The iLab™ Ultrasound Imaging 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.

Device Description

The iLab Ultrasound Imaging System is designed for real time viewing of intravascular anatomies and is intended to be a basic diagnostic tool for imaging and evaluation of patients who are candidates for transluminal procedures.

AI/ML Overview

The iLab™ Ultrasound Imaging System submission (K123535) is for a modification to an existing device, not a new device. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device, rather than comprehensive new acceptance criteria and studies.

Here's a breakdown of the available information regarding acceptance criteria and supporting studies for the modified iLab™ Ultrasound Imaging System (version 2.7.1), acknowledging the limitations of this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a modification and not a new device requiring extensive clinical trials, the acceptance criteria are primarily focused on software verification and validation relative to the predicate device.

Acceptance Criteria	Reported Device Performance
Software Unit and System Level Verification: All requirements in the Software Requirements Specifications are met.	"iLab 2.7.1 update meets the acceptance criteria as noted in the iLab System Software Unit and System Test Plans. All requirements in the Software Requirements Specifications have been verified by the system level testing."
Software Validation (Clinical Experience): iLab 2.7.1 image quality is equivalent or better than the predicate device.	"Validation passed its acceptance criteria in that a majority of the validation test results demonstrate that iLab 2.7.1 image quality is equivalent or better than the predicate device."

2. Sample Sizes Used for the Test Set and Data Provenance

Software Verification: The document states "Software unit and system level verification testing." The specific sample sizes for test cases or environments are not explicitly provided in this summary.
Software Validation: The summary mentions "Validation was performed by testers with clinical experience evaluating IVUS images." The specific number of cases or images used for validation is not explicitly provided.
Data Provenance: The document does not specify the country of origin of the data used for testing or validation. It is implied to be laboratory/internal testing performed by the manufacturer. The studies are retrospective in the sense that they are conducted on pre-existing software and images (or simulated scenarios), rather than a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For software validation, the document states, "Validation was performed by testers with clinical experience evaluating IVUS images." The number of experts is not specified, nor are their detailed qualifications (e.g., specific clinical roles, years of experience).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Given the nature of a software verification and validation report for a modification, a formal adjudication process between independent experts as seen in clinical trials is unlikely to have been documented in this summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The modified iLab Ultrasound Imaging System did not require clinical studies to support substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The software verification and validation activities described are inherently a form of standalone testing, as they focus on the software's performance against its requirements and its image quality relative to a predicate device. However, the term "standalone" in the context of an AI-powered diagnostic device often implies a specific evaluation against a ground truth without human intervention during diagnosis. While the software generates images, its ultimate interpretation in a clinical setting still involves a human reader. The described "validation" focuses on image quality equivalence for human interpretation.

7. The Type of Ground Truth Used

For Software Verification: The "ground truth" for software verification is adherence to the Software Requirements Specifications. The 'truth' is whether the software performs as designed.
For Software Validation: The "ground truth" for image quality validation was based on the performance of the predicate device. The goal was to demonstrate that the image quality of the modified iLab 2.7.1 was "equivalent or better" than the predicate device, as evaluated by testers with clinical experience. This is a comparative ground truth rather than an absolute truth (e.g., pathology).

8. The Sample Size for the Training Set

This information is not provided. This being a software update, the underlying core algorithms for image processing and display would have been developed and trained using data not described in this document, which focuses only on the modifications. If the update involved new machine learning components, details about their training set would typically be required, but this summary doesn't suggest that kind of fundamental change.

9. How the Ground Truth for the Training Set Was Established

This information is not provided, as details about a "training set" for the underlying algorithms are outside the scope of this particular submission for a software modification. If new machine learning models were introduced as part of the update, this information would be critical. However, the description suggests an update to existing software functionalities.

Summary

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K 12353 S

JAN 1 5 2013

Boston Scientific Corporation iLab Ultrasound Imaging System Special Premarket Notification November 15, 2012

510(k) Summary of Safety and Effectiveness Boston Scientific Corporation iLab™ Ultrasound Imaging System

General Information Manufacturer:

Manufacturer:

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description Classification Name(s):

Trade Name:

Generic/Common Name:

Boston Scientific Corporation 47215 Lakeview Boulevard Fremont, CA 94538

2939204

Lori R. Smith Sr. Regulatory Affairs Specialist Tel: (510) 624-1698 Fax: (510) 624-2569 lori.smith@bsci.com

November 15, 2012

Class II Ultrasonic Pulsed Echo Imaging System 21 CFR Part 892.1560 (90IYO) Transducer, Ultrasonic, Diagnostic 21 CFR Part 892.1570 (90ITX)

iLab" Ultrasound Imaging System

Ultrasound Diagnostic Imaging System Ultrasonic Pulsed Echo Imaging System (90IYO) Transducer, Ultrasonic, Diagnostic (90ITX)

Predicate Devices

iLab Ultrasound Imaging System

K072517

Intended Uses/Indications for Use

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Image /page/1/Picture/0 description: The image shows the logo for Boston Scientific. The logo is in a serif font and is black. The word "Boston" is on top of the word "Scientific".

Boston Scientific Corporation iLab Ultrasound Imaging System Special Premarket Notification November 15, 2012

Product Description

Technology

The modified iLab Ultrasound Imaging System employs the same fundamental scientific technology as its predicate device.

Determination of Substantial Equivalence

Summary of Non-Clinical Tests:

Non-clinical data, which includes software verification and validation has been evaluated as detailed in Section VI of this premarket notification. Software unit and system level verification testing demonstrate that the iLab 2.7.1 update meets the acceptance criteria as noted in the iLab System Software Unit and System Test Plans. All requirements in the Software Requirements Specifications have been verified by the system level testing. Validation was performed by testers with clinical experience evaluating IVUS images. Validation passed its acceptance criteria in that a majority of the validation test results demonstrate that iLab 2.7.1 image quality is equivalent or better than the predicate device.

Summary of Clinical Tests:

The modified iLab Ultrasound Imaging System did not require clinical studies to support substantial equivalence.

Conclusion

The proposed modifications to the iLab Ultrasound Imaging System described in this submission are substantially equivalent to the predicate device. The proposed modification in software and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized caduceus with three intertwined snakes and a staff. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in uppercase letters and is evenly spaced around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 15, 2013

Ms. Lori R. Smith Senior Regulatory Affairs Specialist Boston Scientific Corporation 47215 Lakeview Boulevard FREMONT CA 94538

Re: K123535

Trade/Device Name: iLab™ Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: December 18, 2012 Received: December 19, 2012

Dear Ms. Smith: -

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2-Ms. Smith

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Michael D. O'Hara for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Boston Scientific Corporation iLab Ultrasound Imaging System Special Premarket Notification November 15, 2012

Indications for Use Statement

510(k) Number (if known): K123535

Device Name: iLab™ Ultrasound Imaging System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123535 510(k)

Page 1 of 1

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.