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510(k) Data Aggregation
(95 days)
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.
| Test | Test Method Summary | Reported Device Performance |
|---|---|---|
| Spring Constant | Measures the softness of the coil by recording the spring constant of the primary wind. | PASS: Samples passed the established acceptance criterion |
| Complex Shape | Visually inspects the complex shape of the G3 Mini Microcoils. | PASS: Samples passed the established acceptance criterion |
| Particulate | Measures particulate count during simulated use per USP788. | PASS: Samples passed the established acceptance criterion |
| Atraumatic Bead | Visually verifies that the bead end of the coil meets the final assembly specification. | PASS: Samples passed the established acceptance criterion |
| DPU 3 System Outer Diameter | Verifies the OD is within specification to ensure microcatheter compatibility. | PASS: Samples passed the established acceptance criterion |
| Microcatheter Tip Deflection Force | Measures the deflection and/or stability of the microcatheter by recording the force generated at the distal tip as the DPU device is advanced to the tip. | PASS: Samples passed the established acceptance criterion |
| Detachment Zone Tensile Strength | Evaluates the attachment strength of the detachment fiber to prevent unintentional coil detachments. | PASS: Samples passed the established acceptance criterion |
| Stretch Resistance Fiber Tensile Strength | Verifies that the coil provides sufficient stretch resistance under tensile loading to ensure the coil can be retracted and repositioned without stretching. | PASS: Samples passed the established acceptance criterion |
| Track Force (Delivery) | Evaluates the force it takes to deliver the device through a microcatheter and into a clinically relevant model; utilizing the system Catheter Performance Simulation System (CPSS). | PASS: Samples passed the established acceptance criterion |
| Dimensional Inspection of FDL Diameter and Coil Length | Verifies the FDL diameter and the coil length meets the specification. | PASS: Samples passed the established acceptance criterion |
| Coil OD Verification on Final Assembly | Verifies the OD is within specification. | PASS: Samples passed the established acceptance criterion |
| Dimensional Inspection of the Distal Fluro-saver markers | Verifies that the Fluoro Saver Markers are in the correct proximal position to give a visual indication that the microcoil is approaching the distal tip of the microcatheter. | PASS: Samples passed the established acceptance criterion |
| Coil Durability | Evaluates the coil's ability to stay attached to the device during simulated use of six insertions and withdrawals cycled into and out of a clinically relevant aneurysm model. | PASS: Samples passed the established acceptance criterion |
| Detachment, Coil Durability & Reliability | Evaluates the reliability of the detachment mechanism after being cycled into and then out of a clinically relevant anatomical model six times. | PASS: Samples passed the established acceptance criterion |
| Resheathing Reliability | Evaluates the ability to re-insert the device into the split sheath introducer after it has been unzipped after the device has been inserted and withdrawn from a clinically relevant model. | PASS: Samples passed the established acceptance criterion |
| Fluro saver Marker Durability | Evaluates the ability of the Fluoro Saver Markers to stay affixed and in the correct position on the shaft after being cycled into and then out of a clinically relevant anatomical model six times. | PASS: Samples passed the established acceptance criterion |
| Distal Outer Sheath Durability | Evaluates the durability of the distal outer sheath during the simulated use of six insertions and withdrawals of the device into and out of a clinically relevant aneurysm model. | PASS: Samples passed the established acceptance criterion |
| Dimensional Inspection of the Introducer | Introducer underwent dimensional inspection per approved test method. | PASS: Samples passed the established acceptance criterion |
| Introducer Bond Strength | Verifies that the bond strength of the introducer fuse joint. | PASS: Samples passed the established acceptance criterion |
| Coil Transfer to Microcatheter | Evaluates the introducer sheath for allowing for insertion of the embolic coil into the microcatheter through the RHV. | PASS: Samples passed the established acceptance criterion |
| Introducer Flushing | Visually inspects to confirm flushing. | PASS: Samples passed the established acceptance criterion |
| Radiopacity | Verifies the ability to visualize the coil under fluoroscopy for physician to determine the location of the coil during use. | PASS: Samples passed the established acceptance criterion |
| Overall Coil Performance | Evaluates physician's satisfaction rating on performance compared to a predicate device. | PASS: Samples passed the established acceptance criterion |
| MRI Testing | Demonstrates that GALAXY G3 MINI Microcoil to be "MR-conditional" according to the specific conditions used for the assessment. | PASS: Samples passed the established acceptance criterion |
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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(123 days)
MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT 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 may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical. 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 device in this submission includes design changes only to the Device Positioning Unit (DPU) element of the microcoil system. There are no modifications to the microcoil components or to the EnPOWER Detachment Control system.
