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The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The Atlantis™ PV imaging catheter (H749364560) is a sterile, single use, over-the-wire (OTW) imaging catheter with a 8F distal crossing profile and a transducer capable of producing a frequency of 15MHz and a 8F distal crossing profile. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound Imaging Systems: iLab™ (K072517), Galaxy2/Galaxy™ (K980851), and Clearview™ Ultra (K921750). The Atlantis™ PV catheter consists of two main assemblies: Catheter body and Imaging Core. The catheter body is comprised of two sections: Dual lumen and Telescoping section (shaft). The dual lumen section is the "working length" of the catheter. The dual lumen is an over-the-wire (OTW) design containing an imaging core lumen and a guidewire lumen. The telescoping section remains outside of the introducer sheath. The telescoping shaft allows the imaging core to be advanced and retracted for 25 cm of linear movement. The corresponding movement of the transducer occurs inside the imaging core lumen. The catheter body is attached to the telescope shaft via a y-manifold with male/female luer connection. The straight leg of the y-manifold is the guidewire exit port with a female luer thread. The luer thread allows flushing of the guidewire lumen. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking ultrasonic transducer at the distal tip. The distal ends of the imaging core and the catheter body are radiopaque for visualization of the imaging plane and the catheter tip. An electro-mechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) / Instrument. The MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection.

This 510(k) premarket notification for the Boston Scientific Atlantis™ PV Imaging Catheter (K080272) is a submission for a modified device, referencing a previously cleared predicate device (Atlantis™ PV Imaging Catheter, K050684). As such, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than presenting new clinical study data to establish performance against acceptance criteria for a novel device.

Therefore, many of the requested sections regarding acceptance criteria and a dedicated study to prove these are not applicable or cannot be extracted directly from this document. The document confirms that the device meets performance requirements through non-clinical testing for bench, biocompatibility, and sterility, implying that the acceptance criteria are related to these technical and safety aspects, which are deemed consistent with the predicate device.

Here's the information that can be extracted or reasonably inferred based on the provided text, with explanations for the unavailable sections:

Acceptance Criteria and Device Performance Study for K080272

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "The performance test results for bench, biocompatibility and sterility testing of the Atlantis™ PV Imaging Catheter demonstrate that the device meets or exceeds the performance requirements for the specified intended use." It does not provide specific quantitative acceptance criteria or detailed numerical results for these tests. The primary acceptance criterion for this 510(k) is demonstrating substantial equivalence to the predicate device, K050684, for "performance requirements."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The submission references "non-clinical test results" for bench, biocompatibility, and sterility, but it does not specify sample sizes for these tests or the origin of any data (e.g., retrospective or prospective, country of origin), as these are typically part of detailed test reports that are not included in the summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable/not provided because this submission primarily relies on non-clinical testing and substantial equivalence to a predicate device. There is no mention of a clinical "test set" requiring expert ground truth establishment in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the same reasons as in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. The Atlantis™ PV Imaging Catheter is an intravascular ultrasound catheter, a diagnostic imaging device which (based on this document) does not incorporate Artificial Intelligence (AI) to assist human readers. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. This device is a hardware imaging catheter, not an algorithm. Standalone algorithm performance studies are not relevant here.

7. The Type of Ground Truth Used

This information is not applicable/not provided in the context of clinical performance data for this 510(k) submission. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards and methods for assessing bench performance, biocompatibility, and sterility, rather than expert consensus, pathology, or outcomes data typically associated with clinical studies of diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is an imaging catheter and not an AI/machine learning algorithm, so there is no concept of a "training set" in this submission.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/not provided for the same reason as in point 8.

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The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Not Found

This document is a 510(k) clearance letter from the FDA for the Atlantis™ PV Imaging Catheter and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than performance data.

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The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Atlantis PV Imaging Catheter" and focuses on regulatory approval based on substantial equivalence to a predicate device. It does not include details on acceptance criteria, a specific study proving device performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device as outlined in your prompt.

