Search Results
Found 33 results
510(k) Data Aggregation
(25 days)
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
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 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 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and 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.
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. 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).
For the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT microcoils: 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.
For the GALAXY G3 Mini microcoils: 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.
For all Microcoil Delivery Systems: 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, catalog no. DCB2000500, works with the ENPOWER Control Cable and with the standard connecting cable.
The provided text describes a 510(k) premarket notification for microcoil delivery systems, which are medical devices, not an AI/ML powered device. Therefore, a study proving an AI/ML device meets acceptance criteria is not presented in this document.
The document discusses non-clinical performance data for the microcoil delivery systems, specifically focusing on verification and validation testing of minor design modifications related to the Device Positioning Unit's core wire.
Here's the information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text, adapted for the context of a medical device rather than an AI/ML system:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria Summary | Reported Device Performance |
|---|---|---|
| Tracking Force (delivery) - Verification | Not explicitly stated, but "established acceptance criteria" implies a threshold. | Pass |
| Simulated Use: Tracking Force (delivery) - Validation | Not explicitly stated, but "established acceptance criteria" implies a threshold. | Pass |
| Simulated Use: Microcatheter Stability - Validation | Not explicitly stated, but "established acceptance criteria" implies a threshold. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Samples" in the results, but doesn't quantify the number of units tested for each criterion.
- Data Provenance: The tests were conducted internally as "bench testing." The country of origin is not specified, but the applicant, Medos International SARL, is located in Le Locle, Switzerland. The testing is retrospective, as it's part of a 510(k) submission for an already manufactured device with minor modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the study involved non-clinical bench testing of a physical medical device, not a diagnostic or prognostic system requiring expert interpretation of data or images. The "ground truth" here is determined by the physical properties and performance measured during the tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements of physical performance and do not involve human adjudication in the typical sense of reviewing subjective interpretations.
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 is not an AI/ML device, and no MRMC study was performed. The document explicitly states: "Clinical studies were not required as appropriate verification and validation of the minor design modifications was achieved based on the bench testing."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was defined by objective physical measurements and engineering specifications, which determine whether the device meets its design requirements. For example, "tracking force" would have a specified maximum force for successful delivery, and "microcatheter stability" would have an acceptable range of movement.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI/ML training set.
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(31 days)
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil
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 FILL Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations 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 FILL, 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 devices in this submission include minor design changes only to the Device Positioning Unit's introducer sheath (introducer). There are no modifications to components or materials of the micro-coil or the ENPOWER Detachment Control System. Minor dimensional and design modifications to the introducer will help improve deliverability of the micro-coils.
The document describes the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3 FILL, and GALAXY G3 XSFT Microcoil Delivery Systems. These devices are intended for endovascular embolization of intracranial aneurysms, various neurovascular abnormalities, and arterial and venous embolizations in the peripheral vasculature. The submission is for minor design changes to the introducer sheath component of the delivery system's device positioning unit.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table of verification and validation testing, which includes the tests performed, a summary of the test methods, and the results. The acceptance criterion for all tests was "Pass," meaning the samples met the established criteria.
