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510(k) Data Aggregation
(160 days)
PROGIGY SUPPORT CATHETER
The Prodigy Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
The Prodigy Support Catheter is an over-the-wire (OTW) 2-lumen catheter with a 5 mm clastomeric balloon located near the distal tip. One lumen of the catheter is used to inflate and deflate the balloon with contrast fluid. The second lumen provides access for a guidewire. Two side legs are located at the proximal catheter end to provide access to the balloon lumen and the guidewire lumcu. A pressure relief valve is attached at the proximal end of the balloon side leg and allows for connection with an inflation device. There are two radiopaque marker bands located at each end of the balloon. The inflated balloon diameter is variable with increased pressure up to 5 mm. The Prodigy Support Catheter is packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-6.
The provided 510(k) summary focuses on the Prodigy Support Catheter and describes its performance based on biocompatibility and in vitro functional testing, not a clinical study involving human readers or AI. Therefore, most of the requested information regarding AI performance, human reader studies, and ground truth establishment for clinical data is not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission discusses performance tests against established standards rather than specific acceptance criteria values paired with reported performance values. It states biocompatibility and in vitro performance tests were conducted according to the requirements of Guidance for Industry and FDA Staff-Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010, and ISO10993-1:2009 for biocompatibility.
| Test Category | Specific Test Conducted | Performance Evaluation Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) |
| Sensitization | Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Intracutaneous Reactivity | Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Acute Systemic Toxicity | Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Hemolysis | Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Material Mediated Pyrogenicity | Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Thombogenicity | Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Complement Activation | Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| In Vitro Performance | Dimensional Verification | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) |
| Balloon Preparation, Deployment and Retraction | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Balloon Burst Pressure | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Balloon Fatigue | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Balloon Inflation/Deflation Time | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Catheter Bond Strength | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Flexibility and Kink Test | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Torque Strength | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Radiopacity | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) | |
| Balloon Holding Force | Met requirements of FDA Guidance for PTCA Catheters | Pass (Implied by conclusion of substantial equivalence) |
Conclusion: Based on these tests, the device was deemed "substantially equivalent to the currently marketed Minnie Support Catheter, Maverick XL PTCA Catheter and NC Quantum Apex OTW PTCA Dilatation Catheter."
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve a clinical test set from human subjects or derived from existing clinical data. The "test set" consists of multiple samples of the Prodigy Support Catheter for in vitro and biocompatibility testing. The number of devices tested for each in vitro performance test or material batch for biocompatibility is not specified in the summary but would typically be dictated by the relevant standards and internal quality procedures.
Data Provenance: The origin of the data is laboratory testing (in vitro and biocompatibility) of manufactured device samples, not patient data from a specific country or retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study requiring expert readers to establish ground truth for clinical data. Performance was measured against physical and chemical standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert interpretations of clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
Not applicable. This submission does not involve an MRMC study or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by the requirements and methodologies outlined in the referenced international standards (ISO10993-1:2009) and FDA guidance documents ("Guidance for Industry and FDA Staff-Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters," September 8, 2010). This involves predefined physical, chemical, and biological endpoints.
8. The Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of AI or machine learning. Its performance is based on direct manufacturing and laboratory testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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