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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.

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