| Test | Test Method Summary | Reported Device Performance (Results) | Acceptance Criteria (Implied) |
|---|---|---|---|
| Visual Inspection | Visual inspection of the test units to check for cosmetic defects to ensure the units are prepared for verification testing as per established test method. | Pass (All units passed visual inspection) | All units pass visual inspection |
| Tracking Force (delivery) | The purpose of the Track Force test was to evaluate the force it takes to deliver the proposed device through a microcatheter and into a clinically relevant model; utilizing the system Catheter Performance Simulation System (CPSS). Test samples were delivered through a compatible microcatheter to verify track forces per approved test method. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Re-sheathing Reliability | The purpose of the Re-Sheathing Reliability test was to evaluate the ability to re-insert the proposed device into the split sheath introducer after it has been unzipped after the proposed device has been inserted and withdrawal from a clinically relevant model. The introducer sheath underwent 1 re-sheathing cycle to verify reliability per approved test method. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Dimensional Inspection | The Introducer underwent dimensional inspection per approved test method. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Particulate Testing | The full assembly underwent particulate testing per approved test method. Simulated use consisted of pushing forward to the tip of the microcatheter and then pulling back 8" and repeating five times. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Introducer Fuse Joint Testing | The Introducer underwent tensile strength testing per approved test method. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Acute In-Vivo Animal Study | An in-vivo model allowed the assessment of the acute performance of the test article to deliver an embolic coil to the target parent vessel in swine. | Demonstrated acceptable overall performance in all attributes evaluated. | Acceptable overall performance in all attributes. |
| Biocompatibility Testing | A limited subset of the recommended biocompatibility tests, including in vitro cytotoxicity and in vitro hemolysis were successfully conducted on the modified introducer. In addition, chemical characterization of extractables of the Introducers manufactured with the current heat shrink polymer and the Introducers manufactured with a new heat shrink polymer were successfully conducted per ISO 10993-18. | Successfully conducted (in vitro cytotoxicity, in vitro hemolysis, chemical characterization of extractables). | Successful completion of required biocompatibility tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: The document repeatedly states "Samples passédes the established acceptance criterion" but does not specify the numerical sample sizes used for each individual bench test (Visual Inspection, Tracking Force, Re-sheathing Reliability, Dimensional Inspection, Particulate Testing, Introducer Fuse Joint Testing). It mentions "statistical sampling methods" were used for all testing as required by Codman & Shurtleff, Inc. Design Control procedures. For the animal study, it states "an acute in-vivo animal study" was performed in "swine," but the number of animals or tests performed is not specified.
- Data Provenance: The document does not specify the country of origin for the data generated from the verification and validation testing. The studies are described as prospective testing conducted in a laboratory setting for the bench tests, and an acute in-vivo animal study for the performance assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable to the type of testing described. The tests are engineering and biological performance evaluations of a medical device, not diagnostic evaluations requiring expert interpretation of images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. The tests performed are objective measurements and evaluations of device performance characteristics, not subjective assessments requiring adjudication by multiple experts.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a microcoil delivery system, not an AI or imaging-related diagnostic tool that would typically involve human readers or AI assistance in interpretation.
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, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the bench tests was established through objective engineering specifications and validated test methods. For example, for "Tracking Force," the ground truth is a specific force measurement threshold. For "Biocompatibility," the ground truth is adherence to internationally recognized standards (ISO 10993-1, FDA guidance). For the animal study, the ground truth was "acceptable overall performance" in delivering the embolic coil, implying pre-defined success criteria for deployment and functional integrity within the in-vivo model.
8. The sample size for the training set:
- Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set. The device itself is "trained" through prior design iterations and predicate device experience, and then validated through non-clinical testing.
9. How the ground truth for the training set was established:
- Not applicable. As stated above, this is not a machine learning algorithm. The "ground truth" for the design and manufacturing of the device stems from established engineering principles, material science, regulatory standards (e.g., ISO, FDA guidance), and the performance history of predicate devices.
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(108 days)
MicrUs
MicrUs ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel (B and M-mode imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigation, in operating rooms/critical care units.
MicrUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.
MicrUs system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 15 MHz.
The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, inclusive of the predicate devices so claimed.
The MicrUs only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the MicrUs via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived.
The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC.
The basic modification MicrUs EXT-1H ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port.
The MicrUs can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes).
The provided text describes the MicrUs ultrasound imaging system and its intended use, as well as regulatory information from an FDA 510(k) premarket notification. However, it does not explicitly detail specific acceptance criteria or a study designed to prove the device meets performance criteria in the way a clinical performance study would for an AI/ML device.
This document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through new performance studies. The performance standards mentioned are related to safety and effectiveness broadly, not specifically to detailed clinical performance metrics like sensitivity or specificity for a diagnostic algorithm.
Therefore, many of the requested elements for describing acceptance criteria and a study proving their achievement are not present in the provided text.
Here's what can be extracted and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic AI/ML algorithm, nor does it report device performance against such criteria. The "performance standards" listed are related to general safety and operational standards (e.g., IEC, ISO, NEMA) rather than specific diagnostic performance metrics for an AI-powered diagnostic output.
| Acceptance Criteria (Quantitative Performance) | Reported Device Performance |
|---|---|
| Not specified for diagnostic performance | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided. The document does not describe a test set or data derived from a clinical study to evaluate diagnostic performance. The submission is based on demonstrating substantial equivalence through compliance with safety standards and a comparison to predicate devices, not on a new clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Provided. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. No test set requiring adjudication is described.
