(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.
§ 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.