The Sugita AVM Microclip Applier has a spring handle design with a ratchet. The Sugita AVM Microclip Applier serves to open and close the Sugita AVM Microclips. Using the Sugita AVM Microclip Applier, the Sugita AVM Microclips are removed from their packaging and applied, repositioned or removed from the target tissue. The Sugita AVM Microclip Applier has no function of its own and may only be used in combination with the Sugita AVM Microclips. The Sugita AVM Microclip Applier has the same design and materials as the clip applier in the K960037. The body of the Sugita AVM Microclip Applier is manufactured from stainless steel and the jaws are manufactured from Elgiloy, a cobalt-chromium-molybdenum alloy.

AI/ML Overview

The provided document is a 510(k) summary for the Sugita AVM Microclip Applier (K221524). It details the device, its intended use, and its comparison to a predicate device. However, it does not describe an acceptance criteria table, a study proving device performance against acceptance criteria, or any of the detailed study information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Aesculap Slim Clip Applier, K211572) based on similar indications for use, materials, design, and technological characteristics. The only "performance testing" mentioned is non-clinical sterilization and cleaning validation, which supports updated instructions for use, not a clinical performance study using patient data.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a type of performance study that was not conducted or reported here.

Here's what can be extracted and a clear indication of what is not present in the document based on your request:

1. A table of acceptance criteria and the reported device performance

Information Not Available: The document does not provide a table of acceptance criteria or reported device performance against such criteria. The submission focuses on demonstrating substantial equivalence through comparison of design, materials, and intended use, along with validating sterilization and cleaning parameters.

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

Information Not Available: No clinical test set or patient data was used for performance evaluation as described in this document. The "tests" performed were non-clinical validation of sterilization and cleaning parameters.

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)

Information Not Available: No clinical test set requiring expert ground truth establishment was conducted or reported.

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

Information Not Available: No clinical test set requiring adjudication was conducted or reported.

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

Information Not Available: This device is a mechanical surgical applier, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable and was not conducted.

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

Information Not Available: This device is a mechanical surgical applier, not an algorithm. Therefore, standalone algorithm performance is not applicable and was not assessed.

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

Information Not Available: No clinical ground truth was established as no clinical studies were performed for this 510(k) submission.

8. The sample size for the training set

Information Not Available: No training set was used as this is not an AI/machine learning device. The "training" for this submission would involve the development and validation of manufacturing processes, sterilization, and cleaning instructions.

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

Information Not Available: No training set or associated ground truth, in the context of AI/machine learning, was established. The "ground truth" for the non-clinical validations would be successful completion of specified sterilization and cleaning cycles according to established scientific and regulatory standards.

Summary

{0}------------------------------------------------

June 24, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Mizuho America, Inc. Richard Chadwick Senior Manager, Operations and QA 30057 Ahern Avenue Union City, California 94587

Re: K221524

Trade/Device Name: Sugita AVM Microclip Applier Regulation Number: 21 CFR 882.4175 Regulation Name: Aneurysm Clip Applier Regulatory Class: Class II Product Code: HCI Dated: May 25, 2022 Received: May 26, 2022

Dear Richard Chadwick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221524

Device Name

Sugita AVM Microclip Applier

Indications for Use (Describe)

The Sugita AVM Microclip Applier is exclusively designed to place Sugita AVM Microclips during surgical procedures.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image contains the logo for Mizuho America, Inc. The logo features a blue circular graphic with white lines emanating from the center, followed by the company name in bold, blue letters. Below the name, the words "Medical Innovation" are printed in a smaller font.

K221524 510(k) SUMMARY

Applicant Information:

Owner Name:	Mizuho America, Inc.
Address:	30057 Ahern AvenueUnion City, CA 94587
Phone number:	+1(510) 324-4500
Establishment Registration Number:	1223656
Contact Person:	Richard Chadwick
Date Prepared:	June 12, 2022

Device Information:

Device Classification:	Class II
Trade Name:	Sugita AVM Microclip Applier
Common name:	Aneurysm Clip Applier
Classification name:	Aneurysm Clip Applier
Regulation number:	882.4175
Product Code:	HCI

Predicate Device:

Aesculap Slim Clip Applier (K211572).

Reference Device:

Sugita AVM Microclip (K960037).

Device Modification:

The following changes have been made to the Sugita AVM Microclip Applier:

Updated steam sterilization parameters; ●
Updated cleaning instructions; ●
Product specific Instructions for Use. .

Device Description:

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image contains the logo for Mizuho Medical Innovation. The logo features a blue circular graphic on the left, followed by the word "MIZUHO" in large, bold, blue letters. Below "MIZUHO" are the words "Medical Innovation" in a smaller font. Underneath that, the text "Mizuho America, Inc." is displayed.

target tissue. The Sugita AVM Microclip Applier has no function of its own and may only be used in combination with the Sugita AVM Microclips.