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/Not Provided. The document is for an ultrasound imaging system, not an AI-assisted diagnostic tool requiring an MRMC study for improved human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided. The device is an ultrasound imaging system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable/Not Provided. No ground truth data is discussed as there is no specific diagnostic performance study mentioned for a new diagnostic algorithm.
8. The sample size for the training set
- Not Applicable/Not Provided. The document describes an ultrasound imaging system, not an AI/ML device requiring a training set for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. No training set is discussed.
Summary from the provided text:
The MicrUs is an "ultrasonic pulsed echo imaging system" intended for various applications including fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic cardiac adult, and peripheral vessel imaging. It supports B and M-mode imaging, including for needle guidance. The submission focuses on demonstrating compliance with safety and effectiveness standards and substantial equivalence to predicate devices (TELEMED; Echo Blaster K102253).
The "Performance Standards" section (pages 9-10) lists the following criteria, which are primarily related to general safety and technical performance of the ultrasound device, not diagnostic accuracy metrics:
- IEC 60601-1: 2005 (General requirements for basic safety and essential performance)
- IEC 60601-1-2: 2007 (Electromagnetic compatibility)
- IEC 60601-2-37:2007 (Particular requirements for ultrasonic medical diagnostic and monitoring equipment)
- ISO-10993-1:2009, ISO-10993-5, ISO-10993-10:2010 (Biological Evaluation of Medical Devices)
- IEC 62304: 2006 (Medical device software -- Software life cycle processes)
- NEMA UD 2-2004: 2003 (Acoustic Output Measurement Standard)
- NEMA UD 3-2004: 2004 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices)
- AIUM MUS: 2002 (Medical Ultrasound Safety)
- Essential Requirements of Council Directive 93/42/EEC (Medical Device Directive)
- Acoustic output "in accordance with ALARA principle (as low as reasonably achievable)" and below FDA recommended limits.
The document explicitly states: "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5 Predicate Device Comparison." This reinforces that the submission is for an established technology proving equivalence, not for a new diagnostic algorithm requiring dedicated clinical performance studies with acceptance criteria for sensitivity/specificity/accuracy.
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(123 days)
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY
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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(30 days)
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS
The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.
The Micrus Ascent Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning. Certain balloon catheter sizes may have a third radiopaque marker band 3 cm proximal to the tip to facilitate fluoroscopic visualization.
This document describes the acceptance criteria and study that proves the Micrus Ascent Occlusion Balloon Catheter meets these criteria, supporting its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance (Study Results) | Type of Study |
|---|---|---|
| Balloon cycling and fatigue | Modified device met acceptance for balloon cycling and fatigue. (Specific quantitative results or thresholds not provided in the summary.) | In-vitro test |
| Balloon burst diameter and volume changes | Modified device met acceptance for balloon burst diameter and volume changes. (Specific quantitative results or thresholds not provided in the summary.) | In-vitro test |
| Coating integrity of the balloon | Modified device met acceptance for coating integrity of the balloon. (Specific quantitative results or thresholds not provided in the summary.) | In-vitro test |
| Pressure at the design diameter of the balloon | Modified device met acceptance for pressure at the design diameter of the balloon. (Specific quantitative results or thresholds not provided in the summary.) | In-vitro test |
| Inflation and deflation functions | Modified device met acceptance for inflation and deflation functions. (Specific quantitative results or thresholds not provided in the summary.) | In-vitro test |
| Trackability of the device in a simulated tortuous anatomy | Modified device met acceptance for trackability in a simulated tortuous anatomy. (Specific quantitative results or thresholds not provided in the summary.) | In-vitro test |
| Adequacy and acceptability of the preparation method | The preparation method was adequate and acceptable in both in-vitro and in-vivo settings. (In-vivo study demonstrated this.) | In-vitro and In-vivo (porcine model) |
| Device deployment effectiveness | The device deployed effectively and as expected in an animal model. (Specific quantifiable measures of effectiveness not provided, but deemed acceptable by physicians in the in-vivo study.) | In-vivo (porcine model) |
| Trackability meeting physicians' acceptance | The trackability of the device met physicians' acceptance during the in-vivo study. (Qualitative assessment by medical professionals.) | In-vivo (porcine model) |
| Balloon stability in position after placement | The balloon remained stable in position after placement in the animal model. (Stability was observed and deemed acceptable in the in-vivo study.) | In-vivo (porcine model) |
2. Sample Size Used for the Test Set and Data Provenance
- In-vitro tests: The exact sample size for each in-vitro test is not specified in the summary, but multiple tests were conducted across various performance aspects.
