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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.

Study Information

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

8. 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.

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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."

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.

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