(28 days)
The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is indicated for patients with vascular occlusive disease for which angioplasty, atherectomy, the placement of stents, or other intervention is contemplated.
Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for use with the Boston Scientific iLab™ equipment and motor drive unit, MDU5 PLUS™. When used together, the catheter, motor drive unit (MDU), and iLab equipment form a complete imaging system that allows for ultrasonic visualization of peripheral intravascular structures.
The catheter consists of two main components: the catheter body and the imaging core.
The catheter body consists of three sections: the braided proximal shaft, single lumen mid-shaft, and the sonolucent distal tip. The catheter body comprises the usable length of the catheter (110 cm).
The braided proximal shaft provides the pushability to the catheter and serves as a lumen to the imaging core. The mid-shaft provides a flexible transition between the stiffer proximal shaft and the acoustically transparent distal tip. The distal tip serves as the imaging window and houses a septum situated between the inner lumen and the atraumatic rounded tip of the catheter. The self-sealing septum serves as the distal-flush entry point, as the catheter is flushed with water prior to use. This provides the acoustic coupling media required for ultrasonic imaging.
The imaging core consists of a proximal hub assembly, a rotating drive cable, and a radiopaque tip. The hub assembly provides an electro-mechanical interface between the catheter and the motor drive unit. The drive cable houses the low frequency piezoelectric (PZT) transducer at the distal imaging window.
The PZT transducer and the drive cable rotate independently from the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive into transmittable acoustic energy. Reflected ultrasound signals are converted back to electrical impulses, returned to the motor drive unit, and are ultimately processed by the iLab equipment for live visualization of intravascular structures.
The provided text is a 510(k) summary for the Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter. It outlines the device's characteristics, intended use, and substantial equivalence to a predicate device based on non-clinical performance data. Since this is a submission for a medical device that relies on physical characteristics and performance rather than an AI/ML algorithm that predicts or classifies, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present specific numerical acceptance criteria in a table format, nor does it present specific numerical performance results against those criteria. Instead, it describes general performance categories tested. The primary "acceptance criterion" is demonstrating substantial equivalence to the predicate device.
| Performance Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical Integrity | Device maintains structural integrity over expected use. | Bench testing performed to evaluate physical integrity. |
| Functionality | Device operates as intended. | Bench testing performed to evaluate functionality. |
| Image Quality | Provides clear ultrasonic visualization of intravascular structures. | Bench testing performed to evaluate image quality and general imaging capabilities. |
| Measurement Accuracy | Provides accurate measurements. | Bench testing performed to evaluate measurement accuracy. |
| Deliverability | Catheter can be delivered to target safely. | Bench testing performed to evaluate deliverability. |
| Guide Catheter Compatibility | Compatible with specified guide catheters. | Bench testing performed to evaluate guide catheter compatibility. |
| Non-Uniform Rotational Distortion (NURD) | Meets acceptable levels of NURD for accurate imaging. | Bench testing performed to evaluate non-uniform rotational distortion. |
| Dimensional Requirements | Meets specified dimensional requirements. | Bench testing performed to evaluate dimensional requirements. |
| Visibility Under Fluoroscopy | Visible under fluoroscopy. | Bench testing performed to evaluate visibility under fluoroscopy. |
| Interface with Ancillary Devices | Interfaces correctly with Boston Scientific iLab™ equipment and MDU5 PLUS™. | Bench testing performed to evaluate interface with ancillary devices. |
| Environmental Requirements | Withstands specified environmental conditions. | Bench testing performed to evaluate environmental requirements. |
| User Interface Requirements | Meets user interface specifications. | Bench testing performed to evaluate user interface requirements. |
| Catheter Fatigue | Withstands expected fatigue during use. | Bench testing performed to evaluate catheter fatigue. |
| Bending Stiffness | Meets specified bending stiffness. | Bench testing performed to evaluate bending stiffness. |
| Biocompatibility | Biocompatible for its intended use. | Biocompatibility testing in accordance with ISO 10993-1, microbial assessments (bioburden, endotoxin), and pyrogenicity/sterility assurance testing performed. Device is shown to be biocompatible. |
| Acoustic Output | Below FDA Track 1 limits. | Acoustic Output evaluated in accordance with FDA Guidance (September 9, 2008). Results are below FDA Track 1 limits. |
| Electromagnetic Compatibility | Compliant with IEC 60601-1-2 (3rd Edition). | Electromagnetic compatibility testing conducted, demonstrating compliance. |
| Packaging Integrity | Maintains sterility and protects device post-sterilization and during distribution. | Packaging validation in accordance with ISO 11607-1 and ISO 11607-2, with testing after E-beam sterilization, climatic conditioning, and distribution challenge. |
| Sterility | Sterile for its intended use. | Sterility assurance testing and electron beam (E-Beam) irradiation method. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical bench testing. It does not specify a "test set" in terms of patient data. The "samples" would be the catheters themselves. The exact number of catheters used for each type of bench test (e.g., how many were fatigue tested, how many were dimensionally checked) is not provided.
- Sample size for test set: Not specified (refers to physical devices, not patient data).
- Data provenance: Not applicable as it's non-clinical bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a physical medical device (intravascular ultrasound catheter) where performance is measured using engineering and biological standards, not expert interpretation of images or data to establish a ground truth for an AI/ML algorithm.
4. Adjudication Method for the Test Set:
Not applicable, as it's non-clinical bench testing of a physical device.
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. This is not an AI/ML device, and no MRMC study was performed or required. The submission explicitly states "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used:
For the non-clinical performance tests, "ground truth" refers to established engineering specifications, regulatory standards (e.g., ISO, FDA guidance), and physical measurements. For example:
- Dimensional requirements: Engineering specifications for length, diameter, etc.
- Biocompatibility: ISO 10993-1 standards.
- Acoustic Output: FDA guidance for diagnostic ultrasound systems.
- Sterility: Sterility assurance level (SAL).
- Electrical/Mechanical Safety: IEC 60601-1-2.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/ML device.
§ 870.2330 Echocardiograph.
(a)
Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.(b)
Classification. Class II (performance standards).