(23 days)
The Atlantis SR Pro² 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.
The catheters included in the Atlantis™ family of intravascular ultrasound coronary imaging catheters (i.e., SR, SR Plus, SR Pro, and SR Pro') are designed to be used with the Clearview® Ultra with High Frequency (HF) option, Galaxy™ or Galaxy™ 2 intravascular ultrasound imaging instruments. These catheters are comprised of two main assemblies: Imaging core and Catheter body. The catheter body is comprised of three sections: Distal lumen, Proximal lumen, and Telescoping section. The imaging core is composed of a hi-torque, flexible, rotating drive shaft with a radially-looking 40 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) which is in turn connected to the imaging system (e.g., Galaxy™ system). The MDU-Catheter interface consists of an integrated mechanical drive hub and an electrical connection. The catheter body has a distal guidewire lumen with proximal exit port at approximately 1.5 cm from the distal end. The catheter body is attached to the telescope section via a male/female luer connection. A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, an insertion depth indicator is located on the catheter body at 105 cm, corresponding to femoral insertions. Within the catheter body, the distal lumen and proximal lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the quiding catheter. The telescoping section allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the wire exit port, to the proximal end of the distal lumen. A flush port with a one-way valve is used to displace air near the transducer. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The oneway valve helps retain saline in the catheter during use. The Atlantis SR Pro2 catheter modifications are being implemented to improve performance and functionality of the catheter. The Atlantis™ SR Pro2 catheter is the same as the Atlantis™ SR Plus catheter, except for the following changes: Inclusion of a hydrophilic coating (Bioslide™) to the distal 230mm portion of the catheter sheath. The purpose of the hydrophilic-coating is to improve catheter lubricity, thus reducing catheter frictional resistance during introduction into the coronary vessel. A change is made to switch from Dymax adhesive 1-20271-G to Dymax adhesive 191 M-T in the Female Telescope assembly.
The provided text describes specific modifications to an existing device (BSS Atlantis™ SR Plus Coronary Imaging Catheter) to create the BSS Atlantis™ SR Pro2 Coronary Imaging Catheter. The submission primarily focuses on demonstrating substantial equivalence to its predicate device rather than presenting a de novo study with new acceptance criteria and performance data for a novel device.
Therefore, the information regarding acceptance criteria and a study to prove performance is framed within the context of verification testing for modifications to an already cleared device, aiming to show that the changes do not adversely affect safety or effectiveness and that the modified device meets the established performance requirements of the predicate device.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of specific acceptance criteria with numerical targets and corresponding performance values for the Atlantis™ SR Pro2 Coronary Imaging Catheter. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical Integrity and Functionality | "The results demonstrated that the device satisfies all performance, physical, and functional requirements." This included dimensional testing, sheath bond tensile testing, and various functional and performance testing of the sheath assembly, the telescope assembly, and the final sterile device. |
Specifically for the Dymax adhesive change: "The bond strength met the acceptance criteria" during verification testing. |
| Biocompatibility | "The results of the biocompatibility testing demonstrate that the catheter is acceptable for its intended use." This was assessed against ISO 10993 standards and included bioburden, endotoxin, sterility assurance, and latex testing. |
| Acoustic Output | "Acoustic Output testing was not required... as the addition of hydrophilic coating to the distal sheath of the catheter will not change the Acoustic Output measurement of the transducer, thus undetectable to the performance of the catheter." The device was deemed "unchanged from its predicate device." A "rationale for not conducting Acoustic Output testing" and an "Acoustic Output equivalency comparison" were provided (though not detailed in the summary). |
| Material/Manufacturing Variability (Adhesive) | "The bond strength met the acceptance criteria" for the new Dymax adhesive (191 M-T) in the female telescope assembly. |
| Improved Lubricity | The hydrophilic coating was added "to improve catheter lubricity, thus reducing catheter frictional resistance during introduction into the coronary vessel." While the benefit is stated, a specific quantitative acceptance criterion or performance measure for this improvement is not detailed in the summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the bench or biological testing. The provenance of the data is not mentioned (e.g., country of origin, retrospective/prospective), but it is implied to be internal testing conducted by Boston Scientific/Scimed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not relevant or provided in the context of this 510(k) submission. The testing described (bench and biological) does not involve human interpretation or expert ground truth in the way a diagnostic imaging study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., image interpretation), which is not the nature of the testing described for this device modification.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a premarket notification for a medical device (intravascular imaging catheter). It is not an AI-assisted diagnostic device, and no MRMC study was conducted or is relevant to the type of testing described in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an imaging catheter, not an AI algorithm. Its performance is related to its physical and functional capabilities, and its ability to generate images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The testing described uses engineering specifications and laboratory standards as "ground truth." For example:
- Bench Testing: Engineering specifications and performance requirements for physical integrity (e.g., bond strength, dimensions, functional operation).
- Biocompatibility Testing: ISO 10993 standards.
- Acoustic Output: Established measurements from the predicate device and FDA guidance.
8. The sample size for the training set
Not applicable. This involves physical device testing, not training of an algorithm or AI model.
9. How the ground truth for the training set was established
Not applicable. This involves physical device testing, not training of an algorithm or AI model.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).