(30 days)
The Hansen Medical Artisan Extend Control Catheter is intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx ™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.
The Artisan Extend Control Catheter is intended to be used with the Hansen Medical Sensei® X Robotic Catheter System.
The Hansen Medical Artisan Extend Control Catheter is designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The Artisan Extend Control Catheter consists of a Steerable Guide Catheter (SGC) and Sheath. The Control Catheter is designed to be used with the Hansen Medical Sensei® X Robotic Catheter System.
The Hansen Medical Artisan Extend Control Catheter is a Class II steerable guide catheter, a modification of an existing device (K073225). The device is intended to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart, specifically with the Hansen Medical Sensei® X Robotic Catheter System and certain Boston Scientific and St. Jude Medical catheters.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "All of the pre-determined acceptance criteria were met with passing results." However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it lists the types of tests performed.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Tests | Device performs as intended, no leaks, proper flush, adequate tensile strength, compatibility with Sensei X. | Met all pre-determined criteria and passed. |
| Pressure Leak Test | (Presumably no leaks or within acceptable leak rate) | Passed |
| Vacuum Test | (Presumably no failure under vacuum) | Passed |
| Tensile Strength Test | (Presumably maintains structural integrity under specified load) | Passed |
| Flush Test | (Presumably allows proper flushing) | Passed |
| Compatibility with Sensei X Test | (Presumably proper integration and function with the robotic system) | Passed |
| Biocompatibility Tests | No adverse biological reactions beyond accepted levels | Met all pre-determined criteria and passed. |
| ISO MEM Elution Cytotoxicity Test | (Presumably non-cytotoxic) | Passed |
| ISO Kligman Maximization Test | (Presumably non-sensitizing) | Passed |
| ISO Intracutaneous Reactivity Study | (Presumably non-irritating) | Passed |
| ISO Acute Systemic Toxicity Study | (Presumably non-toxic systemically) | Passed |
| ASTM Hemolysis | (Presumably acceptable levels of hemolysis) | Passed |
| ISO Thrombogenicity Study | (Presumably low thrombogenic potential) | Passed |
| ISO Complement Activation Assay | (Presumably low complement activation) | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the performance and biocompatibility tests. It only states that design verification testing was performed.
Regarding data provenance: The tests were conducted by the manufacturer, Hansen Medical, Inc., as part of a 510(k) submission to the FDA. This indicates the data is from an internal testing environment rather than a clinical setting. Given the nature of these engineering and biocompatibility tests, they are inherently prospective for the device being evaluated. There is no information regarding the country of origin of the data beyond the manufacturer's location in Mountain View, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of testing performed. The "ground truth" for these engineering and biocompatibility tests is established by industry standards (e.g., ISO, ASTM) and internal design specifications, not by expert consensus on clinical findings. For example, a leak test has an objective pass/fail criterion based on measurable parameters, not on an expert's interpretation.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective human interpretation of data, typically in clinical evaluations or image analysis. The tests described are objective, pass/fail engineering and laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical evaluation was not required for this device." This device is a modification of a previously cleared predicate device, and the changes (simplified proximal flush assembly) were determined not to affect the intended use or fundamental scientific technology, precluding the need for clinical studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable here. This is a medical device (a catheter), not a software algorithm or AI model. The performance is assessed through physical and biological testing, not through standalone algorithm evaluation.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on:
- Industry Standards: Many tests refer to ISO (International Organization for Standardization) and ASTM (American Society for Testing and Materials) standards, which define methodologies and acceptable ranges for performance and biocompatibility.
- Manufacturer Design Specifications: The "pre-determined acceptance criteria" would have been set by Hansen Medical based on the functional requirements of the device and comparison to the predicate device.
- Objective Measurement: For tests like Pressure Leak, Vacuum, and Tensile Strength, the ground truth is based on measurable physical properties and compliance with a defined range or threshold.
8. The Sample Size for the Training Set
This is not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a physical medical device.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for a physical medical device.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).