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The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 Mini Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The EnPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable.

The provided document describes the development and testing of the GALAXY G3 Mini Microcoil Delivery System. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document reports several performance tests, and for each, the result is "PASS: Samples passed the established acceptance criterion." The specific numerical acceptance criteria are generally not explicitly stated, but the passing result indicates they were met.

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

The document does not explicitly state the exact sample sizes used for each individual performance test (test sets). It generally refers to "samples" being tested.

The data provenance is bench testing, which implies the data was collected within a laboratory setting, likely in the US, given the submission to the FDA. It is retrospective in the sense that it's testing a finished device against predetermined criteria.

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

No individual experts or their qualifications are mentioned for establishing ground truth for the bench tests. The "ground truth" for these tests is based on established engineering specifications, industry standards (e.g., USP788, ISO standards), and clinical relevance/simulated use scenarios. For the "Overall Coil Performance" test, "physician's satisfaction rating" was evaluated, implying input from medical professionals, but the number and qualifications are not specified.

4. Adjudication Method for the Test Set

Not applicable for the reported tests. The tests are primarily objective measurements against established criteria, or visual inspections by qualified personnel (not specified as "experts" in the context of adjudication).

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: "A clinical study was not required as appropriate verification and validation of the GALAXY G3 Mini Microcoil Delivery System was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (microcoil delivery system), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. The performance tests are for the physical device itself.

7. The Type of Ground Truth Used

The ground truth for the bench tests is based on:

• Engineering specifications and design requirements: For dimensional checks, material properties, and functional performance (e.g., spring constant, detachment force, tensile strength).
• Industry standards: Such as USP788 for particulate matter, ISO 11607 for packaging, ISO 10993-1 for biocompatibility, and ISO 11135-1 for sterilization.
• Simulated use in clinically relevant models: For tests like track force, coil durability, detachment durability, resheathing reliability, fluoro saver marker durability, and distal outer sheath durability.
• Physician satisfaction rating: For "Overall Coil Performance" compared to a predicate device, which implies a subjective expert assessment.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set." The listed studies are verification and validation tests for the device itself.

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

Not applicable, as there is no training set for this device.

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The YOGA Microcatheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.

The YOGA Microcatheter is a variable stiffness, end to end braided single lumen catheter designed to access small, tortuous vasculature. The microcatheter has an outer hydrophilic coating that provides lubricity during navigation of vessels. The lubricious PTFE lined inner lumen is designed to facilitate movement of guide wires and other devices. A radiopaque marker band is provided at the catheter tip to aid fluoroscopic visualization. A luer fitting located on the proximal end of the catheter hub is used to attach accessories. A steam shaping mandrel is provided in the package.

The provided document describes the substantial equivalence determination for the YOGA Microcatheter (K162563) based on its comparison to a predicate device, the ENVOY DA Guiding Catheter (K140080), and other reference devices. The focus of the provided text is on demonstrating the device's functional integrity and biological compatibility through various performance tests, rather than clinical efficacy as would be seen with an AI/ML device.

Here's an analysis of the "acceptance criteria and the study that proves the device meets the acceptance criteria" based on the provided text, structured to address your specific points:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the YOGA Microcatheter are implicitly defined by the "PASS" results for each of the performance tests listed. The device is deemed to meet these criteria if its performance matches or is equivalent to established standards or those of the predicate device.

Study Details

The provided document describes physical and biological performance testing for a medical device (microcatheter), not an AI/ML device. Therefore, many of your specific questions regarding AI/ML studies (like ground truth, experts, MRMC, standalone performance) are not applicable to this submission. However, I will answer the relevant points based on the provided text.

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document states that "All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures." However, specific sample sizes for each test are not provided in this document.
   • Data Provenance: The tests are "bench" (in vitro) and "animal" (in vivo) tests conducted by the manufacturer, Codman & Shurtleff, Inc. The document does not specify the country of origin for the animal studies, but the manufacturer is based in Raynham, Massachusetts, USA. The studies are prospective as they were conducted to support the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable as the document describes performance testing for a physical medical device, not an AI/ML algorithm requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests is based on established engineering and biological standards (e.g., ISO, ASTM, USP).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This is not applicable. Adjudication methods are typically relevant for human review of AI/ML outputs or clinical endpoints with subjective interpretation. For the physical and biological tests described, the determination of "PASS" or "FAIL" would be based on objective measurements against pre-defined acceptance criteria, not an adjudication process involving multiple human reviewers.

4. 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:

   • This is not applicable. This document describes the clearance of a physical medical device and does not involve AI or human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is not applicable. The device is a microcatheter, a physical instrument, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for the device's performance is based on established engineering standards, international standards (ISO, ASTM, USP), and validated internal design control procedures. For example, tensile strength is measured against engineering specifications, biocompatibility against ISO 10993 standards, and flow rates against ISO 10555-1. For radiopacity, the ground truth is the visual confirmation by a qualified individual (presumably a radiologist or veterinarian during the animal study) that the catheter is visible under fluoroscopy.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • This is not applicable. There is no "training set" for this physical device.

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The Phenom™ Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy.

This document is a 510(k) premarket notification for the Phenom™ Catheters. As such, it's a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving device meeting specific clinical acceptance criteria in the way a clinical trial would.

Therefore, many of the requested points related to a specific clinical study (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or directly derivable from this type of regulatory document.

However, I can extract information regarding the bench testing performed to establish substantial equivalence, which serves as the "study" in this context to prove the device meets certain performance characteristics relative to predicate devices.

Here's the breakdown based on the provided text, addressing the applicable points and explaining why some are not applicable:

Description of Acceptance Criteria and Substantiating Study

The Phenom™ Catheters are submitted as substantially equivalent to predicate devices, meaning their performance characteristics must be comparable to those existing devices and demonstrate no new safety or effectiveness concerns. The "acceptance criteria" are implicitly defined by the safety and performance standards established by the predicate devices and general regulatory requirements for this class of device. The "study" proving the device meets these criteria is a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various bench tests conducted to support the substantial equivalence. The "acceptance criteria" for these tests would typically be defined internally by the manufacturer to ensure the new device performs comparably to or within acceptable limits derived from the predicate devices. Since specific numerical acceptance criteria (e.g., "burst pressure > X bar") are not explicitly stated in this summary, the table will list the performance tests performed, implying that the acceptance was meeting the internal specifications aligned with the predicate performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This refers to the number of devices or components tested for each bench test. This information is not provided in this summary. Bench testing typically involves a statistically significant number of samples for each test, but the exact numbers are not detailed here.
• Data Provenance: The bench tests are laboratory-based, performed by the manufacturer (Cathera, Inc., Mountain View, CA). This is not human data, so "country of origin" or "retrospective/prospective" does not directly apply in the usual clinical sense. The worst case representation was chosen considering neurovascular anatomy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Bench testing for substantial equivalence does not involve establishing ground truth from human expert interpretation in the way clinical studies with AI algorithms do. Performance is measured against engineering specifications and comparisons to predicate device data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. See point 3.

5. 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

• Not applicable. This device is a catheter, not an AI diagnostic algorithm. Therefore, MRMC studies involving human readers and AI assistance are not relevant to its regulatory approval in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a catheter, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the bench tests are engineering specifications, material standards, and performance characteristics derived from predicate devices. For example, "burst pressure" has a defined threshold, and "biocompatibility" is assessed against ISO standards. The evaluation included performance in "more complex and higher risk neurovascular anatomy," implying simulated environments or models representing this.

8. The sample size for the training set

• Not applicable. As this is a physical medical device (catheter) undergoing bench testing for substantial equivalence, there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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