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Passeo-18 is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae

The Passeo-18 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. Two radiopaque markers are located at either end of the ballon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapend of tip to facilitate advancement of the catheter.

The balloon catheter shaft has two Luer ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables insertion of the guide wire. The balloon catheter has a two lumen co-axial design. The outer lumen is the balloon inflation/deflation lumen. The inner lumen permits the use of guide wires with diameters up to a maximum of 0.018" to facilitate advancement of the balloon catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducers sizes according to the recommendations on the label. The balloon cather has a silicone coating to improve the trackability and pushability characteristics.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "The Passeo-18 PTA Catheter is substantially equivalent to the predicate devices (BIOTRONIK's Pheron peripheral PTA catheter, [K033217](https://510k.innolitics.com/search/K033217) and [K052757](https://510k.innolitics.com/search/K052757)) based on indications for use and general specifications.",
    "Reported Device Performance": "The FDA determined that the Passeo-18 PTA catheter is substantially equivalent to its predicate devices for the indicated uses, indicating it meets the acceptance criteria for safety and effectiveness."
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Not applicable. This is a 510(k) premarket notification for a medical device (PTA catheter), not an AI/ML diagnostic device study involving a test set of data. The submission relies on demonstrating substantial equivalence to a predicate device, not on clinical performance data derived from a specific test set.",
  "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)": "Not applicable. This document pertains to a medical device (PTA catheter) and not an AI/ML diagnostic device requiring expert interpretation for ground truth.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. This document pertains to a medical device (PTA catheter) and not an AI/ML diagnostic device requiring adjudication of expert interpretations.",
  "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": "Not applicable. This document pertains to a medical device (PTA catheter) and not an AI/ML diagnostic device, so no MRMC study was conducted or is relevant.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This document pertains to a physical medical device (PTA catheter) and not an algorithm or AI. Performance is evaluated through bench testing and comparison to predicate devices, not through standalone algorithm performance.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Not applicable. For a 510(k) of this nature, 'ground truth' largely refers to established engineering standards, biocompatibility testing results, and performance characteristics (e.g., inflation diameter at pressure, flexibility, trackability) demonstrated to be equivalent to the predicate device. These are not typically established by expert consensus of patient data, pathology, or outcomes in the same way an AI/ML diagnostic device's ground truth would be.",
  "8. The sample size for the training set": "Not applicable. This is a 510(k) for a medical device (PTA catheter), not an AI/ML diagnostic device. Therefore, there is no training set in the context of an algorithm.",
  "9. How the ground truth for the training set was established": "Not applicable. This is a 510(k) for a medical device (PTA catheter), not an AI/ML diagnostic device. Therefore, there is no training set and no ground truth establishment for a training set."
}

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