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 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 Polaris 2.12 (iLab 3.12) software update supports the iLab™ Polaris Multi-Modality Guidance System and supports existing device IVUS, FFR and DFR™ functionality as well as includes scaling updates to DFR™ equalization values, enhanced imaging modes and OS patches for additional security.

Diastolic hyperemia-Free Ratio™ (DFR) is a resting index that measures multiple diastolic portions during the cardiac cycle. DFR™ calculates the diastolic portion of the cardiac cycle averaged over five beats, using two criteria for the measurement windows: 1) Pa less than mean Pa and 2) down sloping Pa values. No hyperemic agent is required for DFR™ calculation. The Polaris 2.12 software update adds an automatic scaling feature for DFR™ equalization.

AI/ML Overview

This looks like an FDA 510(k) clearance letter and summary for a software update to an existing medical device, the iLab Polaris Multi-Modality Guidance System. Based on the provided text, the submission focuses on non-clinical performance data for a software update, not a new AI/ML-based diagnostic algorithm requiring extensive clinical validation.

Therefore, many of the requested points regarding the study that proves the device meets acceptance criteria (especially those related to clinical performance, ground truth, expert adjudication, and MRMC studies) are explicitly stated as "Not applicable" in the document.

Here's a breakdown of the available information:

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI/ML algorithm. Instead, it states that
"Determination of substantial equivalence is based on an assessment of non-clinical performance data which includes software verification and validation carried out on Polaris 2.12 (iLab 3.12) software. 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."

Device Performance Reported: The core performance claim is "substantial equivalence" to the predicate device (iLab Polaris Multi-Modality Guidance System K191008). This is based on:

Non-clinical performance data: software verification and validation.
Compliance with standards: IEC 62304 and FDA Guidance for Premarket Submissions for Software Contained in Medical Devices.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: This information is not provided in the document. As the submission is based on non-clinical software verification and validation, it's unlikely to involve traditional clinical "test sets" with patient data in the same way an AI diagnostic algorithm would.
Data Provenance: This information is not provided and is likely not relevant given the non-clinical nature of the submission (software V&V).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. The submission explicitly states "Clinical Performance Data: Not applicable. A determination of Substantial Equivalence for this modification is not based on clinical data." Therefore, there was no ground truth derived from expert review of patient cases in the context of this 510(k).

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

Not Applicable. As no clinical "test set" with expert review was used for performance evaluation, no adjudication method was employed.

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

No. The document clearly states: "Clinical Performance Data: Not applicable." Therefore, no MRMC study was conducted.

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

No, not in the context of a new diagnostic algorithm. The device is a "Multi-Modality Guidance System" with IVUS, FFR, and DFR functionalities, intended for use by clinicians. The software update (Polaris 2.12 / iLab 3.12) supports these existing functionalities and includes "scaling updates to DFR™ equalization values, enhanced imaging modes and OS patches for additional security." This is a software update to a guidance system, not a standalone diagnostic algorithm that makes a diagnosis.

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

Not Applicable. As no clinical performance data was submitted, there was no ground truth established from patient data. The "ground truth" for software verification and validation would be adherence to specified software requirements and functionality, confirmed through various engineering tests.

8. The sample size for the training set

Not Applicable. This submission is for a software update to an existing device, not a de novo AI/ML algorithm that requires a "training set" of data.

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

Not Applicable. Since there was no "training set" of data for an AI/ML algorithm, no ground truth was established for it.

In summary: This FDA 510(k) submission primarily relies on non-clinical software verification and validation to demonstrate substantial equivalence for a software update to an existing medical device. It does not introduce a new AI/ML diagnostic algorithm that would typically require the extensive clinical study data (including test sets, ground truth, expert review, and MRMC studies) you've inquired about.

Summary

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May 29, 2020

Boston Scientific Kevin Lam Manager II, Regulatory Affairs Three Scimed Place Maple Grove, Minnesota 55311

Re: K201178

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 30, 2020 Received: May 1, 2020

Dear Kevin Lam:

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

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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 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 medical devices and radiation-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)

K201178

Device Name iLab™ Polaris Multi-Modality System

Indications for Use (Describe)

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 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 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Boston Scientific. The words "Boston" and "Scientific" are stacked on top of each other. The text is in a serif font and is a dark blue color.

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 Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Kevin LamManager II, Regulatory AffairsThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-257-6482Fax: 763-494-2222e-mail: Kevin.Lam@bsci.com
Date Prepared	April 30, 2020
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 Device	iLab™ Polaris Multi-Modality Guidance SystemK191008, July 2, 2019

Device Description

The Polaris 2.12 (iLab 3.12) software update supports the iLab™ Polaris Multi-Modality Guidance System and supports existing device IVUS, FFR and DFRTM functionality as well as includes scaling updates to DFR™ equalization values, enhanced imaging modes and OS patches for additional security.

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Intended Use/Indications for Use

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-tooperator.
. 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. ●

Comparison of Technological Characteristics

The Polaris 2.12 (iLab 3.12) software update is substantially equivalent to the predicate Polaris 2.10 (iLab 3.10) K191008 in intended use, fundamental design technology, functional modalities and performance features. Additions of automatic DFR equalization, imaging modes and OS patches 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 software verification and validation carried out on Polaris 2.12 (iLab 3.12) software. 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 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.

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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 Polaris 2.12 (iLab 3.12) software 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).