The ASAHI Corsair Armet 18 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 ASAHI Corsair Armet 18 is also intended to assist in the delivery of contract media into the peripheral vasculature.

This device should not be used in coronary vasculature or neurovasculature.

Device Description

This product consists of a distal tip, a shaft tube, a protector and a connector. The distal tip and distal side of shaft are coated with hydrophilic coating on the outer surface. The tip is radiopaque, and the distal end is clearly distinguished by the tip.

AI/ML Overview

The provided document, a 510(k) summary for the ASAHI Corsair Armet 18, describes the device's acceptance criteria and the study (non-clinical testing) used to demonstrate its substantial equivalence to a predicate device.

It's important to note that this device is a Percutaneous Catheter, and its performance evaluation relies on non-clinical bench testing rather than clinical studies involving human patients or complex AI algorithms processing medical images. Therefore, some of the requested information (like sample size for test/training sets for AI, expert adjudication, MRMC studies, or specific ground truth methodologies for image-based AI) is not applicable or present in this context.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance
Air Leakage	Met all acceptance criteria.
Appearance / Dimensions	Met all acceptance criteria.
Burst Pressure Under Static Condition	Met all acceptance criteria.
Corrosion Resistance	Met all acceptance criteria.
Kink Resistance	Met all acceptance criteria.
Liquid Leakage Under Pressure	Met all acceptance criteria.
Radio-Detectability	Met all acceptance criteria.
Slide Durability	Met all acceptance criteria.
Tensile Strength / Force at Break	Met all acceptance criteria.
Torque Durability	Met all acceptance criteria.
Torque Transmission	Met all acceptance criteria.
Overall Statement	"In the in vitro bench tests demonstrated that the ASAHI Corsair Armet 18 Microcatheter 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 device. All ASAHI Corsair Armet 18 Microcatheter test samples met the acceptance criteria for each of the tests listed in this submission. There were no deviations from the acceptance criteria."

Note: The specific quantitative acceptance values for each test are not detailed in this summary but are implied to be established based on ISO10555-1 and/or internally validated procedures.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document repeatedly states "All ASAHI Corsair Armet 18 Microcatheter test samples" but does not specify the exact number of samples used for each test. This is typical for bench testing where a representative number of units are tested to ensure consistency and compliance.
Data Provenance: The testing was "in vitro bench tests" performed on finished sterilized product. The applicant is ASAHI INTECC CO., LTD based in Japan, and the primary contact is in Tustin, California, USA. The testing itself would have been conducted in a laboratory, likely in-house or by a contracted lab. The data is retrospective in the sense that it's performed on manufactured devices for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable in this context. This device's evaluation is based on physical and mechanical performance characteristics of a medical device, not on diagnostic interpretations by human experts. The "ground truth" is defined by the objective measurement of physical properties against established engineering and medical device standards (ISO10555-1) and internal specifications.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human review processes, typically in medical imaging studies where there's subjectivity in interpretation. For bench testing, results are quantitative and directly measured against pre-defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is compared. This document is for a medical catheter, not an AI diagnostic system.

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

Not applicable. This device is a physical medical instrument, not an algorithm. Its "performance" is its ability to meet specified physical and mechanical criteria.

7. The Type of Ground Truth Used

The ground truth is quantitative, objective physical and mechanical measurements against established international standards (ISO10555-1) and internally developed/validated acceptance criteria for various performance aspects (e.g., burst pressure, tensile strength, dimensions, kink resistance).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device's non-clinical evaluation, as it is not an AI/machine learning product. The device itself is manufactured, and specific samples from the manufacturing process are chosen for testing.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI algorithm, this question does not apply. The "ground truth" for evaluating the catheter's performance is derived from engineering principles, relevant ISO standards, and established medical device design specifications.

Summary of Approach:

The evaluation of the ASAHI Corsair Armet 18 relies entirely on non-clinical bench testing to demonstrate that its physical and mechanical performance characteristics are substantially equivalent to a legally marketed predicate device (ASAHI Corsair Armet, K161362). The "acceptance criteria" are the thresholds or ranges for various engineering and material properties that the device must meet to ensure safety and effectiveness as a percutaneous catheter. The "study" involves performing a series of standardized tests on a set of manufactured devices and confirming that all tested samples meet these pre-defined criteria.

