The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular in the neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this cather other than for use in the neurovasculature.

Device Description

ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters consists of a guide catheter, available in the following sizes: ASAHI FUBUKI 043 (4.2 Fr), ASAHI FUBUKI 6Fr (6 Fr), ASAHI FUBUKI 7Fr (7 Fr), ASAHI FUBUKI 8Fr (8 Fr). The ASAHI FUBUKI Neurovascular Guide Catheter Dilator Kit consists of a Catheter and Dilator components, available in the following sizes: ASAHI FUBUKI Dilator Kit 4Fr (Catheter 6 Fr, Dilator Shaft 1.75 mm), ASAHI FUBUKI Dilator Kit 5Fr (Catheter 7 Fr, Dilator Shaft 2.00 mm), ASAHI FUBUKI Dilator Kit 6Fr (Catheter 8 Fr, Dilator Shaft 2.21 mm). The catheter consists of three main sections including a tube, a protector section, and a connector. The proximal part of the tube is covered by the protector and the connector is bonded to the proximal end of the tube. A soft tip is bonded to the distal end of the catheter. The inner lumen of the tube (excluding the connector portion) is lined with PTFE to facilitate movement of the guide wire and other devices. The tube is made of polymer resin and is reinforced by a stainless steel and tungsten braid wire. The outer surface of the tube is partially coated with a hydrophilic polymer.

AI/ML Overview

The provided document discusses a 510(k) premarket notification for the "ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters." This is a regulatory submission to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, not a study designed to prove the device meets acceptance criteria in the context of an AI/ML medical device.

The document describes non-clinical testing performed on the device to establish substantial equivalence to predicate devices, but it does not contain information regarding acceptance criteria for an AI/ML device, nor does it detail a study proving an AI/ML device meets such criteria.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance for an AI/ML device.
Sample sizes for a test set or data provenance for an AI/ML model.
The number or qualifications of experts used to establish ground truth for an AI/ML test set.
Adjudication methods for an AI/ML test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes for AI assistance.
Details about a standalone (algorithm-only) performance study for an AI/ML device.
The type of ground truth used for an AI/ML model (e.g., pathology, outcomes data).
The sample size for a training set (relevant for AI/ML).
How ground truth for a training set was established (relevant for AI/ML).

Instead, the document focuses on non-clinical laboratory testing to compare the new catheter device to existing predicate devices. The tests performed are related to the physical and mechanical properties of the catheter, as listed under "NON CLINICAL TESTING / PERFORMANCE DATA":

Corrosion resistance
Force at break
Liquid leakage under pressure
Air leakage into hub assembly during aspiration
Leak and damage under high static pressure
Radio-detectability
Kink resistance
Appearance/Dimensions
Biocompatibility

The conclusion drawn is that the new catheter device is "substantially equivalent" to the predicate devices based on shared intended use, technological characteristics (components, design, materials, sterilization, shelf life, operating principles), and performance data demonstrating it functions as intended with a similar safety and effectiveness profile.

Therefore, I cannot provide the requested information as it pertains to AI/ML device acceptance criteria and study details because the provided text describes a 510(k) submission for a physical medical device (catheter), not an AI/ML-driven device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2015

Asahi Intecc Co., Ltd. % Mr. H. Semih Oktay President CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228

Re: K141981

Trade/Device Name: ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: February 5, 2015 Received: February 6, 2015

Dear Mr. Oktay,

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. 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S 同公

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141981

Device Name ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters

Indications for Use (Describe)

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)

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Image /page/3/Picture/1 description: The image shows the logo for ASAHI INTECC CO., LTD. The logo features a stylized red "A" symbol on the left, followed by the company name in dark teal. The text is in a clear, sans-serif font, making it easily readable. The logo appears to be professionally designed and conveys a sense of corporate identity.

1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel.+81-52-768-1211 Fax.+81-52-768-1221 Branch offices: Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore, Beijing Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi

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

ASAHI FUBUKI 043 and ASAHI FUBUKI

510(k) K141981

APPLICANT	Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024Japan
OFFICIALCORRESPONDENT	Yoshi TeraiPresident, CEOAsahi Intecc USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252FAX: (949) 756-8165e-mail: asahi.ra-fda@asahi-intecc.com
TRADE NAMES:	ASAHI FUBUKI 043ASAHI FUBUKI
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1250
CLASSIFICATIONNAME:	Percutaneous Catheter
PRODUCT CODE	DQY
PREDICATEDEVICES:	K090335, HD Guide CatheterK962362, Envoy Guide CatheterK980453, GUIDER Softip Guiding Catheter
REFERENCEDEVICES:	K083127, Asahi Corsair MicrocatheterK132556, SheathLess Eaucath Coronary Guide CatheterK061601, Precious Guide Catheter
DATE PREPARED:	February 5th , 2015

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INDICATION FOR USE/INTENDED USE:

ASAHI FUBUKI Intended Use:

This product is intended to be used to guide interventional devices for Neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the Neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this product other than for use in the Neurovasculature.

ASAHI FUBUKI 043 Intended Use:

This catheter is intended to be used to guide interventional devices for Neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the Neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this catheter other than for use in the Neurovasculature.

