(508 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, which is in compliance with IEC 60601-2-2. 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 dimensions for the reprocessed NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. As well, the active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Reprocessed NRG Transseptal Needle.
Important Note: The provided document is an FDA 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel efficacy or performing clinical trials with the same rigor as for a new drug or a high-risk de novo device. Therefore, the "study" described is primarily a series of bench and functional tests to ensure the reprocessed device performs comparably to the original and remains safe. It does not involve human subjects, AI performance, or typical clinical effectiveness measures that would require ground truth established by medical experts for a diagnostic algorithm.
Acceptance Criteria and Reported Device Performance
Given the nature of this submission (reprocessed device seeking 510(k) clearance), the "acceptance criteria" are primarily related to the device's functional integrity, safety, and equivalence to the original predicate device after reprocessing.
| Acceptance Criterion (Test Category) | Reported Device Performance / Outcome |
|---|---|
| Biocompatibility | Demonstrated (Implied to meet standards) |
| Cleaning Validation | Demonstrated (Implied to meet standards) |
| Sterilization Validation | Demonstrated (Implied to meet standards) |
| Functional Testing | |
| - Visual Inspection | Demonstrated (Implied to pass standards) |
| - Dimensional Verification | Demonstrated (Implied to match specifications) |
| - Simulated Use | Demonstrated (Implied to perform as intended) |
| - Electrical Continuity | Demonstrated (Implied to meet specifications) |
| - Leak Testing | Demonstrated (Implied to pass standards) |
| - Corrosion Resistance | Demonstrated (Implied to pass standards) |
| - Mechanical Characteristics | Demonstrated (Implied to meet specifications) |
| Electrical Safety Testing | |
| - Dielectric and Current Leakage | Demonstrated (Implied to pass standards) |
| Packaging Validation | Demonstrated (Implied to pass standards) |
| Reprocessing Cycle Limit | Limited to no more than three (3) reprocesses per device. Each device serialized and tracked. |
| Reprocessing Exclusivity | Innovative Health restricts reprocessing to devices not previously reprocessed by other entities. |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify numerical sample sizes for each test mentioned (e.g., how many devices were subjected to cleaning validation, electrical safety, etc.).
- The "data provenance" is derived from internal testing conducted by Innovative Health, LLC, the reprocessor and applicant. It's a retrospective evaluation of reprocessed devices. The country of origin for the data is implicitly the United States, where the company operates.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not directly applicable to this type of device clearance. The "ground truth" for a reprocessed medical device is its ability to meet engineering specifications and safety standards, not a diagnostic accuracy against expert consensus. These "bench and laboratory tests" are typically performed against pre-defined engineering requirements and international standards by qualified engineers and technicians, not medical experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human evaluation of diagnostic images or clinical scenarios where expert disagreement is possible. For functional and safety testing of a physical device, the outcome is typically an objective pass/fail against a standard, not subject to expert adjudication of subjective interpretations.
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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, an MRMC comparative effectiveness study was not done. This is a reprocessed medical device (a transseptal needle), not an AI diagnostic algorithm or a device requiring human interpretation of data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.
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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 an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering specifications, international performance standards, and safety requirements for medical devices (e.g., ISO, ASTM, IEC standards for biocompatibility, sterility, electrical safety, mechanical strength, etc.). It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical trial. The premise is that if the reprocessed device consistently meets these defined physical and chemical parameters, it is substantially equivalent and safe for its intended use as the original device.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML algorithm or 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).