(132 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-thewire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise RF Adapter Cable (packaged separately - Model CW-1002) and a commercially available Electrosurgical Pencil.
The CrossWise RF Transseptal Cannula is designed to facilitate injection of heparinized saline and/or contrast solution. The dimensions for the CrossWise RF Transseptal Cannula can be found on the device label. The CrossWise RF Transseptal Access System offers four configurations compatible with various commercially available guide sheaths (Table 5). All four configurations require use of a single model (CW-1002) CrossWise RF Adapter Cable Model which is packaged separately.
This document does not describe a study involving device performance metrics relevant to AI/ML, such as sensitivity, specificity, or F1 score, or any human reader studies using AI assistance. The provided text is a 510(k) summary for a medical device (CrossWise RF Transseptal Access System) to demonstrate substantial equivalence to predicate devices, focusing on non-clinical performance data like biocompatibility, sterilization, electrical safety, and bench testing.
Therefore, many of the requested categories related to acceptance criteria, device performance, ground truth, and human reader studies cannot be populated from the given text.
Here's a breakdown of the information that can be extracted:
1. A table of Acceptance Criteria and the Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria for performance metrics in a table format. Instead, it states that the device was tested to conform with various international standards and that "The nonclinical bench data support the safety of the device and demonstrate that the CrossWise RF Transseptal System performs as intended in the specified use conditions."
The types of tests performed and the general findings are:
| Test Category | Acceptance Criteria (Implied by standard conformance) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-1 | Meets requirements for intended use. |
| Sterilization | Conformance to ISO 11135, SAL of 10⁻⁶ | Achieves a sterility assurance level (SAL) of 10⁻⁶. |
| Electrical Safety & EMC | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 | Complies with applicable sections of these standards. |
| Bench Testing | (Implied by specific performance tests) | Performs as intended in specified use conditions. |
| - Packaging Integrity | (Implied) | Passed (implied by overall conclusion). |
| - Label Integrity | (Implied) | Passed (implied by overall conclusion). |
| - Visual & Dimensional | (Implied) | Passed (implied by overall conclusion). |
| - Introducer Set Compatibility | (Implied) | Passed (implied by overall conclusion). |
| - Electrical Functionality/Compatibility | (Implied) | Passed (implied by overall conclusion). |
| - Electrical Safety | (Implied) | Passed (implied by overall conclusion). |
| - Mechanical Functionality | (Implied) | Passed (implied by overall conclusion). |
| - Mechanical Durability | (Implied) | Passed (implied by overall conclusion). |
| - Puncture Performance | (Implied) | Passed (implied by overall conclusion). |
| - Particulate Generation | (Implied) | Passed (implied by overall conclusion). |
| - Radiopacity | (Implied) | Passed (implied by overall conclusion). |
| - Corrosion Resistance | (Implied) | Passed (implied by overall conclusion). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of devices or number of tests for each type, other than "Devices were subjected to 2X sterilization and distribution simulation". The document states "Design verification testing was performed on the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable at two time points: immediately after manufacturing (T=0) and after six months of accelerated aging (T=6M AA)."
- Data Provenance: Not explicitly stated, however, the testing appears to be internal validation performed by the manufacturer, Circa Scientific, Inc., or a contract lab on their behalf. It is non-clinical (bench).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a non-AI/ML medical device submission based on physical and electrical performance. Ground truth would be based on instrument readings, standardized methods, and expert evaluation of physical properties, not clinical expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device and testing.
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:
- No. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance data, the "ground truth" is based on:
- Validated test methods outlined in international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ISO 11135 for sterilization).
- Objective measurements from laboratory equipment and physical inspection.
- Functional verification against design specifications.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 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).