software components which aid in supporting Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intravascular, vascular and cardiac pathology
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician/operator in 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
Non-clinical data includes Software Verification and Validation testing and non-clinical bench test methods performed on Polaris 2.10 algorithm.
Smart Minimum and DFR were validated with non-clinical test methods, in which the non-clinical data were sourced from pre-recorded patient level data acquired from VERIFY2 and CONTRAST clinical trials. iFR data from the CONTRAST dataset was re-generated using a bench iFR setup with a commercially available Volcano FFR system. The accuracy of regenerated iFR data from this bench method was validated by demonstrating the equivalency of the bench iFR measurements to the original iFR values in the complete VERIFY2 dataset.
BSC also demonstrated the waveform performance equivalency of the Comet pressure wire to the Volcano pressure wires used in VERIFY2 and St Jude pressure wires used in CONTRAST. A validation study was performed in a bench setup consisting of a pressurized chamber to regenerate patient pressure signals. The accuracy of this bench method was validated by demonstrating the equivalency of the bench FFR, iFR and DFR measurements to their original values in the complete VERIFY2 dataset. The agreement between the two measurements was evaluated in accordance with the FDA statistical analysis guidance including linear regression with lower and upper confidence intervals, Bland-Altman plot measurements were determined equivalent with no statistical difference found using the above analytical methods.
Summary of Performance Studies
Non-clinical data includes Software Verification and Validation testing and non-clinical bench test methods performed on Polaris 2.10 algorithm.
Smart Minimum and DFR were validated with non-clinical test methods, in which the non-clinical data were sourced from pre-recorded patient level data acquired from VERIFY2 and CONTRAST clinical trials. iFR data from the CONTRAST dataset was re-generated using a bench iFR setup with a commercially available Volcano FFR system. The accuracy of regenerated iFR data from this bench method was validated by demonstrating the equivalency of the bench iFR measurements to the original iFR values in the complete VERIFY2 dataset.
BSC also demonstrated the waveform performance equivalency of the Comet pressure wire to the Volcano pressure wires used in VERIFY2 and St Jude pressure wires used in CONTRAST. A validation study was performed in a bench setup consisting of a pressurized chamber to regenerate patient pressure signals. The accuracy of this bench method was validated by demonstrating the equivalency of the bench FFR, iFR and DFR measurements to their original values in the complete VERIFY2 dataset. The agreement between the two measurements was evaluated in accordance with the FDA statistical analysis guidance including linear regression with lower and upper confidence intervals, Bland-Altman plot measurements were determined equivalent with no statistical difference found using the above analytical methods.
There was no statistically significant difference between iFR and DFR when compared to FFR as a reference standard. All parameters passed the pre-defined test criteria with highly overlapping 95% confidence intervals; supporting a determination of substantial equivalence between DFR and iFR diagnostic performance.
The statistical comparison conducted between the two methods demonstrated that BSC DFR™ and Volcano iFR® have high equivalence output with the same raw waveform. Using the same cutoff value as that of iFR® of 0.89 in assessment of the hemodynamic severity of coronary lesions, DFR™ measurements were in agreement with iFR® with 97.6% Accuracy (99.2 % Specificity and 95.8% Sensitivity).
Key Metrics
Accuracy: 97.6%
Specificity: 99.2%
Sensitivity: 95.8%
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".
