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This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

OptiCross™ is a short-rail 40 MHz IVUS imaging catheter. It is compatible with a 0.014" guidewire, and at a minimum, a 5F guide catheter (≥ 0.058"). OptiCross is intended for use with the BSC iLab™ imaging console (K072517) and Boston Scientific's next generation motor drive unit, MDU5 PLUS™. When used together, the catheter, motor drive unit (MDU), and iLab equipment form a complete imaging system that allows for ultrasonic examination of coronary intravascular pathology. The catheter consists of two main components: the catheter body and the imaging core. The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal guidewire lumen. The proximal shaft, distal shaft, and distal quidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter. The distal guidewire lumen (1.6 cm) is used to track the catheter along the guidewire and incorporates a radiopaque marker band (0.5 cm from the distal tip). The distal shaft serves as a flexible and acoustically transparent imaging window. The proximal shaft provides pushability to the distal imaging window and serves as a lumen to the imaging core. Two insertion markers are located on the proximal shaft (90 and 100 cm from the distal tip). These markers facilitate estimation of catheter position relative to the distal tip of the quide catheter. The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs from the proximal end of the quidewire lumen to the proximal end of the imaging window. The telescoping shaft includes 16 incremental markers for lesion length assessment (1 cm apart); the 5-cm. 10-cm, and 15-cm markers are distinct. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability (distal 23 cm). The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly (1) provides an electro-mechanical interface between the catheter and the motor drive unit and (2) incorporates a oneway check valve that is used to flush the interior of the catheter body. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The drive cable and PZT transducer rotate independently of the sheath assembly to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive in to transmittable acoustic energy. Reflected ultrasound signals are converted back to electrical impulses, returned to the motor drive unit, and are ultimately processed by the iLab equipment for visualization.

Acceptance Criteria and Device Performance Study for OptiCross™ Coronary Imaging Catheter

This device, the OptiCross™ Coronary Imaging Catheter, is a Class II diagnostic intravascular ultrasound catheter intended for the ultrasound examination of coronary intravascular pathology in patients undergoing transluminal coronary interventional procedures. Its substantial equivalence to the predicate device, iCross™ (K111043), was determined based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria with specific thresholds. Instead, it describes categories of performance evaluations that were performed and concludes that the device is "substantially equivalent to, and at least as safe and effective as the predicate device." The reported device performance is therefore presented as successful completion of these evaluations in comparison to the predicate.

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

The document describes non-clinical performance evaluations (bench testing, biological safety, acoustic output, packaging validation). It does not specify a "test set" in the context of patient data or image data. The "samples" used for these tests would be manufactured devices and packaging. The number of devices or units tested for each specific bench test is not provided.

• Sample Size: Not specified for individual bench, biological, acoustic, or packaging tests.
• Data Provenance: Not applicable in terms of country of origin for patient data, as this was a non-clinical study. The studies were conducted by the manufacturer, Boston Scientific Corporation, in support of their 510(k) submission. All data is implicitly retrospective to the submission date.

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

Not applicable. The study is a non-clinical performance evaluation of a physical device, not an AI/algorithm-based diagnostic tool requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical performance evaluation, not a study involving human interpretation or adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."

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

Not applicable. This device is an imaging catheter and not an algorithm or AI software for standalone performance evaluation.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Bench Testing: Ground truth was based on engineering specifications, physical measurements, and established performance parameters for intravascular ultrasound catheters.
• Biological Safety Testing: Ground truth was established by adherence to recognized international standards (ISO 10993-1) and regulatory requirements for biocompatibility, sterility, etc.
• Acoustic Output Testing: Ground truth was established by adherence to FDA guidance and limits for diagnostic ultrasound systems.
• Packaging Validation: Ground truth was established by adherence to recognized international standards (ISO 11607-1 and ISO 11607-2) for packaging integrity.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set with established ground truth.

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The Atlantis™ 018 Peripheral Imaging Catheter is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The Atlantis™ 018 Peripheral Imaging Catheter is a sterile, single patient use 40MHz transducer imaging catheter, intended for intravascular ultrasound examination of peripheral vessels. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound (IVUS) Systems: iLab™ (K072517), Galaxy2/Galaxy (K980851), and Clearview™M Ultra (K921750). The Atlantis™ 018 Peripheral Imaging Catheter consists of two main assemblies: Imaging core and Catheter body. The catheter body comprises three sections: Distal lumen, Proximal single lumen, and Telescoping section. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 40 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end makes the connection to the BSC IVUS System Motor Drive Unit (MDU).

The Atlantis™ 018 Peripheral Imaging Catheter is an intravascular ultrasound catheter intended for examination of peripheral vessels. The submission does not detail specific quantitative acceptance criteria with numerical targets. Instead, it relies on demonstrating that the device "meets or exceeds" performance requirements through various tests.

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

1. Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the bench, acoustic output, or animal testing.

• Bench Testing: "Bench testing was conducted to evaluate the physical integrity and functionality of the catheter sheath and imaging core." No specific sample size provided.
• Acoustic Output: "Acoustic output testing was conducted..." No specific sample size provided.
• Animal Testing: "The Atlantis™ 018 Peripheral Imaging Catheter was evaluated through animal testing..." No specific sample size provided.
• Data Provenance: The document does not specify the country of origin for any test data or whether it was retrospective or prospective. It implies these were studies specifically conducted for this submission (prospective, in-house testing).

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a "ground truth" in the context of human interpretation for diagnostic performance. The evaluation is focused on the physical device's performance through bench, acoustic, animal, and biocompatibility tests.

4. Adjudication Method

Not applicable, as this is a device performance evaluation, not a study involving human interpretation with a need for adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for an imaging catheter, not an AI software or a device that directly aids human readers in interpretation.

6. Standalone Performance Study

Yes, the studies described are essentially standalone performance evaluations of the device itself (bench, acoustic, animal, and biocompatibility testing). The "algorithm" here is the physical catheter's ability to produce images and operate safely and effectively.

7. Type of Ground Truth Used

The ground truth for the performance evaluations was based on:

• Bench Testing: Engineering specifications and design requirements (e.g., dimensional accuracy, functional performance).
• Acoustic Output: FDA guidance document limits for diagnostic ultrasound systems and transducers.
• Animal Testing: Clinical acceptability for deliverability and imaging characteristics, as assessed by the animal study.
• Biocompatibility: International Standard ISO-10993 and Blue Book Memo, G95-1.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a "training set." The device is a physical imaging catheter.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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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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