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510(k) Data Aggregation
(78 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Bench Testing | Physical integrity and functionality (dimensional and functional verification) | "Met or exceeded all required specifications." |
| Acoustic Output | Acoustic output within FDA guidance document limits (FDA Track 1 specified limits) | "Test results are below the FDA Track 1 specified limits." |
| Animal Testing | In-vivo deliverability and imaging characteristics demonstrating clinical acceptability for intended use | "Demonstrated clinical acceptability for the intended use." |
| Biocompatibility | Acceptable for intended use per ISO-10993 and G95-1 | "Test results demonstrate the device is acceptable for its intended use." |
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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(39 days)
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
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Non-Clinical Testing: | |
| Bench Performance | Met or exceeded performance requirements |
| Biocompatibility | Met or exceeded performance requirements |
| Sterility | Met or exceeded performance requirements |
| Substantial Equivalence: | |
| Intended Use | Similar to predicate device |
| Fundamental Technology | Similar to predicate device |
| Operating Principle | Similar to predicate device |
| Catheter Design | Similar to predicate device |
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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(43 days)
IVUS Plus is a digital image processing accessory to Boston Scientific's intravascular ultrasound imaging systems, ClearView (K891386) and Insight (K921750). It adds fulllength longitudinal digital display capability, full image rotation capability, and mensuration functions. It is indicated for use in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy
The provided document is a 510(k) summary and FDA clearance letter for a device called "IVUS Plus." This device is described as a digital image processing accessory for intravascular ultrasound imaging systems, adding features like full-length longitudinal digital display, image rotation, and mensuration functions.
However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or performance metrics. The FDA clearance is based on substantial equivalence to predicate devices, meaning it has a similar intended use, design, and operational characteristics to previously approved devices, not necessarily a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The provided document is a regulatory approval, not a scientific study report.
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