ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal anqioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

Device Description

ASAHI PTCA Guide Wire ASAHI SION (hereafter "ASAHI SION"), ASAHI PTCA Guide Wire ASAHI SION blue (hereafter "ASAHI SION blue") and ASAHI PTCA Guide Wire ASAHI SION J (hereafter "ASAHI SION J") are steerable guidewires with a maximum diameter of 0.014 inches (0.36mm) and available in 180cm. 190cm and 300cm lengths. The quide wire is constructed from stainless-steel core wire with platinum-nickel and stainless-steel coils. The coils assembly consists of an inner coil and an outer coil, as well as a safety wire which is soldered to the inner and outer coils and the core wire. The distal end of the quide wire has a radiopaque tip to achieve visibility and is available in a straight (ASAHI SION) and shaped "J" (ASAHI SION blue, ASAHI SION J) and Pre-Shape (ASAHI SION and ASAHI SION blue) to easily bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire (ASAHI SION and ASAHI SION J). A silicone and hydrophilic coating are applied to the distal portion of the guide wire for (ASHI SION blue). The proximal sections of the ASAHI SION Series are coated with PTFE.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification from the FDA for the Asahi PTCA Guide Wire Asahi SION Series. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. However, it does not include information about any studies that would involve AI or human readers.

Here's the breakdown of the information provided for the device's acceptance criteria and studies, as requested, focusing on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that non-clinical laboratory testing was performed and that the device met all acceptance criteria. However, the specific quantitative acceptance criteria values for each test are not explicitly detailed. The performance is reported as meeting these (unstated) criteria and being similar to predicate devices.

Test Performed	Reported Device Performance
Tensile Strength	Met all acceptance criteria and performed similarly to predicate devices.
Torque Strength	Met all acceptance criteria and performed similarly to predicate devices.
Coat Adhesion	Met all acceptance criteria and performed similarly to predicate devices.
Particulate	Met all acceptance criteria and performed similarly to predicate devices.
Biocompatibility	Passed various ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility).

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

The document mentions "non-clinical laboratory testing" and "in vitro bench tests." It does not specify the sample sizes used for these tests. The data provenance is described as non-clinical laboratory testing, implying controlled lab environments, not patient data from specific countries. It is retrospective, as it's testing a finished product against established standards.

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

Not applicable. This is a non-clinical device performance study, not involving human interpretation of data where expert ground truth would be established. The acceptance criteria are based on engineering and material science standards.

4. Adjudication Method for the Test Set:

Not applicable. This is a non-clinical device performance study.

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

No, an MRMC comparative effectiveness study was not conducted or described in this document. This filing is for a physical medical device (guidewire), not a software or AI-based diagnostic tool that would typically involve human readers or AI assistance.

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

No, a standalone algorithm performance study was not conducted or described. The device is a physical guidewire, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by industrial standards and pre-defined specifications for medical devices (e.g., ISO 10993 for biocompatibility, and unspecified internal criteria for mechanical properties like tensile strength, torque strength, coat adhesion, and particulate matter).

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. As there is no training set mentioned, there is no corresponding ground truth establishment process for it.

Summary

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Image /page/0/Picture/0 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 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.

November 21, 2019

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

Re: K191464

Trade/Device Name: Asahi PTCA Guide Wire Asahi SION Series Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 30, 2019 Received: October 2, 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-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, Ph.D. 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) K191464

Device Name ASAHI PTCA Guide Wire ASAHI SION Series

Indications for Use (Describe)

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

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 §801.32(e)]