Summary

{0}------------------------------------------------

September 8, 2020

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 the FDA logo, which consists of 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, Regulatory Affairs 3002 Dow Avenue, Suite 212 Tustin, California 92780

Re: K202252

Trade/Device Name: ASAHI Corsair Armet 18 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 31, 2020 Received: August 10, 2020

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 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

{1}------------------------------------------------

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 (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-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-regulatory-assistance/contact-usdivision-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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202252

Device Name ASAHI Corsair Armet 18

Indications for Use (Describe)

The ASAHI Corsair Armet 18 is intended to provide support to facement of guidewires in the peripheral vasculature, and can be used to exchange one guide wire for another.

The ASAHI Corsair Armet 18 is also intended to assist in the delivery of contract media into the peripheral vasculature.

This device should not be used in coronary vasculature or neurovasculature.

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)

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) Summary K202252

In accordance with the Safety Medical Devices Act of 1990 (SMDA), a 510(K) Summary of safety and effectiveness information upon which this substantial equivalence determination is based, is provided in this section.

DATE PREPARED:	31JUL2020
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 Corsair Armet 18
DEVICE CLASSIFICATION:	Class II, 21CFR§870.1250
CLASSIFICATION NAME:	Percutaneous Catheter
PRODUCT CODE:	DQY, Catheter, Percutaneous
PREDICATE DEVICE(S):	ASAHI Corsair Armet (K161362)

Intended Use/Indications for Use

The ASAHI Corsair Armet 18 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 ASAHI Corsair Armet 18 is also intended to assist in the delivery of contract media into the peripheral vasculature.

This device should not be used in coronary vasculature or neurovasculature.

Device Description:

{4}------------------------------------------------

Comparison with Predicate Device:

A comparison of the ASAHI Corsair Armet 18 Microcatheter and predicate device shows that the technological characteristics of the ASAHI Corsair Armet 18 Microcatheter such as components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate device.

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 Corsair Armet
510(K)	(K161362)	Subject Device / CurrentApplication
Intended Use andIndications	The ASAHI Corsair Armet isintended to provide support tofacilitate the placement of guidewires in the peripheralvasculature, and can be used toexchange one guide wire foranother.The ASAHI Corsair Armet is alsointended to assist in the deliveryof contract media into theperipheral vasculature.	The ASAHI Corsair Armet 18 isintended to provide support tofacilitate the placement of guidewires in the peripheralvasculature, and can be used toexchange one guide wire foranother.The ASAHI Corsair Armet 18 isalso intended to assist in thedelivery of contract media intothe peripheral vasculature.
	This device should not be usedin coronary vasculature orneurovasculature.	This device should not be usedin coronary vasculature orneurovasculature.
Target Body Location	Peripheral
Hydrophilic Coating	Yes
Effective Length	600-1500cm	600-1350cm
Nominal Outer Diameter	Distal: 0.75mmProximal: 0.83mm	Distal: 0.73mmProximal: 0.87mm
Catheter Shaft Material	Polyamide-elastomer
Distal Tip Length	1.2mm	1.50mm
Single Use	Yes
Sterilization	Ethylene Oxide to SAL-6
Shelf life	3 Years

{5}------------------------------------------------

NON-CLINICAL TESTING / PERFORMANCE DATA;

Non Clinical Laboratory testing performed on the ASAHI Corsair Armet 18 Microcatheter to determine substantial equivalence:

Air Leakage ●
Appearance / Dimensions .
Burst Pressure Under Static Condition ●
Corrosion Resistance ●
Kink Resistance .
Liquid Leakage Under Pressure ●
Radio-Detectability
. Slide Durability
Tensile Strength / Force at Break ●
Torque Durability .
Torque Transmission ●

In the in vitro bench tests demonstrated that the ASAHI Corsair Armet 18 Microcatheter 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 device.

All bench testing of the ASAHI Corsair Armet 18 Microcatheter performed on finished sterilized product. The acceptance criteria is based on ISO10555-1. Tests not conducted per ISO10555-1 were completed using in-house validated procedures with internally developed acceptance criteria.

All ASAHI Corsair Armet 18 Microcatheter 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 Corsair Armet 18 Microcatheter is equivalent to the predicate ASAHI Corsair Armet.

BIOCOMPATIBILITY:

The Biological Safety test of the ASAHI Corsair Armet 18 Microcatheter was not required. as the subject device did not change in material from its predicate device deeming biocompatibility testing unnecessary.

CONCLUSION:

The ASAHI Corsair Armet 18 Microcatheter has substantial 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 Corsair Armet 18 Microcatheter is considered, 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).