The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravasular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.

The balloon provides temporary vascular occlusion during these procedures.

The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices.

Device Description

The Branchor Balloon Guide Catheter has the same design, materials and accessories as the predicate device (K203723). The change to the subject device includes performance testing and labeling to allow use with a power injector.

This balloon guide catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon and a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and the recommended balloon injection volume are indicated on the product label. The balloon quide catheter is provided sterile, using ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.

The outer surface of this balloon quide catheter is coated with a hydrophilic coating in order to enhance lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, except the connector part, to facilitate the passage of the quidewire and other devices through the section.

AI/ML Overview

This is a 510(k) Pre-Market Notification submission for a medical device, which focuses on demonstrating substantial equivalence to a predicate device. It is not an AI/ML device, and therefore the concepts of "acceptance criteria for an AI device," "experts used to establish ground truth," "adjudication methods," "MRMC studies," "standalone performance," or "training set" are not applicable in the context of this document.

The document describes non-clinical bench testing for the Branchor Balloon Guide Catheter to support its use with power injectors. The acceptance criteria and the study are as follows:

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

Since this is a substantial equivalence submission for a non-AI device, the "acceptance criteria" here refer to the performance standards met during non-clinical bench testing. The document states that the device "met all acceptance criteria" without explicitly listing numerical thresholds for each test. However, it reports a general "Pass" for each test.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Burst Pressure under static condition	Device does not burst under specified pressure conditions	Pass
Power Injection	Device maintains integrity and functionality during power injection	Pass
Flow Rate	Device allows for adequate flow rate	Pass

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact number of devices tested for each non-clinical bench test (Burst Pressure, Power Injection, Flow Rate). It refers to "non-aged and aged devices" being tested, implying multiple units were used.
Data Provenance: The tests were "non-clinical bench testing," meaning they were conducted in a laboratory setting. The country of origin of the data is not specified, but the applicant is ASAHI INTECC CO., LTD from Japan, with ASAHI INTECC USA, Inc. as the primary contact. The tests are prospective in nature, as they assess the performance of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a non-clinical bench study for a medical device, not a study involving ground truth established by human experts.

4. Adjudication method for the test set:

Not applicable. There is no adjudication method as this is not a study assessing interpretations or diagnoses.

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:

Not applicable. This is a non-AI medical device; therefore, MRMC studies and human reader improvement with AI assistance are irrelevant.

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

Not applicable. This is a non-AI medical device.

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

For this type of device, "ground truth" is established by direct physical measurements and observations of the device's mechanical and functional performance under specified test conditions in a laboratory setting, rather than clinical outcomes or expert consensus. For example:

Burst Pressure: Ground truth is the physical bursting pressure measured.
Power Injection: Ground truth is the device's ability to withstand the forces and pressures of power injection without failure and maintain patency for flow.
Flow Rate: Ground truth is the measured flow rate through the device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device and does not involve a training set.

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

Not applicable. This is not an AI/ML device.

Summary

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October 11, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ASAHI INTECC Co., Ltd % Cynthia Valenzuela Director, Global Regulatory Affairs ASAHI INTECC USA, Inc. 3002 Dow Avenue, Suite 212 Tustin, California 92780

Re: K221951

Trade/Device Name: Branchor Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: September 7, 2022 Received: September 13, 2022

Dear Cynthia Valenzuela:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221951

Device Name

Branchor Balloon Guide Catheter

The balloon provides temporary vascular occlusion during these procedures.

The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary [as required by 21 CFR §807.92(c)]

510(K) K221951

DATE PREPARED:	11 OCT 2022
SUBMITTER:	ASAHI INTECC CO., LTD3-100 Akatsuki-cho, SetoAichi 489-0071, JapanTelephone: +81 561 48 5551
PRIMARY CONTACT:	Mrs. Cynthia ValenzuelaDirector, Global Regulatory AffairsASAHI INTECC USA, INC.3002 Dow Avenue, Suite 212Tustin, California 92780Phone: (949) 413 0071Email: cynthiav@asahi-intecc-us.com
TRADE NAME:	Branchor Balloon Guide Catheter
DEVICE CLASSIFICATION:	Class II, 21 CFR §870.1250
CLASSIFICATION NAME:	Percutaneous Catheter
PRODUCT CODE:	QJP, Catheter, Percutaneous, Neurovasculature
PREDICATE DEVICE:	Branchor Balloon Guide Catheter (K203723)

Device Description:

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Accessories

The Branchor Balloon Guide Catheter is packaged with a peel-away to protect the balloon during catheter introduction, a 1mL syringe for balloon inflation, and a three-way stopcock to connect the syringe for inflation and deflation of the balloon.

Intended Use/Indications for Use

The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.

The balloon provides temporary vascular occlusion during these procedures.

The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices.

