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 cerebral blood vessels.

Device Description

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 180 cm and 300 cm 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 for 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 180 cm wire.

AI/ML Overview

The submission for the ASAHI SION J PTCA Guide Wire (K122469) primarily relies on demonstrating substantial equivalence to a predicate device (ASAHI SION PTCA Guide Wire - K100578) through characterization of its technical features and performance in bench and biocompatibility testing. The acceptance criteria are essentially that the device performs similarly to or better than the predicate device in these tests, and that its materials are biocompatible, especially given its intended use.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Tensile Strength	Conducted. Meets predetermined criteria. (Specific values not provided in summary)
Torque Strength	"Turns to Failure" (Torque Strength) conducted. Meets predetermined criteria. (Specific values not provided in summary)
Torqueability	"Torque Response" conducted. Meets predetermined criteria. (Specific values not provided in summary)
Tip Flexibility	Conducted. Meets predetermined criteria. (Specific values not provided in summary)
Coating Adhesion	Conducted. Meets predetermined criteria. (Specific values not provided in summary)
Catheter Compatibility	"Slipping Ability of Guide Wire with PTCA Balloon Catheter" conducted. Meets predetermined criteria. (Specific values not provided in summary)
Particulate Testing	Leveraged from the predicate device due to identical product constructions, materials, and manufacturing processes, except for the tip shape. Implies compliance with predicate's performance.
Biocompatibility
Systemic Toxicity	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
In Vitro Hemolysis	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Intracutaneous	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Cytotoxicity	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Sensitization	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Pyrogen	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Plasma Recalcification Time	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Coagulation	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
In Vivo Thromboresistance	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
C3a Complement Activation	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
SC5b-9 Complement Activation	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Overall Conclusion	The ASAHI SION J PTCA Guide Wire meets all predetermined performance criteria and performs as intended. Characteristics are substantially equivalent to specified predicate devices and other currently marketed devices for the same indication for use.

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

The document does not specify the exact sample sizes used for each in vitro bench test or for the biocompatibility leveraging. It broadly states that "Enclosed within this submission is performance data" and "In vitro bench testing...were conducted." For biocompatibility, it states it "was leveraged from the predicate devices."

Therefore:

Sample Size: Not explicitly stated for specific tests.
Data Provenance: The bench testing appears to be prospective testing conducted directly on the ASAHI SION J PTCA Guide Wire. The biocompatibility data is retrospective, leveraged from previously 510(k) cleared Asahi Guide Wire products (predicates). The testing was presumably conducted by Asahi Intecc Co., Ltd. (Japan), but the specific country of origin for the leveraged data is not stated, though the predicate device (K100578) was also from Asahi Intecc.

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

This type of information is generally not applicable to a submission for a guide wire, which primarily involves objective engineering and biological tests rather than interpretation by human experts to establish "ground truth" for diagnostic or clinical decision-making. No experts were used in this manner for the described tests.

4. Adjudication method for the test set

Not applicable. The tests described are objective, quantitative/qualitative bench tests and biocompatibility assessments, not subjective assessments requiring adjudication by multiple experts.

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 device is a medical instrument (guide wire), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to its evaluation.

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

Not applicable. This device is a physical medical device, not an algorithm or software. Its performance is evaluated through physical and biological testing.

7. The type of ground truth used

The "ground truth" for the performance tests is based on:

Engineering Specifications/Standards: Predetermined performance criteria likely derived from internal specifications, relevant industry standards, or regulatory guidelines for guide wires.
Benchmarking against Predicate: The performance is implicitly compared to the predicate device, where the predicate's established performance acts as a de facto "ground truth" for acceptable levels.
Established Biocompatibility Standards: The biocompatibility evaluations rely on the well-established safety of the materials in previously cleared devices, which have met regulatory biocompatibility standards.

8. The sample size for the training set

Not applicable. This device is a medical instrument, not a machine learning model. There is no concept of a "training set" in its evaluation.

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

Not applicable for the same reason as above.

Summary

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MAR 8 2013

510(K) Summary

9.0 510(K) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024Japan
OFFICIALCORRESPONDENT	Yoshi TeraiPresident, CEOAsahi Intecc USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252FAX (949) 756-8165e-mail: yoshi.terai@asahi-intecc.com
TRADE NAME:	ASAHI SION J PTCA Guide Wire
COMMON NAME:	Guide Wire
CLASSIFICATIONNAME:	Wire, Guide, Catheter
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1330
PRODUCT CODE	DQX - Catheter Guide Wire
PREDICATEDEVICE:	1. Asahi Intecc - ASAHI SION PTCA Guide Wire - 510(k) K100578

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

Asahi Intecc

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INDICATION FOR USE:

TECHNICAL CHARACTERISTICS:

Comparisons of the ASAHI SION J PTCA Guide Wire and predicate devices show that the technological characteristics, the materials and the manufacturing processes used in the SION J device are the same as those used in the previously 510(k) cleared Asahi predicate devices. This submission represents a change to the tip configuration from a straight Tip design to a pre-shaped J design.

Performance Data:

Enclosed within this submission is performance data that demonstrates that the ASAHI SION J PTCA Guide Wire meets all predetermined performance criteria and performs as intended. All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains reference to predicate ASAHI devices that use the same materials as used in the subject device.

In vitro bench testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence and catheter compatibility as listed below were conducted on the ASAHI SION J PTCA Guide Wire. And the particulate evaluation was leveraged from the predicate device with identical product constructions, materials and manufacturing process except a "J" tip shape of the Guide Wire.

Performance test/evaluation summary:

Device performance: Tensile Strength Turns to Failure (Torque Strength) Torqueability (Torque Response) Tip Flexibility Coating Adhesion Slipping Ability of Guide Wire with PTCA Balloon Catheter Particulate testing

The biocompatibility has been established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products. The biocompatibility testing as listed below was leveraged from the predicate devices with identical materials and manufacturing process.

Biocompatibility/evaluation: Systemic Toxicity Study In Vitro Hemolysis Study Intracutaneous Study Cytotoxicity Study Sensitization Study Pyrogen Study

Asahi Intecc

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Plasma Recalcification Time Coagulation Study In Vivo Thromboresistance Study C3a Complement Activation Study SC5b-9 Complement Activation Study

SUMMARY/CONCLUSION:

The ASAHI SION J PTCA Guide Wire characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.

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Image /page/3/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 curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

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

March 8, 2013

Asahi Intecc USA. Inc. c/o Mr. Yoshi Terai 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705

Re: K122469

Trade/Device Name: ASAHI SION J PTCA Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 17, 2013 Received: February 8, 2013

Dear Mr. Terai:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Yoshi Terai

forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen-P.Faris -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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2.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K122469

Device Name: ASAHI SION J PTCA Guide Wire

Indications for Use:

Prescription Use_ X

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.03.08
10:14:16 -05'00'

Page of

Asahi Intecc

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.