(199 days)
The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.
The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and, optionally, to an external pressure monitoring system via a luer connection.
The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. The active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.
The provided text describes the regulatory clearance of a reprocessed medical device, the Reprocessed NRG Transseptal Needle. The document focuses on demonstrating substantial equivalence to a predicate device through various functional and safety tests, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested categories related to clinical study design, such as sample size, ground truth establishment, and MRMC studies, are not applicable to this submission.
Here's the breakdown based on the provided information:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table format with corresponding performance results. Instead, it lists the types of functional and safety tests conducted to demonstrate that the reprocessed device performs comparably to the predicate. The overall "reported device performance" is that it is "as safe and effective as the predicate device."
| Acceptance Criteria Category | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Functional Testing: | |
| Visual Inspection | Passed (implied by "Each device is inspected") |
| Dimensional Verification | Passed |
| Simulated Use | Passed |
| Electrical Continuity | Passed |
| Leak Testing | Passed |
| Corrosion Resistance | Passed |
| Mechanical Characteristics | Passed |
| Safety Testing: | |
| Biocompatibility | Passed |
| Cleaning Validation | Passed |
| Sterilization Validation | Passed |
| Electrical Safety Testing | Passed (Dielectric and Current Leakage) |
| Packaging Validation | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for each individual test. It generally states that "Bench and laboratory testing were conducted."
- Data Provenance: The device is being submitted for regulatory clearance in the USA (FDA). The tests were likely conducted internally by Innovative Health, LLC. The testing is prospective in the sense that it's performed on reprocessed devices to demonstrate their characteristics before market release, but it's not a clinical trial with patient data.
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 reprocessed medical device submission focusing on engineering and safety performance, not a diagnostic device requiring expert interpretation of results for ground truth.
4. Adjudication Method for the Test Set
Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are relevant for studies where human interpretation of medical images or data requires a consensus.
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
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (a reprocessed transseptal needle), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the various tests (e.g., biocompatibility, electrical continuity, mechanical characteristics) would be established by industry standards, engineering specifications, and validated test methods to ensure the device meets predefined performance criteria comparable to a new, equivalent device. For example, for "electrical continuity," the ground truth is a specific range of resistance or current flow, rather than pathology or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical 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).