The CROSSWALK™ Peripheral Support Catheter is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another. The CROSSWALK™ Peripheral Support Catheter is also intended to assist in the delivery of contrast media into the peripheral vasculature.

Device Description

The ASAHI CROSSWALK™ Peripheral Support Catheters (PSC) are a single lumen catheter with a three layer construction that is composed of a braid reinforced polymer shaft over a PTFE liner. The catheter also has a proximal female hub, a distal radiopaque atraumatic tip, hydrophilic coating and tungsten loaded radiopaque markers on the distal outer surface of the catheter.

There are three sizes in the family, a 0.035", 0.018" and 0.014" quidewire compatible models, whereas the 0.018" and 0.014" models are designed to fit into the 0.035" model for additional proximal support.

AI/ML Overview

The provided text describes the regulatory submission for the ASAHI CROSSWALK™ Peripheral Support Catheter and details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, the ASAHI Corsair Armet.

It does not describe a study involving an AI-powered device or a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss ground truth established by experts or a training set. The device in question is a physical medical catheter, not a software device that would require AI-specific performance criteria.

Therefore, I cannot fulfill most of the requested information regarding acceptance criteria and study proving an AI device's performance (points 2 through 9 in your prompt).

However, I can extract the acceptance criteria and performance data for the physical catheter.

Study Proving Device Meets Acceptance Criteria for ASAHI CROSSWALK™ Peripheral Support Catheter

This document describes the non-clinical bench testing conducted for the ASAHI CROSSWALK™ Peripheral Support Catheter to demonstrate substantial equivalence to its predicate device, ASAHI Corsair Armet. This is a physical medical device, not an AI-powered software.

1. Table of Acceptance Criteria and Reported Device Performance

The general statement provided is that the device met all acceptance criteria for the listed tests and performed similarly to the predicate devices. Specific quantitative acceptance criteria or detailed numerical performance results for each test are not provided in this summary.

Test Performed	Acceptance Criteria Source / General Outcome
Visual Inspection	Met acceptance criteria; performed similarly to predicate.
Corrosion Resistance	Met acceptance criteria; performed similarly to predicate.
Force Break	Met acceptance criteria; performed similarly to predicate.
Liquid Leak	Met acceptance criteria; performed similarly to predicate.
Air Leak	Met acceptance criteria; performed similarly to predicate.
Radio-Detectability	Met acceptance criteria; performed similarly to predicate.
Torque Transmission	Met acceptance criteria; performed similarly to predicate.
Torque Durability	Met acceptance criteria; performed similarly to predicate.
Slide Durability	Met acceptance criteria; performed similarly to predicate.
Kink Resistance	Met acceptance criteria; performed similarly to predicate.
Flow Test	Met acceptance criteria; performed similarly to predicate.
Dimensions	Met acceptance criteria; performed similarly to predicate.
Coating Integrity	Met acceptance criteria; performed similarly to predicate.
Biocompatibility	Verified in accordance with ISO10993-1. Results provide assurance of a safe biocompatibility profile.

Note on Acceptance Criteria:

Acceptance criteria for tests conducted per ISO10555-1 were based on that standard.
Tests not conducted per ISO10555-1 used "in-house validated procedures with internally developed acceptance criteria."
"All ASAHI CROSSWALK™ Peripheral Support Catheter test samples met the acceptance criteria for each of the tests listed in this submission. There were no deviations from the acceptance criteria."

Information Not Applicable (N/A) or Not Provided in the Document:

As the document pertains to a physical medical device and not an AI-powered software, the following points are not relevant or cannot be extracted from the provided text:

Sample size used for the test set and data provenance: The document states "test samples" were used for the non-clinical bench tests but does not specify the exact number of units tested for each test. Data provenance (country of origin, retrospective/prospective) is not applicable to bench testing of physical device properties.
Number of experts used to establish the ground truth for the test set and qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for physical device performance is established through engineered specifications and recognized standards (e.g., ISO).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to human expert adjudication in diagnostic studies, not physical device testing.
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 device does not involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for physical device testing is typically based on engineering specifications, industry standards (e.g., ISO), and validated measurement techniques. It's not clinical "ground truth" derived from patient data or expert consensus.
The sample size for the training set: Not applicable. This device is not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable. This device is not an AI model.

Summary

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November 29, 2019

Asahi Intecc Co., Ltd. Cynthia Valenzuela Director, Regulatory Affairs 3002 Dow Avenue, Suite 212 Tustin, California 92780

Re: K192782

Trade/Device Name: ASAHI CROSSWALK Peripheral Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 30, 2019 Received: September 30, 2019

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,

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192782

Device Name

ASAHI CROSSWALKTM Peripheral Support Catheter

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

SAHI INTECC CO.,LTD.

