Search Results

Balloon Aortic Valvuloplasty

The NuMED Z-MED™ catheter is a coaxial catheter recommended for Balloon Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches. The NuMED Z-MED II™ catheter is a coaxial catheter recommended for Balloon Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study

The K122012 submission for the Z-MED and Z-MED II Catheters primarily relies on in-vitro (bench) testing and a review of existing clinical data for safety and effectiveness. No specific algorithms or human-in-the-loop performance studies are described as this is a medical device (catheter), not an AI/software device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details in-vitro test results for the Z-MED and Z-MED II catheters, as well as two predicate devices (NuCLEUS-X and NuCLEUS). The table below focuses on the Z-MED and Z-MED II results as the subject devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for In-Vitro Testing: The document does not explicitly state the numerical sample size for each in-vitro test (e.g., how many catheters were visually inspected or burst tested). It refers to "All catheters" or "All samples" meeting criteria, indicating that a sufficient number were tested.
• Data Provenance (Clinical):
  • Country of Origin: The clinical evaluation report was prepared to meet the requirements of the Medical Device Directive MOD 93/42/EEC (European Union standard). The clinical use of the Z-MED and Z-MED II catheters for BAV and BMV is mentioned in "those countries where they are used," and for BPV in "the United States."
  • Retrospective/Prospective: The clinical information gathered appears to be a retrospective review of existing clinical literature, device history, previous sales, and reported complaints. It references "Numerous clinical studies reported in literature" and "200 patients" without incidents from BAV prior to TAVI.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the context of this submission. The tests described are in-vitro bench tests for a physical medical device (catheter), which do not typically involve experts establishing ground truth in the way it's done for diagnostic AI/software. The ground truth for in-vitro tests is based on objective physical measurements and engineering specifications.

For the clinical context, the "ground truth" refers to observations from actual patient use, as reported in clinical literature and through device monitoring. No specific number or qualification of experts reviewing patient outcomes is provided beyond the implicit understanding that medical professionals conducted the procedures and reported outcomes.

4. Adjudication Method for the Test Set

This is not applicable for the in-vitro bench testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in cases where there's variability in interpretation (e.g., image analysis by multiple radiologists). The in-vitro tests are objective physical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is not applicable and not mentioned. This type of study is relevant for diagnostic devices, especially those involving human interpretation of data, often comparing human performance with and without AI assistance. The Z-MED and Z-MED II are interventional catheters, not diagnostic devices or AI software. There's no AI component mentioned to compare human readers with or without.

6. Standalone (Algorithm Only) Performance Study

This is not applicable and not mentioned. The devices are physical catheters, not algorithms or software. Therefore, there is no standalone (algorithm only) performance to evaluate.

7. Type of Ground Truth Used

• In-Vitro Testing: The ground truth for the in-vitro tests is established by the predefined engineering specifications and acceptance criteria outlined in the table (e.g., balloon diameter within +/- 10% of labeled, no breaks, inflation/deflation times). These are objective, measurable physical parameters.
• Clinical Evaluation: The "ground truth" for clinical safety and performance is based on real-world patient outcomes and reported incidents/adverse events from existing clinical use and literature reviews.

8. Sample Size for the Training Set

This is not applicable. The Z-MED and Z-MED II are physical medical devices undergoing traditional bench testing and clinical review, not AI models that require training sets.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a physical medical device.

Ask a specific question about this device

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:

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.

Ask a specific question about this device

Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis.
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
  This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

The Mullins-X catheter is an Ultra High Pressure Dilatation catheter recommended for Percutaneous Transluminal Valvuloplasty of the Pulmonary Valve. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen is for balloon inflation and deflation. The balloons of the Mullins-X catheter are made of a non-compliant polymeric material. The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The area under the balloon is enhanced with four radiopaque platinum image bands. Two are 5mm on each side of the balloon center and two more under the balloon shoulders. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped on the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

The provided text describes the Mullins-X PTV Catheter, a medical device. Here's an analysis of its acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size for each in-vitro test. Instead, it refers to "all catheters tested" or "all samples," implying that a sufficient number of units were tested to demonstrate compliance with the acceptance criteria. The data provenance is not mentioned, but as this is an in-vitro study, it is likely conducted in a controlled laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The study described is an in-vitro performance test of a medical device (a catheter), not a diagnostic algorithm that relies on expert interpretation of data. The "ground truth" for these tests is based on objective measurements against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

Not applicable, as this is an in-vitro performance test, not a study requiring human adjudication of results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the scope of this device's testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The "Mullins-X PTV Catheter" is a physical medical device, not a software algorithm. The tests performed are standalone performance tests of the physical catheter itself.

7. The Type of Ground Truth Used

The "ground truth" for these tests is based on:

• Objective Measurements and Specifications: For criteria like diameter, pressure ratings, and time for inflation/deflation, the ground truth is the predefined numerical specification.
• Absence of Defects: For visual inspection and balloon fatigue tests, the ground truth is the absence of anomalies or breaks.
• Statistical Assurance: For balloon burst strength, the ground truth is a statistical confidence level that a certain percentage of balloons will not burst below the rated pressure.

These are established engineering standards and performance requirements for the device.

8. The Sample Size for the Training Set

Not applicable. This is an in-vitro performance test for a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, this device does not involve a training set or AI algorithm.

Ask a specific question about this device