This document describes the premarket notification (510(k)) for the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems. The submission focuses on design changes to the Device Positioning Unit (DPU) element of the microcoil system, emphasizing that there are no modifications to the microcoil components or the detachment control system.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established as "PASS," indicating that the samples met the predetermined criteria for each test. Specific quantitative criteria are not explicitly detailed in this summary.
| Test Category | Acceptance Criteria (Implicit from "PASS") | Reported Device Performance |
|---|---|---|
| Performance Verification | ||
| Microcatheter Stability | Samples passed established criterion | PASS |
| Coil Detachment Durability & Reliability | Samples passed established criterion | PASS |
| Coil Durability (Coil to DPU) | Samples passed established criterion | PASS |
| Distal Outer Sheath Durability | Samples passed established criterion | PASS |
| Track Force (Delivery) | Samples passed established criterion | PASS |
| Re-Sheathing Reliability | Samples passed established criterion | PASS |
| Fluoro Saver Marker Durability | Samples passed established criterion | PASS |
| Detachment Zone Tensile Strength | Samples passed established criterion | PASS |
| Dimensional Inspection of OD | OD within specification for compatibility | PASS |
| Dimensional Inspection of OAL | Appropriate length for compatibility | PASS |
| Dimensional Inspection of Length from Distal Tip to Radiopaque Marker Band | Appropriately placed marker band | PASS |
| Dimensional Inspection of Distal Fluoro Saver Markers | Correct proximal position | PASS |
| Detachment Zone Microcatheter Surface Temperature Comparison | Equivalent temperatures to predicate, no acute tissue inflammatory response | PASS (equivalent, no inflammation) |
| Biocompatibility Testing | ||
| In Vitro Cytotoxicity (Cut DPU3) | PASS | PASS |
| In Vitro Cytotoxicity (Uncut DPU3) | PASS | PASS |
| Guinea Pig Sensitization | PASS | PASS |
| Intracutaneous/Irritation Reactivity | PASS | PASS |
| Acute Systemic Toxicity | PASS | PASS |
| Material Mediated Pyrogenicity | PASS | PASS |
| Endotoxin | PASS | PASS |
| In Vitro Ames Bacterial Reverse Mutation Assay | PASS | PASS |
| In Vitro Mouse Lymphoma Mutagenicity Assay | PASS | PASS |
| In Vivo Mouse Peripheral Blood Micronucleus Assay | PASS | PASS |
| In Vitro Hemolysis | PASS | PASS |
| ASTM Partial Thromboplastin Time | PASS | PASS |
| C3a Complement Activation | PASS | PASS |
| SC5b-9 Complement Activation | PASS | PASS |
| In Vivo Thromboresistance in Dogs | PASS | PASS |
| USP Physicochemical Tests (Aqueous Extracts) | PASS | PASS |
| Determination of Extractable Metals By ICP-OES | PASS | PASS |
| Physicochemical Tests (Non-aqueous Extracts) | PASS | PASS |
| Sterilization Validation | Sterility Assurance Level (SAL) 10⁻⁶ | Achieved SAL 10⁻⁶ |
| Shelf-Life Testing | Will be conducted per FDA guidance | Not yet reported (will be conducted) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states that testing was conducted using "statistical sampling methods as required by the Codman & Shurtleff, Inc. Design Control procedures." However, specific numerical sample sizes for each test are not provided.
The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned. However, being a premarket notification to the U.S. FDA, it can be inferred that the testing was conducted to meet U.S. regulatory standards, likely in a controlled laboratory environment. The testing is bench testing and biocompatibility testing, not human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies described are bench tests and biocompatibility tests, not clinical studies involving human patients or expert interpretation of diagnostic images/data. The "ground truth" for these tests is defined by the technical specifications and performance requirements of the device, assessed through quantitative measurements and established protocols.
4. Adjudication Method for the Test Set
This information is not applicable for the bench and biocompatibility tests described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "A clinical study was not required as appropriate verification and validation of the modified Device Positioning Unit (DPU) was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing." Therefore, there is no effect size for human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device described is a physical medical device (microcoil delivery system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the performance verification testing, the ground truth is established by engineering specifications, direct physical measurements, and adherence to established industry standards and regulatory guidance documents (e.g., ISO, FDA Guidance Document: "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices").
For biocompatibility testing, the ground truth is defined by established international standards (ISO 10993 series) and USP (United States Pharmacopeia) guidelines for biological response within acceptable limits.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for a physical device.
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