(27 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 and Dilator are packaged in two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.
The provided text describes a 510(k) submission for a medical device called the "Evalve Steerable Guide Catheter." This document primarily focuses on demonstrating "substantial equivalence" to predicate devices through bench testing. It does not describe an AI/ML-enabled device or a clinical study that proves the device meets specific performance criteria in a clinical setting with human readers.
Therefore, many of the requested elements are not applicable to the provided text.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format that would typically be found for an AI/ML device's performance. Instead, it refers to "performance specifications" being met through bench testing. The general acceptance criterion implied is "substantial equivalence" to predicate devices, meaning it performs as well or better.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets performance specifications for physical properties. | Bench testing demonstrated that the subject device met performance specifications. |
| Substantially equivalent to predicate devices (K083793 and K091596). | The subject device met performance specifications and is substantially equivalent to the predicate devices. |
| Performs as well as or better than predicate devices. | Performs as well or better than the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The study described is bench testing of a physical medical device, not an AI/ML algorithm evaluated on a data set. There is no "test set" in the context of image data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is not an AI/ML algorithm requiring expert-established ground truth on a test set.
4. Adjudication Method for the Test Set
Not applicable. No test set of data with ground truth requiring adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This document does not mention an MRMC study or any study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm. The device is a physical catheter.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by bench testing against predetermined engineering specifications and comparison to the performance of predicate devices. This involves physical measurements and observations of the catheter's properties (e.g., steerability, lumen patency, material integrity, etc.) rather than medical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML algorithm. There is no "training set" or corresponding ground truth.
Summary of the Study:
The "study" referenced in this document is a series of bench tests (laboratory testing) conducted on the physical "Evalve Steerable Guide Catheter." The purpose of these tests was to demonstrate that the device meets its own performance specifications and is "substantially equivalent" to two previously cleared predicate devices (K083793 and K091596). This approach is standard for 510(k) submissions of non-AI/ML medical devices where clinical efficacy studies may not be required if substantial equivalence to a legally marketed device can be shown through non-clinical means.
§ 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).