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510(k) Data Aggregation
(316 days)
Sugita AVM Microclips
The Sugita AVM Microclips are designed for occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures.
Sugita AVM Microclips are not intended as a replacement for bipolar electrocoagulation of smaller vessels nor do they negate the need for immediate post-operative angiography following arteriovenous malformation surgery.
The Sugita AVM Microclips were cleared by the FDA through 510(k) K960037. The Sugita AVM Microclips are manufactured from Elgiloy, a cobalt-chromiummolybdenum alloy. They are designed for the occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures. The Sugita AVM Microclips are available in the following sizes: 2mm, 3mm, 4mm and 5mm. Other than the modifications identified above, there have been no other changes to the Sugita AVM Microclips.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Subject Device K211183) | Reported Device Performance (Sugita AVM Microclips) |
|---|---|
| MRI Safety - Magnetic Field Interaction (Force) | Force no greater than gravitational field. (Tested according to ASTM F2052-15 - translational attraction determined to be 14°) |
| MRI Safety - Magnetic Field Interaction (Torque) | Magnetically induced torque is not substantial and requires no further evaluation. (Tested according to ASTM F2213-17 – torque showed no movement or alignment) |
| MRI Safety - MRI Related Heat | Maximum Whole Body Averaged SAR 2-W/Kg for 60 min. continuous RF exposure. (Tested according to ASTM F2182-19 – maximum temperature rise of 1.5°C after 15 min. of continuous scan) |
| MRI Safety - Imaging Artifact | The presence of this implant produces an imaging artifact. Therefore, should carefully select pulse sequence parameters if the implant is located in the area of interest. (Tested according to ASTM F2119-2013 – image artifact extends approx. 10mm from implant with 3-Tesla gradient echo pulse sequence) |
| MRI Safety - Spatial Gradient Magnetic Field | Testing supports using a value of 2,000 gauss/cm (20-T/m) for the MRI related labeling of the Sugita AVM Microclips. (5mm Sugita AVM Microclips were attached to a porcine blood vessel in order to conduct a digital force gauge-based Pull-Test.) |
| Steam Sterilization Validation | Validated steam sterilization parameters are provided in the product labeling. (Tested according to ISO 17665-1 to validate steam sterilization parameters for the Sugita AVM Microclips using an FDA cleared nonwoven wrap to a sterility assurance level of (SAL) of 10-6.) |
| MR Conditional Conditions | MR Conditional for Use in Both 1.5T and 3T MR Systems. (Demonstrated through the above MRI safety testing, which included tests for 1.5T and 3T MR systems where applicable.) The predicate device was only cleared for 1.5T MR Systems, making this an improvement and a new acceptance criterion for the modified device. |
| Maintenance of Device Performance (Shelf-life) | Performance data are not needed to establish maintenance of device performance over the shelf life of the Sugita AVM Microclips because the materials of construction of these products are highly stable metal alloys with a long history of use in surgical implants. (The device is provided non-sterile and constructed of inert materials, implying no degradation over time for its core functionality before use, as the device itself doesn't possess a shelf-life.) |
2. Sample Size for the Test Set and Data Provenance
The provided text does not specify exact sample sizes for each MRI compatibility test beyond implying "Sugita AVM Microclips" were used for testing. For the Spatial Gradient Magnetic Field testing, it mentions "5mm Sugita AVM Microclips" were attached to "a porcine blood vessel." The provenance of this data is not explicitly stated as retrospective or prospective, nor is the country of origin. It can be inferred that these are prospective in-vitro tests conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The tests performed are engineering-based performance tests (MRI compatibility, sterilization validation) and do not involve human expert interpretation or ground truth establishment in the traditional clinical sense. These tests rely on established scientific and engineering standards (e.g., ASTM, ISO).
4. Adjudication Method for the Test Set
Not applicable. As the tests are objective engineering measurements against predefined standards, there is no need for an adjudication method by human 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
Not applicable. This device is a physical medical implant (microclips), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests relies on established engineering and scientific standards and measurements as defined by:
- ASTM F2503-13 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment)
- Guidance for Industry and Food and Drug Administration Staff (Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, document issued on May 20, 2021)
- ASTM F2052-15 (Standard Test Method for Measurement of Magnetically Induced Translational Force on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2213-17 (Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2182-19 (Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging)
- ASTM F2119-2013 (Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants)
- ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices)
8. The Sample Size for the Training Set
Not applicable. This device undergoes physical performance testing, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device.
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