July 2, 2019
Boston Scientific Corporation Mugdha Dongre Sr. RA Specialist 150 Baytech Drive San Jose, California 95134
Re: K191008
Trade/Device Name: iLab Polaris Multi-Modality Guidance System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DSK, IYO, ITX Dated: April 15, 2019 Received: April 16, 2019
Dear Mugdha Dongre:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191008
Device Name
iLab™ Polaris Multi-Modality Guidance System
Indications for Use (Describe)
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 ultrages and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| Submitter's Name and
Address | Boston Scientific Corporation
150 Baytech Drive,
San Jose CA 945134
USA | | |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------|
| Contact Name and
Information | Mugdha Dongre
Sr. Regulatory Affairs Specialist
Tel: 408.635.7239
Email: Mugdha.Dongre@bsci.com | | |
| Trade Name | iLab™ Polaris Multi-Modality Guidance System | | |
| Common Name | Computer Diagnostic Programmable
Blood Pressure Computer
Ultrasonic Pulsed Echo Imaging System
Diagnostic Ultrasonic Transducer | | |
| Classification Name | 21 CFR 870.1425 (Programmable Diagnostic Computer)
21 CFR 870.1110 (Blood Pressure Computer)
21 CFR 892.1560 (Ultrasonic Pulsed Echo Imaging System)
21 CFR 892.1570 (Diagnostic Ultrasonic Transducer) | | |
| Product Code | DQK (Computer, Diagnostic, Programmable)
DSK (Computer, Blood-Pressure)
IYO (System, Imaging, Pulsed Echo, Ultrasonic)
ITX (Transducer, Ultrasonic, Diagnostic) | | |
| Predicate Name | iLab™ Polaris Multi - Modality Guidance System | K151613 | October 6, 2015 |
| Reference Devices | Volcano IFR Modality | K133323 | March 14, 2014 |
| Device Description | iLab™ Polaris Multi-Modality Guidance System consists of
hardware and software components which aid in supporting
Intravascular Ultrasound (IVUS), Fractional Flow Reserve
(FFR) and Diastolic hyperemia-Free Ratio™ (DFR™)
functionalities. | | |
510(k) Summary per 21 CFR 807.92
4
Traditional 510(k) Notification iLab Polaris Multi-Modality Guidance System Polaris 2.10 Software
Image /page/4/Figure/1 description: The image shows a flowchart of the iLab™ Polaris Multi-Modality Guidance System with Polaris 2.10. The system has two main branches: Physiology and IVUS. The Physiology branch further divides into FFR and DFR. The image also includes a text description of the software update, its features, and its intended use in cardiovascular procedures.
5
| Polaris 2.10 Software | |
|---|---|
| Intended Use/Indications | |
| for Use | the patient). For example, technical artifacts include: removal |
| of the pressure wire or opening the manifold to flush. Smart | |
| Minimum does not modify or exclude waveform data from | |
| being presented to the user. Overall physiological | |
| measurement performance remains unchanged. | |
| 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 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. | |
| Device Technology | |
| Characteristics and | |
| Comparison to Predicate | |
| Device | The Polaris 2.10 software upgrade introduces two new |
| features; Diastolic hyperemeia- Free Ratio (DFRTM) and | |
| Smart Minimum. Smart Minimum feature is applicable only | |
| during the calculation of Fractional Flow Reserve (FFR). |
6
BSC's Diastolic hyperemia-Free Ratio (DFR™), introduced by the Polaris 2.10 software update, is designed to offer users an index that is subatantially equivalent to Volcano's iFR Modality (reference device K133323) in assessing the hemodynamic severity of a coronary lesion without administration of a hyperemic agent.
The algorithms used to calculate iFR® and DFR™ have similar measuring points:
| Parameters | iFR® | DFRTM |
|---|---|---|
| Clinical | ||
| Application | Resting Flow | |
| Assessment | ||
| without | ||
| Hyperemia | Resting Flow | |
| Assessment | ||
| without | ||
| Hyperemia | ||
| Measure Output | Mean Pd over | |
| Mean Pa | Mean Pd over | |
| Mean Pa | ||
| Algorithm | ||
| Performance | Fully Automatic | |
| Real-time | ||
| Measurement | Fully Automatic | |
| Real-time | ||
| Measurement | ||
| Measure | ||
| Frequency | Every Beat | Every Beat |
| Cardiac Phase | >50% Diastolic | |
| Period | >50% Diastolic | |
| Period | ||
| Averaging | ||
| Method | Five Beats | |
| Average | Five Beats | |
| Average | ||
| Measure | ||
| Precondition | Pd Normalized to | |
| Pa | Pd Equalized to | |
| Pa |
BSC compared the diagnostic performance of the Diastolic hyperemia-Free Ratio (DFR) to the Instantaneous Wave-Free Ratio (iFR) by comparing respective indices (DFR and iFR) to Fractional Flow Reserve (FFR) for the purposes of supporting a determination of substantial equivalence between DFR and iFR. There was no statistically significant difference between iFR and DFR when compared to FFR as a reference standard. All parameters passed the pre-defined test criteria with highly overlapping 95% confidence intervals; supporting a determination of substantial equivalence between DFR and iFR diagnostic performance.