DESCRIPTION:

ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters consists of a guide catheter, available in the following sizes:

Product Name	Outer diameter of Catheter
ASAHI FUBUKI 043	4.2 Fr
ASAHI FUBUKI 6Fr	6 Fr
ASAHI FUBUKI 7Fr	7 Fr
ASAHI FUBUKI 8Fr	8 Fr

The ASAHI FUBUKI Neurovascular Guide Catheter Dilator Kit consists of a Catheter and Dilator components, available in the following sizes:

Product Name	Outer diameter of Catheter	Outer diameter of Dilator Shaft (mm)
ASAHI FUBUKI Dilator Kit 4Fr	6 Fr	1.75
ASAHI FUBUKI Dilator Kit 5Fr	7 Fr	2.00
ASAHI FUBUKI Dilator Kit 6Fr	8 Fr	2.21

The catheter consists of three main sections including a tube, a protector section, and a connector. The proximal part of the tube is covered by the protector and the connector is bonded to the proximal end of the tube. A soft tip is bonded to the distal end of the catheter.

The inner lumen of the tube (excluding the connector portion) is lined with PTFE to facilitate movement of the guide wire and other devices. The tube is made of polymer resin and is reinforced by a stainless steel and tungsten braid wire. The outer surface of the tube is partially coated with a hydrophilic polymer.

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COMPARISON TABLE WITH PREDICATE DEVICES:

Comparisons of the ASAHI FUBUKI 043 and ASAHI FUBUKI with the predicate devices show that the technological characteristics of the ASAHI FUBUKI 043 AND ASAHI FUBUKI such as the intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate devices. A comparison of the ASAHI FUBKI 043 and the ASAHI FUBUKI to the predicate devices is provided in the table below.

Device Name	ASAHIFUBUKI 043	ASAHIFUBUKI	HD GuideCatheter	Envoy	GUIDERSoftipGuidingCatheter	Device NameComparisonCriteria	ASAHIFUBUKI 043	ASAHIFUBUKI	HD GuideCatheter	Envoy	GUIDERSoftipGuidingCatheter
ComparisonCriteria						Tip Shape	Straight	StraightAngled	Unknown	StraightMultipurposeCMultipurposeDModifiedCerebral(Burke)Headhunter 1Simmons 2	40° AngleMultipurposeStraight
Manufacturer	ASAHI INTECCCO., LTD.	ASAHI INTECCCO., LTD.	Concentric	Cordis	Schneider	Primarycathetermaterial	PolyurethanePolyamide	PolyurethanePolyamide	Polyamideelastomer	NylonPolyurethane	Unknown
Indications forUse	This catheter isintended to be used toguide interventionaldevices forNeurovasculartherapy to a lesion ora procedural site for apercutaneousintravascularprocedure in theNeurovasculature.This catheter is alsointended to be usedfor injection ofcontrast media.Do not use thiscatheter other thanfor use in theNeurovasculature.	This product isintended to be usedto guideinterventionaldevices forNeurovasculartherapy to a lesionor a procedural sitefor a percutaneousintravascularprocedure in theNeurovasculature.This catheter is alsointended to be usedfor injection ofcontrast media.Do not use thisproduct other thanfor use in theNeurovasculature.	The HD GuideCatheter isindicated for use infacilitating theinsertion andguidance of anocclusion catheter,infusion catheter orother appropriatemicrocatheter intoa selected bloodvessel in theperipheral,coronary andneurovascularsystems. It mayalso be used as adiagnosticangiographiccatheter.	The EnvoyGuidingCatheter isintended touse in theperipheral,coronary andneurovasculature for theintravascularintroductionofinterventional/ diagnosticdevices.	The SCHNEIDERGUIDER SoftipGuiding Catheterare designed forintroduction ofinterventionaldevices. They areintended tofacilitate theplacement ofinterventionaldevices into theperipheral andcoronary systemsand, in additionalfor the XF models,into theneurovascularsystem.	SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	EthyleneOxide	Ethylene Oxide
Labeled ShaftOuterDiameter	4.2 Fr	6Fr, 7Fr, 8 Fr	3.9Fr - 5.2 Fr	5Fr, 6Fr	5Fr, 6 Fr, 7 Fr, 8Fr, 9 Fr
Inner Diameter	4.2 Fr : 1.10mm(0.043 in)	6Fr : 1.80mm(0.071 in)7Fr : 2.05mm(0.081 in)8Fr : 2.28mm(0.090 in)	Not Provided	5Fr : 1.4mm(0.056 in)6Fr : 1.8mm(0.070 in)	5 Fr : 1.35mm(0.053 in)6 Fr : 1.63mm(0.064 in)7 Fr : 1.85mm(0.073 in)8 Fr : 2.18 mm(0.086 in)9 Fr : 2.51mm(0.099 in)
CatheterEffectiveLength	1200mm - 1300mm	800mm - 1100mm	1150mm -1360mm	900, 1000mm	900, 1000mm

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NON CLINICAL TESTING / PERFORMANCE DATA:

Non clinical laboratory testing was performed on the ASAHI FUBUKI 043 and ASAHI FUBUKI to determine substantial equivalence. The following testing and assessments were performed:

Corrosion resistance ●
Force at break
Liquid leakage under pressure ●
Air leakage into hub assembly during aspiration
Leak and damage under high static pressure ●
Radio-detectability
Kink resistance ●
Appearance/Dimensions .

BIOCOMPATIBILITY:

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The ASAHI FUBUKI 043 and ASAHI FUBUKI was compared to the predicate devices. Based on similariites of the materials used in the subject devcie to its predicates, the biocompatibiity of the ASAHI FUBUKI 043 and ASAHI FUBUKI was verified to be the same as those of the predicates.

CONCLUSION:

The ASAHI FUBUKI 043 and ASAHI FUBUKI has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate devices.

Therefore, the ASAHI FUBUKI 043 and ASAHI FUBUKI are substantially equivalent to the predicate devices.

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).