(21 days)
No
The description focuses on standard digital signal processing and image conversion, with no mention of AI or ML algorithms.
No
Explanation: The device is described as a "basic diagnostic tool for imaging and evaluation of patients" and its intended use is for "ultrasound examinations." It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section states that the system is intended for "ultrasound examinations of intravascular pathology," and the "Device Description" explicitly mentions it is "intended to be a basic diagnostic tool for imaging and evaluation of patients."
No
The device description explicitly states that the iLab™ Ultrasound Imaging System is a "combination of proprietary hardware and software" and lists several hardware components including PC units, displays, control devices, media storage devices, a printer, and a MotorDrive Unit.
Based on the provided information, the iLab™ Ultrasound Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "ultrasound examinations of intravascular pathology" and is indicated for use in patients undergoing "transluminal interventional procedures." This describes a device used in vivo (within the living body) for imaging and diagnosis, not in vitro (outside the living body) for testing biological samples.
- Device Description: The description details a system that uses ultrasound transducers (catheters) inserted into the body to generate images of intravascular anatomies. This is consistent with an in vivo imaging system.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples such as blood, urine, tissue, etc., which is a defining characteristic of IVD devices.
Therefore, the iLab™ Ultrasound Imaging System is a medical imaging device used in vivo, not an IVD.
N/A
Intended Use / 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.
Product codes
IYN, IYO, OBJ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
intravascular anatomies, vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K051679
P 1/3
| 510(k) Summary of Safety and Effectiveness
| Boston Scientific Corporation | ||
|---|---|---|
| iLab™ Ultrasound Imaging System | ||
| Submitted By | Boston Scientific Corporation | |
| IVUS Technology Center | ||
| 47201 Lakeside Parkway | ||
| Fremont, CA 94538 | JUL 1 4 2005 | |
| Contact Person | Robert Z. Phillips | |
| Manager, Regulatory Affairs | ||
| Tel: (510) 624-2307 | ||
| Fax: (510) 624-1449 | ||
| phillipr1@bsci.com | ||
| Date Prepared | July 7, 2005 | |
| Proprietary Name | iLab™ Ultrasound Imaging System | |
| Common Name(s) | Ultrasound Diagnostic Imaging System | |
| Ultrasonic Pulsed Doppler Imaging System (90IYN) | ||
| Ultrasonic Pulsed Echo Imaging System (90IYO) | ||
| Classification Name(s) | Ultrasonic Pulsed Doppler Imaging System 21 CFR Part | |
| 892.1550 (90IYN) | ||
| Ultrasonic Pulsed Echo Imaging System 21 CFR Part 892.1560 | ||
| (90IYO) | ||
| Predicate Device | The iLab™ Ultrasound Imaging System is substantially equivalent | |
| to the following device: | ||
| Product | 510(k) Clearance Date | |
| Galaxy® Intravascular Ultrasound System | K980851 April 22, 1998 |
Description of the Device
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
Confidential
1
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
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 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.
2
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.
3
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.
4
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
5
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