(92 days)
The IVUS modality of the iLab™ Polaris Multi-Modality Guidance 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.
FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.
The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter.
Indications for Auto Pullback Use (IVUS Only)
Automatic Pullback is indicated when the following occurs:
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The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.
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The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.
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Two-dimensional, longitudinal reconstruction of the anatomy is desired.
The iLab™ Polaris Multi-Modality Guidance System is a non-patient contacting, diagnostic device designed to provide three (3) primary modalities: IVUS (Intravascular Ultrasound), FFR (Fractional Flow Reserve) and Diastolic hyperemia-Free Ratio (DFR). The iLab Polaris Multi-Modality Guidance System is supported by the Polaris 2.14 (iLab 3.14) software.
The iLab™ Polaris Multi-Modality Guidance System is offered in both mobile (cart) and integrated (installed) configurations consisting of hardware and software components supporting intravascular ultrasound (IVUS), fractional flow reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities and includes additional Auto Pullback options.
Hardware components of the iLab™ Polaris Multi-Modality Guidance System include: Data Acquisition Processor, Imaging Processor, Control Panel Primary Image display (LCD flat panel), System Power supply/transformer, updated Motor Drive Unit (MDU5+), Motor Drive cable storage, Printer, removable Storage Media, CD/DVD Recorder, Mouse/Mouse Pad, and Bluetooth Communication Module (BCM).
The iLab Polaris Multi-Modality Guidance System includes automatic pullback functionality to aid the physician/operator during IVUS modality when the following occur:
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the physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator,
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the physician/operator wants to make linear distance determinations post-procedurally, ● which requires the imaging core of a catheter to be pulled back at a known uniform speed,
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two-dimensions, longitudinal reconstructions of the anatomy is desired. ●
The document provided is an FDA 510(k) clearance letter for the Boston Scientific Corporation iLab Polaris Multi-Modality Guidance System. This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data (hardware verification and validation), rather than clinical studies proving the device meets specific performance acceptance criteria for diagnostic accuracy or effectiveness.
Therefore, the requested information regarding acceptance criteria for device performance, clinical study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in the provided text, as the clearance was based on non-clinical data.
The letter explicitly states:
- "Clinical Performance Data: Not applicable. A determination of Substantial Equivalence for this modification is not based on clinical data. Substantial Equivalence is based on non-clinical performance data."
This means no clinical study was performed or required for this particular 510(k) submission to demonstrate the device meets performance acceptance criteria relevant to medical diagnosis or treatment outcomes. The focus was on ensuring the updated hardware (MDU5+ Motor Drive Unit) and new auto pullback functionality did not introduce new safety or effectiveness concerns, and that the device maintained the same intended use and fundamental design as the predicate device.
To answer your request, here's what can be inferred from the document:
The provided document describes the FDA 510(k) premarket notification for the iLab™ Polaris Multi-Modality Guidance System. However, this submission specifically states that the determination of substantial equivalence is based on non-clinical performance data and that clinical performance data is not applicable. Therefore, the document does not contain information about clinical acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, or details of ground truth establishment for diagnostic accuracy.
The clearance is for an updated MDU5+ Motor Drive Unit supporting additional Auto Pullback functionality within an existing system, demonstrating that this modification does not raise different questions of safety or effectiveness compared to the predicate device (K201178).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as clinical performance metrics for diagnostic accuracy are not assessed in this submission. The acceptance was based on non-clinical performance (hardware verification and validation) ensuring the updated MDU5+ Motor Drive Unit and new Auto Pullback functionality meet safety and performance standards equivalent to the predicate device.
- Reported Device Performance: The document only states: "Testing was conducted according to applicable international standards, FDA recognized consensus standards, and the same well-established test methods and criteria applied to the predicate device." No specific numerical performance results are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set data was used or described. The submission relied on non-clinical hardware verification and validation.
3. 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)
- Not applicable. No clinical ground truth was established as no clinical study for diagnostic performance was conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set and thus no adjudication method used.
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
- Not applicable. No MRMC study was done. The device description does not imply AI assistance for human readers in a diagnostic capacity; it describes a guidance system for intravascular procedures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. No standalone algorithm performance study was mentioned as the submission was based on non-clinical data for hardware modification.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was used for this submission. The "ground truth" for the non-clinical assessment was adherence to engineering standards and safety/performance criteria for hardware functionality.
8. The sample size for the training set
- Not applicable. No training set for an algorithm was mentioned in this non-clinical submission.
9. How the ground truth for the training set was established
- Not applicable. No training set was mentioned.
Summary: The FDA 510(k) clearance for the iLab™ Polaris Multi-Modality Guidance System with the updated MDU5+ Motor Drive Unit was based solely on non-clinical performance data (hardware verification and validation), as explicitly stated in the document. Therefore, none of the requested clinical performance study details are available in this text.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).