(99 days)
The RX NC Takeru PTCA Balloon Dilatation Catheter is indication of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion.
This product is also indicated for the post-delivery expansion of balloon expandable stents.
RX NC Takeru PTCA Balloon Dilatation Catheter (RX NC Takeru) is a rapid exchange type of balloon dilation catheter, which consists of a distal tube, guidewire transition tube, balloon, radiopaque markers, mid tube, proximal tube, core wire, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. RX NC Takeru has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube to the guidewire port for the exit of a guidewire.
The maximum compatible diameter of a guidewire used together with RX NC Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with RX NC Takeru. The nominal inflated balloon diameters range from 2.0 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.
This document describes the premarket notification (510(k)) for the RX NC Takeru PTCA Balloon Dilatation Catheter. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Not explicitly stated, but implies meeting design specifications for dimensions. | "met all the predetermined acceptance criteria of design verification" |
| Balloon Preparation, Deployment and Retraction | Not explicitly stated, but implies proper preparation, deployment, and retraction without failure. | "met all the predetermined acceptance criteria of design verification" |
| Balloon Rated Burst Pressure | Not explicitly stated, but implies meeting a minimum pressure without rupture. | "met all the predetermined acceptance criteria of design verification" |
| Balloon Fatigue (Repeat Balloon Inflations) | Not explicitly stated, but implies demonstrating durability over repeated inflations. | "met all the predetermined acceptance criteria of design verification" |
| Balloon Compliance | Not explicitly stated, but implies meeting specified compliance characteristics. | "met all the predetermined acceptance criteria of design verification" |
| Balloon Inflation and Deflation Time | Not explicitly stated, but implies meeting clinical performance requirements for speed. | "met all the predetermined acceptance criteria of design verification" |
| Catheter Bond Strength | Not explicitly stated, but implies meeting minimum strength requirements to prevent detachment. | "met all the predetermined acceptance criteria of design verification" |
| Flexibility and Kink Test | Not explicitly stated, but implies demonstrating sufficient flexibility without kinking. | "met all the predetermined acceptance criteria of design verification" |
| Torque Strength | Not explicitly stated, but implies meeting minimum strength requirements for torque transmission. | "met all the predetermined acceptance criteria of design verification" |
| Radiopacity | Not explicitly stated, but implies sufficient visibility under fluoroscopy. | "met all the predetermined acceptance criteria of design verification" |
| Coating Integrity | Not explicitly stated, but implies the coating remains intact. | "met all the predetermined acceptance criteria of design verification" |
| Particulate Evaluation | Not explicitly stated, but implies acceptable levels of particulate release. | "met all the predetermined acceptance criteria of design verification" |
| Balloon Rated Burst Pressure (in Stent) | Not explicitly stated, but implies meeting a minimum pressure without rupture when deployed in a stent. | "met all the predetermined acceptance criteria of design verification" |
| Balloon Fatigue (Repeat Balloon Inflations; in Stent) | Not explicitly stated, but implies demonstrating durability over repeated inflations when deployed in a stent. | "met all the predetermined acceptance criteria of design verification" |
| Transportation and Shelf Life Testing | Not explicitly stated, but implies maintaining device integrity and performance after transport and over its shelf life. | "met all the predetermined acceptance criteria of design verification" |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, Hemocompatibility, Genotoxicity) | Adherence to ISO 10993-1 standards for biological evaluation. | "The results from these tests demonstrate that the RX NC Takeru is biocompatible for its intended use similar to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the performance testing was conducted via "in vitro tests." However, it does not specify the sample size for the test set used for any of the performance tests. The provenance of this test data is not explicitly mentioned but is implied to be from internal Kaneka Corporation testing as part of their design verification and validation. Given it's a 510(k) submission, this is typically part of the manufacturer's own testing for regulatory clearance, not from an independent study with external data provenance in the way clinical trials would.
For biocompatibility, testing was performed on a "reference device (RX Takeru)." The sample size for this is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance testing described consists of bench tests (in vitro) and biocompatibility tests. These types of tests typically rely on established engineering principles, international standards (e.g., ISO), and laboratory procedures, rather than human expert consensus for "ground truth" in the way a diagnostic AI algorithm might. Therefore, the concept of "experts establishing ground truth" for these specific tests would not directly apply.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable to the types of bench and biocompatibility tests described. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies where human interpretation of data (e.g., imaging, clinical symptoms) is involved and discrepancies need to be resolved to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes bench testing and biocompatibility testing, not a clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical device (PTCA Balloon Dilatation Catheter), not an AI algorithm or software device.
7. The Type of Ground Truth Used
For the performance testing (in vitro tests), the "ground truth" is established by adherence to predefined engineering specifications, international standards (e.g., FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" and ISO 10993-1), and internal test protocols. The acceptance criteria for these tests define what constitutes acceptable performance for the device's physical properties and safety.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as the device is a physical medical device and does not have a 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.