ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ

K122469 · Asahi Intecc Co., Ltd. · DQX · Mar 8, 2013 · Cardiovascular

Device Facts

• Record ID: K122469
• Device Name: ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
• 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 facilitate balloon dilatation catheter placement during PTCA/PTA procedures. Constructed with stainless steel core, platinum-nickel/stainless steel coils, and safety wire. Features radiopaque distal tip (pre-shaped 'J' configuration) for visualization and hydrophilic coating on distal portion; proximal section coated with PTFE. Operated by physicians in clinical settings (e.g., cath lab). Device provides mechanical support and navigation through vasculature to target lesion sites. Benefits include improved trackability and access to coronary/peripheral vessels for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included tensile strength, torque strength, torqueability, tip flexibility, coating adhesion, catheter compatibility, and particulate evaluation. Biocompatibility established via systemic toxicity, hemolysis, intracutaneous, cytotoxicity, sensitization, pyrogen, coagulation, thromboresistance, and complement activation studies.

Technological Characteristics

Stainless steel core wire; platinum-nickel and stainless steel coils; PTFE proximal coating; hydrophilic distal coating. 0.014 inch diameter. Pre-shaped 'J' distal tip. Mechanical device; no energy source or software. Biocompatibility established per standard medical device testing protocols.

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 SION PTCA Guide Wire (K100578)

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 J PTCA Guide Wire |
| COMMON NAME: | Guide Wire |
| CLASSIFICATION<br>NAME: | Wire, Guide, Catheter |
| DEVICE<br>CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX - Catheter Guide Wire |
| PREDICATE<br>DEVICE: | 1. Asahi Intecc - ASAHI SION PTCA Guide Wire - 510(k) K100578 |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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.

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 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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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 [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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2.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K122469

Device Name: ASAHI SION J PTCA Guide Wire

Indications 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.

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'

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