(111 days)
The iCross™ and Atlantis™ SR Pro2 Coronary Imaging Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The Catheters are sterile, single use, short rail (SR) 40MHz imaging catheters. These catheters are intended to operate with the BSC ClearView Ultra, Galaxy, Galaxy2, or iLab intravascular ultrasound imaging consoles. The coronary imaging catheter and console form an imaging system for ultrasonic examination of coronary intravascular pathology.
The Catheters consist of two (2) main assemblies: a sheath assembly and an imaging core assembly. The sheath assembly is the outer part of the catheter that comprises much of the working length of the device, and has a hydrophilic coating to the distal 230mm on the catheter. The imaging core is internal to the sheath assembly and rotates independently of the sheath. The imaging core contains the piezoelectric transducer that converts electrical energy from the imaging console to ultrasonic energy that is in turn transmitted. The transducer converts the returned ultrasonic energy into electrical energy for display on the instrument. The rotating imaging core driveshaft directs the path of the ultrasonic energy (beam) from the transducer. A proximal telescoping section allows the imaging core to be retracted and advanced, across an anatomical region of interest, without requiring movement of the sheath within the anatomy.
The provided text is a 510(k) summary for the iCross™ and Atlantis™ SR Pro2 Coronary Imaging Catheters. It describes a change in sterilization method (from Gamma irradiation to Ebeam irradiation) for an already cleared device. As such, the study conducted is primarily for demonstrating substantial equivalence after this change, rather than proving performance against specific clinical acceptance criteria for a novel device.
Therefore, many of the requested categories for a new device's performance study may not be directly applicable or fully detailed in this type of submission.
Here's an analysis based on the provided document:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary: The device in question, the iCross™ and Atlantis™ SR Pro2 Coronary Imaging Catheters, did not undergo a study to demonstrate novel performance against clinical acceptance criteria. Instead, the submission describes a modification to an already cleared device (changing the sterilization method) and the studies conducted were to demonstrate that this modification does not adversely affect the device's original performance, safety, and effectiveness, thereby maintaining substantial equivalence to the predicate. The "acceptance criteria" in this context refer to maintaining the product specifications and safety profiles established for the original device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Modified Device Post-Ebeam Sterilization) | Reported Device Performance |
|---|---|
| Performance Requirements: Continue to meet product specifications. | "the results demonstrated the devices satisfy all functional and physical requirements." |
| Visual Inspections: No adverse changes. | Part of the bench testing, implicitly met by "satisfy all functional and physical requirements." |
| Electrical Tests: No adverse changes. | Part of the bench testing, implicitly met by "satisfy all functional and physical requirements." |
| Mechanical Tests: No adverse changes. | Part of the bench testing, implicitly met by "satisfy all functional and physical requirements." |
| Acoustic Output: Remain below Track 1 acoustic output exposure levels (per FDA Guidance Sep 9, 2008). | "the results continue to be below the Track 1 acoustic output exposure levels." |
| Biocompatibility: Considered biocompatible for intended use. | "the results demonstrate the devices are considered biocompatible for their intended use." |
| Sterility Assurance Level (SAL): Maintain an SAL of 10⁻⁶. | "The sterilization validation confirmed Ebeam irradiated iCross and Atlantis SR Pro2 Coronary Imaging Catheters continue to meet a Sterility Assurance Level (SAL) of 10⁻⁶." |
| Substantial Equivalence: Maintain same design, materials, intended use, and method of manufacture (except sterilization). | "The modified Catheter has the same design, materials, intended use and method of manufacture as the predicate device with the exception of product sterilization using Electron Beam (Ebeam) irradiation instead of Gamma irradiation..." "The testing conducted on the modified Catheters demonstrates they continue to meet performance requirements and are safe and effective for their intended use. The modified iCross and Atlantis SR Pro2 Coronary Imaging Catheters have the same intended use as the predicate and the test results support a determination of substantial equivalence to the currently marketed Catheters." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the bench testing, biocompatibility testing, or sterilization validation. It only states that these tests were "conducted." The data provenance is not mentioned, as these are technical bench and lab tests, not clinical studies. The tests are prospective in nature, as they are conducted specifically for the submission to demonstrate the impact of the Ebeam sterilization.
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)
This section is not applicable to this submission. The "ground truth" for these tests consisted of established product specifications, industry standards (e.g., for acoustic output), and regulatory requirements (e.g., for biocompatibility and SAL). These are objective measurements and validations, not subjective interpretations requiring medical experts to establish ground truth in the way a diagnostic AI might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of medical images or data. The tests conducted here are objective engineering, biological, and sterilization validations, not requiring human adjudication of subjective interpretations.
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
This is not applicable. This submission is for a physical medical device (imaging catheter) with a changed sterilization method, not an AI or diagnostic software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a hardware device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed can be characterized as:
- Engineering Specifications: For functional, physical, electrical, and mechanical requirements.
- Regulatory Standards/Guidance: For acoustic output (FDA Guidance), biocompatibility (standardized tests for medical devices), and sterility (SAL 10⁻⁶ standard).
- Predicate Device Performance: The underlying "ground truth" for the overall device performance is that it should perform equivalently to the predicate device, which was already cleared.
8. The sample size for the training set
This is not applicable. There is no training set mentioned or implied, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set.
§ 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).