(29 days)
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.
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.
The provided document states that no clinical studies were required for the modified iLab™ Ultrasound Imaging System to support substantial equivalence. Therefore, the device's acceptance criteria and performance are not discussed in the context of clinical studies.
The document explicitly states:
- "Summary of Clinical Tests: The modified iLab Ultrasound Imaging System did not require clinical studies to support substantial equivalence."
Instead, the determination of substantial equivalence was based on non-clinical data, including:
- Functional/performance testing
- Interoperability testing
- Electrical Safety testing
The document notes that:
- "Design verification testing demonstrates that the modified device meets the acceptance criteria."
However, the specific acceptance criteria and the reported device performance from these non-clinical tests are not detailed in the provided text.
Given this, I cannot provide the information requested in your numbered list, as the study details, sample sizes, expert involvement, and ground truth information are not present for clinical performance.
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Boston
Scientific
MAR 1 2013
Boston Scientific Corporation iLab Ultrasound Imaging System Special Premarket Notification January 30, 2013
510(k) Summary of Safety and Effectiveness Boston Scientific Corporation iLab™ Ultrasound Imaging System
General Information
Manufacturer:
Establishment Registration Number:
Contact Person:
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
Date Prepared:
Device Description Classification Name(s): January 30, 2013
Class II Ultrasonic Pulsed Echo Imaging System 21 CFR Part 892.1560 (90IYO) Transducer, Ultrasonic, Diagnostic 21 CFR Part 892.1570 (90ITX)
Trade Name:
Generic/Common Name:
iLab™ Ultrasound Imaging System
Ultrasound Diagnostic Imaging System Ultrasonic Pulsed Echo Imaging System (90IYO) Transducer, Ultrasonic, Diagnostic (90ITX)
Predicate Devices
iLab Ultrasound Imaging System
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
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Boston Scientific Corporation iLab Ultrasound Imaging System Special Premarket Notification January 30, 2013
candidates for transluminal interventional procedures such as angioplasty and atherectomy.
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, including functional/performance testing, interoperability testing, and Electrical Safety testing has been evaluated as detailed in Section VI of this premarket notification. Design verification testing demonstrates that the modified device meets the acceptance criteria.
Summary of Clinical Tests:
The modified iLab Ultrasound Imaging System did not require clinical studies to support substantial equivalence.
Conclusion
The modifications in performance specifications and labeling for the iLab™ Ultrasound Imaging System are not substantial changes or modifications that would significantly affect the safety or efficacy of the device. The proposed iLab Ultrasound Imaging System, which introduces the new MDU5 PLUS motordrive, is essentially equivalent in technology, principle of operation, packaging, and indications for use as the iLab Ultrasound Imaging System previously cleared in K123535.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2013
Lori R. Smith Senior Regulatory Affairs Specialist Boston Scientific Corp. 47215 Lakeview Boulevard FREMONT CA 94538
Re: K130243
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, ITX Dated: January 30, 2013 Received: February 4, 2013
Dear Lori R. 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 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.
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Page 2- Lori R. Smith
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Smith
for
Janine 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 January 30, 2013
Indications for Use Statement
510(k) Number (if known):
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)
Sm
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K130243 510(k)
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§ 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.