(17 days)
Atlas® PTA Balloon Dilatation Catheters are indicated for use in Percutaneous Transluminal Angioplasty (PTA) 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® PTA Balloon Dilatation Catheter is a high performance 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" guidewires and is available in 75 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.
The provided text describes a 510(k) submission for the Atlas® PTA Balloon Dilatation Catheter, focusing on its substantial equivalence to predicate devices. The document explicitly states that the submission is for a "modified indications for use statement" and outlines performance data used to demonstrate equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific numerical acceptance criteria. Instead, it states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Equivalence | "The subject device, the Atlas® PTA Balloon Dilatation Catheter, met all the predetermined acceptance criteria of design verification and validation activities for the modified indications for use statement, as specified by applicable standards, guidance, test protocols and/or customer inputs." |
| Technological Characteristics and Performance Criterion | "The results from these tests demonstrate that the technological characteristics and performance criteria of the subject Atlas® PTA Balloon Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use." |
| Specific In Vitro Tests | The device's performance was evaluated through: |
- Puncture Resistance
- Robustness
- Balloon Removal
(The specific results for these tests are not provided, only that they were performed and supported comparability/equivalence.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes in vitro tests ("Puncture Resistance," "Robustness," "Balloon Removal") for performance data. It does not mention clinical trials or studies with human subjects that would have a "test set" in the context of diagnostic accuracy or effectiveness on patients. Therefore, information about sample size for a test set (in a clinical sense) or data provenance (country, retrospective/prospective) is not applicable here as this is an engineering performance evaluation, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Since the performance data is based on in vitro engineering tests, there is no mention of human experts being used to establish ground truth in the way it would be for a diagnostic tool or clinical assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. As the performance data is based on in vitro engineering tests, there is no mention of an adjudication process typically used in clinical studies involving interpretation by multiple readers.
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
This information is not applicable. The document does not describe an MRMC study or any study involving human readers or AI assistance. This is a medical device (balloon catheter) and its clearance is based on performance equivalence, not AI-assisted interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument (balloon catheter), not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in vitro tests, the "ground truth" would be established by the physical and mechanical properties and measurements against defined specifications and industry standards for balloon catheters. The document lists "applicable standards, quidance, test protocols and/or customer inputs" as the basis for acceptance criteria, which implies objective measurement against known benchmarks rather than subjective expert consensus or clinical outcomes data.
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" in the context of device development for this type of medical instrument. The performance evaluation is based on engineering tests, not machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 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).