- In-vivo study: The test set for the in-vivo study consisted of 7 devices in a porcine model.
- Data Provenance: The data provenance is from in-vitro laboratory testing and an in-vivo animal study (porcine model). This is prospective data generated specifically for the 510(k) submission. No country of origin is explicitly stated, but it can be inferred the testing was conducted by or for Micrus Endovascular Corporation, based in San Jose, CA, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For the in-vivo study, the summary states that "the trackability of the device met physicians' acceptance" and "the device deployed effectively and as expected." This implies subjective assessment by medical professionals.
- Number of experts: Not explicitly stated, but the phrasing "physicians' acceptance" suggests more than one, or at least a general consensus attributed to medical professionals involved in the study.
- Qualifications of those experts: Not explicitly stated, but it can be inferred they were veterinarians or medical researchers with expertise in animal models and catheter deployment.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "physicians' acceptance" in the in-vivo study seems to refer to a qualitative observation and concurrence, rather than a structured adjudication process for ground truth establishment.
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 conducted. This was a substantial equivalence submission for a modified device, focusing on demonstrating performance against established benchmarks and the predicate device's performance, not comparative effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm or "human-in-the-loop performance" is not applicable. The studies assessed the physical device's performance characteristics.
7. The Type of Ground Truth Used
- In-vitro tests: The ground truth for in-vitro tests was based on engineering specifications, design parameters, and established industry standards for catheter performance (e.g., balloon burst pressure, cycling durability, coating integrity).
- In-vivo study: The ground truth for the in-vivo study was based on direct observation, successful deployment, stability, and "physicians' acceptance" within the porcine model, indicating successful functionality in a biological system.
8. The Sample Size for the Training Set
This device did not involve machine learning or AI algorithms requiring a training set. The term "training set" is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established
As there was no training set (see point 8), this question is not applicable.
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(66 days)
MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
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(79 days)
MICRUS MICROCATHETER, MODEL COURIER 270
Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
Micrus Courier Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.
The provided text is a 510(k) Summary for the Micrus Courier 270 Microcatheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about specific "acceptance criteria" based on device performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving that the device meets such criteria in terms of clinical or diagnostic effectiveness.
Medical devices like microcatheters are typically evaluated for performance in terms of mechanical properties, biocompatibility, and functional aspects (e.g.,
delivery of agents, trackability). The document states that the "Micrus Courier 270 Microcatheter is substantially equivalent to other Micrus Courier Microcatheters in terms of intended use, design, specifications, and materials," and that "The Micrus Courier 270 Microcatheter uses the same methods and materials in construction, packaging, and sterilization as its predicate." This implies that the 'acceptance criteria' for this 510(k) submission are met by demonstrating equivalence to a legally marketed predicate device, rather than through a de novo clinical trial demonstrating specific performance metrics against a predefined threshold.
Therefore, most of the requested information cannot be extracted from the provided text, as it pertains to clinical performance study details (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance) typically found in documents for AI/ML-driven devices or devices requiring clinical performance data beyond substantial equivalence.
Information that can be inferred or is directly stated:
- Intended Use/Indications for Use: Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Substantial Equivalence to Predicate Device | The device is substantially equivalent to predicate devices in terms of intended use, design, specifications, and materials. |
| Uses the same methods and materials in construction, packaging, and sterilization as its predicate. | |
| Modification to the device has not altered the fundamental technology of the predicate devices. |
Note: The document does not provide specific quantitative performance metrics (e.g., in a clinical setting) against which acceptance criteria would typically be set for AI/ML or novel diagnostic devices. The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No information available. This type of study data is not typically part of a 510(k) summary for a substantial equivalence claim for a microcatheter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
No information available. Ground truth establishment with experts is not detailed as there isn't a performance study described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No information available. Adjudication methods are not applicable to the type of information presented in this 510(k) summary.
