This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

Device Description

The ASAHI Gladius Mongo18 PV ES is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190cm. 235cm and 300cm length. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available pre shaped. The guide wire is constructed from a stainless-steel core wire with platinum-nickel coil. The coil is soldered to the core wire. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The solder of distal end is Au-Sn and other solder is Ag-Sn. The distal end of the quide wire has a radiopaque tip to achieve visibility. For the models covered by this submission, a hydrophilic coating is applied to the quide wire along the distal structure. The proximal section of the guide wire is coated with PTFE. The purpose of these surface coatings is to provide lubricity when guide wire is passed through percutaneous catheters. The basic structure, construction, and coating of the ASAHI Gladius Mongo18 PV ES are unchanged from that previously described in the predicate ASAHI Gladius (K150445).

AI/ML Overview

This document describes the premarket notification (510(k)) for the ASAHI Gladius Mongo18 PV ES, a catheter guide wire for peripheral vascular use. The submission argues for substantial equivalence to a predicate device (ASAHI Gladius, K150445) and several reference devices.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the ASAHI Gladius Mongo18 PV ES "met all acceptance criteria and performed similarly to the predicate device" in bench testing. However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it lists the types of tests performed.

Test Type	Acceptance Criteria (Not explicitly stated quantitatively, but implied "met all acceptance criteria")	Reported Device Performance (Implied "met all acceptance criteria" and "performed similarly to the predicate device")
Tensile Strength	Met defined strength requirements	Performed similarly to predicate
Torque Strength	Met defined torque limits	Performed similarly to predicate
Torqueability	Maintained steerability and control	Performed similarly to predicate
Tip Flexibility	Maintained intended flexibility and shape	Performed similarly to predicate
Coating Integrity	Maintained intact and functional coating	Performed similarly to predicate
Catheter Compatibility	Ensured smooth passage through catheters	Performed similarly to predicate
Visual Inspection	No visible defects	Performed similarly to predicate
Corrosion Resistance	Resisted corrosion under test conditions	Performed similarly to predicate
Kink Resistance	Resisted kinking under test conditions	Performed similarly to predicate
Radiopacity	Visible under fluoroscopy	Performed similarly to predicate
Dimensional Verification	Met specified dimensions	Performed similarly to predicate
Particulate	Met particulate limits	Performed similarly to predicate

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set: The document does not specify the exact sample size for the non-clinical bench tests (e.g., how many guidewires were tested for tensile strength).
Data Provenance: The studies were bench tests conducted following FDA guidance. The manufacturing company is ASAHI INTECC CO., LTD., located at 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan, implying the testing likely occurred in or under the purview of the company's R&D facilities. This is a pre-market, prospective evaluation of the device's physical and mechanical properties.

3. Number of Experts and Qualifications for Test Set Ground Truth

This submission is for a medical device (guide wire) and primarily relies on non-clinical bench testing rather than interpretation of diagnostic images or patient outcomes. Therefore, the concept of "ground truth" established by human experts in the way it applies to AI/software performance (e.g., radiologists for imaging studies) is not applicable here. The "ground truth" for these tests is the objective physical and mechanical properties measured on the device itself against established engineering specifications and performance criteria derived from the predicate device and FDA guidance.

4. Adjudication Method for Test Set

As the "ground truth" is established through objective bench testing measurements against pre-defined criteria, an adjudication method (like 2+1, 3+1 for human disagreements) is not applicable. The results are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No. This is a physical medical device (guidewire), not a diagnostic imaging AI or software. Therefore, an MRMC study involving human readers with and without AI assistance is not applicable.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done? This question typically applies to AI algorithms. For this physical medical device, the "standalone" performance refers to the device's inherent physical and mechanical properties as measured in bench tests, independent of its use by a human operator for the specific tests mentioned. The non-clinical bench testing effectively represents this "standalone" performance against established engineering criteria.

7. Type of Ground Truth Used

The ground truth for the non-clinical testing was based on objective engineering specifications, physical and mechanical measurements, and performance criteria derived from the predicate device's validated performance and FDA guidance documents.

8. Sample Size for the Training Set

Sample Size: This device did not undergo a "training" process in the sense of a machine learning algorithm. The "training" for such a device would be its design, manufacturing processes, and quality control. There isn't a "training set" of data in the AI sense for this device.

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

Not Applicable. As mentioned above, there is no "training set" for this type of device in the context of an FDA 510(k) submission for substantial equivalence based on bench testing. The design and manufacturing processes are validated to produce devices meeting pre-defined specifications.

Summary

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

September 7, 2022

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 and 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.

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

Re: K213868

Trade/Device Name: ASAHI Gladius Mongo18 PV ES Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX

Dear Cynthia Valenzuela:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on September 6, 2022. Specifically, FDA is updating this SE Letter due to the clearance date (September 6, 2022) not appearing on the original letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lydia Glaw, OHT2: Office of Cardiovascular Devices, (301) 796-1456, Lydia.Glaw(@fda.hhs.gov.

Sincerely,

Samuel G. Raben -S

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

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

Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K213868

Trade/Device Name: ASAHI Gladius Mongo18 PV ES Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: July 6, 2022 Received: July 8, 2022

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

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

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-continung-education/cdrl-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-regulatoryassistance/contact-us-division-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.