The Sugita AVM Microclip Applier has the same design and materials as the clip applier in the K960037. The body of the Sugita AVM Microclip Applier is manufactured from stainless steel and the jaws are manufactured from Elgiloy, a cobalt-chromium-molybdenum alloy.

Indications for Use:

The Sugita AVM Microclip Applier is exclusively designed to place Sugita AVM Microclips during surgical procedures.

Comparison of Technological Characteristics to the Predicate Device:

The Sugita AVM Microclip Applier and the predicate device have the same intended use for holding and applying intracranial aneurysm clips.

The materials, design, technological characteristics and operating principles of the subject device are unchanged from the reference device (K960037) and are substantially equivalent to the predicate device, Aesculap Slim Clip Applier (K211572).

The comparison of the indications for use, materials and technological characteristics of the Sugita AVM Microclip Applier to the predicate and reference devices is outlined in the table below:

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image contains the logo for Mizuho America, Inc. The logo features a blue circular graphic on the left, followed by the company name "MIZUHO" in large, bold, blue letters. Below the company name, there is the text "Medical Innovation" and "Mizuho America, Inc." in a smaller font size.

Product	Sugita AVMMicroclip Applier	Sugita AVMMicroclip	Aesculap Slim ClipApplier	Conclusion
510(k) number	Subject DeviceK221524	Reference DeviceK960037	Predicate DeviceK211572
Manufacturer	Mizuho America, Inc.	Mizuho America, Inc.	Aesculap, Inc.
Indications forUse	The Sugita AVMMicroclip Applier isexclusively designedto place Sugita AVMMicroclips duringsurgical procedures.	The Sugita AVMMicroclips aredesigned forocclusion of fragilecapillary vessels tostop bleeding fromarteriovenousmalformations andother analogousvenous structures.Sugita AVMMicroclips are notintended as areplacement forbipolarelectrocoagulation ofsmaller vessels nordo they negate theneed for immediatepost-operativeangiographyfollowingarteriovenousmalformationsurgery.	The slim clip applieris used to open,close and applypermanent/temporaryAesculap YASARGILtitanium aneurysmclips.	SAME as thepredicatedevice for therespectiveaneurysmclips
Materials	Stainless Steel;Jaws: Elgiloy (cobalt-chromium-molybdenum alloy –ASTM F1058)	Stainless Steel;Jaws: Elgiloy (cobalt-chromium-molybdenum alloy –ASTM F1058)	Stainless Steelwith proprietarycoating	SAME as thereferencedevice
TechnologicalCharacteristics
Designated Clipsfor use with thedevice	Sugita AVMMicroclips.	Sugita AVMMicroclips.	YASARGIL TitaniumAneurysm Clips(Standard and Mini).	SAME as thereferencedevice
Design	Designed to open andclose the clips,remove them fromtheir packaging andaid in delivery to thesurgical site.	Designed to open andclose the clips,remove them fromtheir packaging andaid in delivery to thesurgical site.	Designed to open,close and applypermanent/temporaryAesculap YASARGILTitanium AneurysmClips.	SAME
Latch	Yes	Yes	Yes	SAME
Non-Sterile	Yes	Yes	Yes	SAME
Cleaned prior touse by the enduser	Validated cleaninginstructions areprovided	Cleaning instructionswere provided	Yes	SubstantiallyEquivalent

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image contains the logo for Mizuho America, Inc. The logo features a circular graphic with blue and white lines, followed by the word "Mizuho" in a large, bold, blue font. Below "Mizuho" are the words "Medical Innovation" in a smaller font, and below that is "Mizuho America, Inc." in an even smaller font.

Non-clinical Performance Testing

Sterilization and cleaning validation testing was conducted to support the updated recommended steam sterilization and cleaning parameters for the subject device.

Pre-vacuum Steam Sterilization Parameters
Sterilization Temperature	Retention Time	Drying Time
132°C / 269.6°F	4 minutes	20 minutes
134°C / 273.2°F	3 minutes	20 minutes

Shelf-life

The Sugita AVM Microclip Applier does not have a shelf life because it is provided non-sterile and is constructed of inert materials.

Biocompatibility

The proposed changes do not impact the contact duration or biocompatibility profile of the Sugita AVM Microclip Applier.

Conclusion

There have been no device design or material changes to the Sugita AVM Microclip Applier. Validated parameters for steam sterilization and cleaning are provided to update the Instructions for Use of the device and do not raise new questions of safety or effectiveness. The Sugita AVM Microclip Applier is substantially equivalent to the predicate device. Both devices have the same intended use and similar Indications for Use, technological characteristics and operating principles.

Regulation Number and Section

§ 882.4175 Aneurysm clip applier.

(a)
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.(b)
Classification. Class II (performance standards).