ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO

K122468 · Asahi Intecc Co., Ltd. · DQX · Mar 8, 2013 · Cardiovascular

Device Facts

• Record ID: K122468
• Device Name: ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 8, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended 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 cerebral blood vessels.

Device Story

Steerable guide wire (0.014 inch diameter; 180 cm or 300 cm lengths) used to navigate coronary and peripheral vasculature; facilitates placement of balloon dilatation catheters. Constructed from stainless steel core with platinum-nickel and stainless steel coils; distal end features radiopaque tip for visualization; available in straight or pre-shaped 'J' configurations. Distal portion coated with silicone and hydrophilic material; proximal section coated with PTFE. Operated by physicians in clinical settings during interventional procedures. Provides tactile feedback and steerability to navigate vessel curves; enables precise positioning of therapeutic catheters. Benefits patient by allowing access to target lesion sites for angioplasty.

Clinical Evidence

No clinical data. Evidence consists of in vitro bench testing and biocompatibility evaluation. Bench testing included tensile strength, torque strength, torqueability, tip flexibility, coating adhesion, catheter compatibility, and particulate evaluation. Biocompatibility was established via leveraging data from predicate devices using identical materials and manufacturing processes, including systemic toxicity, hemolysis, intracutaneous, cytotoxicity, sensitization, pyrogen, plasma recalcification, coagulation, thromboresistance, and complement activation studies.

Technological Characteristics

Stainless steel core wire; platinum-nickel and stainless steel coils; safety wire soldered to core and coils. Distal tip: silicone and hydrophilic coating. Proximal shaft: PTFE coating. Diameter: 0.014 inches. Lengths: 180 cm, 300 cm. Mechanical navigation principle. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) to facilitate balloon dilatation catheter placement. Contraindicated for use in cerebral blood vessels.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Asahi Intecc - ASAHI SION PTCA Guide Wire (K100578)
• Asahi Intecc - JoWire Neo's PTCA Guide Wire (K022762)

Submission Summary (Full Text)

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#### MAR 8 2013

9. 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.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya, Aichi 463-0024<br>Japan |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL<br>CORRESPONDENT | Yoshi Terai<br>President, CEO<br>Asahi Intecc USA, Inc.<br>2500 Red Hill Avenue, Suite 210<br>Santa Ana, CA 92705<br>Tel: [phone]<br>FAX [phone]<br>e-mail: [e-mail] |
| TRADE NAME: | ASAHI SION blue PTCA Guide Wire |
| COMMON NAME: | Guide Wire |
| CLASSIFICATION<br>NAME: | Wire, Guide, Catheter |
| DEVICE<br> | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION:<br>PRODUCT CODE | DQX - Catheter Guide Wire |
| PREDICATE<br>DEVICE: | 1. Asahi Intecc - ASAHI SION PTCA Guide Wire - 510(k) K100578<br>2. Asahi Intecc - JoWire Neo's PTCA Guide Wire - 510(k) K022762 |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The ASAHI SION blue PTCA Guide Wire is a steerable quide 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 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 as a pre shaped "J ". Silicone and hydrophilic coatings 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 180 cm wire.

Asahi Intecc

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## Indication 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 cerebral blood vessels.

## TECHNICAL CHARACTERISTICS:

Comparisons of the ASAHI SION blue PTCA Guide Wire and predicate devices show that the technological characteristics, the materials and the manufacturing processes used in the SION blue 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 and silicone coating application of the guide wire tip with minor dimensional changes of the quide wire.

#### PERFORMANCE DATA:

Enclosed within this submission is performance data that demonstrates that the ASAHI SION blue 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 blue PTCA Guide Wire. And the particulate evaluation was conducted with a combination assessment with the subject device itself and data leveraged from the predicate devices with identical product material and manufacturing process.

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 evaluation

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

Asahi Intecc

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Cytotoxicity Study Sensitization Study Pyrogen Study Plasma Recalcification Time Coagulation Study In Vivo Thromboresistance Study C3a Complement Activation Study SC5b-9 Complement Activation Study The Children Comments of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Child

# SUMMARY/CONCLUSION:

The ASAHI SION blue 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a globe, signifying the department's mission to protect and promote the health and well-being of all Americans.

#### Public Health Service

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: K122468

Trade/Device Name: ASAHI SION blue 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 13, 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),-pleasego 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 [phone] or [phone] 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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Indications For Use Statement 2.0

510(k) Number (if known):

Device Name: ASAHI SION blue PTCA Guide Wire

Indications for Use:

ASAHI PTCA GUIDE WIRES are intended to facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA GUIDE WIRES are not to be used in the cerebral blood vessels.

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
13:52:05 -05'00'

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