The ASAHI Silverway consists of a one-piece core wire and a coil assembly that extends the entire length of the device. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. In addition, coatings are applied on the surface of the ASAHI Silverway. The distal and proximal sections are coated with silicone. The intermediate section is coated with hydrophilic coating. The ASAHI Silverway has a nominal outer diameter of 0.89mm (0.035in) and is available in various lengths from 150cm to 300cm and tip shapes.

AI/ML Overview

This document describes the premarket notification (510(k)) for the ASAHI® Silverway® guidewire. The acceptance criteria and study details are focused on non-clinical performance given the type of device and the 510(k) pathway, which establishes substantial equivalence rather than independent safety and effectiveness.

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

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

The document states that the ASAHI Silverway "met all acceptance criteria" and "performed similarly to the predicate devices." While specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, maximum torque to twist in degrees) are not explicitly listed in the public summary, the general categories of tests performed indicate the areas for which acceptance criteria would have been established.

Test Category	Reported Device Performance
Dimensional Verification	Met all acceptance criteria / Performed as intended
Tensile Strength	Met all acceptance criteria / Performed as intended
Torque Strength	Met all acceptance criteria / Performed as intended
Torqueability	Met all acceptance criteria / Performed as intended
Tip Flexibility	Met all acceptance criteria / Performed as intended
Coating Adhesion	Met all acceptance criteria / Performed as intended
Catheter Compatibility	Met all acceptance criteria / Performed as intended
Radiopacity (ISO 11070)	Met all acceptance criteria / Performed as intended
Corrosion (ISO 11070)	Met all acceptance criteria / Performed as intended
Biocompatibility (ISO 10993)	Found to be biocompatible (met all relevant test criteria)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not explicitly state the specific number of units tested for each non-clinical test. It generally refers to "non-clinical laboratory testing."
Data Provenance: The tests were "non-clinical laboratory testing" presumably conducted by or for ASAHI INTECC CO., LTD. Given the company's address (Japan), the testing was likely performed in Japan or by a qualified lab contracted by them. The studies are by nature prospective in that new guidewires were manufactured and then tested according to predefined protocols.

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

This section is not applicable to this type of regulatory submission. For a guidewire, "ground truth" is typically defined by engineering specifications, material properties, and performance benchmarks established through industry standards (e.g., ISO, ASTM) and comparison to predicate devices, rather than expert human interpretation of complex data (like medical images).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is non-clinical laboratory testing against pre-defined engineering and material standards, there is no need for expert adjudication in the way it might be applied to, for example, classifying medical images. Test results are objective measurements.

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 device is a medical guidewire, not an AI/imaging device. Therefore, no MRMC study or AI assistance evaluation would be relevant or expected.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is based on:

Engineering specifications and design requirements: Did the device meet its designed dimensions, material properties, and functional characteristics?
International standards: Adherence to relevant ISO (e.g., ISO 11070 for catheter guidewires, ISO 10993 for biocompatibility) and ASTM standards.
Performance of predicate devices: Substantial equivalence is demonstrated by performing "similarly to the predicate devices." The predicates themselves would have established a benchmark for acceptable performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense. The "training" in manufacturing comes from process validation and quality control, but not a data-driven model training.

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

Not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

July 1, 2019

Asahi Intecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 1783 Forest Drive, #254 Annapolis, Maryland 21401

Re: K183062

Trade/Device Name: ASAHI Silverway Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 31, 2019 Received: June 3, 2019

Dear Candace Cederman:

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-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 Kenneth Cavanaugh, Ph.D. Director (Acting) DHT2C: Division of Coronary and Peripheral Interventional 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) K183062

Device Name ASAHI® Silverway®

Indications for Use (Describe)

This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

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 21 CFR 807.92)

Image /page/3/Picture/2 description: The image shows the logo for ASAHI INTECC CO., LTD. The logo features the company name in a bold, sans-serif font, with the first letter 'A' stylized in red. Below the logo, the company's address is printed: 3-100 Akatsuki-cho, Seto, Aichi 489-0071, Japan.