Samuel G. Raben -S

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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K213868

Device Name

ASAHI Gladius Mongo18 PV ES

Indications for Use (Describe)

This product is intended to facilitate the placement and exchange of diagnostic devices during intravascular procedures. This device is intended for peripheral vascular use only.

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)

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."

FORM FDA 3881 (6/20)

Page 1 of 1

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

510(K) Summary

[as required by 21CFR § 807.92(c)]

SAHI INTECC CO.,LTD. Global Headquarters and R&D Center 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan TEL : +81-561-48-5551 FAX : +81-561-48-5552 http://www.asahi-intecc.co.jp/

ASAHI Gladius Mongo18 PV ES

510(K) K213868

DATE PREPARED:	30, August 2022
APPLICANT:	ASAHI INTECC CO., LTD.3-100 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
ALTERNATE CONTACT:	Mr. Hiroshi ObaraManager, Regutatory, AffairsASAHI INTECC CO., INC.3-100 Akatsuki-choSeto, Aichi, Japan 489-0071Email: yoshi@asahi-intecc-us.com
TRADE NAME:	ASAHI Gladius Mongo18 PV ES
DEVICE CLASSIFICATION:	Class II, 21CFR § 870.1330
CLASSIFICATION NAME:	Catheter Guide Wire
PRODUCT CODE:	DQX
PREDICATE DEVICE(S):	ASAHI Peripheral Guide Wires (K150445)
REFERENCE DEVICE(S):	ASAHI PTCA Guide Wire FIELDER XT (K072431)ASAHI PTCA Guide Wires, ASAHI Peripheral GuideWires, ASAHI Guide Wire Extension (K163426)ASAHI PTCA Guide Wire ASAHI Gladius Mongo(K180784)

Intended Use/Indications for Use:

This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

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

Description:

Accessory

There are no accessories packed with ASAHI Gladius Mongo18 PV ES.

Predicate	Device Name	510(K) Number
Primary Predicate	ASAHI Gladius	K150445
Reference Device	FIELDER XT	K072431
Reference Device	ASAHI PTCA Guide Wires,ASAHI Peripheral Guide Wires,ASAHI Guide Wire Extension	K163426
Reference Device	ASAHI Gladius Mongo	K180784

Comparison with Predicate Device and Reference Device:

The subject device has the following similarities to those which previously received 510(k) clearance.

Have the same intended use and indications for use
. Use the same operating principle;
Incorporate the same basic designs; and ●
Incorporate the same materials ●

{6}------------------------------------------------

Name of Devices	ASAHI Gladius Mongo18 PV ES	ASAHI Gladius
	Subject	Predicate
	K213868	K150445
	ASAHI INTECC	ASAHI INTECC
510(k)ManufacturerClassification Regulation	21 CFR 830.1330, Cardiovascular
Common Name	Catheter Guide Wire
Product Code	DQX
Class	II
Intended Use	Guide wire for percutaneous intervention
Indications for Use	This product is intended to facilitate the placement andexchange of diagnostic and therapeutic devices duringintravascular procedures. This device is intended for peripheralvascular use only.	This product is intended to facilitate the placement andexchange of diagnostic and therapeutic devices duringintravascular procedures. This device is intended for peripheralvascular use only.
Nominal OD	0.46mm (0.018inch)	0.36mm (0.014inch)0.46mm (0.018inch)
Overall Length	190cm, 235cm, 300cm	190cm, 235cm,300cm
Outer Coil	Pt-Ni	Pt-Ni and SUS
Tapered Core Wire	SUS	SUS
Inner Structure	SUS Coil	SUS Coil
Tip Shape	Straight, Pre-shape	Straight, Pre-shape
Coating	Hydrophilic Hydrophobic	Hydrophilic Hydrophobic
Sterilization	Provided sterile via Ethylene Oxide to SAL 10-6	Provided sterile via Ethylene Oxide to SAL 10-6

Comparison with Predicate Device

{7}------------------------------------------------

Non Clinical Testing / Performance Data:

The substantial equivalence of the ASAHI Gladius Mongo18 PV ES was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, June 15, 2018.

Tensile Strength
Torque Strenath o
Torqueability ●
Tip Flexibility ●
Coating Integrity ●
Catheter Compatibility
Visual Inspection ●
Corrosion Resistance ●
Kink Resistance
Radiopacity
Dimensional Verification ●
o Particulate

The in vitro bench tests demonstrated that the ASAHI Gladius Mongo18 PV ES met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device and the reference device.

BIOCOMPATIBILITY:

The ASAHI Gladius Monqo 18 PV ES was compared to the predicate and reference devices. Based on similarities of the materials used in the subject device to its predicate and reference, the biocompatibility of the ASAHI Gladius Mongo18 PV ES was verified to be the same as those of the predicate and reference devices.

CONCLUSION:

The ASAHI Gladius Mongo18 PV ES has similar intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate device. Performance data demonstrates that the device functions as intended.

Therefore, the ASAHI Gladius Mongo18 PV ES 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.