ILAB ULTRASOUND IMAGING SYSTEM

K123535 · Boston Scientific Corp · IYO · Jan 15, 2013 · Radiology

Device Facts

• Record ID: K123535
• Device Name: ILAB ULTRASOUND IMAGING SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: IYO · Radiology
• Decision Date: Jan 15, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

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 Story

The iLab Ultrasound Imaging System is a diagnostic tool for real-time intravascular ultrasound (IVUS) imaging. It processes ultrasonic pulsed echo signals to visualize intravascular anatomy. Used in clinical settings by healthcare professionals to evaluate patients undergoing transluminal interventional procedures like angioplasty and atherectomy. The system provides visual output to assist clinicians in assessing vascular pathology and guiding interventional decision-making. This submission covers a software update (version 2.7.1) to the existing system.

Clinical Evidence

No clinical studies were required. Evidence consists of bench-level software verification and validation testing. Validation was performed by clinicians evaluating IVUS images to confirm image quality equivalence to the predicate.

Technological Characteristics

Ultrasonic pulsed echo imaging system; Class II; 21 CFR 892.1560/892.1570. System utilizes software version 2.7.1. Connectivity and specific hardware materials are not detailed beyond the system's classification as an ultrasonic diagnostic imaging system.

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures, such as angioplasty and atherectomy, requiring ultrasound examination of intravascular pathology.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• iLab Ultrasound Imaging System (K072517)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] [e-mail]

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

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.

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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

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.

## 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

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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 [phone] or [phone] 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:

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.

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)

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