(92 days)
Not Found
No
The summary describes a multi-modality guidance system with IVUS, FFR, and DFR functionalities, including an automatic pullback feature. There is no mention of AI, ML, or any related concepts like training data, test data, or performance metrics typically associated with AI/ML algorithms. The performance studies focus on hardware verification and validation against a predicate device.
No
The device is described as a "non-patient contacting, diagnostic device designed to provide three (3) primary modalities: IVUS (Intravascular Ultrasound), FFR (Fractional Flow Reserve) and Diastolic hyperemia-Free Ratio (DFR)." Its intended use is for ultrasound examinations and to provide hemodynamic information for diagnosis and treatment planning, rather than directly providing therapy.
Yes.
The "Device Description" section explicitly states: "The iLab™ Polaris Multi-Modality Guidance System is a non-patient contacting, diagnostic device designed to provide three (3) primary modalities: IVUS (Intravascular Ultrasound), FFR (Fractional Flow Reserve) and Diastolic hyperemia-Free Ratio (DFR)." Additionally, the "Intended Use / Indications for Use" section indicates that FFR and DFR are "intended to provide hemodynamic information for use in the diagnosis and treatment of patients".
No
The device description explicitly lists numerous hardware components, including processors, displays, power supplies, and a motor drive unit. The performance studies also mention hardware verification and validation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed in vitro (outside the body).
- Device Function: The iLab™ Polaris Multi-Modality Guidance System is described as a "non-patient contacting, diagnostic device" that provides imaging (IVUS) and physiological measurements (FFR and DFR) within the body during interventional procedures.
- Intended Use: The intended use clearly states it's for "ultrasound examinations of intravascular pathology" and to "provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters." These are procedures performed directly on the patient.
The device is used in vivo (within the body) to provide real-time guidance and diagnostic information during procedures, not to analyze samples collected from the patient.
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 (comma separated list FDA assigned to the subject device)
DQK, DSK, ITX, IYO
Device Description
The iLab™ Polaris Multi-Modality Guidance System is a non-patient contacting, diagnostic device designed to provide three (3) primary modalities: IVUS (Intravascular Ultrasound), FFR (Fractional Flow Reserve) and Diastolic hyperemia-Free Ratio (DFR). The iLab Polaris Multi-Modality Guidance System is supported by the Polaris 2.14 (iLab 3.14) software.
The iLab™ Polaris Multi-Modality Guidance System is offered in both mobile (cart) and integrated (installed) configurations consisting of hardware and software components supporting intravascular ultrasound (IVUS), fractional flow reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities and includes additional Auto Pullback options.
Hardware components of the iLab™ Polaris Multi-Modality Guidance System include: Data Acquisition Processor, Imaging Processor, Control Panel Primary Image display (LCD flat panel), System Power supply/transformer, updated Motor Drive Unit (MDU5+), Motor Drive cable storage, Printer, removable Storage Media, CD/DVD Recorder, Mouse/Mouse Pad, and Bluetooth Communication Module (BCM).
The iLab Polaris Multi-Modality Guidance System includes automatic pullback functionality to aid the physician/operator during IVUS modality when the following occur:
- 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-dimensions, longitudinal reconstructions of the anatomy is desired.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intravascular, Vascular and Cardiac
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
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 hardware verification and validation carried out using the updated MDU5+ Motor Drive Unit. Testing was conducted according to applicable international standards, FDA recognized consensus standards, and the same well-established 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 25, 2021
Boston Scientific Corporation Rochell Aranha Regulatory Affairs Specialist I Three Scimed Place Maple Grove Hennepin, Minnesota 55311
Re: K210889
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: DQK, DSK, ITX, IYO Dated: March 24, 2021 Received: March 25, 2021
Dear Rochell Aranha:
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,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
iLabTM 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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | □ Over-The-Counter Use (21 CER 801 Subpart C) |
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3
510(k) Summary per
21 CFR 807.92
| Sponsor | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Rochell Aranha
Specialist I, Regulatory Affairs
Phone: 763-255-0017
Fax: 763-257-6482
e-mail: Rochell.Aranha@bsci.com |
| Date Prepared | March 24, 2021 |
| Proprietary Name | iLab™ Polaris Multi-Modality Guidance System |
| Common Name | Computer Diagnostic Programmable |
| Product Code | DQK, DSK, IYO, ITX |
| Classification | Class II, 21 CFR 870.1425 |
| Predicate Name | iLab™ Polaris Multi-Modality Guidance System
K201178, May 29, 2020 |
Device Description
The iLab™ Polaris Multi-Modality Guidance System is a non-patient contacting, diagnostic device designed to provide three (3) primary modalities: IVUS (Intravascular Ultrasound), FFR (Fractional Flow Reserve) and Diastolic hyperemia-Free Ratio (DFR). The iLab Polaris Multi-Modality Guidance System is supported by the Polaris 2.14 (iLab 3.14) software.
The iLab™ Polaris Multi-Modality Guidance System is offered in both mobile (cart) and integrated (installed) configurations consisting of hardware and software components supporting intravascular ultrasound (IVUS), fractional flow reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities and includes additional Auto Pullback options.
Hardware components of the iLab™ Polaris Multi-Modality Guidance System include: Data Acquisition Processor, Imaging Processor, Control Panel Primary Image display (LCD flat panel), System Power supply/transformer, updated Motor Drive Unit (MDU5+), Motor Drive cable storage, Printer, removable Storage Media, CD/DVD Recorder, Mouse/Mouse Pad, and Bluetooth Communication Module (BCM).
The iLab Polaris Multi-Modality Guidance System includes automatic pullback functionality to aid the physician/operator during IVUS modality when the following occur:
- 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,
4
- two-dimensions, longitudinal reconstructions of the anatomy is desired. ●
Intended Use/Indications for Use
The IVUS modality of the iLab™ Polaris Multi-Modality Guidance System is intended for ultrasound examinations of intravascular pathology. Intrasound 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.
5
Comparison of Technological Characteristics
The iLab Polaris Multi-Modality Guidance System with updated MDU5+ Motor Drive Unit supporting additional Auto Pullback functionality is substantially equivalent to the predicate il ab Polaris Multi-Modality Guidance System (K201178) in intended use, fundamental design technology, functional modalities and performance features. Additional auto pullback options for user selection do not raise different questions of safety or effectiveness.
Non-clinical Performance
Determination of substantial equivalence is based on an assessment of non-clinical performance data which includes hardware verification and validation carried out using the updated MDU5+ Motor Drive Unit. Testing was conducted according to applicable international standards, FDA recognized consensus standards, and the same well-established test methods and criteria applied to the predicate device. The following standards and guidance are applicable in demonstration of substantial equivalence related to the testing:
- EN 62304:2006+AMD 1:2015-//EC 62304 (Edition 1.1 2015-06) (FDA/CDRH Recognition ● No.-13-79) Medical Device Software - Software Life-Cycle Processes
- ANSI AAMI BP-22:1994 (R) 2011 (FDA/CDRH Recognition No.3-44) Blood Pressure ● Transducers
- ANSI AAMI ES 60601-1: 2005/(R)2012 and A1:2012 (FDA/CDRH Recognition No.19-4) -● Medical Electrical Equipment- Part1: General requirements for Basic Safety and Essential Performance
- . IEC 60601-1-2:2014 4th Ed. (FDA/CDRH Recognition No.19-8) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
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, functional modalities and performance features the iLab Polaris Multi-Modality Guidance System with updated MDU5+ Motor Drive Unit including additional Auto Pullback speeds 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.