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KardiFlexTM NC Coronary Dilatation Catheter is indicated for:
• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
· in-stent restenosis.
· post-delivery expansion of balloon expandable coronary stents.

Device Description

The KardiFlex™ NC Coronary Dilatation Catheter is designed to allow rapid exchange of the catheter using a standard length of 0.014" guide wire. Balloon diameters range from 1.5mm to 5.0mm and lengths from 6mm to 30mm. The balloon material is made of a minimally Nylon material and balloons have a rated burst pressure of 22 atmospheres. The minimally material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.

The KardiFlex™ NC Coronary Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-5.0mm) radiopaque platinum marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length of a specific pressure. The dilatation catheter is coated with hydrophilic coating, which is activated when wet. The proximal shaft of the catheter is composed of a female luer connector (hub) bonded to a PTFE coated stainless steel tube (hypotube).

The KardiFlex™ NC Coronary Dilatation Catheter consists of 10 parts: hub, strain relief, hypotube, distal outer body, inner body, balloon, radiopaque platinum marker band, tip, balloon sheath and stylet.

AI/ML Overview

This document describes the regulatory submission for the KardiFlex™ NC Coronary Dilatation Catheter (K202578). This is a physical device, not an AI/ML powered device, so many of the requested fields are not applicable.

Here's a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Pass test" for each specified performance test. The reported device performance for all listed tests is "Pass test," indicating that the device met these criteria.

Acceptance Criteria (Test)	Reported Device Performance
Biocompatibility Testing:
In vitro cytotoxicity	Pass test
Intracutaneous reactivity	Pass test
Skin sensitization	Pass test
Acute systemic toxicity	Pass test
Hemocompatibility (Hemolysis, Coagulation, etc.)	Pass test
Material mediated pyrogenicity	Pass test
Bench Testing (Zero Time and Accelerated Aged):
Tip Configuration	Pass test
Surface	Pass test
Dimensional Verification	Pass test
Corrosion Resistance	Pass test
Radio-detectability of Balloon Position	Pass test
Freedom from Leakage	Pass test
Hub	Pass test
Balloon Rated Burst Pressure	Pass test
Balloon Failure Mode	Pass test
Balloon Fatigue	Pass test
Diameter at Nominal Pressure	Pass test
Balloon Compliance	Pass test
Inflation Time	Pass test
Deflation Time	Pass test
Catheter Bond Strength	Pass test
Entry Tip Crossing Profile	Pass test
Balloon Preparation, Deployment and Retraction	Pass test
Rated Burst Pressure (in stent)	Pass test
Balloon Fatigue (In stent)	Pass test
Tip Pull Test	Pass test
Flexibility and Kink Test	Pass test
Torque Strength	Pass test
Coating Integrity	Pass test
Particulate Evaluation	Pass test
Shaft Loose Part	Pass test
Package Labeling	Pass test
Shelf Life	Pass test
Package Seal Verification	Pass test
Shipping and Handling	Pass test
Chemical performance	Pass test
EtO Sterilization	Pass test
Sterility	Pass test
Bacterial Endotoxin	Pass test

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each individual test. However, it indicates that "the subject device, KardiFlex™ NC Coronary Dilatation Catheter, was subjected to the following applicable testing." This implies that a sufficient number of device units (the "test set") were used for each test to demonstrate compliance with the relevant standards.

The data provenance is from bench testing and biocompatibility testing conducted by the manufacturer, Medcaptain Life Science Co., Ltd., based in Shenzhen, Guangdong, China. This is prospective testing, as it's performed on the device prototypes to demonstrate compliance before marketing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

This is not applicable as the evaluation involves physical device performance against established engineering and biological standards, not human interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. The tests performed are objective, quantitative technical assessments (e.g., measuring burst pressure, inflation time, etc.) against pre-defined thresholds from regulatory standards (ISO, FDA guidance). There is no "adjudication method" in the sense of reconciling differing expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable. The KardiFlex™ NC Coronary Dilatation Catheter is a physical medical device (balloon catheter), not an AI/ML diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study with or without AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" used for these tests are the established performance specifications and safety requirements outlined in international standards (e.g., ISO 10993, ISO 10555) and FDA guidance documents. These are objective, quantifiable criteria that the device's physical properties and behavior must meet.

8. The Sample Size for the Training Set

This is not applicable. As a physical device, there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing process are refined through engineering development and quality control, not by training on a dataset.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no "training set" for a physical device.

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