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The Atlantis TM PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The Atlantis™ PV Imaging Catheter consists of two main assemblies: an over-the-wire (OTW) exchange style sheath assembly and an imaging core assembly. The sheath is comprised of the following three sections: Radiopaque soft tip, Proximal dual lumen, and Telescoping section. The imaging core is composed of a hi-torque flexible, rotating drive cable with a radially looking 15 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the MotorDrive Unit (MDU) / Instrument. A flush port with a one-way valve is used to displace air near the transducer. The catheter is for use with the BSS ClearView Ultra™ and Galaxy™ IVUS Imaging Systems.

The Boston Scientific Scimed (BSS) Atlantis™ PV Imaging Catheter is an intravascular ultrasound imaging catheter. The provided submission describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against pre-defined acceptance criteria with human subjects or expert readers.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) found in a clinical study for a new diagnostic or AI device. Instead, it details various non-clinical tests performed to demonstrate the device's safety and efficacy for its intended use and its substantial equivalence to predicate devices. The "performance" reported is that the device met the requirements of these tests.

| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bench Testing | Ensure physical integrity, functionality, and performance of the catheter components (sheath, telescoping assembly, imaging core assembly) and the final sterile device, consistent with its design and intended use. | Testing included dimensional testing, sheath bond tensile testing, and various functional performance tests. This testing demonstrated the physical integrity and functionality of the catheter. |
| Acoustic Output Testing | Acoustic output levels must be below the FDA Track 1 limits as described in the FDA Guidance, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Sept. 30, 1997)." | Acoustic output test results for the Atlantis™ PV imaging catheter are below the FDA Track 1 limits. |
| Animal Testing | In-vivo functional and imaging characteristics must be assessed and found consistent with the intended clinical use of the device. | The performance of the Atlantis™ PV imaging Catheter was consistent with the intended clinical use of the device. |
| Biological Safety Testing | Satisfy biocompatibility requirements per ISO 10993, and meet bioburden, endotoxin, and sterility assurance testing standards. | The Atlantis™ PV Imaging Catheter was subjected to and passed a series of biocompatibility tests per ISO 10993, bioburden, endotoxin, and sterility assurance testing. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it describes non-clinical testing rather than a patient-based test set with specific data samples.
• Data Provenance: The document does not specify the country of origin for the animal study. The other tests are bench tests performed within the manufacturer's testing environment. All testing appears to be "retrospective" in the sense that it's performed on manufactured devices/components for regulatory submission, rather than prospective clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The ground truth for these non-clinical tests is established by engineering specifications, regulatory standards (like FDA guidance for acoustic output, ISO 10993 for biocompatibility), and observed physical/biological responses in animal models. No human experts are explicitly mentioned as establishing a "ground truth" for interpretation in the same way they would for reading images.
• Qualifications of Experts: N/A as per the above.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The testing described does not involve human interpretation or subjective assessment that would require an adjudication method. The outcome of these tests is determined by objective measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on hardware safety and performance in a non-clinical setting, not on the diagnostic accuracy with human readers.
• Effect Size of Human Readers Improve with AI vs without AI: Not applicable, as no MRMC study or AI component is described.

6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was Done

• Standalone Study: Not applicable. This device is an imaging catheter; it does not contain an AI algorithm that would have a standalone performance. The "performance" described is the functionality of the physical device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the verifiable correctness or compliance with established standards for device performance and safety:

• Bench Testing: Engineering specifications, design tolerances, and functional requirements.
• Acoustic Output Testing: FDA Guidance values (FDA Track 1 limits).
• Animal Testing: Physiological and imaging observations in an animal model, judged against expected normal and pathological states to determine the device's functional and imaging characteristics, consistent with its intended use.
• Biological Safety Testing: ISO 10993 standards and recognized methods for bioburden, endotoxin, and sterility assurance.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a medical device (catheter) and its non-clinical testing, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm described in this submission.

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