The statistical comparison conducted between the two methods demonstrated that BSC DFR™ and Volcano iFR® have high equivalence output with the same raw waveform. Using the same cutoff value as that of iFR® of 0.89 in assessment of the hemodynamic severity of coronary lesions,
7
| | Polaris 2.10 Software
DFR™ measurements were in agreement with iFR® with
97.6% Accuracy (99.2 % Specificity and 95.8% Sensitivity). |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Polaris 2.10 utilizes the same fundamental technology with
the same intended use and indication of use as that of the
predicate (K151613) and reference device (K133323). The
Polaris 2.10 software update does not impact the intended use,
indication of use, performance, manufacturing process or any
other system hardware components of the iLab™ Polaris
Multi-Modality Guidance System and its associated
accessories i.e, Comet Pressure guidewire and compatible
ultrasound catheters. No new risks or issues of safety and
effectiveness are raised by this change. |
| | In addition, verification and validation addresses the
modifications between the predicate and the subject device,
further supporting a determination that the subject device is
substantially equivalent to that of the predicate device. |
| Non-Clinical Performance
Data | Non-clinical data includes Software Verification and
Validation testing and non-clinical bench test methods
performed on Polaris 2.10 algorithm. |
| | Smart Minimum and DFR were validated with non-clinical
test methods, in which the non-clinical data were sourced
from pre-recorded patient level data acquired from VERIFY2
and CONTRAST clinical trials. iFR data from the
CONTRAST dataset was re-generated using a bench iFR
setup with a commercially available Volcano FFR system.
The accuracy of regenerated iFR data from this bench method
was validated by demonstrating the equivalency of the bench
iFR measurements to the original iFR values in the complete
VERIFY2 dataset. |
| | BSC also demonstrated the waveform performance
equivalency of the Comet pressure wire to the Volcano
pressure wires used in VERIFY2 and St Jude pressure wires
used in CONTRAST. A validation study was performed in a
bench setup consisting of a pressurized chamber to regenerate
patient pressure signals. The accuracy of this bench method
was validated by demonstrating the equivalency of the bench
FFR, iFR and DFR measurements to their original values in
the complete VERIFY2 dataset. The agreement between the
two measurements was evaluated in accordance with the FDA
statistical analysis guidance including linear regression with
lower and upper confidence intervals, Bland-Altman plot |
| Polaris 2.10 Software | |
| | measurements were determined equivalent with no statistical
difference found using the above analytical methods. |
| | Software Verification and Validation testing demonstrated
compliance with following international and FDA- recognized
consensus standards and FDA guidance documents: |
| | - IEC 62304 Medical device software- Software life
cycle processes, (Edition 1.1 2015-06). FDA/CDRH
recognition number 13-79 |
| | - FDA Guidance issued on May 11, 2005, Guidance for
the Content of Premarket Submissions for Software
Contained in Medical Devices |
| | - FDA Guidance issued on March 13, 2007, Statistical
Guidance on Reporting Results from Studies
Evaluating Diagnostic Tests |
| Clinical Performance Data | Not applicable; determination of substantial equivalence is
based on an assessment of non-clinical performance data. |
| Conclusion | iLab™ Polaris Multi- Modality Guidance System (subject
device with Polaris 2.10 software) is substantially equivalent
to the currently marketed predicate device, iLab™ Polaris
Multi- Modality Guidance System (K151613) in terms of
indications for use, technological characteristics and safety
and effectiveness.
The modifications to the predicate device are within
predetermined specifications. Additionally, non-clinical
performance tests provided in this 510(k) premarket
notification demonstrate substantial equivalence to the
predicate device and that conformance to IEC standards and
guidance documents have been appropriately addressed. The
tests performed support substantial equivalence of the
modified device and demonstrate that the iLab™ Polaris
Multi- Modality Guidance System, is as safe and effective as
its predicate device without raising any new safety and/or
effectiveness concerns |
8