(127 days)
The RX Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion. This product (balloon models 2.0-5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.
Rx Takeru PTCA Balloon Dilatation Catheter (Rx Takeru) is a rapid exchange type of balloon dilation catheter, which consists of a distal tube, guidewire transition tube, balloon, radiopaque marker(s), 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 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 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 Takeru. The nominal inflated balloon diameters range from 1.5 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 performance testing and acceptance criteria for the RX Takeru PTCA Balloon Dilatation Catheter.
1. A table of acceptance criteria and the reported device performance
The document states that the RX Takeru "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." Specific numerical acceptance criteria and reported performance values are not provided in the given text.
The performance tests conducted include:
| Test Type | Acceptance Criteria Not Explicitly Stated but "Met" | Reported Performance Not Explicitly Stated but "Adequate" |
|---|---|---|
| Dimensional Verification | Met | Adequate for intended use |
| Balloon Preparation | Met | Adequate for intended use |
| Deployment and Retraction | Met | Adequate for intended use |
| Balloon Rated Burst Pressure | Met | Adequate for intended use |
| Balloon Fatigue (Repeat Inflations) | Met | Adequate for intended use |
| Balloon Compliance | Met | Adequate for intended use |
| Balloon Inflation and Deflation Time | Met | Adequate for intended use |
| Catheter Bond Strength | Met | Adequate for intended use |
| Flexibility and Kink Test | Met | Adequate for intended use |
| Torque Strength | Met | Adequate for intended use |
| Radiopacity | Met | Adequate for intended use |
| Coating Integrity | Met | Adequate for intended use |
| Particulate Evaluation | Met | Adequate for intended use |
| Balloon Rated Burst Pressure (in Stent) | Met | Adequate for intended use |
| Balloon Fatigue (Repeat Inflations; in Stent) | Met | Adequate for intended use |
| Transportation Testing | Met | Adequate for intended use |
| Shelf Life Testing | Met | Adequate for intended use |
| Biocompatibility Tests: | ||
| Cytotoxicity | Met | Biocompatible for intended use |
| Sensitization | Met | Biocompatible for intended use |
| Intracutaneous Reactivity | Met | Biocompatible for intended use |
| Acute Systemic Toxicity | Met | Biocompatible for intended use |
| Pyrogen | Met | Biocompatible for intended use |
| Hemocompatibility (in vivo thromboresistance, hemolysis, complement) | Met | Biocompatible for intended use |
| Genotoxicity (mouse lymphoma, bacterial reverse mutation, in vivo cytogenetics assay) | Met | Biocompatible for intended use |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the performance or biocompatibility tests. All the tests mentioned are "in vitro" (bench) tests and biocompatibility tests conducted according to international standards (ISO 10993-1). There is no mention of human subject data, therefore, data provenance in terms of country of origin or retrospective/prospective nature is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The tests performed are laboratory-based physical and chemical tests, and biocompatibility studies. "Ground truth" in the context of expert review for diagnostic devices is not relevant here. The "truth" is established by the results of the specified test methodologies and their adherence to predetermined acceptance criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. As these are not studies involving human interpretation or subjective assessments, adjudication methods are not relevant.
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
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement. This device is a PTCA balloon dilatation catheter, not a diagnostic imaging device with AI components.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device (catheter), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests relies on adherence to established engineering and material science specifications, validated test methods (e.g., those recommended by FDA guidance documents like "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and international standards (e.g., ISO 10993-1 for biocompatibility). The "truth" is whether the device physically performs according to these criteria.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described in this document.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.