(209 days)
An intravascular diagnostic catheter is a device used to record intracardiac pressure, to sample blood, and to introduce substances into the heart and vessels.
The 4F SiteSeer (II) catheter is an intravascular diagnostic catheter for use in the cardiovascular system.
The provided text is a 510(k) summary for the AVE 4F SiteSeer (II) Cardiovascular Angiographic Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against specific acceptance criteria in a clinical study for an AI-powered device. Therefore, much of the requested information regarding AI device evaluation (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable or present in this document.
However, I can extract information related to the device's technical performance and the studies conducted to show substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in the way an AI device might have for diagnostic accuracy. Instead, it details performance testing done to show substantial equivalence to predicate devices. The "reported device performance" are the results demonstrating this equivalence.
| Performance Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Summary of Results) |
|---|---|---|
| Mechanical Performance | Similar to predicate devices (AVE 4F SiteSeer, AVE Envision, Cordis Infiniti, Cordis Vista Bright Tip) | Demonstrated equivalence in tensile strength, bending stiffness, straight-line torque, high-pressure static leak, flow rate, and natural frequency testing to predicate devices. |
| Biocompatibility | Compliance with ISO 10993 for predicate device materials | Demonstrated biocompatibility in acute intracutaneous reactivity, acute systemic toxicity, cytotoxicity, hemolysis, material-mediated pyrogen, and sensitization tests. |
| Sterilization | Similar to predicate devices | Similar to predicate devices. |
| Packaging | Similar to predicate devices | Similar to predicate devices. |
| Materials of Construction | Similar to predicate devices | Similar to predicate devices. |
| Shelf-Life | Meets performance specifications for labeled life expiration date | Demonstrated device meets all performance specifications within its labeled life expiration date. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as this is a traditional medical device (catheter) submission, not an AI/ML device, and no "test set" of patient data was used in the context of an AI study. The "testing" referred to are engineering and biocompatibility tests on the physical catheter.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as ground truth in the context of diagnostic accuracy is not relevant for this type of device submission. Expert judgment might have been involved in establishing test protocols or assessing results for mechanical properties, but this is not detailed as "ground truth" for a test set.
4. Adjudication Method for the Test Set
This information is not applicable. See Point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable. This is not an AI-assisted diagnostic device, so no MRMC study was conducted.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
This information is not applicable in the context of diagnostic performance. The "ground truth" for the device's performance would be the objective measurements from the engineering and biocompatibility tests compared against established standards or predicate device performance.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. See Point 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).