(30 days)
The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.
The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.
The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-the-wire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise Multi-Use RF Adapter Cable (packaged separately – Model CW-1001) and a commercially available Electrosurgical Pencil.
This 510(k) clearance letter details the substantial equivalence of new models of the CrossWise RF Transseptal Access System to a previously cleared predicate device. It specifically states that the new models have minor modifications and leverage most of the performance data of the predicate device.
Therefore, the acceptance criteria and study details discussed below refer to the bench testing conducted for these minor modifications, as this is the only performance data explicitly mentioned for the subject device. The document does not contain information about clinical studies with human participants, expert ground truth adjudication, or AI performance, as it is related to a medical device's physical and functional equivalence, not an AI or diagnostic tool.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The provided 510(k) clearance letter details the acceptance criteria and the non-clinical performance data for the CrossWise RF Transseptal Access System line extensions (Models CW-1085C, CW-1085V, and CW-1013F). The study conducted to prove the device meets these criteria was a series of bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
The letter explicitly states that the new models leverage most of the performance data of the predicate device. The following table summarizes the specific tests conducted for the minor modifications of the new models and the implied performance criteria based on the conclusion of substantial equivalence.
| Acceptance Criterion | Performance for Subject Device (CW-1085C, CW-1085V, CW-1013F) | Notes |
|---|---|---|
| Dilator Hub Snap Compatibility | Bench tested to confirm proper connection with 7 new compatible commercial introducer sheaths (CardioCurve, Vizigo, Faradrive), as well as previously compatible sheaths (Agilis, Swartz, Watchman, FlexCath). | The document states "minor dimensional changes to accommodate proper connection with other commercial introducer sheaths", and "Similar to PD; Subject Device dilator extrusions are identical with minor proximal hub modifications for compatibility with new sheaths. This does not raise new questions of safety or effectiveness." This implies successful snap compatibility. |
| Sheath Compatibility | Bench tested to confirm proper fit and function within the specified compatible commercial introducer sheaths (CardioCurve, Vizigo, Faradrive). | The document states "minor dimensional changes to accommodate proper connection with other commercial introducer sheaths", implying that compatibility was successfully demonstrated. |
| Dilator Leak Test | Bench tested. | No specific performance metrics are given, but the conclusion of safety and intended performance implies the device passed this test. This typically involves ensuring no fluid leakage under specified pressures. |
| Dilator Tensile | Bench tested. | No specific performance metrics are given, but the conclusion of safety and intended performance implies the device passed this test. This typically involves testing the strength and integrity of the dilator under tension. |
| ISO 80369-7 Luer Testing | Conformed to ISO 80369-7:2021 standard for small-bore connectors for intravascular/hypodermic applications. | The document lists ISO 80369-7:2021 under "Performance Standards" and explicitly states "ISO 80369-7 Luer Testing" was performed. Conformance to this standard means the luer connectors meet established safety and functional requirements to prevent misconnections and ensure proper fluid transfer. |
| Biological Evaluation (Biocompatibility) | Conformed to ISO 10993-1:2018. | Explicitly listed under "Performance Standards". The conclusion of substantial equivalence indicates the device's biocompatibility is acceptable. |
| Sterilization Method / SAL | Achieved Sterility Assurance Level (SAL) of 10^-6 using Ethylene Oxide (EO). | Explicitly listed in the comparison table as "Identical" to predicate device. |
| Nonpyrogenic | Yes | Explicitly listed in the comparison table as "Identical" to predicate device. |
| Shelf-Life | 2 Years | Explicitly listed in the comparison table as "Identical" to predicate device. No further stability/shelf-life testing was required for the line extension models due to no change in material, design, or processing that could lead to age-related failure. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a number of devices or units. The testing refers to "minor modifications" to the dilator hub and compatibility with new introducer sheaths. For bench tests like these, a statistically representative sample size would have been used for each test (e.g., n=3, 5, or 10 units per test configuration), but the exact numbers are not provided.
- Data Provenance: The data is non-clinical bench testing conducted by the manufacturer, Circa Scientific, Inc. The location of the testing is not specified, but it would have been conducted in a laboratory setting under controlled conditions. This is not retrospective or prospective in the clinical sense, as it does not involve patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This document describes the clearance of a medical device (a transseptal access system), not an AI or diagnostic tool that relies on expert interpretation of data to establish ground truth. The acceptance criteria are based on objective engineering and performance standards demonstrated through bench testing.
4. Adjudication Method for the Test Set
- Not applicable. As this is non-clinical bench testing of a physical medical device against engineering standards, there is no expert adjudication process in the manner of medical image interpretation or clinical outcomes. Test results would have been analyzed and verified by qualified engineering and quality personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is typically conducted for diagnostic devices or AI systems where human readers interpret patient cases. This clearance is for a physical medical device used in interventional cardiology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Engineering and Performance Standards: The "ground truth" for the bench tests would have been established by predefined engineering specifications, internationally recognized standards (e.g., ISO 80369-7, ISO 10993-1, ISO 11070-1), and the performance characteristics of the predicate device. For example, the ground truth for "Dilator Leak Test" would be "no leakage observed under specified pressure," and for "ISO 80369-7 Luer Testing" would be "full compliance with all requirements of the standard."
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 870.5175 Septostomy catheter.
(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).