Search Results

The Edwards Balloon Catheter is indicated for balloon pulmonic valvuloplasty.

The Edwards Balloon Catheter is used for balloon pulmonic valvuloplasty. The device consists of a nylon balloon, a thermoplastic elastomer (polyether block amide) multi-durometer braided shaft with 130 cm working length, platinum/iridium radio-detectable markers, and a polycarbonate y-connector that consists of a balloon inflation port and guidewire lumen. The effective length of the balloon is 4 cm and is offered in 16 mm, 20 mm, 23 mm and 25 mm diameters.

The provided text does not contain information about specific acceptance criteria, reported device performance metrics, or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for the Edwards Balloon Catheter, which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis based on the available information:

• Acceptance Criteria and Reported Device Performance: This information is not present in the document. The document states that "Non-clinical testing was completed to demonstrate that the Edwards Balloon Catheter meets the established performance characteristics, and to verify that design requirements are satisfied," but it does not list these specific characteristics or the quantitative results.

• Sample size used for the test set and the data provenance: Not applicable as no specific clinical or performance test sets with sample sizes are detailed. The testing mentioned is non-clinical (bench testing).

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set requiring expert ground truth is described.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set requiring adjudication is described.

• 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 device is a medical catheter, not an AI-driven diagnostic or assistive device.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical catheter, not an AI algorithm.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The testing described is non-clinical (bench testing) to assess device integrity and function, not diagnostic accuracy against a ground truth.

• The sample size for the training set: Not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.

• How the ground truth for the training set was established: Not applicable as this is a physical medical device, not a machine learning algorithm.

Summary of Non-Clinical Testing (from the document):

The document lists the following non-clinical tests that were performed:

• Biocompatibility evaluation per ISO 10993-1
• Ethylene oxide sterilization validation
• Package qualification
• Device functional testing:
  • Surface/visual Inspection
  • Dimensional inspection
  • Radiopacity
  • Balloon diameter
  • Insertion force into sheath
  • Balloon inflation/deflation time
  • Balloon compliance
  • Catheter kink test
  • Balloon catheter retrieval force
  • Balloon fatigue and burst
  • Leakage test
  • Bond testing

The document concludes that "The Edwards Balloon Catheter is substantially equivalent to the predicate device, the NuMed Z-MED™ Balloon Dilatation Catheter" based on these non-clinical tests, and that "The differences between the subject and predicate devices do not have an adverse impact on safety or effectiveness, as demonstrated by bench testing." However, the specific quantitative acceptance criteria for each test and the precise performance results are not detailed in this public FDA letter.

Ask a specific question about this device

The Vida PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:

• A patient with isolated pulmonary valve stenosis .
• A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention.

The Vida PTV Dilatation Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" quidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.

Here's a breakdown of the acceptance criteria and the study information for the Vida PTV Dilatation Catheter, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document provides a table of acceptance criteria for several in-vitro tests but does not provide the reported device performance for each criterion. It only states that the device "met all predetermined acceptance criteria."

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

The document does not explicitly state the sample sizes used for each of the in-vitro tests listed. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The tests are described as "in vitro tests."

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

Not applicable. The study describes in-vitro performance testing of a medical device, not a diagnostic or AI-driven system that would require expert-established ground truth. The acceptance criteria are based on physical and functional requirements.

4. Adjudication Method for the Test Set:

Not applicable. As this is an in-vitro performance study, there is no mention of adjudication methods typically associated with clinical or expert review studies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This document describes the performance testing of a physical medical device (catheter), not a diagnostic tool or an AI system that would assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI algorithm. The performance tests are for the physical properties and function of the catheter itself.

7. The Type of Ground Truth Used:

The "ground truth" for the in-vitro tests are the predefined acceptance criteria based on physical measurements, functional performance (e.g., inflation/deflation times), and visual inspection standards. These criteria are established based on "FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures."

8. The Sample Size for the Training Set:

Not applicable. This is not a study involving a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established:

Not applicable. No training set, as this is not an AI or machine learning study.

Ask a specific question about this device

The Bard PTV Dilatation Catheters are 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.

The Bard PTV Dilatation Catheter is a high performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over the wire catheter is compatible with 0.035" guidewire and is available in 75 and 100 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard PTV Dilatation Catheter, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the specific numerical sample size for each individual test. It refers to "All results showed the subject device passed the specified criteria" and "all samples were able to be fully deflated," suggesting multiple units were tested for each criterion.
• Data Provenance: The data is from in vitro testing conducted by Bard Peripheral Vascular, Inc. The document does not specify the country of origin of the data beyond the company's location (Tempe, Arizona, USA). It is prospective in the sense that these tests were performed on the device to demonstrate equivalence for regulatory submission.

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

This information is not applicable to this submission. The "ground truth" here is the performance specifications of the device, which are determined through engineering principles, regulatory standards (e.g., ISO10555-1 mentioned for Tip Tensile), and comparison to predicate devices. There is no expert review or consensus process for establishing the "ground truth" of mechanical performance metrics like burst pressure or tensile strength in the way there would be for image analysis or clinical diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are objective, quantitative mechanical and functional assessments (e.g., measuring diameter, forces, times), there is no need for expert adjudication of results. The results are Pass/Fail based on comparison to pre-defined numerical criteria.

