Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and mechanical performance of the guide wire, with no mention of AI or ML.

Therapeutic

No.
The device is a guide wire, which is an accessory used to facilitate the placement of other therapeutic devices (balloon dilatation catheters). It does not directly provide a therapeutic effect itself.

Diagnostic

No

Explanation: The device description and intended use clearly state that the guide wires are designed to facilitate the placement of balloon dilatation catheters, which is an interventional or therapeutic function, not a diagnostic one. There is no mention of the device being used to identify or analyze medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details the physical construction of a guidewire made of stainless steel, platinum-nickel, and other materials, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is used to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This is a procedure performed in vivo (within the living body).
Device Description: The description details a physical guide wire designed to be inserted into blood vessels.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests outside of the body on biological samples. This device is an interventional medical device used inside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DQX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary, neurovasculature (not to be used)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

The ASAHI SION Series was tested to assess biocompatibility of the modified coating material.
Biocompatibility tests performed:

Cytotoxicity (MEM Elution Test - L-929)
Sensitization (Kligman Maximization Test - ISO)
Irritation (Intracutaneous Injection Test - ISO)
Systemic Toxicity (Rabbit Pyrogen Test (material mediated))
Systemic Toxicity (MHLW) (Systemic Injection)
Hemocompatibility (Hemolysis)
Hemocompatibility (Unactivated Partial Thromboplastin Time Assay (UPTT))
Hemocompatibility (Complement Activation Assay (Direct))
Hemocompatibility (Thrombogenicity)
All biocompatibility tests passed.

Key Metrics

Not Found

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)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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

1

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

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.

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.

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 and
Indications	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.
Device Description	The ASAHI SION PTCA
Guide Wire is a steerable
guide wire with a maximum
diameter of 0.014 inches
(0.36mm) and available in
180cm to 300cm lengths. The
extension wire is connected
to the end of the guide wire
outside the body. The guide
wire is constructed from a
stainless- steel core wire with
platinum-nickel and stainless-
steel coils. The coil assembly
consists of an inner coil and
an outer coil, and there is a
safety wire which is soldered
to the inner and outer coils
and the core wire. The distal
end of the guide wire has a
radiopaque tip to achieve
visibility, and is available in
straight configuration and can
be made to bend easily with
the vessel curve. A
hydrophilic coating is applied
to the distal portion of the
guide wire. The proximal
section of the guide wire is
coated with PTFE.	The ASAHI SION blue PTCA
Guide Wire is a steerable
guide wire with a maximum
diameter of 0.014 inches
(0.36mm) and available in
180cm to 300cm lengths. The
guide wire is constructed from
a stainless steel core wire with
platinum -nickel and stainless-
steel coils. The coil assembly
consists of an inner coil and an
outer coil, and there is a safety
wire which is soldered to the
inner and outer coils and the
core wire. The distal end of the
guide wire has a radiopaque
tip to achieve visibility. The
distal end of the coil part is
available straight and is made
soft to easily bend with the
vessel curve, or available in
pre-shaped "J". Silicone and
hydrophilic coating are applied
to the distal portion of the
guide wire. The proximal
section of the guide wire is
coated with PTFE. The
extension wire is connected to
the end of the guide wire
outside the body for 180cm
wire.	The ASAHI SION J PTCA
Guide Wire is a steerable
guide wire with a maximum
diameter of 0.014 inches
(0.36mm) and available in
180cm to 300cm lengths.
The guide wire is
constructed from a stainless
steel core wire with
platinum-nickel and
stainless-steel coils. The coil
assembly consists of an
inner coil and an outer coil,
and there is a safety wire
which is soldered to the
inner and outer coils and the
core wire. The distal end of
the guide wire has a
radiopaque tip to achieve
visibility and is available as a
pre-shaped "J".
A hydrophilic coating is
applied to the distal portion
of the guide wire. The
proximal section of the guide
wire is coated with PTFE.
The extension wire is
connected to the end of the
guide wire outside the body
for 180cm wire.	The ASAHI PTCA Guide Wire
ASAHI SION, ASAHI SION blue
and the 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
guide 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 guide wire has a
radiopaque tip to achieve visibility
and is available in a straight
(SION) and shaped "J" (SION blue,
SION J and Pre-Shape SION and
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 (ASAHI SION blue). The proximal
sections of the SION series are
coated with PTFE. The extension
wire is connected to the end of the
guide wire outside of the body for
180cm 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: 15mm
Hydrophilic: 191mm	285mm
Distal end with radiopaque tip	Straight
Proposed addition of:
Pre-shape model	Straight & J-Shape
Proposed addition of:
Pre-shape model	J- Shape
Proposed addition of:
190cm model
Proximal section coating	PTFE	PTFE
Proposed 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
Cytotoxicity
MEM Elution Test - L-929	ISO 10993-5	Pass
Sensitization
Kligman Maximization Test - ISO	ISO 10993-10	Pass
Irritation
Intracutaneous Injection Test - ISO	ISO 10993-10	Pass
Systemic Toxicity
Rabbit Pyrogen Test (material mediated)	ISO 10993-11	Pass
Systemic Toxicity (MHLW)
Systemic Injection	SO 10993-11 and MHLW
Notice Assessment of
Medical Devices #36	Pass
Hemocompatibility
Hemolysis	ISO 10993-4	Pass
Hemocompatibility
Unactivated Partial Thromboplastin Time Assay (UPTT)	ISO 10993-4	Pass
Hemocompatibility
Complement Activation Assay (Direct)	ISO 10993-4	Pass
Hemocompatibility
Thrombogenicity	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.