SUGITA AVM MICROCLIP

K960037 · Mizuho America, Inc. · HCH · Feb 5, 1997 · Neurology

Device Facts

• Record ID: K960037
• Device Name: SUGITA AVM MICROCLIP
• Applicant: Mizuho America, Inc.
• Product Code: HCH · Neurology
• Decision Date: Feb 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Indications for Use

Indicated for the occlusion of small vessels as a compliment to bipolar coagulation in patients requiring control of bleeding on arteriovenous malformations or similar venous structures.

Regulatory Classification

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)

Submission Summary (Full Text)

{0}

FEB - 5 1997
Mizuho
K960037
Mizuho America Inc.
123 Brimbal Avenue,
Beverly, MA 01915
800-699-CLIP(2547)
TEL: [phone]
FAX: [phone]

# 510(k) SUMMARY

## Sugita AVM Microclip

Applicant:
Mizuho America Inc.
123 Brimbal Avenue
Beverly, MA 01915

Contact: Brian Connelly
Telephone: [phone]
FAX: [phone]

Submitted by:
Curtin &amp; Associates International
1200 East Street
Dedham, MA 02026

Contact: Donald A. Lincoln
Telephone: [phone]
FAX: [phone]

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

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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.

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°.