← Product Code [HCH](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCH) · K960037 # SUGITA AVM MICROCLIP (K960037) _Mizuho America, Inc. · HCH · Feb 5, 1997 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCH/K960037 ## Device Facts - **Applicant:** Mizuho America, Inc. - **Product Code:** [HCH](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCH.md) - **Decision Date:** Feb 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5200 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use Occlusion of small vessels as a compliment to bipolar coagulation. ## Device Story Sugita AVM Microclip; miniaturized version of Sugita Aneurysm Clip; spring-action mechanism; used for occlusion of small vessels; adjunct to bipolar coagulation; neurosurgical application; physician-operated; provides mechanical vessel occlusion to control bleeding during AVM procedures. ## Clinical Evidence Bench testing only. Sterilization cycle testing (50 cycles at 250°F) showed <10% change in closing force. Multiple opening testing (100 cycles) showed <10% change in holding force. Twist testing confirmed structural return to initial configuration. MRI compatibility testing at 1.5 Tesla showed deflection angle <3.5°. ## Technological Characteristics Spring-action aneurysm clip; miniaturized form factor; material and production methods identical to predicate Sugita Aneurysm Clip; mechanical operation; MRI compatible (1.5T). ## Regulatory 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. ## Predicate Devices - Sundt AVM Micro Clip ([K902544](/device/K902544.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FEB - 5 1997 Mizuho K960037 Mizuho America Inc. 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 SUGITA The leading name in neurosurgical instrumentation {1} # 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. Summary 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°. --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCH/K960037](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCH/K960037) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com