(142 days)
The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters are 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. Emerge Over-The-Wire and Emerge Monorail PTCA Dilation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-the-Wire (OTW) platforms. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheter will be available with balloon diameters 2.00 mm to 4.00 mm and balloon lengths 8 mm to 30 mm.
The provided document is a 510(k) summary for the Boston Scientific Emerge™ Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation Catheter. It outlines the device description, intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.
This document does not contain information typically found in a study proving a device meets acceptance criteria related to AI/ML software performance. Instead, it focuses on the physical and biological performance of a medical device (a PTCA dilatation catheter), demonstrating its safety and effectiveness through bench testing and biocompatibility. Therefore, most of the questions you've asked, which are relevant to AI/ML software evaluation, cannot be answered from this document.
However, I can extract the information that is present and indicate where requested information is not applicable or not provided.
Device Acceptance Criteria and Performance (Physical Device)
The acceptance criteria for this medical device (a PTCA Dilatation Catheter) are derived from the "Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010." The reported device performance is based on successful completion of the listed tests, demonstrating conformance to these requirements.
| Acceptance Criteria (Implied by Test) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Completed successfully |
| Sensitization | Completed successfully |
| Intracutaneous Reactivity | Completed successfully |
| Acute Systemic Toxicity | Completed successfully |
| Materials Mediated Pyrogenicity | Completed successfully |
| USP Physicochemical | Completed successfully |
| Hemolysis (Direct Contact) | Completed successfully |
| Hemolysis (Extract Method) | Completed successfully |
| Complement Activation | Completed successfully |
| Coagulation | Completed successfully |
| In Vitro Hemocompatibility | Completed successfully |
| FTIR Analysis | Completed successfully |
| Residual NPGDA analysis | Completed successfully |
| In-vitro Performance: | |
| Effective Length | Completed successfully |
| Shaft Inner and Outer Diameter | Completed successfully |
| Balloon Crossing Profile | Completed successfully |
| Balloon Preparation, Deployment, and Retraction | Completed successfully |
| Withdrawal into a Guide Catheter | Completed successfully |
| Shaft and Bond Burst Pressure | Completed successfully |
| Balloon Rated Burst Pressure | Completed successfully |
| Balloon Fatigue (Repeat Inflations) | Completed successfully |
| Balloon Compliance | Completed successfully |
| Balloon Inflation/Deflation Time | Completed successfully |
| Catheter Bond Strength Tensile | Completed successfully |
| Tip Pull Test | Completed successfully |
| Flexibility and Kink | Completed successfully |
| Torque Strength | Completed successfully |
| Radiopacity | Completed successfully |
| Coating Integrity | Completed successfully |
| Particulate Evaluation | Completed successfully |
| Balloon Rated Burst Pressure in Stent | Completed successfully |
| Balloon Fatigue (Repeat Inflations) in Stent | Completed successfully |
The document states: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."
Inapplicable/Not Provided Information for AI/ML Software Evaluation
Given that this is a submission for a physical medical device (a balloon catheter) and not an AI/ML software, the following requested information is not applicable or not provided in the document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as testing was primarily bench testing and biocompatibility, not data-driven AI/ML performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device refers to its physical and biological properties.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device does not involve human readers interpreting data enhanced by AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, "ground truth" would refer to the validated physical and chemical properties and biological responses, measured through standardized tests.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML model for this device.
- How the ground truth for the training set was established: Not applicable.
§ 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.