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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.

AI/ML Overview

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.

Test Performed	Acceptance Criteria	Z-MED Results	Z-MED II Results
Visual Inspection	The catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device.	All catheters were visually inspected without any anomalies.	All catheters were visually inspected without any anomalies.
Balloon Preparation Test	Each catheter shall be prepped per the procedure without functional difficulties or anomalies.	All catheters tested were without functional difficulties or anomalies.	All catheters tested were without functional difficulties or anomalies.
Diameter and Profile Test	The balloon diameter at rated burst pressure shall be within +/- 10% of the labeled balloon diameter and the samples should fit through the selected introducer with no problems.	All catheters met the acceptance criteria.	All catheters met the acceptance criteria.
Balloon Distensibility	The results must demonstrate that the balloon diameter is within +/- 10% of the labeled diameter at the RBP and will not be significantly increased at increasingly higher pressures.	All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures.	All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures.
Balloon Minimum Burst Strength	The results must show statistically that with at least 95% confidence, 99.9% of the balloons will not burst at or below the maximum recommended rated burst pressure.	(Specific pressures listed for various balloon sizes, all indicating performance at or above the acceptance criteria)	(Specific pressures listed for various balloon sizes, all indicating performance at or above the acceptance criteria)
Repeated Balloon Inflation (Balloon Fatigue) Test	No breaks allowed.	No Breaks.	No Breaks.
Balloon Inflation/Deflation Test	Inflation achieved in less than 12 seconds and deflation achieved in less than 20 seconds.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Balloon Deflatability Test	There should be no interference with balloon deflation.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Tip Pull and Torque Test	Must withstand at least 10 turns without breaking.	No breaks.	No breaks.
Bond Strength Test	All bonds must withstand at least 3 lbs. of pull strength.	All bonds met the established acceptance criteria.	All bonds met the established acceptance criteria.
Catheter Body Maximum Pressure Test	All samples must withstand 30 ATM (400psi).	>30 ATM	>30 ATM

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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