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 a combination of proprietary hardware and software that has been 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. The iLab™ System is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging intravascular anatomies with transducer ranges of 9 to 40 MHz. The iLab™ System is also designed to be compatible with multiple Ultrasound Imaging Catheters manufactured by BSC used in different anatomies throughout the body. The system is also supported by a MotorDrive Unit that is compatible with all existing BSC Intravascular Ultrasound (IVUS) catheter products. The iLab™ System consists of two compact PC units (one for Image Processing and one for Data Acquisition), up to two displays, control devices, media storage devices, and a printer. The Data Acquisition PC (front-end PC) digitizes the RF Ultrasound echo, performs digital signal processing, and stores IVUS frames in a vector-based format. Once saved, the vectorbased frame of data is packetized and sent over a private Local Area Network (LAN) connection onto the Image Processing PC (back-end PC) subsystem. The real-time vector data is unpacked and the frame data is converted from vector-based to raster-based frame, which can then be displayed on the primary and secondary (optional) displays. The iLab™ System is available in two configurations: a Cart-based Configuration and an Installed Configuration. There is no functional or electrical difference between the Cart-Based and Installed Configurations; differences are limited to cable lengths and the location of the modules of the system.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the iLab™ Ultrasound Imaging System based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (Galaxy® Intravascular Ultrasound System) for market clearance. The acceptance criteria are therefore implicitly tied to meeting similar safety and performance standards as the predicate, rather than specific numerical thresholds presented as acceptance criteria for the iLab™ System's performance in isolation.

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety Standards Compliance	The iLab™ System complies with EN 60601-1 and EN 60601-1-2 standards as verified by independent test facilities.
Acoustic Output Safety	Acoustic output data generated with the Galaxy® System (predicate device) using the same MotorDrive Unit supports the iLab™ System. Design reviews, unit testing, and design verification confirmed that the transmission signals of the iLab™ System are identical to those generated by the Galaxy® System. As both systems use the same transducers, the signal frequency and acoustic efficiency are identical, leading to the same final acoustic output level.
Functional and Performance Requirements	Bench testing (hardware unit-level, software unit-level, system-level) was performed to evaluate the performance and functionality. The results demonstrate that the device satisfies all performance and functional requirements.
Software Verification and Validation	The iLab™ System software was verified and validated in accordance with applicable FDA guidance documents.
Fundamental Technology and Intended Use Equivalence	The iLab™ System utilizes the same fundamental technology (ultrasound energy through a transducer in a catheter for 2D imaging of vessel anatomy) and has the same intended use (ultrasound examinations of intravascular pathology for patients undergoing transluminal interventional procedures) as the predicate device, the Galaxy® Intravascular Ultrasound Imaging System. The iLab™ System is similar in design, function, and application to the predicate device.
Compatibility with Existing Catheters and MotorDrive Unit	The iLab™ System is designed to be compatible with multiple Ultrasound Imaging Catheters manufactured by BSC and is supported by a MotorDrive Unit compatible with all existing BSC Intravascular Ultrasound (IVUS) catheter products. This MotorDrive Unit is the same one used with the predicate device.
No Functional/Electrical Difference between Configurations	There is no functional or electrical difference between the Cart-Based and Installed Configurations of the iLab™ System; differences are limited to cable lengths and module location. This implies both configurations meet the same performance.
Real-time Viewing of Intravascular Anatomies	The device is designed for real-time viewing of intravascular anatomies.
Diagnostic Tool for Imaging and Evaluation of Patients	The device is intended to be a basic diagnostic tool for imaging and evaluation in patients who are candidates for transluminal procedures.
Transducer Range Compatibility	The system is designed for imaging intravascular anatomies with transducer ranges of 9 to 40 MHz.

Here's the additional information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: See table above.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data or case numbers. The testing described is primarily focused on bench testing of the system's electrical, acoustic, and functional components.
- Data Provenance: The provenance of data for these tests is implicitly from the Boston Scientific Corporation's internal testing labs ("Bench testing was performed... This testing included hardware unit-level tests, software unit-level test, and system-level tests.") and independent test facilities for electrical safety. It is not based on clinical patient data or a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document as the testing described is primarily technical and bench-based, not involving expert interpretation of clinical images for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the evaluation did not involve human interpretation of images requiring adjudication. The assessment was against technical specifications and predicate device equivalence.
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, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission focused on demonstrating substantial equivalence through technical and bench testing, not a clinical study comparing human reader performance with or without AI assistance. The device itself is an imaging system, not explicitly described as having AI assistance for interpretation.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- The document describes the iLab™ Ultrasound Imaging System as a complete hardware and software system for real-time imaging, intended as a basic diagnostic tool. The performance evaluations discussed (electrical, acoustic, functional) are for the system itself in a standalone manner, but not as an "algorithm only" in the context of automated interpretation or decision support. It's a fundamental imaging device, not an AI-driven interpretive algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Internal specifications and predicate device characteristics served as the "ground truth" for the technical and functional tests. For example, electrical safety was validated against EN standards, and acoustic output was deemed equivalent to the predicate device due to identical components and signal generation. There is no mention of pathology, expert consensus on clinical images, or outcomes data being used as ground truth for this submission.
8. The sample size for the training set:
- Not applicable. The document describes a medical device clearance based on substantial equivalence, primarily through bench testing comparing it to a predicate device. It does not mention any "training set" in the context of machine learning or AI development.
9. How the ground truth for the training set was established:
- Not applicable. As no training set is mentioned, the method for establishing its ground truth is not provided.

