(245 days)
The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line, including the Eagle Eye Platinum catheter, Eagle Eye Platinum ST catheter and the PV.014P catheter, are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. These devices are not currently indicated for use in the cerebral vessels.
The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
The EEP line of digital IVUS catheters consists of the following products:
- Eagle Eye Platinum Catheter, Part # 809746001, Model 85900P ●
- Eagle Eye Platinum Short Tip Catheter, Part # 400-0200.141, Model 85900PST
- Visions PV .014 Platinum, Part # 400-0200.233, Model 85910P
The EEP line of catheters incorporates a cylindrical ultrasound transducer array located near the distal tip of the catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.
All of the EEP line of catheters utilizes an internal lumen that allows the catheters to track over a 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The EEP line catheters are introduced either percutaneously or via surgical cut down into the vascular system.
The EEP line of catheters may be used with the In-Vision Imaging System, Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheters are designed to work with Volcano VH IVUS system software v1.2 or higher. This catheter will not operate if connected to any other imaging system.
The provided text is a 510(k) summary for the Eagle Eye Platinum (EEP) Digital IVUS Catheter Line. It describes modifications to an existing device (change in hydrophilic coating) rather than a novel device. Therefore, the "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate that the modified device's performance, safety, and effectiveness are substantially equivalent to the predicate device, despite the change.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table with specific numerical acceptance criteria and reported performance values. Instead, it lists the types of tests performed and states that they were "successfully completed."
Reported Device Performance (Implicit):
| Test Category | Test Performed | Outcome |
|---|---|---|
| Bench Testing | Friction Force | Successfully completed |
| Coating Adhesion | Successfully completed | |
| Particulate Generation | Successfully completed | |
| Biocompatibility Testing | Cytotoxicity | Successfully completed |
| Sensitization | Successfully completed | |
| Intracutaneous Reactivity | Successfully completed | |
| Systemic Toxicity | Successfully completed | |
| Pyrogenicity | Successfully completed | |
| ASTM Hemolysis | Successfully completed | |
| Partial Thromboplastin Time | Successfully completed | |
| In vivo Thromboresistance | Successfully completed | |
| C3a Complement Activation | Successfully completed | |
| SC5-b Complement Activation | Successfully completed | |
| Bacterial Endotoxins (LAL) | Successfully completed | |
| LEAP Latex Elisa for Antigenic Protein | Successfully completed | |
| Platelet and Leukocyte Counts | Successfully completed | |
| Genotoxicity | Successfully completed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample sizes used for any of the bench or biocompatibility tests.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Given that these are non-clinical (bench and lab) tests, the concepts of retrospective/prospective clinical data do not directly apply.
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 the provided document. The tests performed are non-clinical, measuring physical and biological properties. They do not involve expert interpretation of medical images or diagnoses, which would typically require "ground truth" established by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as #3. Adjudication methods are used in clinical studies where expert consensus is needed to establish ground truth for interpreted data.
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
There is no indication of an MRMC study being performed. The document focuses on the substantial equivalence of device modifications through non-clinical testing, not on the performance of human readers with or without an AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no indication of a standalone algorithm performance study. The device itself (an IVUS catheter) is a hardware device that generates images; it is not an AI algorithm. Its performance is related to its physical and biological properties, and its ability to generate images, which is assessed through bench testing and biocompatibility.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Bench Testing: The "ground truth" would be established by known standards or product specifications. For example, friction force would be compared against a specified maximum, and coating adhesion would be assessed against a defined acceptable level.
- Biocompatibility Testing: The "ground truth" is defined by established regulatory and scientific protocols for assessing biological safety. These tests have pre-defined pass/fail criteria based on cytotoxicity, sensitization, systemic toxicity, etc.
8. The sample size for the training set
This section is not applicable. The device is a medical hardware device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
§ 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).