(126 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. 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 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).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Steerable Guide Catheter, structured according to your request:
Acceptance Criteria and Study for the Steerable Guide Catheter (K083793)
This 510(k) summary describes a traditional device submission. For such medical devices, "acceptance criteria" typically refer to the successful completion of a series of performance tests against pre-defined specifications rather than algorithmic performance metrics found in AI/ML submissions. Similarly, the "study" is a set of bench tests confirming the device's physical and functional properties. Since this is a physical medical device and not an AI/ML algorithm, many of the requested fields are not applicable (N/A) or have interpretations in the context of device engineering rather than software performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Steerable Guide Torque | Met specifications | Detailed specifications are not provided in this summary, but the device passed. |
| Bending Range | Met specifications | Detailed specifications are not provided in this summary, but the device passed. | |
| Leakage Testing | Met specifications | Detailed specifications are not provided in this summary, but the device passed. | |
| Biocompatibility | Biocompatibility Studies | Met specifications | Implies that the materials are suitable for contact with the body. |
| Sterilization | Sterilization Validation | Met specifications | Confirms the device can be consistently sterilized. |
| Dimensional/Physical | Dimensional Characteristics | Substantially Equivalent | Compared to predicate devices. |
| Physical Characteristics | Substantially Equivalent | Compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of devices tested for each bench test (torque, bending, leakage, etc.). However, for mechanical performance testing of physical devices, multiple units are typically tested to establish statistical confidence in meeting design specifications.
- Data Provenance: The testing was conducted by the manufacturer, Evalve, Inc., in the United States (Menlo Park, CA). The study is prospective in the sense that the tests were designed and executed to validate the performance of the newly manufactured device according to its design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of device submission. For a steerable guide catheter, "ground truth" is established by engineering specifications and objective measurements (e.g., measuring torque values, bending angles, or leakage rates against defined thresholds) rather than expert consensus on medical images or clinical outcomes. The "experts" involved would be the design engineers, quality assurance personnel, and test technicians who developed and executed the test protocols.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists, pathologists) when establishing a ground truth for diagnostic studies. For mechanical and performance bench testing of a physical device, results are typically objective measurements against predefined acceptance criteria, and any discrepancies would be resolved through re-testing or investigation into the testing methodology or device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging systems or AI algorithms where human reader performance is being evaluated, often with and without AI assistance. The Steerable Guide Catheter is a physical instrument, and its performance is assessed via bench testing, not human interpretation of data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Steerable Guide Catheter is a physical medical device, not an algorithm. Its performance is inherent in its physical properties and mechanical function, which were tested in a "standalone" fashion (i.e., the device itself was subjected to tests).
7. The Type of Ground Truth Used
The "ground truth" for this device is based on engineering specifications and objective physical measurements. For example:
- Torque: Measured in units like N·cm, with acceptance based on a defined range.
- Bending Range: Measured in degrees or specific angles, with acceptance based on the ability to achieve a certain steerability.
- Leakage: Measured by observing fluid passage under pressure, with acceptance based on the absence of leakage.
- Biocompatibility: Confirmed through established biological safety tests (e.g., ISO 10993 series) which have defined pass/fail criteria.
- Sterilization: Validated through standard microbiological methods (e.g., ISO 11137 for radiation sterilization) with defined sterility assurance levels (SAL).
This "ground truth" is not derived from expert consensus, pathology, or outcomes data in the medical sense, but rather from scientific and engineering principles applied to device design and manufacturing.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process are informed by engineering principles, material science, and prior device knowledge, but not by a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this physical medical device. The "ground truth" for its design and performance specifications would be established through:
- Engineering design requirements: Based on the intended use and predicate device characteristics.
- Regulatory standards: Adhering to relevant ISO standards for medical devices, biocompatibility, and sterilization.
- Pre-clinical testing: Early prototypes undergoing various tests to optimize design.
The overall submission demonstrates that the device's design, dimensional and physical characteristics met predetermined specifications and are substantially equivalent to existing predicate devices based on the bench testing performed.
§ 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).