(1265 days)
The NuMED NuCLEUS and NuCLEUS-X BAV Catheters are indicated for Balloon Aortic Valvuloplasty.
The NuCLEUS BAV and the NuCLEUS-X BAV are both coaxial catheters, with the NuCLEUS-X currently cleared in the United States under K081680 for Balloon Pulmonic Valvuloplasty (BPV). The NuCLEUS BAV is currently only marketed outside of the United States. The outer body of both devices is made of {Redacted as b4} tubing, while the inner shaft (or tubing) material is the only difference between the two devices. In the NuCLEUS-X Catheter, the inner tubing is comprised of {Redacted as b4}while in the NuCLEUS Catheter, the inner tubing is comprised of {Redacted as b4} The sponsor states that the {Redacted as b4}makes it less likely to stretch when force is used. From an engineering perspective, in terms of composition, testing, and intended use, FDA believes there is no significant difference in these technological characteristics between the inner tubing of the two catheters based upon the non-clinical performance testing results. Furthermore, these two devices would be expected to perform in a similar manner in the clinical setting during balloon aortic valvuloplasty procedures. The catheters also feature a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. The balloon is designed with a waist formed into the middle of the balloon to allow accurate balloon placement. Upon reaching a specified pressure, the waist will expand to the rated balloon diameter and dilate the valve to the rated diameter. The distal lumen terminates at the tip of the catheters and will accept the passage of the 0.035" guidewire. This lumen has 3 radiopaque platinum marker bands. One under each of the balloon shoulders and one located at the "waist" or center of the balloon for placement using fluoroscopy. The catheters are packaged in a {Redacted as b4} sheath and double packed in two {Redacted as b4} sealed Tyvek pouches.
This document describes the regulatory evaluation of the NuMED NuCLEUS and NuCLEUS-X BAV Catheters. The assessment includes non-clinical bench studies and the leveraging of extensive clinical experience with similar devices and the BAV procedure in general.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data for the NuMED NuCLEUS-X and NuCLEUS BAV Catheters are primarily derived from non-clinical bench testing:
| Test Performed | Acceptance Criteria | NuCLEUS-X BAV Results | NuCLEUS BAV Results |
|---|---|---|---|
| Visual Inspection | Catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device. | All catheters were visually inspected without any anomalies. | All catheters were visually inspected without any anomalies. |
| Balloon Preparation Test | Each catheter shall be prepped per the procedure without functional difficulties or anomalies. | All catheters tested were without functional difficulties or anomalies. | All catheters tested were without functional difficulties or anomalies. |
| Diameter and Profile Test | The balloon diameter at rated burst pressure shall be within +/- 10% of the labeled balloon diameter and the samples should fit through the selected introducer with no problems. | All catheters met the acceptance criteria. | All catheters met the acceptance criteria. |
| Balloon Distensibility | The results must demonstrate that the balloon diameter is within +/- 10% of the labeled diameter at the RBP and will not be significantly increased at increasingly higher pressures. | All data obtained demonstrated that the balloon diameter is w/in +/-10% of the labeled diameter at the RBP. All data obtained demonstrated that the diameter of the balloons will not be significantly increased at increasingly higher pressures. | All data obtained demonstrated that the balloon diameter is within +/-10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures. |
| Repeated Balloon Inflation (Balloon Fatigue Test) | No breaks allowed. | 30 Samples - no breaks | 30 Samples - no breaks |
| Balloon Minimum Burst Strength | The results must show statistically that with at least 95% confidence, 99.9% of the balloons will not burst at or below the maximum recommended rated burst pressure. | 20 samples of smallest diameter-shortest length, smallest diameter-longest length, largest diameter-shortest length, largest diameter-longest length, and all diameters in between (various sizes listed). | 20 samples of smallest diameter-shortest length, smallest diameter-longest length, largest diameter-shortest length, largest diameter-longest length, and all diameters in between (various sizes listed). |
| Balloon Inflation/Deflation Test | Inflation achieved in less than 12 seconds and deflation achieved in less than 20 seconds. | Twenty samples of all Diameters. All catheters met the established acceptance criteria. | Twenty Samples of all Diameters. All catheters met the established acceptance criteria. |
| Balloon Inflstability Test | There should be no interference with balloon deflation. | Twenty Samples of all Diameters. All catheters met the established acceptance criteria. | Twenty Samples of all Diameters. All catheters met the established acceptance criteria. |
| Tip Pull and Torque Test | Must withstand at least 10 turns without breaking. | Twenty random samples of each shaft size. No breaks reported. | Twenty random samples of each shaft size. No breaks reported. |
| Bond Strength Test | All bonds must withstand at least 3 lbs. of pull strength. | Twenty samples of each shaft size. All bonds met the established acceptance criteria. | Twenty samples of each shaft size. All bonds met the established acceptance criteria. |
| Catheter Body Maximum Pressure Test | All samples must withstand 30 ATM (400psi). | Twenty samples of each guidewire size. >30ATM | Twenty samples of each guidewire size. > 400 psi |
Note: The document references specific sizes for the Balloon Minimum Burst Strength for each device, which are too extensive to list individually in this summary table, but they are detailed in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
For the formal performance testing (bench studies), samples were taken across various models and sizes of both the NuCLEUS-X and NuCLEUS catheters.
