(98 days)
The Sterling ES MR and OTW PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The 2.00 mm - 4.00 mm balloon devices are also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Sterling ES PTA Balloon Dilatation Catheters consist of a Monorail and an Over-The-Wire 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 0.014 in (0.39 mm) guide wires 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.
Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The working lengths of the balloon catheters are 143 cm.
This document describes the 510(k) summary for the Sterling ES MR and OTW PTA Balloon Dilatation Catheters. It's important to note that this is a submission for a medical device (a physical product), not an AI/software device. Therefore, many of the typical AI/software acceptance criteria and study components you've requested (like MRMC studies, ground truth establishment for algorithms, training sets, and expert adjudication of AI performance) are not applicable to this type of device.
This submission focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility.
Here's an attempt to fill in the requested information based on the provided text, with clarifications where the concepts are not applicable:
- Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Technological Characteristics: Substantially equivalent design, packaging, fundamental technology, manufacturing, sterilization, and intended use as the predicate device (Sterling OTW PTA Balloon Dilatation Catheter, K053116). This would implicitly include aspects like balloon diameter, length, working pressures, shaft design, guide wire compatibility, radiopacity. | The Sterling ES MR and OTW catheters incorporate a substantially equivalent design, packaging, fundamental technology, manufacturing, sterilization and intended use as those featured in the predicate BSC Sterling OTW PTA Balloon Dilatation Catheter. Specific performance metrics are not detailed, but the conclusion states that based on testing, it's appropriate for intended use. |
| Safety and Performance: No new safety or performance issues identified during device testing. This implies the device performs as safely and effectively as the predicate for its intended use. | "No new safety or performance issues were identified during device testing." "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." |
| Biocompatibility: The device materials must be biocompatible for their intended use. | "biocompatibility testing were performed to support a determination of substantial equivalence." (Specific results not detailed, but implied as acceptable). |
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Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. For a physical device, "test set" would refer to the number of devices or components tested during bench testing. This information is typically detailed in the full 510(k) submission, not the summary.
- Data Provenance: The testing was "bench testing" and "biocompatibility testing." This implies laboratory testing on physical device samples, not patient data from a specific country. It's prospective in the sense that the testing was performed on the device candidates to support the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/software devices typically refers to the confirmed diagnosis or measurement used to evaluate an algorithm's performance. For a balloon catheter, "ground truth" might loosely refer to validated measurements of its physical properties against specifications, but this isn't established by external "experts" in the clinical diagnostic sense. The device's performance is measured against engineering specifications and predicate device performance.
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Adjudication method for the test set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of medical data (e.g., images for AI performance evaluation). For a physical device, performance is typically measured against objective criteria and specifications established during design and verified during testing.
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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. This is a physical medical device, not an AI/software product. MRMC studies are used to evaluate diagnostic performance of imaging systems or AI algorithms with human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm or software. There is no "standalone" algorithm performance to evaluate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI/clinical sense). For this device, the "ground truth" is implied to be engineering specifications, validated test methods for mechanical properties (e.g., burst pressure, balloon diameter at pressure), and established biocompatibility standards. The predicate device's performance also serves as a benchmark for "ground truth" performance expectations.
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The sample size for the training set
- Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The "training" for such a device is its design and manufacturing process, optimized through engineering principles.
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How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/software device, this question is not relevant.
§ 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).