(143 days)
The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Sterling Monorail Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires.
The Sterling Monorail PTA Balloon Dilatation Catheter is a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.
The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. Markers on the 80 cm and 90 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 135 cm and 150 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The effective lengths of the balloon catheter are 80 cm, 90 cm, 135 cm, and 150 cm. A needle with a luer port is included for flushing the distal inner lumen prior to the insertion of appropriate guidewires.
The provided text is a Food and Drug Administration (FDA) 510(k) premarket notification for a medical device called the Sterling™ Monorail™ PTA Balloon Dilatation Catheter. This document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting a detailed clinical study for novel device performance claims. Therefore, much of the requested information regarding acceptance criteria and performance studies for a new AI/software-based device will not be found in this type of submission.
However, I can extract the information available and explain why some of the requested points are not applicable to this document.
1. A table of acceptance criteria and the reported device performance
The document states that the "Sterling Monorail PTA Balloon Dilatation Catheter met all acceptance criteria for the bench and biocompatibility testing with results similar to the predicate." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not explicitly listed in a table format in this document. Instead, it provides a general statement of compliance.
It lists the types of tests performed:
| Test Type | Specific Tests Mentioned |
|---|---|
| Biocompatibility | - MEM Elution Cytotoxicity |
| - Hemocompatibility (Direct Contact) | |
| - Chemical Characterization-USP Physicochemical | |
| - Natural Rubber Latex | |
| Bench Testing (in-vitro performance) | - Bond Integrity |
| - Working Length | |
| - Deflation Time | |
| - Balloon Rated Burst Pressure (RBP) | |
| - Balloon Multiple Inflation | |
| - Crossing Profile | |
| - Full Catheter Tensile Extension and Deflation | |
| - Balloon Burst Mode | |
| - Balloon Compliance | |
| - Balloon Nominal Diameter | |
| - Burst in a Stent | |
| - Balloon Body Length | |
| - Guidewire Movement | |
| - Sheath Withdrawal | |
| - Balloon Multiple Inflation in a Stent | |
| - Particulate Evaluation | |
| - Proximal Balloon Bond and Shaft Tensile Strength | |
| - Marker Band to Balloon Alignment | |
| - Torque After Conditioning |
2. Sample sizes used for the test set and the data provenance
The document does not specify sample sizes for each of the listed tests. The provenance of the data is generally in-vitro bench testing and biocompatibility testing, likely conducted by the manufacturer (Boston Scientific) in controlled laboratory environments. This is typical for a 510(k) submission and not considered "country of origin" in the sense of clinical data. It is neither retrospective nor prospective clinical data; it is in-vitro (laboratory) data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to a 510(k) submission for a mechanical medical device like a balloon catheter. "Ground truth" established by human experts is typically relevant for AI/software devices where human interpretation is involved. For this device, the "truth" is determined by physical measurements and chemical analyses against established engineering and biological standards.
4. Adjudication method for the test set
This question is also not applicable. Adjudication methods are used in studies where there is subjective interpretation of data, often by multiple human readers, to establish a consensus or "ground truth." For the bench and biocompatibility tests of this device, the results are typically objective measurements against predefined specifications.
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 question is not applicable. The device described is a physical medical instrument (a balloon catheter), not an AI/software device. Therefore, no MRMC study involving human readers and AI assistance would be performed for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical balloon catheter, not an algorithm or software. It does not perform any standalone algorithmic analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" is defined by established engineering specifications and medical device standards (e.g., ISO, ASTM, internal company specifications for performance characteristics like burst pressure, deflation time, etc.). For biocompatibility, the ground truth is against established biological safety standards (e.g., ISO 10993-1). This is not expert consensus, pathology, or outcomes data in the clinical sense, but rather compliance with scientific and engineering benchmarks.
8. The sample size for the training set
This question is not applicable. This device is not an AI/software device that would use a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this type of medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).