- Visual Inspection, Balloon Preparation, Diameter & Profile, Balloon Distensibility, Balloon Inflation/Deflation, Balloon Inflstability, Bond Strength, Catheter Body Max Pressure: "All catheters" or "Twenty samples of all Diameters" or "Twenty samples of each guidewire size" were tested and met the criteria.
- Repeated Balloon Inflation (Balloon Fatigue Test): 30 samples for both NuCLEUS-X and NuCLEUS.
- Balloon Minimum Burst Strength: 20 samples for different configurations (smallest diameter-shortest length, smallest diameter-longest length, largest diameter-shortest length, largest diameter-longest length, and all diameters in between) for both NuCLEUS-X and NuCLEUS.
- Tip Pull and Torque Test: Twenty random samples of each shaft size for both NuCLEUS-X and NuCLEUS.
Data Provenance: The non-clinical (bench) data was generated by the manufacturer, NuMED, Inc. The clinical data is based on existing, published literature and clinical experience from various sources globally. The document does not specify a country of origin for the clinical data in most cases, but some references mentioned (e.g., European Heart Journal, Revista Espanola de Cardiogia) indicate international provenance. The clinical data is retrospective, drawing from previously documented clinical studies and experiences.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the clinical evaluation, the "ground truth" and assessment of the devices and BAV procedure were established by:
- Sponsor-provided literature: NuMED provided "two clinical reports containing extensive published literature" summarizing the clinical use of their devices.
- FDA Reviewers: The FDA specifically states, "The specifically-cited clinical experience using the NuMED NuCLEUS family of catheters for BAV is a scientifically sound approach that was agreed upon by the scientific and clinical reviewers of this de novo." These reviewers are presumably experts in cardiology and medical device evaluation within the FDA, though their specific qualifications (e.g., years of experience as cardiologists) are not detailed in this document.
For the bench testing, the ground truth is based on engineering specifications and direct physical measurements, not expert consensus on qualitative data.
4. Adjudication Method for the Test Set
For the bench testing, no "adjudication method" in the sense of expert review consensus is mentioned. The tests have clear pass/fail acceptance criteria demonstrated by direct measurements.
For the clinical evaluation, the "adjudication" was effectively performed by the FDA's "scientific and clinical reviewers" who assessed the provided literature, including the NuMED NuCLEUS family of catheters, and determined that the body of evidence supported the safety and effectiveness. This is implicit in the FDA's "FDA Comment" sections on each cited paper. No formal N+1 reader adjudication scheme is described regarding the clinical literature review.
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 document describes the evaluation of a physical medical device (balloon catheter) for regulatory approval, not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC comparative effectiveness study involving human readers with or without AI assistance was conducted or is relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. As mentioned above, this is a physical medical device, not an algorithm. The "standalone performance" is represented by the extensive bench testing which evaluates the device's physical properties and functionality.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth for bench studies is based on engineering specifications and measurable physical properties. For example, balloon diameter within +/- 10% of labeled, inflation/deflation times, burst pressure, bond strength, and visual inspection for anomalies. These are objective measures against predefined criteria.
- Clinical Evaluation: The ground truth for the clinical aspect is primarily based on published clinical literature and extensive real-world clinical experience (outcomes data) with similar devices and the BAV procedure, as well as specific mentions of the NuMED NuCLEUS catheters in successful procedures. This includes demonstrating:
- Well-accepted use of BAV as a palliative treatment for severe aortic stenosis.
- BAV as a preparatory step for TAVR.
- Successful outcomes where NuMED NuCLEUS catheters were used.
- The similarity in design between NuCLEUS and NuCLEUS-X making existing NuCLEUS clinical data applicable to NuCLEUS-X.
8. The Sample Size for the Training Set
Not Applicable in the context of machine learning. For the clinical evaluation, the "training set" equivalent would be the vast body of worldwide clinical experience with BAV, which is described as "extensive," "many years," and involving "numerous BAV clinical studies." This represents a very large, but unquantified, patient population. For the specific NuMED NuCLEUS family, the cited clinical studies involved cohorts of 20, 212, and 50 patients, and various unspecified "patients" in other papers.
9. How the Ground Truth for the Training Set Was Established
Not Applicable for machine learning. For the clinical evaluation, the "ground truth" (i.e., the established understanding of the BAV procedure and the performance of these catheters) was established through:
- Accumulated Clinical Data: Decades of clinical practice and research on Balloon Aortic Valvuloplasty (BAV) using various devices.
- Published Studies: Peer-reviewed medical literature documenting the efficacy, safety, and outcomes of BAV procedures, including specific mentions of NuMED NuCLEUS catheters.
- FDA Assessment: The FDA's "scientific and clinical reviewers" critically evaluated this body of literature and experience to form their conclusions regarding the safety and effectiveness of the device and procedure.
§ 870.1255 Balloon aortic valvuloplasty catheter.
(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.