(186 days)
Ultra-Thin SDS Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The proposed Ultra-Thin SDS Balloon Dilatation Catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller.
This document is a 510(k) premarket notification for a medical device called the "Ultra-Thin SDS Balloon Dilatation Catheter". It is a submission to the FDA seeking clearance to market the device by demonstrating its substantial equivalence to a legally marketed predicate device.
Let's break down the requested information:
1. Table of Acceptance Criteria & Reported Device Performance:
The provided document does not explicitly state specific acceptance criteria with numerical targets or a "reported device performance" against those criteria in a tabular format as would be typical for clinical studies or performance testing summaries. Instead, it makes a general statement of compliance.
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Acceptance Criteria (Implicit): Assumed to be "conformance to the requirements for its intended use" and "no new safety or performance issues."
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Reported Device Performance:
"Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. 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. No new safety or performance issues were raised during the testing regimen."Therefore, a table cannot be constructed with the provided information. The document confirms that testing was done and that the device met the requirements without new issues, but not specific numeric results or thresholds.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "Bench testing and biocompatibility testing" but does not give any details on the number of devices or samples tested.
- Data Provenance: The testing was "performed to support a determination of substantial equivalence." This refers to internal testing conducted by the manufacturer, Boston Scientific Corporation, based in Galway, Ireland. The testing is likely retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. This document describes a 510(k) submission primarily based on bench and biocompatibility testing, not clinical studies involving expert interpretation of patient data to establish ground truth.
4. Adjudication method for the test set:
- Not applicable / Not specified. As this document does not describe a clinical study requiring expert adjudication of results, this information is not relevant.
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. This document describes a medical device (a balloon dilatation catheter), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This document describes a medical device (a balloon dilatation catheter), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used:
- Not applicable for clinical ground truth. For the bench and biocompatibility testing, the "ground truth" would be established by specifications and regulatory standards for material properties, mechanical performance (e.g., burst pressure, fatigue), and biological safety.
8. The sample size for the training set:
- Not applicable / Not specified. This is a medical device (catheter) submission, not an AI model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable / Not specified. As above, there is no "training set." The performance of the device is assessed against engineering specifications and biocompatibility standards.
§ 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).