(26 days)
The Atlas Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
The Atlas Gold PTA Dilatation Catheter is balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The over the wire catheter is compatible with 0.035" guidewire and is available in 80 and 120 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.
Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.
Here's a breakdown of the acceptance criteria and study information for the Atlas Gold PTA Dilatation Catheter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the device "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not provide a specific table detailing the acceptance criteria values for each test alongside the performance results. Instead, it lists the types of tests performed.
Therefore, a table cannot be constructed with specific numerical acceptance criteria and performance data. The reported device performance is broadly stated as follows:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In Vitro Tests | "The results from these tests demonstrate that the technological characteristics and performance criteria of the Atlas Gold PTA Dilatation Catheter is comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the similar intended use." |
| Dimensional Verification | Met criteria (implied by overall statement) |
| Media Interaction | Met criteria (implied by overall statement) |
| Equipment Interface | Met criteria (implied by overall statement) |
| Sheath Compatibility | Met criteria (implied by overall statement) |
| Rated Burst Pressure | Met criteria (implied by overall statement) |
| Balloon Burst Mode | Met criteria (implied by overall statement) |
| Catheter Shaft Leaks | Met criteria (implied by overall statement) |
| Catheter Shaft Burst | Met criteria (implied by overall statement) |
| Fatigue | Met criteria (implied by overall statement) |
| Balloon Nominal Pressure | Met criteria (implied by overall statement) |
| Balloon Distensibility | Met criteria (implied by overall statement) |
| Inflation Time | Met criteria (implied by overall statement) |
| Deflation Time | Met criteria (implied by overall statement) |
| Balloon to Shaft Tensile | Met criteria (implied by overall statement) |
| Catheter Shaft Elongation | Met criteria (implied by overall statement) |
| Hub to Shaft Tensile | Met criteria (implied by overall statement) |
| Tip Tensile | Met criteria (implied by overall statement) |
| Tip Morphology | Met criteria (implied by overall statement) |
| Trackability | Met criteria (implied by overall statement) |
| Tip Visibility | Met criteria (implied by overall statement) |
| Catheter Shaft Visibility | Met criteria (implied by overall statement) |
| Marker Band Visibility | Met criteria (implied by overall statement) |
| Marker Band Alignment | Met criteria (implied by overall statement) |
| Balloon Burst Strength in Stent/Stent Graft | Met criteria (implied by overall statement) |
| Fatigue in Stent/Stent Graft | Met criteria (implied by overall statement) |
| Balloon Removal from Stent/Stent Graft | Met criteria (implied by overall statement) |
| Visual Inspection of Packaging | Met criteria (implied by overall statement) |
| Dye Penetration | Met criteria (implied by overall statement) |
| Pouch Tensile Strength | Met criteria (implied by overall statement) |
| Biocompatibility Tests | "The results from these tests demonstrate that the subject device...is comparable to the predicate device and that it is considered safe and biocompatible for its intended use." |
| Cytotoxicity | Met criteria (implied by overall statement) |
| Sensitization | Met criteria (implied by overall statement) |
| Intracutaneous Reactivity | Met criteria (implied by overall statement) |
| Acute Systemic Toxicity | Met criteria (implied by overall statement) |
| Hemocompatibility | Met criteria (implied by overall statement) |
| Material Mediated Pyrogenicity | Met criteria (implied by overall statement) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in the context of clinical data for algorithmic performance. The tests described are in vitro (laboratory) tests on the device itself and biocompatibility tests. The document does not provide sample sizes for these tests, nor does it mention country of origin or whether the data is retrospective or prospective, as these are typically considerations for clinical studies involving patient data, not mechanical or biocompatibility testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable. The evaluations were based on engineering specifications and laboratory testing protocols, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable. There's no mention of an adjudication process as would be used for subjective assessments or expert reviews of clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of this device's submission.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not conducted or mentioned. The device is a physical medical instrument (catheter), not a software algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the performance evaluation relies on established engineering specifications, test protocols, and recognized standards (e.g., ISO 10993-1:2009 for biocompatibility). For mechanical and performance tests, the ground truth is often defined by the design requirements and the physical properties expected of the device.
8. Sample Size for the Training Set:
This information is not applicable. There is no software algorithm or AI that requires a training set for this device. The evaluation is based on direct device testing.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set mentioned for this 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).