ASAHI PTCA Guide Wire ASAHI

SION Series 510(K): K191464

DATE PREPARED:	05NOV2019
APPLICANT:	ASAHI INTECC CO., LTD.
	3-100 Akatsuki-cho, Seto
	Aichi 489-0071, Japan
PRIMARY CONTACT:	Mrs. Cynthia Valenzuela
	Director, Regulatory Affairs
	ASAHI INTECC USA, INC.
	3002 Dow Avenue, Suite 212
	Tustin, California 92780
	Phone: (714) 442 0575
	Fax: (949) 377 3255
	Cell Phone: (949) 413 0071
	Email: cynthiav@asahi-intecc-us.com
TRADE NAME:	ASAHI PTCA Guide Wires SION Series
DEVICE CLASSIFICATION:	Class II, 21CFR§870.1330
CLASSIFICATION NAME:	Wire, Guide, Catheter
PRODUCT CODE:	DQX, Wire, Guide, Catheter
PREDICATE DEVICE(S):	Primary Predicate:ASAHI PTCA Guide Wire ASAHI SION (K100578)ASAHI PTCA Guide Wire ASAHI SION blue (K122468)ASAHI PTCA Guide Wire ASAHI SION J (K122469)

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Intended Use/Indications for Use

Description:

Comparison with Predicate Device(s):

ASAHI PTCA Guide Wire ASAHI SION (K100578)
. ASAHI PTCA Guide Wire ASAHI SION blue (K122468)
ASAHI PTCA Guide Wire ASAHI SION J . (K122469)

Comparisons of the ASAHI SION Series and predicate devices show that the technological characteristics of the ASAHI SION Series such as:

· Indications for use
· Fundamental scientific technology
Fundamental design
· Materials and processes for packaging and sterilization of devices

are similar to the currently marketed predicate devices. A tabular comparison of the specific technological characteristics between the predicate device and subject device is provided below.

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Table 1: Comparison table

Name of Device	ASAHI SION	ASAHI SION blue	ASAHI SION J PTCA	SUBJECT DEVICE
510(K) Number:	K100578	K122468	K122469	K191464
Intended Use andIndications	ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneoustransluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guidewires are not to be used in the neurovasculature.
Device Description	The ASAHI SION PTCAGuide Wire is a steerableguide wire with a maximumdiameter of 0.014 inches(0.36mm) and available in180cm to 300cm lengths. Theextension wire is connectedto the end of the guide wireoutside the body. The guidewire is constructed from astainless- steel core wire withplatinum-nickel and stainless-steel coils. The coil assemblyconsists of an inner coil andan outer coil, and there is asafety wire which is solderedto the inner and outer coilsand the core wire. The distalend of the guide wire has aradiopaque tip to achievevisibility, and is available instraight configuration and canbe made to bend easily withthe vessel curve. Ahydrophilic coating is appliedto the distal portion of theguide wire. The proximalsection of the guide wire iscoated with PTFE.	The ASAHI SION blue PTCAGuide Wire is a steerableguide wire with a maximumdiameter of 0.014 inches(0.36mm) and available in180cm to 300cm lengths. Theguide wire is constructed froma stainless steel core wire withplatinum -nickel and stainless-steel coils. The coil assemblyconsists of an inner coil and anouter coil, and there is a safetywire which is soldered to theinner and outer coils and thecore wire. The distal end of theguide wire has a radiopaquetip to achieve visibility. Thedistal end of the coil part isavailable straight and is madesoft to easily bend with thevessel curve, or available inpre-shaped "J". Silicone andhydrophilic coating are appliedto the distal portion of theguide wire. The proximalsection of the guide wire iscoated with PTFE. Theextension wire is connected tothe end of the guide wireoutside the body for 180cmwire.	The ASAHI SION J PTCAGuide Wire is a steerableguide wire with a maximumdiameter of 0.014 inches(0.36mm) and available in180cm to 300cm lengths.The guide wire isconstructed from a stainlesssteel core wire withplatinum-nickel andstainless-steel coils. The coilassembly consists of aninner coil and an outer coil,and there is a safety wirewhich is soldered to theinner and outer coils and thecore wire. The distal end ofthe guide wire has aradiopaque tip to achievevisibility and is available as apre-shaped "J".A hydrophilic coating isapplied to the distal portionof the guide wire. Theproximal section of the guidewire is coated with PTFE.The extension wire isconnected to the end of theguide wire outside the bodyfor 180cm wire.	The ASAHI PTCA Guide WireASAHI SION, ASAHI SION blueand the ASAHI SION J aresteerable guidewires with amaximum diameter of 0.014 inches(0.36mm) and available in 180cm,190cm and 300cm lengths. Theguide wire is constructed fromstainless-steel core wire withplatinum-nickel and stainless-steelcoils. The coils assembly consistsof an inner coil and an outer coil,as well as a safety wire which issoldered to the inner and outercoils and the core wire. The distalend of the guide wire has aradiopaque tip to achieve visibilityand is available in a straight(SION) and shaped "J" (SION blue,SION J and Pre-Shape SION andSION blue) to easily bend with thevessel curve. A hydrophilic coatingis applied to the distal portion ofthe guide wire (ASAHI SION andASAHI SION J). A silicone andhydrophilic coating are applied tothe distal portion of the guide wirefor (ASAHI SION blue). The proximalsections of the SION series arecoated with PTFE. The extensionwire is connected to the end of theguide wire outside of the body for180cm and 190cm wires.

