Search Results

The 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 Guide and a Dilator provided EtO 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, an atraumatic distal tip, and a Dilator with a single central lumen. 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 a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.

The subject 510(k) pertains to a design change to the Steerable Guide Catheter. The proposed change to the Steerable Guide Catheter consists of a design and processing modification to the internal feature of the tip ring component at the distal tip.

This document describes K172394, the Steerable Guide Catheter, which is a design modification to an existing device. The performance data section is brief, focusing on a single test.

Here’s a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the tensile strength evaluation or the process validation. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided in the document. The study involved physical testing of a medical device, not interpretation of data by human experts to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. The study involved physical testing of a medical device, not expert adjudication.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a physical performance test (tensile strength and process validation) of a medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a physical catheter, not an algorithm or AI system. The performance testing was of the physical device itself.

7. The Type of Ground Truth Used

For the tensile strength evaluation, the "ground truth" would be the measured tensile strength values compared against predetermined engineering specifications (though these specifications are not explicitly stated in the provided text). For process validation, the "ground truth" would be consistent manufacturing output that meets specified performance metrics.

8. The Sample Size for the Training Set

This is not applicable, as there is no "training set" for physical device testing in the context of an algorithm or AI.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no "training set."

Ask a specific question about this device

The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO 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, an atraumatic distal tip, and a Dilator with a single central lumen. 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 a tray enclosed in a sealed Tyvek pouch and boxed in a cardboard shelf-carton.

This document is a 510(k) premarket notification for a medical device called the "Steerable Guide Catheter." It aims to demonstrate substantial equivalence to previously marketed predicate devices. The information provided heavily focuses on regulatory compliance and comparison to predicates rather than detailed performance study results of the new device against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria and study data are not explicitly stated in the provided text. The document asserts that the new device "meets the same performance specifications as the predicate device" due to "equivalent in fundamental scientific design," but it doesn't present the acceptance criteria or a dedicated study for the new device as an individual entity.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific performance acceptance criteria for the new Steerable Guide Catheter (K161985) are not explicitly defined, nor are detailed quantitative performance results reported. The document states that the new device "meets the same performance specifications as the predicate device." This implies an equivalence rather than a separate set of criteria and direct test results for K161985.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set or data provenance for a performance study of the new Steerable Guide Catheter (K161985). It makes a claim of equivalence to predicates without detailing newly generated test data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The document does not describe a study involving expert assessment of generated data for the new device's performance.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a study that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to the provided text. The submission focuses on substantial equivalence to predicate devices, not on comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical instrument (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not explicitly stated in the context of performance testing for the new device. The submission relies on "technological characteristics such as design, material, and indications for use" being substantially equivalent to predicates. The "ground truth" for the submission is the regulatory acceptance of the predicate devices based on their established performance and safety profiles.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for a physical medical device.

Ask a specific question about this device

The 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 Catheter (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, an atraumatic distal tip, and a Dilator with a single central lumen. 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 a tray enclosed in two sealed Tyvek pouches, and boxed in a cardboard shelf-carton.

The provided text does not contain information about acceptance criteria or a study proving that an AI-based device meets these criteria. Instead, it is a 510(k) summary for a Steerable Guide Catheter, a physical medical device, and its associated FDA clearance letter.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these concepts are not applicable to the clearance of this type of physical device as presented in the document.

The document discusses bench testing for the physical device to demonstrate substantial equivalence to predicate devices, focusing on various performance characteristics related to the catheter's physical integrity and function (e.g., Guide Hemostasis, Tensile test, Torque test).

Ask a specific question about this device

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

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.

Ask a specific question about this device