(6 days)
The Atlas™ PTA Balloon 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 catheter is not for use in coronary arteries.
The Atlas™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.
This 510(k) summary for the Atlas™ PTA Balloon Dilatation Catheter (K052236) does not contain the specific acceptance criteria or a detailed study description to prove the device meets said criteria.
Here's an explanation of what is available and what is missing, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| (Specific performance metrics, e.g., bursting pressure, catheter flexibility, marker band visibility, etc., are not detailed.) | (None specifically reported in this summary.) |
Explanation: The summary explicitly states: "The Atlas™ PTA Balloon Dilatation Catheter 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 list what those specific acceptance criteria were or present the data from tests that demonstrate the device met them.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Explanation: This 510(k) refers to "design verification and validation" but does not detail the specific test sets, their sizes, or the nature of experiments conducted (e.g., in vitro, in vivo, clinical trials).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable/Not provided.
- Qualifications of Experts: Not applicable/Not provided.
Explanation: No information is given about expert involvement in establishing ground truth for any test data, as no specific test data or ground truth methodology is discussed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/Not provided.
Explanation: Since no detailed test set or ground truth establishment is described, neither is an adjudication method.
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:
- MRMC Study: No.
- Effect Size: Not applicable.
Explanation: This is a 510(k) for a medical device (balloon catheter), not an AI-powered diagnostic tool. MRMC studies and AI assistance metrics are not relevant to this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No.
Explanation: This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable/Not provided.
Explanation: As no specific data or evaluation of diagnostic accuracy is discussed, the concept of "ground truth" as typically used for AI or diagnostic imaging devices is not relevant here. The "ground truth" for a physical device might relate to engineering specifications and performance, but these are not detailed.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable/Not provided.
Explanation: This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: Not applicable/Not provided.
Explanation: As above, this is not an AI/ML device, so no training set and its ground truth establishment are relevant.
Summary of what the document does provide:
- Device Name: Atlas™ PTA Balloon Dilatation Catheter
- Submitter: Bard Peripheral Vascular, Inc.
- Predicate Device: Atlas™ PTA Balloon Dilatation Catheter (K040243)
- Change: Additional balloon sizes.
- Intended Use: Percutaneous Transluminal Angioplasty (PTA) of the iliac arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for coronary arteries.
- Conclusion: The device met all predetermined acceptance criteria for design verification and validation, establishing substantial equivalence to the predicate device.
To get the specific acceptance criteria and detailed study data, one would typically need to refer to the full design verification and validation documentation which is referenced but not included in this 510(k) summary.
§ 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).