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Name of Device	ASAHI SION	ASAHI SION blue	ASAHI SION J PTCA
	K100578	K122468	K122469
Regulatory Status:
Regulation Number:	21 CFR§ 870.1330	21 CFR§ 870.1330	21 CFR§ 870.1330
Regulation Name:	Guide Wire	Guide Wire	Guide Wire
Regulatory Class:
Product Code:	DQX	DQX	DQX
Product Information:
Core wire	Stainless-steel	Stainless-steel	Stainless-steel
Overall length	180cm & 300cm	180cm & 300cm	180cm & 300cm
	Proposed change:Addition of 190cm	Proposed change:Addition of 190cm Model	Proposed change:Addition of 190cm Model
	Model
Outside diameter of wire	0.014" (0.36mm)	0.014" (0.36mm)	0.014" (0.36mm)
Coil length of radiopaque part	3cm	3cm	3cm
Distal wire coating	Hydrophilic	Hydrophilic and Silicone oil	Hydrophilic
Distal section coating length	285mm	Silicone: 15mmHydrophilic: 191mm	285mm
Distal end with radiopaque tip	StraightProposed addition of:Pre-shape model	Straight & J-ShapeProposed addition of:Pre-shape model	J- ShapeProposed addition of:190cm model
Proximal section coating	PTFE	PTFEProposed inclusion:Alternate PTFE coating	PTFE
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Provided Sterile	Yes	Yes	Yes
Sterility Level	SAL10-6	SAL10-6	SAL10-6
Single Use	Yes	Yes	Yes
Shelf Life	3 Years	3 Years	3 Years

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NON CLINICAL TESTING / PERFORMANCE DATA;

Non Clinical laboratory testing was performed on the ASAHI SION Series to determine substantial equivalence. The following testing was performed:

Tensile Strength
Torque Strength ●
Coat Adhesion ●
Particulate .

In the in vitro bench tests demonstrated that the ASAHI SION Series 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.

BIOCOMPATIBILITY:

The ASAHI SION Series was tested to assess biocompatibility of the modified coating material.

Table 2: Biocompatibility Summary

Test Method	Standard	Pass / Fail
CytotoxicityMEM Elution Test - L-929	ISO 10993-5	Pass
SensitizationKligman Maximization Test - ISO	ISO 10993-10	Pass
IrritationIntracutaneous Injection Test - ISO	ISO 10993-10	Pass
Systemic ToxicityRabbit Pyrogen Test (material mediated)	ISO 10993-11	Pass
Systemic Toxicity (MHLW)Systemic Injection	SO 10993-11 and MHLWNotice Assessment ofMedical Devices #36	Pass
HemocompatibilityHemolysis	ISO 10993-4	Pass
HemocompatibilityUnactivated Partial Thromboplastin Time Assay (UPTT)	ISO 10993-4	Pass
HemocompatibilityComplement Activation Assay (Direct)	ISO 10993-4	Pass
HemocompatibilityThrombogenicity	ISO 10993-4	Pass

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CONCLUSION:

The ASAHI PTCA Guide Wire ASAHI SION Series 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 PTCA Guide Wire ASAHI SION Series 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.