(104 days)
The Percu-Pro™ Steerable Introducer is intended to be used for the introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.
The Cardiosolutions Percu-Pro™ Steerable Introducer is a 14Fr Introducer. The set also consists of a dilator, stylet, and tear-away introducer sheath. The steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in 65 cm or 80 cm working lengths. The device is provided sterile and is intended for single use only.
Here's an analysis of the acceptance criteria and study information for the Percu-Pro™ Steerable Introducer based on the provided text:
Preamble: This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance standards. Therefore, the "acceptance criteria" are primarily related to meeting established industry standards and guidance for similar devices, and the "device performance" is reported in terms of compliance with these standards and suitability for intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion / Test Name | Reported Device Performance / Outcome |
|---|---|---|
| Biocompatibility & Hemocompatibility (ISO 10993) | Cytotoxicity | Demonstrated suitability for intended use |
| Systemic Injection | No intracutaneous reaction observed (O indicated for pass) | |
| Intracutaneous Injection | No intracutaneous reaction observed (O indicated for pass) | |
| Sensitization Maximization | Demonstrated suitability for intended use | |
| Material Mediated Pyrogenicity | Demonstrated suitability for intended use | |
| Direct Hemolysis | Demonstrated suitability for intended use | |
| Partial Thromboplastin Time | Demonstrated suitability for intended use | |
| In Vivo Thromboresistance Study in Dog | Demonstrated suitability for intended use | |
| ASTM Hemolysis - Direct Contact | Demonstrated suitability for intended use | |
| SC5b-9 Complement Activation Assay | Demonstrated suitability for intended use | |
| C3a Complement Activation Assay | Demonstrated suitability for intended use | |
| Mechanical Testing (ISO 10555 & FDA Guidance) | Visual Surface Inspection | All test results demonstrate that the properties and performance of the device are suitable for its intended use. |
| Dimensional Verification | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| Corrosion Resistance | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| Tensile Break Force | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| Tip Separation Force | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| Freedom from Leakage Under Pressure | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| Air Leakage During Aspiration | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| Luer Hub Compliance | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| Flexural Fatigue Tolerance | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| In Vitro Simulated Use Studies | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| Functional Performance Testing | All test results demonstrate that the properties and performance of the device are suitable for its intended use. | |
| Radiopacity | All test results demonstrate that the properties and performance of the device are suitable for its intended use. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "Safety and Performance Testing." This testing included Biocompatibility and Hemocompatibility testing in accordance with ISO 10993, and Mechanical testing conducted in accordance with ISO 10555 and FDA Guidance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of devices or tests performed per criterion) for either the biocompatibility/hemocompatibility or mechanical testing. It lists the categories of tests conducted.
- Data Provenance: The studies were conducted by Cardiosolutions Inc. as part of their 510(k) submission. The location of the testing facilities is not explicitly stated. The nature of the tests (biocompatibility and mechanical properties) indicates they are "benchtop" or "laboratory" studies, not directly involving human patients (except for the in vivo thromboresistance study in dogs, which is an animal model). These were likely prospective tests designed to evaluate the physical and biological properties of the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. For this type of device (intravascular catheter introducer), "ground truth" as typically defined in diagnostic AI studies (e.g., expert consensus on medical images) is not relevant. The "truth" is established by adherence to a pass/fail criterion for each technical standard or guidance document. The expertise would lie in the engineers and scientists performing and interpreting these technical tests in accordance with the specified ISO standards and FDA guidance. Their qualifications are not explicitly stated but are implicitly assumed to be appropriate for conducting such specialized testing.
4. Adjudication Method for the Test Set
- Not Applicable. Similar to the point above, adjudication in the sense of resolving disagreements among human readers on a diagnosis is not relevant here. The tests likely have clear pass/fail criteria based on quantitative measurements or qualitative observations by a single or multiple trained personnel, but not in a "reader adjudication" format typically seen in clinical studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study is designed to assess the performance of diagnostic systems (e.g., AI with/without human readers). This 510(k) pertains to a medical device (introducer sheath) that is not a diagnostic system. The studies described are focused on the physical and biological properties of the device itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a physical medical instrument, not a software algorithm or AI. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is primarily based on defined scientific and engineering standards and specifications. This includes:
- ISO 10993 series: For biocompatibility and hemocompatibility, which sets criteria for acceptable biological response.
- ISO 10555 series: For sterile, single-use intravascular catheters, which defines mechanical requirements.
- FDA Guidance: On Premarket Notification 510(k) Submission for Short Term and Long Term Intravascular Catheters, which provides additional criteria.
- For the in vivo dog study mentioned, the ground truth would be the observed biological response to the device in the animal model, interpreted against established safety benchmarks for thrombus formation.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware medical device, not an AI or machine learning algorithm that requires a "training set." The device is manufactured according to a design, and then tested for compliance with established standards.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this hardware device, the concept of establishing ground truth for it does not apply.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).