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510(k) Data Aggregation
(146 days)
The Upstream Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.
The Upstream Support Catheter is not intended for use in the coronary, cerebral or carotid vasculature.
The Upstream Support Catheter is a sterile, single lumen polymer coated stainless steel hypotube, with a tapered tip at the distal end and a proximal hub.
The Upstream Support Catheter is intended for use with 0.014" guidewires. The Upstream Support Catheter is provided in 95 cm length and its outer diameter is 0.8mm (0.0315"). A hub at the proximal end of the Upstream Support Catheter allows guidewire access.
The provided 510(k) summary for the Upstream Support Catheter does not describe an AI/ML powered device, therefore, many of the requested fields are not applicable. The device is a physical medical device (catheter) and the acceptance criteria and supporting studies are based on traditional engineering and biocompatibility testing, not AI/ML performance metrics.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission outlines benchmark and performance data based on in vitro bench testing for the physical properties and biocompatibility of the catheter. Specific numerical acceptance criteria and reported performance values are not explicitly listed in a comparative table format in the provided text. However, it states that "All of these tests demonstrated that the Upstream Support Catheter meets its intended performance specifications."
| Acceptance Criteria Category | Reported Performance (Qualitative/Outcome) |
|---|---|
| Biocompatibility (ISO 10993) | Device materials are biocompatible. (Tests included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic injection, hemolysis, thromboresistance, complement activation) |
| Tensile Force Testing | Meets intended performance specifications. |
| Air Leakage Testing | Meets intended performance specifications. |
| Corrosion Resistance Testing | Meets intended performance specifications. |
| Liquid Leakage Pressure Testing | Meets intended performance specifications. |
| Catheter Torque Testing | Meets intended performance specifications. |
| Hub Compatibility Testing | Meets intended performance specifications. |
| Surface and Dimensional Analysis | Meets intended performance specifications. |
| Radiopacity Testing | Meets intended performance specifications. |
| Component Biocompatibility Testing | Meets intended performance specifications. |
| Package Testing | Meets intended performance specifications. |
| Sterilization Validation Testing | Meets intended performance specifications. |
| Substantial Equivalence to Predicates | Device performs as intended, meets all design specifications, materials are biocompatible, and raises no new safety/effectiveness questions compared to Asahi Tornus Support Catheter (K051772) and Spectranetics Quick-Cross Extreme Support Catheter (K082561, K092396). |
2. Sample Size for Test Set and Data Provenance
This information is not applicable to this device submission. The testing performed was primarily in vitro bench testing on the physical device itself. There isn't a "test set" in the context of diagnostic data, and thus no country of origin or retrospective/prospective data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. Ground truth for a physical catheter's performance is established through engineering specifications and standardized testing protocols, not through expert consensus on diagnostic data.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "test set" requiring adjudication in the context of diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The device is a physical catheter, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
This information is not applicable. The device is a physical catheter, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications, industry standards (e.g., ISO 10555-1, ISO 10993), and internal performance requirements established by the manufacturer.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" for a physical medical device. The device design is based on engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" in the AI/ML sense. The "ground truth" for the device's design and manufacturing is established through the adherence to design specifications, material properties, and manufacturing processes aimed at achieving the intended performance and safety profile, informed by industry standards and preclinical testing.
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