Comparison of Indications for Use and Technological Characteristics:

The Branchor Balloon Guide Catheter has identical

Indications for use, .
Fundamental principles of operation, .
. Fundamental design and materials,
Packaging and sterilization of devices

as the marketed predicate device. A tabular comparison of the specific technological characteristics between the predicate device and subject device is provided below. The labeling changes to allow the use of power injectors with the subject device do not raise new questions of safety and effectiveness.

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Table 1: Comparison Table

Name of Device	Branchor Balloon Guide Catheter	Branchor Balloon Guide Catheter
	Predicate	Subject Device
510(K) Number:	K203723	K221951
Indications for Use	The Branchor Balloon GuideCatheter is indicated for use tofacilitate the insertion andguidance of an intravascularcatheter into a selected bloodvessel in the neuro vasculature,and injection of contrast media.	The Branchor Balloon GuideCatheter is indicated for use tofacilitate the insertion andguidance of an intravascularcatheter into a selected bloodvessel in the neuro vasculature,and injection of contrast media.
	The balloon provides temporaryvascular occlusion during theseprocedures.	The balloon provides temporaryvascular occlusion during theseprocedures.
	The Branchor Balloon Guide Cathetercan also be used as a conduit forretrieval devices.	The Branchor Balloon GuideCatheter can also be used as aconduit for retrieval devices.
Device Description	This balloon guide catheter is avariable stiffness catheter that has aradio-opaque marker at the distal endof the balloon to facilitate fluoroscopicvisualization and indicate the balloonposition, a branched connector at theproximal end, and is equipped with abraid reinforced coaxial lumen. Aballoon is attached to the distal end,and the dimensions of this balloonguide catheter and recommendedballoon injection volume are providedon the product label.The outer surface of this balloon guidecatheter is coated with a hydrophiliccoating for enhanced lubricity when thesurface is wet.The shaft lumen is provided with PTFEcoating, with the exception of theconnector section to facilitate thepassage of the guidewire and otherdevices through the section.	This balloon guide catheter is avariable stiffness catheter that has aradio-opaque marker at the distal endof the balloon to facilitate fluoroscopicvisualization and indicate the balloonposition, a branched connector at theproximal end, and is equipped with abraid reinforced coaxial lumen. Aballoon is attached to the distal end,and the dimensions of this balloonguide catheter and recommendedballoon injection volume are providedon the product label.The outer surface of this balloonguide catheter is coated with ahydrophilic coating for enhancedlubricity when the surface is wet.The shaft lumen is provided withPTFE coating, with the exception ofthe connector section to facilitatethe passage of the guidewire andother devices through the section.

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Name of Device	Branchor Balloon Guide Catheter	Branchor Balloon Guide Catheter
510(K) Number:	K203723	K221951
RegulationNumber:	21 CFR § 870.1250	21 CFR § 870.1250
RegulationDescription:	Catheter, Percutaneous,Neurovasculature	Catheter, Percutaneous,Neurovasculature
Regulatory Class:	II	II
Product Code:	QJP	QJP
Size	Shaft OD: 3.00 mmShaft ID: 2.28 mm	Shaft OD: 3.00 mmShaft ID: 2.28 mm
Effective Length	90 cm, 100 cm	90 cm, 100 cm
Balloon Material	Polyurethane elastomer	Polyurethane elastomer
Shaft Material	Polyurethane ElastomerPolyamide 12 ElastomerPolyamide 12Stainless SteelPolytetrafluoroethylene	Polyurethane ElastomerPolyamide 12 ElastomerPolyamide 12Stainless SteelPolytetrafluoroethylene
Accessories	Peel-awaySyringeThree way stopcock	Peel-awaySyringeThree way stopcock
Sterilization Method	Ethylene Oxide	Ethylene Oxide
Sterility Level	SAL10-6	SAL10-6
Single Use	Yes	Yes
Radiopaque Markers	Yes	Yes
Anatomical Sites	Neuro vascular	Neuro vascular

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PERFORMANCE TESTING:

Non-clinical bench testing was performed on the Branchor Balloon Guide Catheter to allow use with power injectors. The following testing was performed:

Table 2: Performance Testing

Test	Result
Burst Pressure under static condition	Pass
Power Injection	Pass
Flow Rate	Pass

The testing of non-aged and aged devices was performed.

The in vitro bench tests demonstrated that the Branchor Balloon Guide Catheter met all acceptance criteria. Performance data demonstrates that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device.

BIOCOMPATIBILITY, STERILIZATION and SHELF LIFE:

The change to the subject device does not impact biocompatibility, sterilization, and shelf life, as compared to the predicate device.

CONCLUSION:

The Branchor Balloon Guide Catheter has similar intended use, same technological characteristics, such as components, design, materials, sterilization method, shelf life and operating principles, as the predicate device. Performance data demonstrate that the subject device functions as intended. The conclusions drawn from the nonclinical tests demonstrate that the Branchor Balloon Guide Catheter is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).