Global Headquarters and R&D Center 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan TEL: +81-561-48-5551 FAX: +81-561-48-5552 http://www.asahi-intecc.co.jp/

ASAHI CROSSWALK™ Peripheral Support Catheter

K192782 510(K)

DATE PREPARED:	30SEP2019
APPLICANT:	ASAHI INTECC CO., LTD3-100 Akatsuki-cho, SetoAichi 489-0071, Japan
PRIMARY CONTACT:	Mrs. Cynthia ValenzuelaDirector, Regulatory AffairsASAHI INTECC USA, INC.3002 Dow Avenue, Suite 212Tustin, California 92780Phone: (714) 442 0575Fax: (949) 377 3255Email: cynthiav@asahi-intecc-us.com
TRADE NAME:	ASAHI CROSSWALK™ Peripheral Support Catheter
DEVICE CLASSIFICATION:	Class II, 21CFR§870.1250
CLASSIFICATION NAME:	Percutaneous Catheter
PRODUCT CODE:	DQY, Catheter, Percutaneous
PREDICATE DEVICE(S):	Primary Predicate:ASAHI Corsair Armet (K161362)

Intended Use/Indications for Use

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Device Description:

Comparison with Predicate Device:

A comparison of the ASAHI CROSSWALK™ Peripheral Support Catheter and predicate devices show that the technological characteristics of the ASAHI CROSSWALK™ such as components. design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices.

The intended use/indications of the Subject Device are a subset of the predicate. There are specific design features of the Subject Device that are similar to the predicate which has demonstrated equivalence for these similar features.

Name of Device	ASAHI Corsair Armet	ASAHI CROSSWALK™
510(K)	K161362	Current Application
Intended Use and Indications	The ASAHI Corsair Armet isintended to provide support tofacilitate the placementof guide wires in the peripheralvasculature, and can be usedto exchange one guide wire foranother. The ASAHI CorsairArmet is also intended to assistin the delivery of contrastmedia into the peripheralvasculature. This device shouldnot be used in coronaryvasculature orneurovasculature.	The CROSSWALK™ isintended to provide support tofacilitate the placement of guidewires in the peripheralvasculature, and can be used toexchange one guide wire foranother. The CROSSWALK™is also intended to assist in thedelivery of contrast media intothe peripheral vasculature.
Target Body Location	Peripheral
Hydrophilic Coating	Yes
Effective Length	600-1500mm	900-1700mm
Nominal Outer Diameter	Distal: 0.75mmProximal: 0.83mm	Distal014: 0.0285in (0.724mm)018: 0.0330in (0.838mm)035: 0.0550in (1.397mm)Proximal014: 0.0350in (0.889mm)018: 0.0350in (0.889mm)035: 0.0550in (1.397mm)

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Catheter Shaft Material	Polyamide-elastomer	Polyamide/Polyamide-elastomer
Distal Tip Length	1.2mm	1.0cm (10mm)
Single Use	Yes
Sterilization	Ethylene Oxide
SAL	10-6
Shelf life	3 Years	1 Year

NON CLINICAL TESTING / PERFORMANCE DATA;

Non Clinical Laboratory testing was performed on the ASAHI CROSSWALK™ Peripheral Support Catheter to determine substantial equivalence. The following tests were performed:

Visual Inspection ●
Corrosion Resistance ●
Force Break ●
Liquid Leak ●
Air Leak ●
Radio-Detectability ●
Torque Transmission
Torque Durability
Slide Durability ●
Kink Resistance ●
Flow Test ●
Dimensions ●
Coating Integrity ●

In the in vitro bench tests demonstrated that the ASAHI CROSSWALK™ Peripheral Support Catheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrates that the device functions as intended, and is substantially equivalent to the predicate devices.

All bench testing of the ASAHI CROSSWALK'™ Peripheral Support Catheter was performed on finished sterilized product. The acceptance criteria were based on ISO10555-1. Tests not conducted per ISO10555-1 were conducted using in-house validated procedures with internally developed acceptance criteria.

All ASAHI CROSSWALK™ Peripheral Support Catheter test samples met the acceptance criteria for each of the tests listed in this submission. There were no deviations from the acceptance criteria. Testing shows that the ASAHI CROSSWALK™ Peripheral Support Catheter is equivalent to the predicate ASAHI Corsair Armet.

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BIOCOMPATIBILITY:

The Biological Safety of the ASAHI CROSSWALK™ Peripheral Support Catheter was verified in accordance with the ISO10993-1, Biological Evaluation of Medical Devices. The testing was performed by independent laboratories. The results provided assurance that the peripheral support catheters have a safe biocompatibility profile.

CONCLUSION:

The ASAHI CROSSWALK™ Peripheral Support Catheter has identical intended use, the same 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.

Therefore, the ASAHI CROSSWALK™ Peripheral Support Catheter is substantially equivalent to the 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).