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 Astato XS 40 Peripheral Guide Wire in this submission has a coil-type distal end. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the quide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). The distal end is coated with a hydrophilic coating. The ASAHI Astato XS 40 guide wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter of 0.36 mm.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "ASAHI Astato XS 40" guide wire. It details the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence, rather than a study designed to meet specific acceptance criteria for AI performance.

Therefore, the requested information points regarding AI acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this document as it describes a traditional medical device (guide wire) and not an AI/ML-driven device.

However, I can extract the acceptance criteria and performance data for the physical device as described in the document.

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

The document states that "The in vitro bench tests demonstrated that the ASAHI Astato XS 40 met all acceptance criteria and performed similarly to the predicate devices." While specific numeric acceptance criteria are not provided, the following tests were performed:

Acceptance Criteria (Implied)	Reported Device Performance
Tensile Strength	Met acceptance criteria
Torque Strength	Met acceptance criteria
Torqueability	Met acceptance criteria
Tip Flexibility	Performed similarly to secondary predicate, ASAHI Astato 30
Coating Adhesion/Integrity	Met acceptance criteria
Catheter Compatibility	Met acceptance criteria

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

This information is not provided in the document. The document refers to "in vitro bench tests" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this is not an AI/ML device requiring expert-established ground truth. The tests performed are engineering-based performance tests for a physical device.

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

This information is not applicable as this is not an AI/ML device requiring adjudication of results.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as the "ground truth" for a physical device like a guide wire would be established by physical measurements and engineering standards, not typical "ground truth" as understood in AI/ML performance evaluation.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2016

Asahi Intecc Co., Ltd. % Ms. Candace Cederman Senior Regulatory Affairs Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K153443

Trade/Device Name: Asahi Astato XS 40 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 25, 2015 Received: January 8, 2016

Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153443

Device Name ASAHI Astato XS 40

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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(c)]

ASAHI Astato XS 40

510(k) K153443

Date Prepared: Fi February 2016

A-A

APPLICANT	ASAHI Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024, Japan
OFFICIAL CORRESPONDENT	Carroll CouncilmanSr. RA ManagerASAHI Intecc USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252FAX: (949) 756-8165e-mail: ASAHI.ra-fda@ASAHI-intecc.com
TRADE NAME:	ASAHI Astato XS 40
DEVICE CLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATION NAME:	Catheter, Guide, Wire
PRODUCT CODE	DQX- Catheter Guide Wire
PREDICATE DEVICES:	Primary Predicate:ASAHI Astato XS 20 Peripheral Guide Wire (K103057)Secondary Predicate:ASAHI Astato 30 Peripheral Guide Wire (K071721)Reference Device:ASAHI RG3 (K141339)

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.

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Device Description:

Comparison with predicate devices:

Comparisons of the ASAHI Astato XS 40 and predicate devices show that the technological characteristics of the Subject device such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices.

The intended use/indications between the Subject Device and its primary predicates are identical. There are specific design features of the Subject device that are similar to the primary predicate but not identical. Additional predicate devices have been used to demonstrate equivalence for these similar features.

Name of Device	ASAHI Peripheral Guide Wire• ASAHI Astato XS 40	Astato XS 20• Astato 30
510(k)	Current Application	K103057 K071721
Intended Use andIndications	This product is intended to facilitate the placement and exchange ofdiagnostic and therapeutic devices during intravascular procedures.
	This device is intended for peripheral vascular use only.
Sterilization	Provided sterile via Ethylene Oxide to SAL10-6
Shelf Life	3 Years
Target Body Location	Peripheral
Outer DistalHydrophilic coating	Yes
Proximal Coating	PTFE
Overall Length	200-300 cm	180-300 cm
Nominal OD	0.36 mm (0.014in)with tapered end	Astato XS 20:0.36 mm (0.014in) with tapered endAstato 30:0.45 mm (0.018in) with tapered end
Outer Coil Material	Platinum-Nickel
Core Wire Material	Stainless Steel

Non Clinical testing / Performance Data:

Non clinical laboratory testing was performed on the ASAHI Astato XS 40 to determine substantial equivalence. The following testing/assessments were performed:

Tensile Strength ●
Torque Strength

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Torqueability ●
. Tip Flexibility (compared to secondary predicate, ASAHI Astato 30)
Coating Adhesion/Integrity ●
. Catheter Compatibility

The in vitro bench tests demonstrated that the ASAHI Astato XS 40 met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices.

BIOCOMPATIBILITY:

The ASAHI Astato XS 40 was compared to the primary predicate device and to the reference device ASAHI PTCA Guide Wire RG3. Based on the similar intended use, as well as the similarities of the materials and manufacturing methods used in the subject device and its predicate/reference devices, no additional biocompatibility testing of the ASAHI Astato XS 40 was conducted.

Conclusion:

The ASAHI Astato XS 40 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 devices. Performance data demonstrates that the device functions as intended.

Therefore, the ASAHI Astato XS 40 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.