Summary

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K051679
P 1/3

510(k) Summary of Safety and EffectivenessBoston Scientific Corporation
iLab™ Ultrasound Imaging System
Submitted By	Boston Scientific CorporationIVUS Technology Center47201 Lakeside ParkwayFremont, CA 94538	JUL 1 4 2005
Contact Person	Robert Z. PhillipsManager, Regulatory AffairsTel: (510) 624-2307Fax: (510) 624-1449phillipr1@bsci.com
Date Prepared	July 7, 2005
Proprietary Name	iLab™ Ultrasound Imaging System
Common Name(s)	Ultrasound Diagnostic Imaging SystemUltrasonic Pulsed Doppler Imaging System (90IYN)Ultrasonic Pulsed Echo Imaging System (90IYO)
Classification Name(s)	Ultrasonic Pulsed Doppler Imaging System 21 CFR Part892.1550 (90IYN)Ultrasonic Pulsed Echo Imaging System 21 CFR Part 892.1560(90IYO)
Predicate Device	The iLab™ Ultrasound Imaging System is substantially equivalentto the following device:
	Product	510(k) Clearance Date
	Galaxy® Intravascular Ultrasound System	K980851 April 22, 1998

Description of the Device

The system is designed for imaging intravascular anatomies with transducer ranges of 9 to 40 MHz. The iLab™ System is also designed to be compatible with multiple Ultrasound Imaging Catheters manufactured by BSC used in different anatomies throughout the body. The system

Confidential

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is also supported by a MotorDrive Unit that is compatible with all existing BSC Intravascular Ultrasound (IVUS) catheter products.

The iLab™ System consists of two compact PC units (one for Image Processing and one for Data Acquisition), up to two displays, control devices, media storage devices, and a printer. The Data Acquisition PC (front-end PC) digitizes the RF Ultrasound echo, performs digital signal processing, and stores IVUS frames in a vector-based format. Once saved, the vectorbased frame of data is packetized and sent over a private Local Area Network (LAN) connection onto the Image Processing PC (back-end PC) subsystem. The real-time vector data is unpacked and the frame data is converted from vector-based to raster-based frame, which can then be displayed on the primary and secondary (optional) displays.

The iLab™ System is available in two configurations: a Cart-based Configuration and an Installed Configuration. There is no functional or electrical difference between the Cart-Based and Installed Configurations; differences are limited to cable lengths and the location of the modules of the system.

Intended Use/Indications

Device Technology Characteristics and Comparison to Predicate Device

The iLab™ System applies ultrasound energy through a transducer enclosed within a catheter. This ultrasound energy is directed from the catheter in the lumen of a vessel into the interior vessel wall of the patient in order to obtain a two-dimensional image of the vessel anatomy. The two-dimensional image, reconstructed from the reflected RF Ultrasound echo, can be used to evaluate the morphology of the vessel and as such potentially detect abnormalities or obstructions. Each of the technological characteristics found in the iLab™ System are identical or similar to those of the predicate device, Galaxy® Intravascular Imaging System. The iLab™ System is similar in design, function, and application to these ultrasound systems.

Non-clinical Test Results

Bench electrical safety and acoustic output safety testing demonstrate that the iLab™ System and its accessories meet or exceed performance requirements and is safe and effective for its intended use.

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Bench Testing

Bench testing was performed to evaluate the performance and functionality of the iLab™ System. This testing included hardware unit-level tests, software unit-level test, and systemlevel tests. The results demonstrate that the device satisfies all performance and functional requirements.

Electrical Safety Testing

The iLab™ System complies with EN 60601-1 and EN 60601-1-2 standards as verified by independent test facilities. The iLab™ System software was verified and validated in accordance with applicable FDA quidance documents.

Acoustic Output Testing

Acoustic output testing for the iLab™ System is supported by acoustic output data generated with the Galaxy® System for the acoustic output requirements of the iLab™ System, pre and post submission, as required by FDA Guidance, "Information for Manufactures Seeking Market Clearance of Diagnostic Utrasound Systems and Transducers", issued September 30, 1997. The component generating acoustic output on the Galaxy® and iLab™ Systems is the MotorDrive Unit. The MotorDrive Unit was tested with the Galaxy® System (predicate device) and was previously cleared by premarket notification K980851. The iLab™ System utilizes the same MotorDrive Unit.

Design reviews, unit testing, and design verification have been carried out to ensure the transmission signals of the iLab™ System are identical to those generated by the Galaxy® System. Since both the Galaxy® and iLab™ Systems are designed to use the same transducers (catheters), the signal frequency and acoustic efficiency of these transducers (catheters) will be exactly same for each system. Therefore, the final acoustic output level for the Galaxy® and the iLab™ Systems will be the same and acoustic output testing is unwarranted.

Conclusion

The iLab™ Ultrasound Imaging System utilizes the same fundamental technology and has the same intended use as the predicate device, the Galaxy® Intravascular Ultrasound Imaging System. The tests support a determination of substantial equivalence of the modified device. the iLab™ Ultrasound Imaging System to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the circle.

MAY 2 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation c/o Mr. Robert Z. Phillips Manager, Regulatory Affairs IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94539

Re: K051679

Trade/Device Name: iLab Ultrasound Imaging System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II Product Code: OBJ Dated: July 21, 2005 Received: July 23, 2005

Dear Mr. Phillips:

This letter corrects our substantially equivalent letter of July 14, 2005.

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 (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.

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.

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Page 2 - Mr. Phillips

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); good manufacturing practice requirements as set 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-4008. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

eame

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K051679 510(k) Number:

iLab™ Ultrasound Imaging System Device Name:

Indications for Use: The iLab™ Ultrasound Imaging System- is intended for of intravascular ultrasound examinations pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

Prescription Use _ X

AND/ OR

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

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.Bimmerman fp
(Division Sign-Off)

Division of Cardlovascular Devices 510(k) Number

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).