(163 days)
The infusion catheter is intended to assist in the controlled infusion of diagnostic or therapeutic solutions into the peripheral or coronary vasculature. The target vessel effective diameter is ≥ 2.0 mm. The catheter is placed by a physician using a guide catheter and over a guidewire that extends beyond the final position of the infusion catheter.
The TherOx® Infusion Catheter is a sterile, single-use, 4.6 French (F) intravascular catheter with a 127 cm usable length. The catheter is comprised of three sections; 1) a distal atraumatic soft tip 2) a semi-rigid but flexible shaft; and 3) a proximal luer hub for connection of solution-delivery devices. A radiopaque band at the distal tip allows fluoroscopic visualization of the catheter's location in the vessel.
TherOx, Inc. sought 510(k) clearance for their TherOx® Infusion Catheter, indicating substantial equivalence to the Boston Scientific/Target Therapeutics Tracker® - 38 Infusion Catheter. The study performed was a non-clinical test data summary comparing the TherOx® Infusion Catheter to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (based on predicate device and standards) | TherOx® Infusion Catheter Performance |
|---|---|---|
| Physical/Material | ||
| Outer Diameter | Comparable to predicate to allow intended use | 4.6 F (0.060 in) overall (smaller than predicate's 5.3F/5F) |
| Inner Diameter | Sufficient for recommended guidewire | 0.046 in overall, 0.037 in min at marker band (slightly smaller than predicate at marker band) |
| Usable Length | Comparable to predicate for physician manipulation | 127 cm (longer than predicate's 115cm/117cm) |
| Materials | Biocompatible and suitable for intravascular use | High density polyethylene (HDPE) shaft, rigid HDPE luer, LDPE plasticized tip (minor differences from predicate, but compliant) |
| Radiopacity | Visible under fluoroscopy | Radiopaque band at distal tip allows visualization |
| Sterile | Sterile | Sterilized with ethylene oxide |
| Single-Use | Single-use only | Single-use only |
| Shelf Life | Established shelf life | 3-year shelf life established |
| Functional/Performance | ||
| Strength | Meets standards (ISO 10555 series) for intravascular catheters | Test results met acceptance criteria |
| Flexibility | Meets standards (ISO 10555 series) for intravascular catheters | Test results met acceptance criteria |
| Pressure | Meets standards (ISO 10555 series) for intravascular catheters | Test results met acceptance criteria |
| Flow | Meets standards (ISO 10555 series) for intravascular catheters | Test results met acceptance criteria |
| Biocompatibility | Meets ISO 10993-1 | Satisfies ISO 10993-1 requirements |
| Sterilization | Validated per ISO 11135 | Validated per ISO 11135 |
| Packaging | Designed and tested per ISO 11607 | Designed and tested per ISO 11607 |
| Joint Strength | Within specified requirements | Test results met acceptance criteria |
| Dimensional Conformance | Within specified requirements | Test results met acceptance criteria |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the exact sample size (number of catheters) used for each individual test. It mentions "production samples that were sterilized twice in a validated sterilization cycle" and "samples that were sterilized twice and then thermally aged to simulate an expected shelf life." This implies a sufficient number of devices were tested to validate the performance and shelf life.
- Data Provenance: The data is from non-clinical bench testing conducted by TherOx, Inc. explicitly for this 510(k) submission. It is prospective in the sense that the tests were performed to demonstrate compliance of the TherOx® Infusion Catheter. The country of origin of the data is implied to be where TherOx, Inc. is located (Irvine, CA, USA) or where their testing facilities are.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a non-clinical bench study, not a clinical study involving human expert interpretation. Therefore, there were no experts used to establish a "ground truth" in the sense of clinical diagnosis or interpretation. The "ground truth" or acceptance criteria were derived from international standards (ISO 10555 series, ISO 10993-1, ISO 11135, ISO 11607) and internal device specifications, as well as comparison to the predicate device. The engineers and scientists conducting the tests would have been qualified in their respective fields of materials science, biomechanics, and medical device testing.
4. Adjudication method for the test set:
- Not applicable. As a non-clinical bench study, there was no adjudication method involving multiple human readers or experts to determine a consensus "ground truth." Test results were compared directly to the predetermined acceptance criteria outlined in the relevant standards and internal specifications.
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, an MRMC comparative effectiveness study was not performed. This submission is for a physical medical device (an infusion catheter) and evaluates its mechanical and material properties, not an AI or imaging diagnostic tool that would involve human reader interpretation.
6. 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 or software. No standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests was established by predetermined engineering specifications and compliance with recognized international and national standards for intravascular catheters and medical device testing. These standards dictate acceptable ranges for physical dimensions, material properties, strength, flexibility, pressure resistance, flow rates, biocompatibility, sterilization efficacy, and packaging integrity. The predicate device's characteristics also served as a reference point.
8. The sample size for the training set:
- Not applicable. This is a non-clinical bench study for a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there was no training set for a machine learning model.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).