(240 days)
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.
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.
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.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.