The Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion of cerebral blood vessels.

Device Description

The Sugita Titanium Aneurysm Clip is made from the titanium alloy Ti6AI4V. This alloy was chosen for the new clip because of its excellent compatibility with magnetic resonance imaging (MRI) devices. Titanium and its alloys cause much less artifact and are subject to much smaller magnetomechanical effects than other clips materials such as the cobalt-chrome alloys or stainless steel. Ti6Al4V also has excellent mechanical properties. The Sugita Titanium Aneurysm Clips are available in 55 models of various shapes and sizes. These shapes and sizes are identical to the corresponding models of the Sugita Elgiloy clips.

AI/ML Overview

The provided document is a 510(k) summary for the Sugita Titanium Aneurysm Clip, detailing its substantial equivalence to previously marketed devices. It focuses on mechanical properties and MRI compatibility. The document does not contain information about a study involving human readers, AI assistance, or expert consensus for establishing ground truth in the context of image analysis or diagnostic performance. Therefore, I cannot fully complete the table and answer all points as some of the requested information is not present in the provided text.

Here's the information that can be extracted and a clear indication of what is missing:

Acceptance Criteria and Device Performance for Sugita Titanium Aneurysm Clip

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated Goal / Benchmark)	Reported Device Performance (Sugita Titanium Aneurysm Clip)
Retention of original closing force after 500 openings and closings (compared to predicate device)	Retains 98.5% of original closing force (Yasargil Titanium Clips retain 97.1%)
MR safety and compatibility	Safe for use in MR environment up to 10 T
Artifact on MR images	Artifact on MR images up to 1.5 T does not extend significantly beyond the clip region
Streak artifact on CT images	Minimal streak artifact, much less than cobalt-chromium alloy clips

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for test set: Not specified in terms of number of clips tested, but implicitly involves various models from the 55 available clips.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is presented as "laboratory data" and "testing."

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. The ground truth for this device is based on physical and mechanical measurements (e.g., closing force, MRI artifact evaluation), not human expert interpretation of images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As per point 3, this is not a study involving human readers or interpretation requiring adjudication.

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. This document describes a medical device (aneurysm clip) and its mechanical/material properties, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance evaluation was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Mechanical and Physical Properties Measurement: The ground truth for the evaluation was based on objective laboratory measurements for mechanical properties (e.g., closing force using the ASTM measurement technique) and physical characteristics (e.g., MRI safety, artifact extent on MR and CT images).

8. The sample size for the training set

Not Applicable. This is not a study involving a "training set" for an algorithm or a diagnostic model.

9. How the ground truth for the training set was established

Not Applicable. As per point 8, there is no training set in this context.

Summary

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KQ90202

510(k) Summary

Sugita Titanium Aneurysm Clip

Common/Classification Name: Intracerebral Aneurysm Clip, 21 CFR 882.5200

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

978-921-1718 978-921-4003 (FAX)

Contact: Jon Macomber, Prepared: April 14, 1999

LEGALLY MARKETED PREDICATE DEVICES A.

The Sugita Titanium Aneurysm Clip is substantially equivalent to the Aesculap Titanium Aneurysm Clip which was cleared by FDA as K970050 on November 26, 1997. It is also substantially equivalent in some characteristics to the Sugita (Elgiloy) Aneurysm Clip, cleared for marketing under P820009 as a Class III device and reclassified into Class II on May 18, 1983, and to the Spetzler Ti-100 Titanium Aneurysm Clip cleared by FDA as K955064 on October 17, 1996.

DEVICE DESCRIPTION B.

The Sugita Titanium Aneurysm Clip is made from the titanium alloy This alloy was chosen for the new clip because of its Ti6AI4V. excellent compatibility with magnetic resonance imaging (MRI) Titanium and its alloys cause much less artifact and are devices. subject to much smaller magnetomechanical effects than other clips materials such as the cobalt-chrome alloys or stainless steel. Ti6Al4V also has excellent mechanical properties.

The Sugita Titanium Aneurysm Clips are available in 55 models of various shapes and sizes. These shapes and sizes are identical to the corresponding models of the Sugita Elgiloy clips.

C. INTENDED USE

The Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion

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K990202

of cerebral blood vessels.

SUBSTANTIAL EQUIVALENCE SUMMARY D.

The Sugita Titanium Aneurysm Clip is a medical device, and it has similar indications for use statement as the legally marketed Sugita Aneurysm Clip. However, the differences in indications statements do not change the intended therapeutic use. The Sugita Titanium Aneurysm Clip has the same technological characteristics and is made from the same material as the Aesculap Titanium Clip. For most of the characteristics, this premarket notification will describe the characteristics of the Sugita Titanium Aneurysm Clip in sufficient detail to assure substantial equivalence. One characteristic, mechanical properties, may not be precise enough to ensure so laboratory data are submitted equivalence, herein which demonstrate that the Sugita Titanium Aneurysm Clip is substantially equivalent to the predicate device with regard to mechanical properties.

E. TECHNOLOGICAL CHARACTERISTICS

The Sugita Titanium Aneurysm Clip is made from the titanium alloy The 55 models manufactured in the titanium alloy are Ti6AI4V. identical to the corresponding Sugita Elgiloy models in shape and size.

F. TESTING

As is discussed in detail elsewhere in this 510(k), the data show that after 500 openings and closings, the Mizuho Titanium Aneurysm Clips on average retain 98.5% of their original closing force (using the ASTM measurement technique). This compares with 97.1% for the Yasargil Titanium Clips. The MR safety and compatibility summary in Section IV demonstrates that the clip is safe for use in the MR environment up to 10 T, and that the artifact on MR images up to 1.5 T does not extend significantly beyond the region occupied by the clip. Streak artifact on CT images is minimal, much less than is seen with cobalt-chromium alloy clips.

G. CONCLUSIONS

The 510(k) decision algorithm brings us to a determination of Substantial Equivalence, as defined in the Federal Food, Drug, and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 4 1999

Mizuho America, Inc. c/o T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re: K990202

Trade Name: Sugita Titanium Aneurysm Clip Regulatory Class: II Product Code: HCH Dated: April 15, 1999 Received: April 15, 1999

Dear Dr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - T. Whit Athey, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K990202

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Sugita Titanium Aneurysm Clip Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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Sign-Off) 11:11:11 City 1 General Restorative Dev ت 510(K) Number _

Regulation Number and Section

§ 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).