3-100 Akatsuki-cho, Seto, Aichi 489-0071 Japan Tel. +81-561-48-5551 Fax. +81-561-48-5552 Branch office: Tokyo, Nagova, Osaka, Hong Kong, EU, Singapore, Beijing, India, Middle Eastern Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi

ASAHI® Silverway® 510(k) K183062

Date Prepared:	28 June 2019
Applicant:	ASAHI INTECC CO., LTD.3-100 Akatsuki-cho,Seto, Aichi 489-0071 Japan
Contact:	Yoshi TeraiPresident/CEOASAHI INTECC USA, Inc.3002 Dow Avenue, Suite 212Tustin, CA 92780Tel: (949) 756-8252, FAX: (949) 756-8165e-mail: ASAHI.ra-fda@ASAHI-intecc.com
Trade Name:	ASAHI® Silverway®
Device Classification:	Class 2 per 21 CFR §870.1330
Classification Name:	Catheter, Guide, Wire
Product Code:	DQX - Catheter Guide Wire
Primary Predicate Device:	EMERALD Guidewire, K935170
Reference Devices:	RADIFOCUS Glidewire, K863138ASAHI CHIKAI, K110584ASAHI CHIKAI black, K141751ASAHI SOFT, K022762ASAHI Gladius Mongo, K180784ASAHI Gladius, K150445

INTENDED USE/INDICATIONS FOR USE:

This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

DEVICE DESCRIPTION:

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0.89mm (0.035in) and is available in various lengths from 150cm to 300cm and tip shapes.

COMPARISON WITH PREDICATE DEVICES:

Comparisons of the ASAHI® Silverway® and predicate / reference devices show that the technological characteristics of the subject device such as the components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate and reference devices. The ASAHI Silverway and predicate device are constructed with a core wire covered by a coil. The available lengths and tip shapes of the ASAHI Silverway are within the ranges of the predicate and reference devices. Currently, the ASAHI Silverway is available in an 0.035" diameter which is within the range of the sizes available for the predicate and reference devices. The ASAHI Silverway has both a hydrophilic and hydrophobic (silicone) coating, whereas the predicate and reference devices have either a hydrophilic or hydrophobic coating. The intended use of the subject device and its predicates are the same.

Name of Devices	ASAHI Silverway	EMERALDGuidewire	RADIFOCUSGlidewire
510(k)	SubjectK183062	PredicateK935170	ReferenceK863138
Intended Use andIndications	This product isintended for use inthe percutaneousintroduction ofcatheters. Not for usein the coronaryarteries or intracranialvessels.	Cordis Guidewiresare intended for usein the percutaneousintroduction ofcatheters.	The Glidewire isdesigned to direct acatheter to thedesired anatomicallocation duringdiagnostic orinterventionalprocedures.
Nominal OD	0.89mm(0.035in)	0.46~~1.65mm(0.018~~0.065in)	0.46~~0.97mm(0.018~~0.038in)
Overall Length	150~300cm	80~260cm	30~300cm
Outer Coil	Stainless Steel	Stainless Steel	NA
Tapered Core Wire	Stainless Steel	Stainless Steel	Ni-Ti
Inner Structure	Stainless SteelCoil	Stainless SteelSafety Wire	NA
Tip Shape	AngleJ-tip	StraightJ-tip	StraightAngleJ-Tip
Coating	SiliconeHydrophilic	PTFE	Hydrophilic
Sterilization	Provided sterile viaEthylene Oxide toSAL 10-6	Provided sterile viaEthylene Oxide	Provided sterile viaEthylene Oxide

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NON-CLINICAL TESTING/PERFORMANCE DATA:

Non-clinical laboratory testing was performed on the ASAHI® Silverway® to determine substantial equivalence. The following testing/assessments were performed:

Non-clinical laboratory testing was performed on the ASAHI Silverway to determine substantial equivalence. The following testing/assessments were performed:

Dimensional Verification ●
Tensile Strength ●
. Torque Strength
Torqueability ●
Tip Flexibilitv .
Coating Adhesion ●
. Catheter Compatibility
Radiopacity, ISO 11070
Corrosion, ISO 11070 ●

The in vitro bench tests demonstrated that the ASAHI Silverway met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate devices.

BIOCOMPATIBILITY:

The ASAHI Silverway was tested in accordance with ISO 10993 and found to be biocompatible. The following tests were performed.

Cytotoxicity	ISO 10993-5: Tests for in vitro cytotoxicity
Intracutaneous Reactivity/Irritation	ISO 10993-10: Tests for irritation and skin sensitization
Sensitization	ISO 10993-10: Tests for irritation and skin sensitization
Acute Systemic Toxicity	ISO 10993-11: Tests for systemic toxicity
Material Mediated Pyrogenicity	USP, General Chapter <151>,ISO 10993-11: Tests for systemic toxicity
Hemolysis	ASTM F756ISO 10993-4: tests for interactions with blood
Partial Thromboplastin Time	ASTM F2382
Thrombogenicity	ISO 10993-4: tests for interactions with blood
SC5b-9 Complement Activation	ISO 10993-4: tests for interactions with blood

CONCLUSION:

The ASAHI® Silverway® has identical intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate and reference devices.

Therefore, the ASAHI Silverway is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.