(29 days)
No
The device description and performance studies focus on mechanical function and sterilization, with no mention of AI/ML terms or data processing.
No
This device is an applier for surgical clips, described as having "no function of its own" and being used to "open and close" and "apply, reposition or remove" the clips. It is an instrument used during a procedure, rather than a device that directly provides a therapeutic effect.
No
The device is an applier for surgical clips, used to physically place and manipulate the clips during surgery. It does not perform any assessment of a patient's condition or diagnose a disease.
No
The device description clearly states it is a physical instrument made of stainless steel and Elgiloy, designed to manipulate surgical clips. There is no mention of software components.
Based on the provided information, the Sugita AVM Microclip Applier is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to place Sugita AVM Microclips during surgical procedures. This is a surgical instrument used in vivo (within the body) during a medical procedure.
- Device Description: The description details a mechanical device for manipulating surgical clips. It does not mention any components or functions related to testing samples of human origin in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly described as a surgical tool for a specific surgical procedure.
N/A
Intended Use / Indications for Use
The Sugita AVM Microclip Applier is exclusively designed to place Sugita AVM Microclips during surgical procedures.
Product codes
HCI
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key results:
Pre-vacuum Steam Sterilization Parameters:
- Sterilization Temperature: 132°C / 269.6°F, Retention Time: 4 minutes, Drying Time: 20 minutes
- Sterilization Temperature: 134°C / 273.2°F, Retention Time: 3 minutes, Drying Time: 20 minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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
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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 Avenue |
| Union 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:
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
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 AVM
Microclip Applier | Sugita AVM
Microclip | Aesculap Slim Clip
Applier | Conclusion |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510(k) number | Subject Device
K221524 | Reference Device
K960037 | Predicate Device
K211572 | |
| Manufacturer | Mizuho America, Inc. | Mizuho America, Inc. | Aesculap, Inc. | |
| Indications for
Use | The Sugita AVM
Microclip Applier is
exclusively designed
to place Sugita AVM
Microclips during
surgical procedures. | The Sugita AVM
Microclips are
designed for
occlusion of fragile
capillary vessels to
stop bleeding from
arteriovenous
malformations and
other analogous
venous structures.
Sugita AVM
Microclips are not
intended as a
replacement for
bipolar
electrocoagulation of
smaller vessels nor
do they negate the
need for immediate
post-operative
angiography
following
arteriovenous
malformation
surgery. | The slim clip applier
is used to open,
close and apply
permanent/temporary
Aesculap YASARGIL
titanium aneurysm
clips. | SAME as the
predicate
device for the
respective
aneurysm
clips |
| Materials | Stainless Steel;
Jaws: Elgiloy (cobalt-
chromium-
molybdenum alloy –
ASTM F1058) | Stainless Steel;
Jaws: Elgiloy (cobalt-
chromium-
molybdenum alloy –
ASTM F1058) | Stainless Steel
with proprietary
coating | SAME as the
reference
device |
| Technological
Characteristics | | | | |
| Designated Clips
for use with the
device | Sugita AVM
Microclips. | Sugita AVM
Microclips. | YASARGIL Titanium
Aneurysm Clips
(Standard and Mini). | SAME as the
reference
device |
| Design | Designed to open and
close the clips,
remove them from
their packaging and
aid in delivery to the
surgical site. | Designed to open and
close the clips,
remove them from
their packaging and
aid in delivery to the
surgical site. | Designed to open,
close and apply
permanent/temporary
Aesculap YASARGIL
Titanium Aneurysm
Clips. | SAME |
| Latch | Yes | Yes | Yes | SAME |
| Non-Sterile | Yes | Yes | Yes | SAME |
| Cleaned prior to
use by the end
user | Validated cleaning
instructions are
provided | Cleaning instructions
were provided | Yes | Substantially
Equivalent |
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.