(32 days)
The iLab Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravasular ultrasound is indicated for patients who are are candidates for transluminal 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 Permanent Pullback Sled is a device which is used with the iLab Ultrasound Imaging System. The permanent sled is a mechanized device to assist with the acquisition of two-dimensional images obtained from compatible Boston Scientific intravascular ultrasound imaging catheters. This device is designed to be used with Boston Scientific IVUS catheters that have telescoping capability where the catheter anchor housing can engage in the anchor post of the sled.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical sense of a clinical or performance study with detailed metrics like sensitivity, specificity, or accuracy.
Instead, this document is a 510(k) premarket notification for the iLab™ Ultrasound Imaging System, specifically regarding a modification to a "Permanent Pullback Sled." The focus is on demonstrating substantial equivalence to a previously cleared predicate device.
Here's an analysis of the available information based on your requested points:
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A table of acceptance criteria and the reported device performance
The document describes design verification testing for the modified "Permanent Pullback Sled." The acceptance criteria were primarily "Pass/Fail" for each test. The reported performance is that "All predetermined acceptance criteria were met."
Test Category Acceptance Criteria Reported Performance Design Verification Tests Pass/Fail Met Motordrive Pullback Pass/Fail Met Force to Open Latch Pass/Fail Met Motordrive/Pullback Sled Connection Pass/Fail Met Linear Velocity Pass/Fail Met Cleaning Materials Exposure Pass/Fail Met Acoustic Noise Pass/Fail Met Holding Force of Nose Section to Anchor Seal Pass/Fail Met Sled Travel Distance Pass/Fail Met Nose Clip Insertions Pass/Fail Met Sled Pullbacks Pass/Fail Met Environmental Requirements Pass/Fail Met Packaging Validation Pass/Fail Met Visual Inspection Pass/Fail Met Functional Testing Pass/Fail Met -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document doesn't specify sample sizes for each design verification test. It refers to "fully packaged units" for packaging validation but doesn't give a number.
The data provenance is from "Design verification testing" and "packaging testing" performed on the "permanent sled," implying in-house bench testing by Boston Scientific Corporation, likely in the USA (where Boston Scientific is headquartered and the submission was made). This would be considered prospective bench testing rather than using retrospective clinical data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable and not present in the document. The "ground truth" for bench testing typically refers to engineering specifications and measurements, not expert clinical interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the testing described is engineering design verification, not a clinical study involving human readers and adjudicated outcomes.
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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 MRMC study was done. This document describes a modification to an ultrasound imaging system component, not an AI-powered diagnostic tool requiring such a study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. The device is an ultrasound imaging system and a mechanical sled component, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Design verification testing" and "Packaging validation," the ground truth implicitly refers to the engineering specifications and requirements for the device. Each test had a pre-defined "Pass/Fail" criterion based on these specifications.
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The sample size for the training set
This is not applicable. There is no mention of an algorithm or a training set for machine learning in this submission for an ultrasound system component.
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How the ground truth for the training set was established
This is not applicable, as there is no training set mentioned.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2015
Boston Scientific Corporation % Mr. George J. Prendergast Senior Regulatory Affairs Specialist 47215 Lakeview Blvd. FREMONT CA 94538
Re: K152316
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: August 17, 2015 Received: August 18, 2015
Dear Mr. Prendergast:
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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K152316
Device Name iLab Ultrasound Imaging System
Indications for Use (Describe)
The iLab Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravasular ultrasound is indicated for patients who are are candidates for transluminal procedures such as angioplasty and atherectomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Boston Scientific Corporation iLab Ultrasound Imaging System
This 510(k) Summary is provided in this Premarket Notification in accordance with requirements of the Safe Medical Device Act (SMDA) of 1990. The content is submitted in conformance with 21 CFR Part 807.92.
| Submitted By: | Boston Scientific Corporation47215 Lakeview Blvd.Fremont, CA. 94538 |
|---|---|
| Contact Person: | George J. PrendergastSenior Regulatory Affairs SpecialistTel: 510-624-1634George.Prendergast@bsci.com |
| Date: Prepared: | August 14, 2015 |
| Proprietary Name: | iLab™ Ultrasound Imaging System |
| Common Name: | Ultrasound Diagnostic Imaging System/Ultrasonic Pulsed Echo Imaging System (90IYO)Transducer, Ultrasonic, Diagnostic (90ITX) |
| Classification Name: | Class IIUltrasonic Pulsed Echo Imaging System21 CFR Part 892.1560 (90IYO)Transducer, Ultrasonic, Diagnostic21 CFR Part 892.1570 (90ITX)Radiology/Cardiology Panel |
| Product Code: | 90IYO, 90ITX |
Boston Scientific Corporation Special 510(k) iLab Ultrasound Imaging System
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Predicate Device:
iLab™ Ultrasound Imaging System
| Product | 510(k) | Clearance Date |
|---|---|---|
| iLab Ultrasound ImagingSystem | K130243 | March 1, 2013 |
Description of the Device:
iLab Ultrasound Imaging System
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.
Permanent Pullback Sled
The Permanent Pullback Sled is a device which is used with the iLab Ultrasound Imaging System. The permanent sled is a mechanized device to assist with the acquisition of twodimensional images obtained from compatible Boston Scientific intravascular ultrasound imaging catheters. This device is designed to be used with Boston Scientific IVUS catheters that have telescoping capability where the catheter anchor housing can engage in the anchor post of the sled.
Intended Use / Indications For Use:
The iLab Ultrasound 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 intended use/indications for use are identical to the predicate device
Technological Characteristics:
The modified iLab Ultrasound Imaging System employs the same Indications for Use, fundamental scientific technology, and principle of operation as its predicate device.
There are similarities and differences between the materials used in the proposed Permanent Pullback Sled in comparison to the Disposable Pullback Sled.
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Design verification testing and packaging testing were performed on the permanent sled. The passing results of testing demonstrate the device is safe and effective and do not raise different questions of safety and effectiveness than the predicate.
Determination of Substantial Equivalence: Non-Clinical Data
Determination of substantial equivalence is based in part on an assessment of non-clinical performance data. Non-clinical data included design verification of the proposed nonsterile, permanent sled. All predetermined acceptance criteria were met during design verification as specified in the requirements of 21 CFR 820.30. The design verification testing results did not raise different questions of safety and effectiveness associated with changes made to the device.
Bench/Performance Testing
Design verification testing included the following tests which passed based on a Pass/Fail basis: Motordrive Pullback, Force to Open Latch, Motordrive/Pullback Sled Connection, Linear Velocity, Cleaning Materials Exposure, Acoustic Noise, Holding Force of Nose Section to Anchor Seal, Sled Travel Distance, Nose Clip Insertions, Sled Pullbacks, and environmental requirements.
Packaging Validation
The permanent sled packaging integrity was tested on fully packaged units after being subjected to climactic conditioning and distribution challenge conditioning. Testing included Visual Inspection and functional testing.
Non Clinical Testing Conclusion
The non-clinical testing demonstrates the proposed device is as safe and as effective and performs as well as or better than the legally marketed device.
Clinical Data / Animal Data:
No clinical or animal data were generated to support this submission.
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Conclusion:
The proposed modifications to the iLab Ultrasound Imaging System described in this submission are substantially equivalent to the predicate device. The proposed modification of the iLab Imaging System and labeling are not substantial changes. They do not significantly affect the safety and efficacy of the device.
§ 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.