(139 days)
The SC HONK YTONK PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a semi-compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) quidewire to facilitate catheter advancement to and through the stenosis that is to be dilated. The proximal portion of the catheter is a single-lumen, stainless steel hypotube that includes a single luer hub for balloon inflation /deflation. The balloon design provides for an inflatable segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip aids advancement to and through the stenosis. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aid for the placement of the catheter's balloon. The 1.50 mm device size has one radiopaque marker band, while all other sizes have two radiopaque marker bands. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just distal of the balloon.
This document is a 510(k) Premarket Notification for the SC HONKYTONK™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device, the Emerge™ Monorail PTCA Dilatation Catheter (K163174), through non-clinical testing. This type of submission generally relies on bench testing and does not typically involve clinical studies with human participants or AI performance evaluations as described in your prompt.
Therefore, many of the requested categories are not applicable to this type of regulatory submission and the provided document.
Here's an breakdown based on the information provided and standard 510(k) practices for this type of device:
Acceptance Criteria and Device Performance for SC HONKYTONK™ PTCA Dilatation Catheter
This submission relies on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" are implied by the successful completion and meeting of specifications for each test. The "reported device performance" refers to the outcomes of these non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device meets specified engineering and functional requirements. | "Met all acceptance criteria and performed similarly to the predicate device." |
| Dimensional Verification | Within specified tolerances. | Successful |
| Simulated Use | Functions correctly under simulated clinical conditions. | Successful |
| Balloon Fatigue | Maintains integrity after multiple inflation/deflation cycles. | Successful |
| Inflation/Deflation Time | Within specified time limits. | Successful |
| Flexibility/Kink | Maintains patency and structural integrity during manipulation. | Successful |
| Radiopacity | Clearly visible under fluoroscopy. | Successful |
| Particulate | Meets limits for particulate matter release. | Successful |
| Component Dimensional Compatibility | Components fit and function together as designed. | Successful |
| Rated Burst Pressure | Withstands specified pressure without bursting prematurely. | Successful (Specific pressures listed in Table 5-1 match expectations) |
| Compliance | Balloon expands to expected diameter at rated pressure. | Successful |
| Bond Strength (including Tip Pull) | Connections remain secure under stress. | Successful |
| Torque | Transmits rotational force effectively. | Successful |
| Coating Integrity | Coatings remain intact and functional. | Successful |
| Biocompatibility | Materials are biocompatible and do not elicit adverse biological responses. | "SC HONKYTONK™ PTCA Balloon Dilatation Catheter to be biocompatible." |
| Cytotoxicity | Non-toxic to cells. | Successful |
| Intracutaneous Reactivity | No significant irritation. | Successful |
| Complement Activation (SC5b-9) | Low or acceptable level of complement activation. | Successful |
| Material Mediated Pyrogenicity | No pyrogenic response. | Successful |
| Partial Thromboplastin Time | No or acceptable impact on blood clotting time. | Successful |
| Sensitization | No allergic/sensitization response. | Successful |
| Hemolysis (Direct and Extract) | Acceptable level of red blood cell lysis. | Successful |
| Thrombogenicity | Low thrombogenic potential. | Successful |
| Acute Systemic Toxicity | No short-term systemic toxic effects. | Successful |
| Heparinized Blood Platelet and Leukocyte Count Assay | Acceptable impact on blood cell counts. | Successful |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of "patients" or "images" since this is a non-clinical bench study. The "sample size" refers to the number of devices or components tested for each specific bench test (e.g., a certain number of balloons for burst pressure, a certain number of catheters for simulated use). These numbers are not detailed in the summary document but would be part of the full testing report submitted to the FDA.
- Data Provenance: Non-clinical (bench) laboratory testing performed by the manufacturer, Sino Medical Sciences Technology Inc. The data is generated in a controlled laboratory environment, not from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A). This is a non-clinical bench study for a PTCA catheter. "Ground truth" in the clinical sense (e.g., expert diagnosis of an image) is not established. The "truth" is based on engineering specifications and validated test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple readers (typically human experts reviewing images/data). This submission is based on automated or semi-automated bench test results against predefined criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a non-clinical 510(k) submission for a medical device (catheter), not an AI/CADe/CADx device that would involve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a non-clinical 510(k) submission for a medical device (catheter) with no AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Industry Standards: The "ground truth" for non-clinical testing is based on the device's design specifications, relevant ISO/ASTM standards (e.g., for material properties, biocompatibility), and comparison to the predicate device's established performance parameters. For example, a balloon's rated burst pressure is a design specification, and the test verifies it meets that "ground truth."
8. The sample size for the training set
- Not Applicable (N/A). There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured, and specific units are selected for verification and validation (V&V) testing.
9. How the ground truth for the training set was established
- Not Applicable (N/A). As there is no training set.
§ 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.