Search Results

Multi-Track Angiographic Catheter (K952984, K003902) - Recommended for use in Multi-Track Anglography of cardiovascular vessels and/or chambers. It can be used for catheterization for anglogiap. In and pressure measurement in any chamber or vessel.

Ghost II PTA (K003972, K011557) - This catheter is recommended for Percutaneous Gransbuminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Z-MED Catheter (K991977, K003114, K003643, K011557) - 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 사 does not require surgical intervention. And;

(K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (ISSIN67) Internoral, ilias, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Tyshak Mini Pediatric PTV Catheter (K003276, K011557, K032591) - This catheter is I your recuration for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications.

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

Tyshak Catheter (K991977, K003114, K011557) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

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

(K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (RSS1007, Norths of I'ms cancenal arteries. These catheters are not designed to be used in the coronary arteries.

Tyshak II Catheter (K003052, K011557, K030589) - This catheter is recommended for I Yshak II Catherer in Catherer (PTV) of the pulmonary valve.

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

Z-MED II Catheter (K003052, K011557, K030589) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis .
• A patient with isolated pulmonary stenosis with other minor congenital heart disease that l does not require surgical intervention. And;

High Pressure PTA (Marauder) (K010880, K011557) - This catheter is recommended for right Fressure I 17x (maraduct) (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Z-5 Atrioseptostomy (K960070, K011557) - Used for the palliation of several congenital heart 2-5 All loseptosition of the great arteries, total anomalous pulmonary venous drainage without delects. transposition of the Ereal arcess, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

Z-5 Braided Atrioseptostomy (K001804, K011557) - Used for the palliation of several 2-3 Draided Attrioseptostom. (2001 of the great arteries, total anomalous pulmonary venous congential licar delected transportion, tricuspid atresia, mitral stenosis, mitral atressa, and pulmonary atresia with intact ventricular septum.

Tyshak X Catheter (K022722) - 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 I does not require surgical intervention.

Tyshak II X Catheter (K022722) - 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 1 does not require surgical intervention.

Z-MED X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

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

Z ·MED II X Catheter (K022722) - 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.

COEfficient Catheter (K014124) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

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

Ghost PTA (K931009, K011557) - This catheter is recommended for Percutaneous Gross ITTA (KSJ1007) RW115872 - The femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Mullins PTA (K013601) - This catheter is recommended for Percutaneous Transluminal Millins ITA (INVL001) - This Satileter and renal arteries. These catheters are not designed to be used in the coronary arteries.

Mullins X PTA (K022722)_- This catheter is recommended for Percutaneous Transluminal Mullins A F FA (XN22122) - Frid Sains and renal arteries. These catheters are not designed to be used in the coronary arteries.

PTS (K003320, K011557) - For use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

Not Found

The provided document is a 510(k) summary for NuMED Catheters, primarily focusing on extending the shelf life of their existing devices from 3 to 5 years, and outlining their various intended uses. It does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic or therapeutic efficacy.

The document details:

• K040830 - All NuMED Catheters: A submission for various catheters (angiographic, PTA, PTV, atrioseptostomy, etc.).
• Purpose of Submission: To extend the shelf life validation from 3 to 5 years, indicating a focus on stability rather than primary diagnostic or therapeutic performance.
• Predicate Devices: Numerous existing NuMED catheters.
• Regulatory Information: Class II devices, product codes, and relevant CFR sections.
• Indications for Use: Detailed indications for each specific catheter type (e.g., Multi-Track Angiographic Catheter for angiography, Ghost II PTA for Percutaneous Transluminal Angioplasty of femoral, iliac, and renal arteries, Z-MED Catheter for Percutaneous Transluminal Valvuloplasty of the pulmonary valve).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria for diagnostic or therapeutic performance because this information is not present in the provided text. The document is a regulatory submission for shelf-life extension and outlines intended uses, not a clinical performance study.

Ask a specific question about this device

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications.

• 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 NuMED, Inc. Tyshak Mini Pediatric PTV catheter is a coaxial catheter for use in PTV applications where a small introduction site is necessary. The catheters inner and outer shafts are constructed of polymeric 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 polymeric material. This balloon is of the non-compliant variety. This balloon is designed to insert through the smallest possible introduction sleeve. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter is blue in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y connector and the inflation extension is labeled with balloon diameter x balloon length x introducer size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches. The Tyshak Mini catheter is available in standard diameters from 3mm to 10mm. The lengths available will be 0.8cm - 4cm. The Guidewire size will be 0.014'', and the shaft size will be 2.5Fr and 3.5Fr.

The provided text describes the NuMED Tyshak Mini Pediatric PTV Catheter as a device for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in pediatric applications. However, it does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on:

• Device Description: What the catheter is made of and its specifications.
• Biocompatibility Testing: States that the materials are the same as an already approved device and meet biocompatibility guidance.
• Laboratory (Bench) Testing: Mentions that bench testing was performed in accordance with GMPs and results are on file, but does not provide any specific results or acceptance criteria for these tests.
• Intended Use/Indications For Use: Specifies the medical conditions for which the catheter is intended.
• Comparison Information: Compares the new device (with additional sizes) to the previously approved Tyshak Mini catheter, highlighting expanded size ranges.
• Substantial Equivalence Determination: The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. This is a regulatory pathway, not a performance study proving specific clinical acceptance criteria.

Therefore, many of the requested details about acceptance criteria and a study proving performance cannot be extracted from the provided text because such information is not present. The document primarily serves as a 510(k) submission for substantial equivalence based on prior device approval and bench testing.

Here's an attempt to answer based on the available information, noting where information is explicitly not present:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not applicable. This document does not describe a clinical performance study with a test set of patient data. The "bench testing" mentioned refers to laboratory tests, not a clinical study involving patient samples.
• Data Provenance: Not applicable. No clinical data is presented. The document refers to "bench testing" and "biocompatibility testing," which are laboratory tests, not human data.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. There is no mention of a study involving experts establishing ground truth for a test set. The FDA's substantial equivalence determination is based on comparison to an existing device, not an evaluation of diagnostic or interventional performance against expert ground truth.

4. Adjudication Method

• Not applicable. No study involving human experts and ground truth adjudication is described.

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

• No. The document does not describe an MRMC study or any study comparing human reader performance with or without AI assistance. This device is a catheter, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• No. This device is a physical catheter, not an algorithm, so a standalone algorithm performance study is not relevant or described.

7. Type of Ground Truth Used

• Not applicable. No ground truth for a diagnostic or interventional performance study is mentioned. The "ground truth" implicitly referred to for establishing substantial equivalence is the technical specifications and safety profile of the predicate device (NuMED Tyshak Mini Catheter 510/k #K003276) and compliance with relevant standards (biocompatibility, GMP).

8. Sample Size for Training Set

• Not applicable. This document is for a physical medical device (catheter), not an AI/ML algorithm that employs a "training set."

9. How Ground Truth for Training Set Was Established

• Not applicable. As above, this is not an AI/ML device, so there is no training set or associated ground truth.

Ask a specific question about this device