(237 days)
The Sapphire 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
The Sapphire coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a polymer coated stainless steel hypotube. Lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.5-4.0mm and lengths from 10-30mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment with the exception of balloon diameters less than 2.0mm which incorporate a centrally positioned single marker band. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
The provided text describes the regulatory submission for the Sapphire Coronary Dilatation Catheter, focusing on demonstrating substantial equivalence to predicate devices rather than proving a specific AI algorithm's performance against acceptance criteria. Therefore, much of the requested information regarding AI-specific criteria, studies, and data provenance is not applicable.
However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the test results "met all acceptance criteria" and were "similar to predicate devices." However, it does not explicitly list specific numerical acceptance criteria for each performance test. Instead, it refers to general guidelines and the successful fulfillment of these criteria.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| In vitro Performance Tests: | |
| Dimensional verification | Met all acceptance criteria |
| Balloon preparation | Met all acceptance criteria |
| Deployment and retraction | Met all acceptance criteria |
| Balloon rated burst pressure | Met all acceptance criteria |
| Balloon fatigue | Met all acceptance criteria |
| Balloon compliance | Met all acceptance criteria |
| Balloon inflation and deflation time | Met all acceptance criteria |
| Catheter bond strength | Met all acceptance criteria |
| Tip pull strength | Met all acceptance criteria |
| Flexibility and kinking | Met all acceptance criteria |
| Torque strength | Met all acceptance criteria |
| Radiopacity | Met all acceptance criteria |
| Coating integrity | Met all acceptance criteria |
| Particulate evaluation | Met all acceptance criteria |
| Biocompatibility Tests: | |
| Cytotoxicity | Met all acceptance criteria |
| Sensitization | Met all acceptance criteria |
| Hemocompatibility (hemolysis) | Met all acceptance criteria |
| Hemocompatibility (complement activation) | Met all acceptance criteria |
| Hemocompatibility (in vivo thromboresistance) | Met all acceptance criteria |
| Hemocompatibility (prothromboplastin time) | Met all acceptance criteria |
| Hemocompatibility (platelet and leukocyte counts) | Met all acceptance criteria |
| Pyrogenicity | Met all acceptance criteria |
| Acute systemic toxicity | Met all acceptance criteria |
| Intracutaneous reactivity | Met all acceptance criteria |
| Genotoxicity (bacterial mutagenicity) | Met all acceptance criteria |
| Genotoxicity (in vitro mouse lymphoma) | Met all acceptance criteria |
The document also states that the tests "ensure that the Sapphire coronary dilatation 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)." This guidance document would contain the specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document describes product performance and biocompatibility tests, which are laboratory or in vitro studies, not typically involving "test sets" in the context of AI algorithms or clinical trials. Therefore:
- Sample size for the test set: Not applicable in the context of clinical or AI performance. The number of physical units or samples tested for each in vitro or biocompatibility assessment is not specified in this summary.
- Data provenance: Not explicitly stated as country of origin, retrospective, or prospective, as these are not clinical studies. These are laboratory-based validation tests performed internally by the manufacturer (OrbusNeich Medical, Inc.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a medical catheter, not an AI diagnostic tool that requires ground truth established by human experts for performance evaluation. The "ground truth" for these tests would be the established scientific and engineering principles for device performance and biocompatibility.
4. Adjudication Method for the Test Set
This information is not applicable. As these are laboratory tests, an adjudication method for human interpretation of results is not relevant. The results are based on objective measurements against engineering specifications and biocompatibility standards.
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. The device is a physical medical catheter, not an AI algorithm intended to assist human readers. Therefore, an MRMC study and effect size of AI assistance are not relevant.
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 catheter, not an AI algorithm.
7. The Type of Ground Truth Used
For the performance and biocompatibility studies:
- Ground Truth: The "ground truth" for the device's performance is based on established engineering specifications, international standards, and regulatory guidelines (e.g., FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters). The tests aim to demonstrate that the device functions according to its design and regulatory requirements.
8. The Sample Size for the Training Set
This information is not applicable. The device is subjected to engineering and biocompatibility testing, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" or "ground truth" establishment in the context of machine learning for this physical medical 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.