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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.

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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.

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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.

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