Sugita AVM Microclip Applier

K221524 · Mizuho America, Inc. · HCI · Jun 24, 2022 · Neurology

Device Facts

• Record ID: K221524
• Device Name: Sugita AVM Microclip Applier
• Applicant: Mizuho America, Inc.
• Product Code: HCI · Neurology
• Decision Date: Jun 24, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4175
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Manual surgical instrument; spring handle design with ratchet; used by surgeons in OR. Device functions to open, close, reposition, and remove Sugita AVM Microclips from packaging and apply them to target tissue. No independent function; used exclusively with Sugita AVM Microclips. Provides mechanical assistance for clip placement during neurosurgical procedures; benefits patient by enabling precise occlusion of fragile vessels.

Clinical Evidence

Bench testing only. Validation of updated steam sterilization parameters (132°C for 4 min or 134°C for 3 min, both with 20 min drying) and cleaning instructions provided. No clinical data required.

Technological Characteristics

Manual surgical instrument; stainless steel body; jaws manufactured from Elgiloy (cobalt-chromium-molybdenum alloy, ASTM F1058). Spring handle with ratchet mechanism. Non-sterile; reusable; requires manual cleaning and steam sterilization.

Indications for Use

Indicated for use by surgeons to place Sugita AVM Microclips during surgical procedures for the occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures.

Regulatory Classification

Identification

An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.

Predicate Devices

• Aesculap Slim Clip Applier (K211572)

Reference Devices

• Sugita AVM Microclip (K960037)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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#### 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 Avenue<br>Union City, CA 94587 |
| Phone number: | [phone] |
| 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:

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

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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:

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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 AVM<br>Microclip Applier | Sugita AVM<br>Microclip | Aesculap Slim Clip<br>Applier | Conclusion |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510(k) number | Subject Device<br>K221524 | Reference Device<br>K960037 | Predicate Device<br>K211572 | |
| Manufacturer | Mizuho America, Inc. | Mizuho America, Inc. | Aesculap, Inc. | |
| Indications for<br>Use | The Sugita AVM<br>Microclip Applier is<br>exclusively designed<br>to place Sugita AVM<br>Microclips during<br>surgical procedures. | The Sugita AVM<br>Microclips are<br>designed for<br>occlusion of fragile<br>capillary vessels to<br>stop bleeding from<br>arteriovenous<br>malformations and<br>other analogous<br>venous structures.<br>Sugita AVM<br>Microclips are not<br>intended as a<br>replacement for<br>bipolar<br>electrocoagulation of<br>smaller vessels nor<br>do they negate the<br>need for immediate<br>post-operative<br>angiography<br>following<br>arteriovenous<br>malformation<br>surgery. | The slim clip applier<br>is used to open,<br>close and apply<br>permanent/temporary<br>Aesculap YASARGIL<br>titanium aneurysm<br>clips. | SAME as the<br>predicate<br>device for the<br>respective<br>aneurysm<br>clips |
| Materials | Stainless Steel;<br>Jaws: Elgiloy (cobalt-<br>chromium-<br>molybdenum alloy –<br>ASTM F1058) | Stainless Steel;<br>Jaws: Elgiloy (cobalt-<br>chromium-<br>molybdenum alloy –<br>ASTM F1058) | Stainless Steel<br>with proprietary<br>coating | SAME as the<br>reference<br>device |
| Technological<br>Characteristics | | | | |
| Designated Clips<br>for use with the<br>device | Sugita AVM<br>Microclips. | Sugita AVM<br>Microclips. | YASARGIL Titanium<br>Aneurysm Clips<br>(Standard and Mini). | SAME as the<br>reference<br>device |
| Design | Designed to open and<br>close the clips,<br>remove them from<br>their packaging and<br>aid in delivery to the<br>surgical site. | Designed to open and<br>close the clips,<br>remove them from<br>their packaging and<br>aid in delivery to the<br>surgical site. | Designed to open,<br>close and apply<br>permanent/temporary<br>Aesculap YASARGIL<br>Titanium Aneurysm<br>Clips. | SAME |
| Latch | Yes | Yes | Yes | SAME |
| Non-Sterile | Yes | Yes | Yes | SAME |
| Cleaned prior to<br>use by the end<br>user | Validated cleaning<br>instructions are<br>provided | Cleaning instructions<br>were provided | Yes | Substantially<br>Equivalent |

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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.