(192 days)
The Ringer Perfusion Balloon Catheter is indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.
The Ringer perfusion balloon catheter is a rapid exchange catheter with a spiral-shaped inflatable balloon on the distal end and a wire lumen for delivery over a ≤ 0.014" guidewire. The inflated spiral balloon approximates a hollow cylinder. Radiopaque markers at the proximal and distal end of the balloon facilitate visualization and intravascular placement of the catheter prior to inflation. The catheter shaft has positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip. The Ringer perfusion balloon catheter has been sterilized with ethylene oxide.
The Ringer perfusion balloon catheter is indicated for balloon dilatation of coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: Successful delivery, inflation, deflation, and removal of the study device; no vessel perforation, flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the study device; achievement of final TIMI flow grade of 3 at the conclusion of the PCI procedure for the target lesion. | Met in 57/60 (95%) of the subjects. |
| Primary Safety Endpoint: Occurrence of clinically relevant events during prolonged balloon inflations and freedom from MACE at hospital discharge. | Met in 95% (57/60) of the subjects. |
| Secondary Efficacy Endpoint 1: Successful PCI defined as final residual stenosis ≤20% diameter stenosis (in-stent) or ≤ 50% diameter stenosis (stand-alone balloon) by visual angiographic estimation and freedom from MACE at hospital discharge. | Met in 93% (56/60) of the subjects. |
| Secondary Efficacy Endpoint 2: Maintenance of TIMI-2 or -3 flow into distal coronary bed during study device inflation. | Achieved in 100% of cases. |
| Secondary Safety Endpoint: Tolerance of at least one study device inflation equal to or greater than one minute (prolonged inflation) at target site. | Met in 50/60 (83.3%) of subjects. |
| Procedural Success | 95% of cases |
| No Serious Adverse Events attributable to the subject device | Achieved (implicitly, as 95% primary safety endpoint was met) |
2. Sample size used for the test set and the data provenance
- Sample Size: 60 subjects.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, it refers to the study as "G200321, 'Ringer PTCA Study'," which suggests a dedicated clinical study, typically prospective in nature for device clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide specific details about the number of experts used or their qualifications for establishing ground truth within the clinical study. Angiographic estimations (e.g., final residual stenosis, TIMI flow grade) are typically performed by interventional cardiologists or trained core lab personnel, but this is not explicitly stated.
4. Adjudication method for the test set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1). Clinical endpoints for device studies are often determined by the treating physician or a study's Clinical Events Committee (CEC), but this information is not elaborated upon.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with AI assistance was not done. This study focuses on the performance of a medical device (a balloon catheter) rather than an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is a study evaluating a physical medical device (balloon catheter) in human subjects, not a standalone algorithm.
7. The type of ground truth used
The ground truth for the clinical study was established through a combination of:
- Angiographic evaluation: Visual assessment of TIMI flow grade and residual stenosis.
- Clinical outcomes: Occurrence of clinically relevant events, freedom from MACE (Major Adverse Cardiac Events) at hospital discharge, and tolerance of prolonged inflations.
- Procedural observations: Successful delivery, inflation, deflation, removal, and absence of complications like vessel perforation or dissection.
8. The sample size for the training set
This information is not applicable as this is a clinical study for a physical medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" in the context of this device's clinical evaluation.
§ 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.