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 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. ●

AI/ML Overview

The document provided is an FDA 510(k) clearance letter for the Boston Scientific Corporation iLab Polaris Multi-Modality Guidance System. This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data (hardware verification and validation), rather than clinical studies proving the device meets specific performance acceptance criteria for diagnostic accuracy or effectiveness.

Therefore, the requested information regarding acceptance criteria for device performance, clinical study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in the provided text, as the clearance was based on non-clinical data.

The letter explicitly states:

"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."

This means no clinical study was performed or required for this particular 510(k) submission to demonstrate the device meets performance acceptance criteria relevant to medical diagnosis or treatment outcomes. The focus was on ensuring the updated hardware (MDU5+ Motor Drive Unit) and new auto pullback functionality did not introduce new safety or effectiveness concerns, and that the device maintained the same intended use and fundamental design as the predicate device.

To answer your request, here's what can be inferred from the document:

The provided document describes the FDA 510(k) premarket notification for the iLab™ Polaris Multi-Modality Guidance System. However, this submission specifically states that the determination of substantial equivalence is based on non-clinical performance data and that clinical performance data is not applicable. Therefore, the document does not contain information about clinical acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, or details of ground truth establishment for diagnostic accuracy.

The clearance is for an updated MDU5+ Motor Drive Unit supporting additional Auto Pullback functionality within an existing system, demonstrating that this modification does not raise different questions of safety or effectiveness compared to the predicate device (K201178).

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as clinical performance metrics for diagnostic accuracy are not assessed in this submission. The acceptance was based on non-clinical performance (hardware verification and validation) ensuring the updated MDU5+ Motor Drive Unit and new Auto Pullback functionality meet safety and performance standards equivalent to the predicate device.
Reported Device Performance: The document only states: "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." No specific numerical performance results are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set data was used or described. The submission relied on non-clinical hardware verification and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical ground truth was established as no clinical study for diagnostic performance was conducted for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set and thus no adjudication method used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was done. The device description does not imply AI assistance for human readers in a diagnostic capacity; it describes a guidance system for intravascular procedures.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. No standalone algorithm performance study was mentioned as the submission was based on non-clinical data for hardware modification.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth was used for this submission. The "ground truth" for the non-clinical assessment was adherence to engineering standards and safety/performance criteria for hardware functionality.

8. The sample size for the training set

Not applicable. No training set for an algorithm was mentioned in this non-clinical submission.

9. How the ground truth for the training set was established

Not applicable. No training set was mentioned.

Summary: The FDA 510(k) clearance for the iLab™ Polaris Multi-Modality Guidance System with the updated MDU5+ Motor Drive Unit was based solely on non-clinical performance data (hardware verification and validation), as explicitly stated in the document. Therefore, none of the requested clinical performance study details are available in this text.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K210889

Device Name

iLabTM Polaris Multi-Modality Guidance System

Indications for Use (Describe)

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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510(k) Summary per

21 CFR 807.92

Sponsor	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752
Contact Name andInformation	Rochell AranhaSpecialist I, Regulatory AffairsPhone: 763-255-0017Fax: 763-257-6482e-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 SystemK201178, May 29, 2020

Device Description

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,

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

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.

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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.

Regulation Number and Section

§ 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).