(65 days)
The SUREFIRE® GUIDE SHEATH is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
The Surefire® Guide Sheath is designed to act as a conduit for diagnostic agents and facilitates deployment at the desired treatment location. The Guide Sheath is a 0.035" guide wire compatible, single lumen, fixed length catheter body with a luer lock hub.
The document describes the performance testing for the Surefire® Guide Sheath. Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that a "battery of tests was performed according to protocols based on the requirements of the international standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device." However, specific numerical acceptance criteria (e.g., "tensile strength must be > X N") and the exact numerical performance results are not detailed in the provided text for most tests.
The document lists various tests under "Performance Testing & Verification Testing" and states that "The following series of tests have been provided in this submission:" and "Testing listed below was provided in the original submission."
| Test Category | Acceptance Criteria (Stated in Document) | Reported Device Performance (Stated in Document) |
|---|---|---|
| Performance Testing | "meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device" | A battery of tests was performed and was shown to meet the acceptance criteria. (Specific results not provided). |
| Biocompatibility Testing | Recommended tests in FDA General Program Memorandum, "Biological Evaluation of Medical Devices Part -1 Evaluation and testing" (ISO 10993). Specific standards mentioned: ASTM F756 and ISO 10993-4 (Hemolysis), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Intra-cutaneous Irritation, Sensitization), ISO 10993-11 (Pyrogenicity), USP Standards (Particulate), Complement System evaluation. | All listed biocompatibility tests were performed and presumably met the acceptance criteria as the device was cleared. (Specific results not provided). |
| Risk/Hazard Analysis (EN ISO 14971) | "Performance characteristics for this indication for use were determined." Justified that "the performance of the Surefire® Guide Sheath is substantially equivalent to the performance and safety of the Surefire® Infusion System." | A risk/hazard analysis was conducted, and it was justified that the performance is substantially equivalent to the predicate. (Specific risk levels or performance metrics not provided). |
| Additional Safety Mfg. Controls | Visual, functional, dimensional, and sterility tests. | These additional controls were performed to ensure safety. (Specific results not provided). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for any of the performance or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective, as these are typically bench-top or lab-based tests for medical devices of this nature, not clinical studies.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
This information is not applicable to the type of device and testing described. The Surefire® Guide Sheath is an intravascular catheter, and its performance is evaluated through engineering and biocompatibility bench testing, not through human expert assessment of data like in image-based diagnostic AI.
4. Adjudication Method for the Test Set:
This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials or expert consensus studies, which are not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI algorithms comparing human performance with and without AI assistance. The Surefire® Guide Sheath is a physical medical device (catheter), not an AI diagnostic tool.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
No, a standalone (algorithm only) performance study was not done. This is relevant for AI algorithms without human intervention. The Surefire® Guide Sheath is a physical device that is used by a human operator. Its performance is assessed through bench tests of its physical properties and biocompatibility.
7. The Type of Ground Truth Used:
The "ground truth" for the performance testing of the Surefire® Guide Sheath is primarily defined by international standards and engineering specifications.
- Engineering Specifications: For tests like Kink Testing, Tensile Testing, High-Pressure Injection, Trackability, Torque, and Dimensional Inspection, the ground truth is established by predetermined engineering specifications and functional requirements for the device. For example, a certain force must be withstood in a tensile test, or a specific pressure must be tolerated during injection.
- International Standards (Biocompatibility): For biocompatibility, the ground truth is established by well-defined tests and pass/fail criteria outlined in standards such as ASTM F756, ISO 10993 series, and USP Standards. These standards provide methodologies and acceptable limits for biological responses.
8. The Sample Size for the Training Set:
This information is not applicable. The Surefire® Guide Sheath is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical medical device.
§ 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).