ATLANTIS PV IMAGING CATHETER, MODEL 36456

• K Number: K022860
• Device Name: ATLANTIS PV IMAGING CATHETER, MODEL 36456
• Manufacturer: BOSTON SCIENTIFIC, TARGET
• Date Cleared: 2002-11-21 ( 85 days)
• Product Code: ITX
• Regulation Number: 892.1570
• Type: Special
• Panel: RA
• Reference & Predicate Devices: K890772 , K970049

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.