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), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

Device Description

The ASAHI PTCA Guide Wire ASAHI Gaia Next (hereafter "ASAHI Gaia Next") is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm length. The extension wire may be connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless-steel core wire with a platinum-nickel and stainless-steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The distal end of the quide wire has a radiopaque outer coil and inner coil to achieve visibility 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 coil assembly construction is similar to predicate device.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the ASAHI PTCA Guide Wire ASAHI Gaia Next. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting results from a study proving device performance against specific acceptance criteria for a new, novel technology. Therefore, many of the requested categories (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not available from this regulatory submission. This document details non-clinical bench testing to show the device performs similarly to a predicate.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of precise quantitative acceptance criteria (e.g., "tensile strength must be >X Newtons") or specific numerical performance results for each test. Instead, it states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" in bench testing.

Acceptance Criteria & Test Category	Reported Device Performance Summary
Non-Clinical Bench Testing:
Tensile Strength	Met all acceptance criteria and performed similarly to predicate devices.
Torque Strength	Met all acceptance criteria and performed similarly to predicate devices.
Torqueability	Met all acceptance criteria and performed similarly to predicate devices.
Tip Flexibility	Met all acceptance criteria and performed similarly to predicate devices.
Coating Adhesion / Integrity	Met all acceptance criteria and performed similarly to predicate devices.
Catheter Compatibility	Met all acceptance criteria and performed similarly to predicate devices.
Visual Inspection	Met all acceptance criteria and performed similarly to predicate devices.
Corrosion Resistance	Met all acceptance criteria and performed similarly to predicate devices.
Kink Resistance	Met all acceptance criteria and performed similarly to predicate devices.
Radio-detectability	Met all acceptance criteria and performed similarly to predicate devices.
Dimensional Verification	Met all acceptance criteria and performed similarly to predicate devices.
Coating Integrity/Particulate	Met all acceptance criteria and performed similarly to predicate devices.
Biocompatibility Testing:
Hemocompatibility (due to coil change):	Verified to be the same as predicates/reference devices.
- Hemolysis	Verified to be the same as predicates/reference devices.
- SC5b-9 Complement Activation	Verified to be the same as predicates/reference devices.
- Unactivated Partial Thromboplastin Time	Verified to be the same as predicates/reference devices.
- Thrombogenicity	Verified to be the same as predicates/reference devices.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document refers generally to "bench testing" without providing the number of units tested for each non-clinical performance test.
Data Provenance: The tests are described as "in vitro bench tests." This implies tests were conducted in a laboratory setting. The country of origin of the data is not explicitly stated, but the applicant is ASAHI INTECC CO., LTD from Japan.

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

Not Applicable. This device is a guide wire, and the evaluation involves non-clinical engineering and biological performance testing, not diagnostic interpretation requiring expert consensus on "ground truth."

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

Not Applicable. As mentioned above, this is non-clinical bench testing. Adjudication methods are relevant for human-read diagnostic studies.

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 is a medical device (guide wire), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not Applicable. This is a medical device (guide wire), not an AI-powered diagnostic tool. No standalone algorithm performance was evaluated.

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

For the non-clinical bench tests, the "ground truth" or reference for acceptance is against established engineering and material science standards and performance specifications for guide wires, and comparison to the predicate device. For biocompatibility, it's against established biological safety standards.

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. The testing described is for a physical medical guide wire.

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

Not Applicable. See point 8.

Summary

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January 2, 2020

Asahi Intecc Co., Ltd. % Cynthia Valenzuela Director, Regulatory Affairs Asahi Intecc USA, Inc. 3002 Dow Ave, Suite 212 Tustin, California 92780

Re: K192599

Trade/Device Name: ASAHI PTCA Guide Wire ASAHI Gaia Next Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 27, 2019 Received: December 3, 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 (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,

Lydia Glaw, Ph.D. Assistant Director 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) K192599

Device Name ASAHI PTCA Guidewire ASAHI Gaia Next

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)]

