(28 days)
Z-MED-X Catheter - 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. And; This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, illiac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Tyshak-X Catheter - 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. And; 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.
Tyshak II-X Catheter - 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. And;
Z-MED II-X Catheter - 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. And;
Mullins-X PTA - 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 only change from the current catheter configuration to the new X line is the inner tubing configuration. The current inner tubing on all catheter models is composed of Pebax polyamide material. The tubing is sized to accept a 0.035" guidewire and provide adequate guidewire movement and catheter trackability. This tubing is also fitted with radiopaque image bands of platinum/iridium. This tubing is common to all catheters in NuMED's product lines. The proposed tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. This tubing is loaded with 20% BaSO4 and is Colored blue with Pantone 295C. All materials have been certified as biocompatible. This tubing is designed to enhance guidewire movement and also to avoid any stretching of the catheter body during a tougher than normal catheter removal.
The provided document describes bench testing performed on various balloon catheters (Tyshak-X, Tyshak II-X, Z-MED-X, Z-MED II-X, Mullins-X) to demonstrate substantial equivalence to predicate devices, primarily due to a change in the internal tubing material.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides the acceptance criteria for several bench tests. It doesn't explicitly state the "reported device performance" as direct numerical results for each test (e.g., "Deflation achieved in 15 seconds"). Instead, the context of the submission (510(k) for substantial equivalence) implies that the new devices met these criteria, as the FDA granted approval. The "Comparison Information" section states, "The only change from the current catheter configuration to the new X line is the inner tubing configuration," and that "All materials have been certified as biocompatible." This suggests the tests performed on the new material confirmed its suitability and performance aligned with the predicate devices.
| Bench Testing Performed | Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|---|
| 2. Balloon Deflatability | Deflation achieved in less than 20 seconds. | Met acceptance criteria. |
| 3. Inflation/ Deflation Times Test | Inflation and deflation achieved in less than 20 seconds. | Met acceptance criteria. |
| 5. Maximum Luminal Injection Pressure Test | Must withstand 400 psi. | Met acceptance criteria. |
| 6. Bond Integrity | Minimum of 2 lbs. at all test points. | Met acceptance criteria. |
| 7. Diameter/ Profile Test and Introducer Test | Must fit through rated introducer size. | Met acceptance criteria. |
| 9. Guidewire Compatibility | Minimal resistance while pushing catheter over guidewire. Force may not be great enough to bend guidewire. | Met acceptance criteria. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for the bench tests. It only lists the types of tests performed. The data provenance is laboratory (bench) testing, likely conducted by NuMED, Inc. in Hopkinton, NY, USA. The testing is prospective in the sense that it was performed to evaluate specific changes to the device before market entry.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is bench testing of a medical device, not a study involving human data interpretation where experts would establish ground truth for a test set. The "ground truth" for these tests is defined by the physical properties and performance characteristics measured against the pre-defined acceptance criteria.
4. Adjudication Method for the Test Set
Not applicable. This is bench testing, not a clinical trial or study requiring expert adjudication of results. The results of the bench tests are direct measurements against specified criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This submission pertains to bench testing of a device's physical properties.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes the physical characteristics and performance of a medical device (balloon catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests is defined by the pre-established acceptance criteria for each test, which are based on engineering specifications and expected device performance. For example, "Deflation achieved in less than 20 seconds" is the ground truth for the Balloon Deflatability test.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI or machine learning study.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).