(399 days)
Occlusion of small vessels as a compliment to bipolar coagulation.
These devices are miniaturized versions of the currently marketed Sugita Aneurysm Clip. They are used to occlude small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
The provided text describes a 510(k) summary for the Sugita AVM Microclip, focusing on its design, intended use, and a summary of test data. However, it does not contain the level of detail regarding acceptance criteria and the comprehensive study methodology typically found in regulatory submissions for AI/ML-driven devices.
The information provided is more akin to validation testing for a medical device that does not involve algorithmic performance or human-AI interaction. Therefore, I cannot fully answer all aspects of your request as the input document does not contain the necessary information.
Based on the provided text, here's what can be extracted and inferred:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Changes During Sterilization | Change in closing force < 10% after 50 sterilization cycles at 250°F for 20 mins. | "The change in closing force for all clips tested was less than 10%." |
| Multiple Opening Testing | Holding force change < 10% after 100 openings and closings. | "The results showed that holding force changed less than 10%." |
| Twist Testing | Ability to return to initial configuration after twisting motion. | "All clips passed." |
| MRI Compatibility | Angle of deflection < 3.5° in a 1.5 Tesla field. | "The angle of deflection for the clips tested was less than 3.5°." |
Study Information (Based on available text):
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Sample sizes used for the test set and data provenance:
- No specific sample sizes (number of clips) are explicitly stated for each test ("sample devices," "sample clips").
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These appear to be laboratory-based engineering tests rather than clinical studies.
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Number of experts used to establish the ground truth and their qualifications:
- Not applicable. These are engineering performance tests of a physical device, not diagnostic or interpretive tasks requiring expert ground truth establishment.
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Adjudication method for the test set:
- Not applicable. The tests involve objective measurements (e.g., force, angle of deflection, visual inspection for shape retention) rather than subjective assessments requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The device is a physical surgical clip, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" for these tests is based on objective physical measurements and engineering specifications, e.g., precisely measured closing/holding force, angle of deflection, visual confirmation of original shape.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
In summary, the provided document details the mechanical and material performance testing of a physical medical device (surgical clip) against established engineering criteria, not the performance of an AI/ML algorithm or a device requiring complex diagnostic interpretation.
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Image /page/0/Picture/1 description: The image shows the word "MIZUHO" in white letters against a black background. The letters are bold and slightly stylized. The background is a rounded rectangle.
123 Brimbal Avenue, Beverly, MA 01915 800-699-CLIP(2547) TEL: 508-921-1718 FAX: 508-921-4003
510(k) SUMMARY
Sugita AVM Microclip
Applicant:
Mizuho America Inc. 123 Brimbal Avenue Beverly, MA 01915
Contact: Brian Connelly
Telephone: 508-921-1718 FAX: 508-921-4003
Submitted by:
Curtin & Associates International 1200 East Street Dedham, MA 02026
Contact: Donald A. Lincoln
Telephone: 617-329-1955 FAX: 617-329-2529
Date this Summary was prepared: INSERT DATE
Trade Name: Sugita AVM Microclip Common Name: AVM Clip Classification Name: Could not be determined
Legally Marketed Devices to Which Substantial Equivalence is claimed
Sundt AVM Micro Clip - K902544
1
SUGITA The leading name in neurosurgical instrumentation
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510(k) SUMMARY-continued Sugita AVM Microclip
Description of Device: These devices are miniaturized versions of the currently marketed Sugita Aneurysm Clip. They are used to occlude small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
Intended Use of the Device: Occlusion of small vessels as a compliment to bipolar coagulation.
Summary of Technological Characteristics: The devices are based in design upon a currently marketed spring action aneurysm clip. The material is the same, the production methods are the same, but the clip size is reduced to allow for the intended use.
Summarv of test data:
CHANGES DURING STERILIZATION: The sample devices were subjected to sterilization at 250°F using a 20 minute cycle. This was repeated 50 times with the closing force being measured before the first cycle and at the conclusion of the test. The change in closing force for all clips tested was less than 10%.
MULTIPLE OPENING TESTING: Sample clips were subjected to 100 openings and closings. The results showed that holding force changed less than 10%.
TWIST TESTING: Samples were subjected to a twisting motion to determine the clips ability to return to its initial configuration. All clips passed.
MRI COMPATIBILITY: Sample clips were subject to testing in a 1.5 Tessla field. The angle of deflection for the clips tested was less than 3.5°.
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).