(28 days)
The Pioneer Plus catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus catheter is not indicated for use in the coronary or cerebral vasculature.
Percutaneous catheter that utilizes IVUS imaging and a hollow Nitinol needle to facilitate redirection and placement of a 0.014° OTW guidewire into peripheral vessels. The guidewire can then facilitate placement of subsequent devices. The device is a single use, sterile catheter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pioneer Plus Catheter:
Summary of Acceptance Criteria and Device Performance (Based solely on the provided text):
The provided 510(k) summary primarily focuses on changes to an existing device (Pioneer Plus Catheter, K081804). As such, it relies on demonstrating that the modified device remains substantially equivalent to its predicate, rather than establishing entirely new performance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (regarding needle retraction failure) | "A Warning and mitigation steps for managing a needle retraction failure were added to the Instructions for Use. The modifications provide additional safety information to clinicians to facilitate safe use of the Pioneer Plus Catheter." |
| Maintenance of original performance and functional specifications | "Manufacturing process improvements were implemented on the needle subassembly to enhance production consistency and insure the product continues to meet its original specifications. Testing on the needle subassembly was completed and confirmed the process changes did not negatively affect its performance or functionality." |
| No negative impact on performance or functionality due to changes | "Testing on the needle subassembly was completed and confirmed the process changes did not negatively affect its performance or functionality." |
| Equivalence to Predicate Device | "The information above demonstrates equivalence and supports a determination of substantial equivalence between the Subject and Predicate Pioneer Plus Catheters." |
Study Information:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Testing on the needle subassembly," but does not provide details on the number of units tested.
- Data Provenance: Not explicitly stated. The testing appears to be internal to Medtronic Vascular ("Medtronic Vascular Ms. Lucinda Fox Regulatory Affairs Manager"). It is not specified if the data is from a particular country or if it's retrospective or prospective. Given it's for a "Special 510(k) - Changes Being Effected," it's likely a controlled, prospective internal test of the modified components.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable to this submission. The submission is not for an AI/machine learning device that requires expert-established ground truth for its performance evaluation. This is a medical device (catheter) where performance is assessed through engineering testing (e.g., mechanical, functional) and comparison to specifications, not diagnostic accuracy against a ground truth.
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Adjudication method for the test set:
- Not applicable. As the performance is based on engineering testing of the modified needle subassembly, there wouldn't be an adjudication method in the context of diagnostic accuracy.
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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 not an AI-assisted device, therefore, an MRMC study is not relevant or mentioned.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For a physical device like this, the "ground truth" for performance is typically engineering specifications, material properties, and functional requirements verified through physical testing, rather than expert consensus on diagnostic interpretations or pathology. The assessment here is about the device's ability to "meet its original specifications" and that process changes "did not negatively affect its performance or functionality."
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The sample size for the training set:
- Not applicable. This submission is for a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context.
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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 model, this question is irrelevant to this submission.
Conclusion from the Document:
This 510(k) is a "Special 510(k) - Changes Being Effected" for the Pioneer Plus Catheter. The primary purpose of the submission is to demonstrate that minor changes (specifically, manufacturing process improvements to the needle subassembly and additions to the Instructions for Use regarding needle retraction failure) do not negatively impact the device's safety or effectiveness and that the device remains substantially equivalent to its cleared predicate. The "study" mentioned is internal "Testing on the needle subassembly" to confirm its performance after the process changes. No details on this testing (e.g., sample size, specific tests, results) are provided beyond the statement that it "confirmed the process changes did not negatively affect its performance or functionality."
§ 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).