(29 days)
The Sterling ES Monorail and Over-the-Wire PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal 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 designs 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 wire lumen permits the use of 0.014" guidewires 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 approximately 143 cm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sterling™ ES MR and OTW PTA Balloon Dilatation Catheters:
Summary of Device and Performance Information:
The Sterling™ ES MR and OTW PTA Balloon Dilatation Catheters are Percutaneous Transluminal Angioplasty (PTA) catheters indicated for use in the peripheral vasculature and for treating obstructive lesions in arteriovenous dialysis fistulae. Smaller balloon sizes (2.00 mm - 4.00 mm) are also indicated for post-dilatation of stents. The device is a modification of a previously cleared device (K080982).
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the Sterling™ ES MR and OTW PTA Balloon Dilatation Catheters.
The document mentions: "The safety and effectiveness of the modified Sterling ES MR and OTW PTA Balloon Dilatation Catheter is demonstrated with design control activities and bench testing on file at Boston Scientific."
This statement indicates that performance was assessed, but the details of what was measured, how well it performed, and what standards it had to meet are not included in the provided 510(k) summary and FDA letter.
Based on the available information, a table cannot be constructed with specific acceptance criteria and reported device performance.
Regarding the other requested information:
While the document confirms a study was done ("bench testing on file at Boston Scientific"), it does not provide any of the detailed information requested for points 2 through 9.
Here's why and what's missing:
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No Clinical Study Details: The provided text explicitly states "bench testing" and "design control activities" were used to demonstrate safety and effectiveness. This indicates that a clinical study (involving human subjects) was likely not the primary method for demonstrating substantial equivalence for this particular modification, at least not in the context of this 510(k) summary. If a clinical study were performed, details like sample size, data provenance, ground truth establishment, etc., would be crucial.
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Focus on Substantial Equivalence: The 510(k) submission process primarily focuses on demonstrating "substantial equivalence" to a predicate device. For modifications to existing devices, this often relies heavily on bench testing and comparisons of materials, design, and manufacturing processes, rather than extensive new clinical trials, unless the modification significantly alters safety or effectiveness.
Therefore, for aspects 2-9, the answer is that the information is not provided in the given text.
Detailed breakdown of missing information for points 2-9:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
* Information Not Provided. The document only refers to "bench testing." Details on sample size or data provenance for such testing are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
* Information Not Provided. This type of information would typically be relevant for studies involving image interpretation or clinical outcomes, which is not described here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
* Information Not Provided. This applies to clinical studies with expert reviewers, which is not detailed.
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
* Information Not Provided. This device is a physical medical device (catheter), not an AI-powered diagnostic or interpretive tool. An MRMC study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
* Information Not Provided. As noted, this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
* Information Not Provided. For physical device bench testing, "ground truth" would typically refer to known physical properties or specified performance parameters measured against accepted standards (e.g., burst pressure, inflation time, guidewire compatibility). The document does not specify these.
8. The sample size for the training set
* Information Not Provided. No training set for an algorithm is mentioned or implied.
9. How the ground truth for the training set was established
* Information Not Provided. No training set is mentioned.
§ 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).