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
No information available. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No information available. This is not an AI/ML device, and no standalone algorithm performance study is mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
No information available. Ground truth for performance metrics is not discussed, as the document focuses on substantial equivalence of design and function. The 'ground truth' for the regulatory submission is essentially the predicate device's established safety and effectiveness.
8. The sample size for the training set
No information available. This is not an AI/ML device, and no training set is relevant.
9. How the ground truth for the training set was established
No information available. Not applicable.
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(29 days)
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM
The Micrus Ascent and Summit Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent and Summit Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.
The Micrus Ascent and Summit Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning.
The provided text is a 510(k) Premarket Notification for medical devices (Micrus Occlusion Balloon Catheters). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting clinical study data to prove the device meets specific acceptance criteria related to efficacy or performance in a clinical setting.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this 510(k) summary.
Here's a breakdown of what can be inferred and what is explicitly unobtainable from the provided text:
1. A table of acceptance criteria and the reported device performance
- UNOBTAINABLE from this document. This 510(k) focuses on demonstrating "substantial equivalence" based on design, specifications, materials, and intended use, not on specific performance metrics or clinical acceptance criteria. There are no performance criteria or corresponding results reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- UNOBTAINABLE from this document. There is no mention of a "test set" or clinical study data in the traditional sense. The submission likely relies on non-clinical (bench) testing and comparisons to the predicate device to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- UNOBTAINABLE from this document. As no specific clinical test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- UNOBTAINABLE from this document. No clinical test set means no adjudication method.
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
- UNOBTAINABLE from this document. This document describes a medical device (balloon catheter), not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- UNOBTAINABLE from this document. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- UNOBTAINABLE from this document. No clinical ground truth is established or discussed. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- UNOBTAINABLE from this document. This is not an AI device, so there's no concept of a "training set."
9. How the ground truth for the training set was established
- UNOBTAINABLE from this document. Not applicable.
Summary of Device and 510(k) Approach (based on the provided text):
The Micrus Ascent and Summit Occlusion Balloon Catheters are being submitted for 510(k) clearance by claiming substantial equivalence to an existing predicate device: K080861, Micrus Ascent Occlusion Balloon Catheter.
Key points from the document regarding the "study" (which is primarily a comparison for substantial equivalence):
- Rationale for Equivalence: The submission asserts that the new devices are substantially equivalent to the predicate in terms of intended use, design, specifications, methods and materials in construction, packaging, and sterilization and materials. The modification to the device (new sizes or slight variations) has not altered the fundamental technology of the predicate devices.
- Intended Use: The devices are intended for temporary occlusion in peripheral and neuro vasculature, to stop/control blood flow, and to assist in the delivery of diagnostic/therapeutic agents.
- Device Description: Coaxial dual lumen balloon catheters with an inner guidewire lumen and an outer inflation/deflation lumen. Designed for use over 0.014" or smaller guidewires, with a vent hole and two radiopaque markers.
- Predicate Device: Micrus Ascent Occlusion Balloon Catheter (4x7mm) cleared under K080861.
In essence, the "study" here is the compilation of documentation and analysis demonstrating that the new devices are so similar to an already cleared device that they do not raise new questions of safety or effectiveness, and therefore do not require extensive clinical trials or performance studies as would be seen for novel devices.
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(126 days)
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
Micrus Courier Flex Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
Micrus Courier Flex Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.
The provided 510(k) summary for the Micrus Courier Flex Microcatheter does not contain any information regarding acceptance criteria, device performance studies, or data related to AI/algorithm performance.
This document describes a medical device (a microcatheter) and is primarily focused on demonstrating substantial equivalence to a previously approved predicate device. It defines the intended use, describes the device's physical characteristics, and confirms that it uses similar materials and manufacturing processes as its predicate.
Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" are typically associated with performance studies for diagnostic or AI-driven devices, which are not detailed in this document.
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(27 days)
MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
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