(30 days)
The Evalve Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
The Steerable Guide Catheter consists of a Steerable Guide (Guide) and a Dilator provided EO sterile and for single-use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, a Dilator with a single central lumen and an atraumatic distal tip. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.
The provided text describes a 510(k) premarket notification for a medical device called the "Evalve Steerable Guide Catheter." This submission focuses on demonstrating substantial equivalence to predicate devices primarily through bench testing of performance characteristics and biocompatibility.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance |
|---|---|
| 1. Functional Testing | Met performance specifications |
| 2. Luer to Hemostasis Valve Housing Torque Strength | Met performance specifications |
| 3. Handle Interface Hypotube (Distal) to Shaft Tensile Strength | Met performance specifications |
| 4. Handle Interface Hypotube (Proximal) and Hemostasis Valve Housing to Shaft Tensile Strength | Met performance specifications |
| 5. Force to Curve (75°±5°) | Met performance specifications |
| 6. Force to Curve (Hard Stop) | Met performance specifications |
| 7. Packaging Inspection | Met performance specifications |
| 8. Bubble Emission | Met performance specifications |
| 9. Seal Strength | Met performance specifications |
| 10. Biocompatibility testing: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity: Systemic Injection, Acute Systemic Toxicity: Material Mediate Pyrogen, Hemocompatibility: Hemolysis, Hemocompatibility, Coagulation: Partial Thrombolplastin Time (PTT), Hemocompatibility, Complement Activation:C3a and SC5b-9. | Met performance specifications for all listed biocompatibility tests. |
Study Details
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Sample size used for the test set and the data provenance:
The document does not specify the sample sizes for the functional, mechanical, packaging, or biocompatibility tests. It only states that "Bench testing demonstrated that the subject device met performance specifications." The data provenance is not explicitly mentioned as being from a specific country, but the submission is to the U.S. FDA, and the manufacturer is based in Menlo Park, CA, USA, implying the testing likely occurred in or for a U.S. context. All testing described is retrospective (bench testing of manufactured devices) rather than prospective clinical data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the described study is bench testing of a physical device, not related to expert evaluation of medical images or patient data. Ground truth for these tests would be objective measurements against predefined engineering specifications. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable as there is no human interpretation or adjudication involved in the objective bench tests described. -
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:
No MRMC study was performed. This submission is for a physical medical device (a catheter) and does not involve AI or human readers for diagnostic interpretation. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission is for a physical medical device and does not involve an algorithm or AI. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the ground truth would be pre-defined engineering specifications, material standards, and industry-accepted testing methodologies for device performance (e.g., tensile strength values, force to bend within a certain range, biochemical test results). -
The sample size for the training set:
Not applicable. This submission is for a physical medical device and does not involve an AI algorithm with a training set. -
How the ground truth for the training set was established:
Not applicable. As there is no AI algorithm, there is no training set or ground truth for a training set.
In summary, the provided document describes a 510(k) submission for a steerable guide catheter, demonstrating substantial equivalence to predicate devices through a series of bench tests. The "study" is a compilation of these bench tests, which objectively evaluate the physical and functional properties of the device against engineering specifications and biocompatibility requirements. It does not involve clinical trials, human subject data, or AI components.
§ 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).