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

This information is not applicable. This submission is for a medical device (dilatation catheter), not an AI diagnostic or assistance system that would involve human readers or cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This refers to an algorithm's performance, which is not relevant for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria and performance evaluation is based on:

• Engineering specifications and design requirements: Derived from the intended use and safety considerations.
• Regulatory standards: Such as ISO10555-1 mentioned for the Tip Tensile test.
• Performance of predicate devices: The "Predicate Mullins-X Acceptance Criteria" serve as a benchmark, and in some cases, the subject device's criteria are "more robust."

Essentially, the ground truth is established by a combination of relevant standards and established performance benchmarks for similar devices.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device. It does not involve a training set as would be used in machine learning or AI.

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

This information is not applicable for the same reason as point 8.

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

This catheter is 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.

The COEfficient PTV Catheter is a coaxial over-the-wire catheter with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter into the pulmonary valve while the other lumen is for balloon inflation and deflation. The balloon of the COEfficient model is made of a non-compliant polyethylene. The balloons are designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The catheter body ends proximally in a bifurcated 'Y' connector with a guidewire port and a balloon extension. The balloon extension is marked with the product lot number and the balloon size. The outer body and inner body tubing is made of pebax. The area under the balloon is enhanced with either one or two radiopaque platinum image bands depending on the model. If marked with one image band, it is centered under the midpoint of the balloon. If it is marked with two image bands, they are located under the shoulders of the balloon. This catheter is of the same design and construction as the NuMED PTV catheters for which the 510(K) has been approved. The differences are lower profile, smaller shaft, and higher rated burst pressure.

Here's an analysis of the provided text regarding the NuMED COEfficient PTV Catheter, focusing on acceptance criteria and study information:

Based on the provided Summary of Safety and Effectiveness Data for the NuMED COEfficient PTV Catheter (K014124), the device's acceptance criteria and studies primarily revolve around demonstrating substantial equivalence to a predicate device and meeting biocompatibility and bench testing standards.

It's important to note that this document is a 510(k) summary, which typically focuses on demonstrating equivalence rather than an independent clinical study proving efficacy against specific quantitative clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly defined by the characteristics of the predicate device, the NuMED Z-MED PTV Catheter. The device performance is reported as meeting or being comparable to these characteristics, with specific improvements highlighted.

• Introducer: 4 Fr - 7 Fr (Lower Profile)
• Shaft Size: 3.5 Fr (Smaller Shaft)
• Guidewire Size: 0.018"
• Usable Length: 75 cm
• Balloon Diameter: 4 mm - 12 mm
• Balloon Length: 2 cm - 4 cm |
  | Rated Burst Pressure | Implicitly, a safe and effective burst pressure for intended use. | Improved: Higher rated burst pressure (stated qualitatively compared to predicate). |

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

The document does not describe a clinical "test set" in the traditional sense of a patient cohort. The support for the device largely comes from:

• Materials Biocompatibility Testing: The "test set" here would refer to the materials themselves. The document states the materials were tested, but does not specify the sample size of material samples or the specific tests performed (though it references the Tripartite Biocompatibility Guidance).
• Laboratory (Bench) Testing: The "test set" here refers to the device units subjected to various bench tests (e.g., burst pressure, dimensional accuracy). The document states "All bench testing was performed," but does not specify the sample size of devices tested for each parameter.
• Comparison to Predicate: The "test set" is effectively the design and performance specifications of the NuMED COEfficient PTV Catheter compared to the NuMED Z-MED PTV Catheter.

Data Provenance: The data provenance is internal to NuMED, Inc. (Hopkinton, NY, USA), with testing described as being performed in accordance with GMPs (Good Manufacturing Practices). This constitutes retrospective evaluation against established standards and comparison to a previously approved device. There is no indication of prospective patient data collection for this 510(k) submission.

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

This type of information is not applicable to this submission. The ground truth for biocompatibility is established by standardized testing protocols (e.g., ISO standards referenced by the Tripartite Guidance). The ground truth for bench testing (e.g., burst pressure, dimensions) is established by engineering specifications and direct measurement, not expert consensus. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device, which would have been determined at its time of approval.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring expert adjudication for this 510(k) submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI/imaging diagnostic tool, and the submission is for substantial equivalence rather than a comparative clinical effectiveness trial. Therefore, an effect size of human readers improving with/without AI assistance is not relevant or provided.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm study was not done. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established by:

• Predicate Device Equivalence: The primary ground truth is the established safety and effectiveness of the NuMED Z-MED PTV Catheter, to which the COEfficient PTV Catheter is demonstrated to be substantially equivalent.
• Standardized Bench Test Results: Objective measurements against engineering specifications (e.g., burst pressure, dimensions, inflation characteristics).
• Biocompatibility Standards: Compliance with recognized international and national guidelines for biocompatibility (Tripartite Biocompatibility Guidance).

There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for establishing the ground truth for this specific submission, as it relies on equivalence to a predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, there is no training set for this device.

Ask a specific question about this device