(60 days)
The Selethru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Selethru PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Selethru is a sterile, single-use, intravascular medical device with a working length of 142cm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional pushability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. The semi-compliant balloons are available in diameters ranging from 1.5-4.0mm and lengths from 10-30mm, and have a rated burst pressure of 16 atm. The proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter tip (marker located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters). The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a guide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of the catheter with a single standard length guidewire. Two radiopaque Platinum/Iridium marker bands are located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.
This is a medical device submission, not an AI/ML product. The document describes a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter (Selethru PTCA Balloon Dilatation Catheter). Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, is not applicable.
The document does, however, provide information about the acceptance criteria and performance of this traditional medical device.
Here's an analysis of the provided text, focusing on the device's performance and acceptance criteria:
1. Table of acceptance criteria and the reported device performance:
The document states that both in vitro performance tests and biocompatibility tests were conducted. The crucial summary statement is: "The test results met all acceptance criteria and ensure that the Selethru Catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."
While specific numerical acceptance criteria values are not provided in this summary, the types of tests performed indicate the areas where performance was assessed against established criteria.
| Type of Performance Test | Specific Tests Conducted | Acceptance Criteria (Implied: Met) | Reported Device Performance (Implied: Met) |
|---|---|---|---|
| In Vitro | Dimensional verification | Met established specifications for dimensions. | Suitable for intended use |
| Balloon rated burst pressure | Met established pressure limits. | Suitable for intended use | |
| Balloon fatigue | Demonstrated durability under repeated inflation/deflation cycles. | Suitable for intended use | |
| Balloon compliance | Met specified inflation characteristics. | Suitable for intended use | |
| Balloon inflation and deflation time | Met specified time limits for inflation/deflation. | Suitable for intended use | |
| Catheter bond strength | Met established strength requirements for bonded components. | Suitable for intended use | |
| Tip pull strength | Met established strength requirements for the catheter tip. | Suitable for intended use | |
| Flexibility and kinking | Maintained integrity and functionality under bending/kinking stress. | Suitable for intended use | |
| Torque strength | Met established resistance to twisting forces. | Suitable for intended use | |
| Radiopacity | Visible under fluoroscopy at required levels. | Suitable for intended use | |
| Coating integrity | Maintained functional coating without degradation. | Suitable for intended use | |
| Particulate evaluation | Met limits for particulate matter. | Suitable for intended use | |
| Biocompatibility | Cytotoxicity | Non-toxic to biological cells. | Suitable for intended use |
| Sensitization | Did not cause allergic reactions. | Suitable for intended use | |
| Intracutaneous reactivity | Caused minimal local tissue irritation. | Suitable for intended use | |
| Acute systemic toxicity | Did not cause adverse systemic effects. | Suitable for intended use | |
| Hemocompatibility (hemolysis, complement activation, and in vivo thromboresistance) | Did not cause significant damage to blood components (red cells, complement), and resisted clot formation. | Suitable for intended use | |
| Pyrogenicity | Did not induce fever. | Suitable for intended use |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. For in vitro and biocompatibility tests, sample sizes would typically be determined by relevant ISO standards or FDA guidance documents for medical devices. The data provenance would be laboratory testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this is a physical medical device, not an AI/ML product requiring expert ground truth for image interpretation or diagnosis. Biocompatibility and in vitro test results are evaluated against established scientific and engineering standards by qualified laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable as this is not an AI/ML device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in vitro tests, the "ground truth" is defined by engineering specifications and performance standards (e.g., burst pressure measured by a transducer, dimensional measurements validated against design drawings). For biocompatibility tests, the "ground truth" is defined by biological response measurements against established safety thresholds (e.g., cell viability in cytotoxicity tests, hemolysis rates, pyrogenicity assays) based on recognized standards (e.g., ISO 10993 series).
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML product that undergoes a "training" phase.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not an AI/ML product.
§ 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.