(28 days)
The Primi™ Support Catheter is intended to be used in conjunction with guidewires in order to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The support catheter also may be used to selectively infuse/deliver physician specified diagnostic and/or therapeutic agents, such as sterile saline, contrast agents, vaso-dilators, anti-blastics, lytics, and anti-thrombotics, with or without a guidewire in position.
The ThermopeutiX Support Catheter that is the submission is a single lumen catheter with a radiopaque marker that aids in positioning the catheter and a tapered tip to facilitate entry. The catheter utilizes an integral spine wire. The catheter is available in several diameters and lengths which are 0.014", 0.018", or 0.035" guidewire compatible. The working lengths are 90 cm thru 170 cm. Reference Table 1 for model number availability. The distal portion of the catheter shaft has a hydrophilic coating to facilitate insertion. The device has a luer hub connector to allow infusion of diagnostic and/or therapeutic agents. The device is supplied sterile and is intended for single use only. Reference Table 2 below for physical and performance characteristics.
The provided text describes a 510(k) premarket notification for the ThermopeutiX Primi™ Support Catheter with an advanced hydrophilic coating. This submission aims to demonstrate substantial equivalence to a previously cleared version of the same catheter (K130850) by ThermopeutiX, Inc., with the primary difference being the advanced hydrophilic coating.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the physical and performance characteristics of the predicate device and the new device. The study demonstrates that the new device's performance is either identical or comparable, and meets internal protocol requirements and product specifications.
| Element/Feature | Acceptance Criteria (from Predicate Device) | Reported Device Performance (New Device) |
|---|---|---|
| Working Length (s) | 90 cm – 170 cm; polymer shaft with integral spine wire | 90 cm – 170 cm; polymer shaft with integral spine wire |
| Outside Diameter (s) | Distal:0.045" – 0.064" | |
| Proximal: 0.060" – 0.080" | Distal:0.045" – 0.064" | |
| Proximal: 0.060" – 0.080" | ||
| Lumen | One | One |
| Guide wire Compatibility | 0.014"-0.035" | 0.014"-0.035" |
| Guide wire Use | Over the Wire | Over the Wire |
| Distal End Configuration | Tapered tip for ease of crossing | Tapered tip for ease of crossing |
| Fluid connection | Luer hub connector | Luer hub connector |
| Flow rate @ 150 psi w/Saline | 0.014" wire models > 0.80 cc/sec | |
| 0.035" wire models > 0.50 cc/sec | 0.014" wire models > 0.80 cc/sec | |
| 0.035" wire models > 0.50 cc/sec | ||
| Flow rate @ 150 psi w/Contrast | 0.014" wire models > 0.30 cc/sec | |
| 0.035" wire models > 0.15 cc/sec | 0.014" wire models > 0.30 cc/sec | |
| 0.035" wire models > 0.15 cc/sec | ||
| Maximum Injection Pressure | Do not exceed 300 psi | Do not exceed 300 psi |
| Coating | Yes; hydrophilic, distal portion | Yes; advanced hydrophilic, distal portion (provides comparable lubricity with a reduction in particulates) |
| Coating Length | 65 cm, 115 cm or 140 cm | 65 cm, 115 cm or 140 cm |
| Coating Thickness | Proprietary | Same as predicate (considered equivalent) |
| Radiopaque Markers | One | One |
| Sheath Compatibility | 5 Fr and 6 Fr | 5 Fr and 6 Fr |
| Materials Used | Identical list of materials as the new device, except for the coating. | Hub-Pebax |
| Outer Shaft-Pebax | ||
| Inner Shaft-HDPE | ||
| Distal Shaft-Pebax w/radiopaque filler | ||
| Core Wire-Stainless Steel tapered wire | ||
| Coating-Advanced hydrophilic proprietary coating | ||
| Marker Band Platinum/Iridium |
Study Proving Device Meets Acceptance Criteria:
The study conducted is a non-clinical performance and safety study comparing the new device with the advanced hydrophilic coating to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify an exact numerical sample size for each individual test. It states "The non-clinical tests performed on sample devices are listed below," and "All performance testing was repeated on samples with a minimum of 10 month aging." This indicates that multiple samples were used for testing, including aged samples, but the exact number isn't quantified.
- Sample Size for Test Set: Not explicitly stated as a number, but "sample devices" were used, including aged samples.
- Data Provenance: The data is from in-vitro (bench) testing performed by the manufacturer, ThermopeutiX, Inc., in the United States. This is prospective testing performed for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of submission (510(k) for a medical device with minor modification) typically relies on engineering and biological testing against established standards and product specifications, rather than expert interpretation of a test set in the way AI/ML algorithms use ground truth. Therefore, the concept of "experts establishing ground truth for the test set" is not applicable here. The "ground truth" is the objective physical and performance measurements determined by standardized testing protocols.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study is based on objective physical and performance measurements via bench testing, not subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI, not for performance testing of a physical medical device like a catheter. The aim here is to show "substantial equivalence" of device characteristics and safety, not to measure human reader improvement with AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device, not an algorithm or AI system. The "standalone" performance is the device's measured performance during bench testing without human intervention in the device's function.
7. The Type of Ground Truth Used
The ground truth used for this study is based on objective physical and performance measurements derived from standardized engineering and biocompatibility tests (e.g., flow rate, tensile strength, lubricity, cytotoxicity, etc.) and comparison to the known characteristics of the predicate device. It's essentially test results against predetermined specifications and accepted standards (e.g., ISO, ASTM).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The device itself is the product, and its performance is being evaluated, not an algorithm's learning capability.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 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).