ASAHI PTCA Guide Wire ASAHI Gaia Next

DATE PREPARED:	18 NOV 2019
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 PTCA Guide Wire ASAHI Gaia Next
DEVICE CLASSIFICATION:	Class II, 21CFR § 870.1330
CLASSIFICATION NAME:	Catheter Guide Wire
PRODUCT CODE:	DQX - Wire, Guide, Catheter
PREDICATE DEVICE(S):	ASAHI PTCA Guide Wire ASAHI Gaia (K171933)
REFERENCE DEVICE(S):	ASAHI PTCA Guide Wire CONFIANZA PRO 12 (K052339)ASAHI PTCA Guide Wire ASAHI SION blue (K122468)ASAHI PTCA Guide Wire ASAHI Gaia (K138653)ASAHI Neurovascular Guide Wire ASAHI CHIKAI black (K141751)ASAHI PTCA Guide Wire ASAHI Fielder XT-A (K153106)ASAHI PTCA Guide Wire ASAHI SUOH 03 (K162842)ASAHI PTCA Guide Wire ASAHI Gladius Mongo (K180784)

510(K) K192599

Intended Use/Indications for Use

Description:

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coating is applied to the distal portion of the guide wire. The coil assembly construction is similar to predicate device.

Comparison with Predicate Device(s):

Predicate Device: ASAHI PTCA Guide Wire ASAHI Gaia (K171933)

Comparisons of the ASAHI Gaia Next and predicate devices show that the technological characteristics of the ASAHI Gaia Next such as components, design, materials, sterilization Method:, shelf life and operating principle are identical or similar to the currently marketed predicate device. A tabular comparison of the specific technological characteristics between the predicate device and subject device is provided below.

The main changes from the predicate ASAHI Gaia are as follows:

Outer Coil Material ●
. Outer Coil Wire
Inner Coil Material .

Name of Device	ASAHI PTCA Guide WireASAHI Gaia Next	ASAHI PTCA Guide WireASAHI Gaia
510(K)	K192599	K171933
Intended Use and Indications	ASAHI PTCA Guide Wires are intended to facilitate the placement of balloodilatation catheters during percutaneous transluminal coronary angioplasty(PTCA) and percutaneous transluminal angioplasty (PTA), including use incrossing or assisting in crossing de novo coronary chronic total occlusions(CTO).The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
Sterilization	Ethylene Oxide to SAL 10-6
Shelf Life	2 Years	3 Years
Target Body Location	Coronary, Peripheral
Outer Coil Material	Stainless SteelPlatinum Nickel	Platinum Nickel
Outer Coil Wire	7-wire woven coil	Single wire coil
Core Wire Material	Stainless Steel	Stainless Steel
Inner Coil Material	Stainless SteelPlatinum Nickel	Stainless Steel
Distal Tip Shape	Pre-shape	Straight, Pre-shape
Overall Length	190cm	190cm, 300cm
Distal Section Coating length	40cm	40cm
Outside Diameter of Wire	ASAHI Gaia Next 1Distal 0.27mm/Proximal 0.36mmASAHI Gaia Next 2Distal 0.30mm/Proximal 0.36mmASAHI Gaia Next 3Distal 0.30mm/Proximal 0.36mm	ASAHI Gaia FirstDistal 0.26mm/Proximal 0.36mmASAHI Gaia SecondDistal 0.28mm/Proximal 0.36mmASAHI Gaia ThirdDistal 0.30mm/Proximal 0.36mm

Non Clinical Testing / Performance Data:

The substantial equivalence of the ASAHI Gaia Next line extension was evaluated in bench testing that followed the recommendations in the FDA draft guidance document; Coronary,

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Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018.

. Tensile Strength
. Torque Strength
Torqueability .
Tip Flexibility
Coating Adhesion / Integrity .
Catheter Compatibility ●
. Visual Inspection
. Corrosion Resistance
Kink Resistance
. Radio - detectability
Dimensional Verification ●
Coating Integrity/Particulate ●

The in vitro bench tests demonstrated that the ASAHI Gaia Next 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 device.

BIOCOMPATIBILITY:

The ASAHI Gaia Next was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates / reference devices, the biocompatibility of the ASAHI Gaja Next was verified to be the same as those of the predicates / reference devices. Additional Hemocompatibility testing was conducted due to the change in the coil:

Hemolysis ●
SC5b-9 Complement Activation
Unactivated Partial Thromboplastin Time ●
Thrombogenicity ●

CONCLUSION:

The ASAHI Gaia Next 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 device. Performance data demonstrates that the device functions as intended.

Therefore, the ASAHI Gaia Next is substantially equivalent to the predicate device,

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.