(21 days)
The Sterling SL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, ilio-femoral, infrapopliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Sterling SL PTA Balloon Dilatation Catheters 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 (0.36 mm) or 0.018 in (0.46 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. The working lengths of the balloon catheter are 90 cm and 150 cm.
The provided document is a 510(k) summary for a medical device, the Sterling SL Monorail and OTW PTA Balloon Dilatation Catheters. It describes the device, its intended use, and its substantial equivalence to predicate devices based on design control activities and bench testing.
However, this document does not contain information about acceptance criteria, clinical study data, or performance metrics in a way that would allow for the detailed answers requested. Specifically:
- Acceptance criteria and reported device performance: The document states "The substantial equivalence of the modified Sterling PTA Balloon Dilatation Catheters is demonstrated with design control activities and bench testing on file at Boston Scientific." It does not provide a table of specific acceptance criteria (e.g., burst pressure, inflation/deflation times, guidewire compatibility) or actual performance results against these criteria.
- Sample size and data provenance: No information on sample sizes for test sets or their provenance (country of origin, retrospective/prospective) is provided.
- Number and qualifications of experts for ground truth: Not applicable, as this is a device performance study based on bench testing, not an AI or diagnostic imaging study requiring expert adjudication.
- Adjudication method: Not applicable for the same reason as above.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic device.
- Standalone performance: While the bench testing represents "standalone" device performance, no specific results or metrics are provided to quantify this.
- Type of ground truth: Not applicable in the traditional sense of a diagnostic study. The "ground truth" would be engineering specifications and ASTM/ISO standards for device performance.
- Training set sample size: Not applicable, as this is not a machine learning device.
- Ground truth for training set: Not applicable.
In summary, the provided text describes a submission for a medical device (balloon catheter) demonstrating substantial equivalence through design control and bench testing. It is not an AI or diagnostic imaging device, and therefore, most of the requested information regarding acceptance criteria and study details for such devices is not present in this document.
§ 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).