ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE

K103057 · Asahi Intecc Co., Ltd. · DQX · Nov 19, 2010 · Cardiovascular

Device Facts

• Record ID: K103057
• Device Name: ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 19, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Indications for Use

The ASAHI Astato XS 20 Peripheral Guide Wire 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 Story

ASAHI Astato XS 20 Peripheral Guide Wire is a steerable guide wire (0.014 inch diameter; 180 cm or 300 cm length) used to facilitate placement/exchange of diagnostic and therapeutic devices during peripheral vascular procedures. Device consists of stainless steel core wire with platinum-nickel distal coil; distal end is radiopaque for visualization. Hydrophilic coating applied to distal coil; proximal section features PTFE coating (Type I or II). Used in clinical settings by physicians; device provides mechanical support and navigation through vasculature. Benefits include improved device delivery and exchange during peripheral interventions.

Clinical Evidence

No clinical data. Evidence consists of in vitro bench testing and biocompatibility studies. Bench testing included tensile strength, torque strength, torque response, tip flexibility, coating adhesion, slipping ability in PTA balloon catheters, and particulate testing. Biocompatibility testing included systemic toxicity, hemolysis, intracutaneous, cytotoxicity, sensitization, pyrogen, plasma recalcification, coagulation, in vivo thromboresistance, and complement activation studies.

Technological Characteristics

Stainless steel core wire; platinum-nickel distal coil; hydrophilic distal coating; PTFE proximal coating (Type I or II). 0.014 inch diameter; 180/300 cm lengths. Radiopaque distal tip. Mechanical navigation principle. Sterilized device.

Indications for Use

Indicated for patients undergoing intravascular procedures requiring the placement and exchange of diagnostic and therapeutic devices in the peripheral vasculature.

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 - Astato 30 Peripheral Guide Wire (K071721)
• Asahi - Treasure Guide Wire (K061984)
• Asahi - JoWire Neo's PTCA Guide Wire (K022762)
• Asahi - Asahi PTCA Guide Wire (Miracle bros 12/Confianza Pro 12) (K052339)
• Asahi - Asahi PTCA Guide Wire (PTFE coating type II) (K070945)

Submission Summary (Full Text)

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K.10305.7.

# 510(K) SUMMARY

#### 9.0 510(K) SUMMARY

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NOV 1 9 2010

This 510(k) summary of safety and effectiveness information is being submitted in This over, Summar 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 Astato XS 20 Peripheral 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 |
| PREDICATE DEVICE: | Asahi - Astato 30 Peripheral Guide Wire - 510(k) K071721<br>Asahi - Treasure Guide Wire - 510(k) K061984<br>Asahi - JoWire Neo's PTCA Guide Wire - 510(k) K022762<br>Asahi - Asahi PTCA Guide Wire (Miracle bros 12/Confianza Pro 12)<br>- 510(k) K052339<br>Asahi - Asahi PTCA Guide Wire (PTFE coating type II)<br>- 510(k) K070945 |

#### Description of the Device Subject to Premarket Notification:

The ASAHI Astato XS 20 Peripheral 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 length. The quide wire is constructed from a stainless steel core wire with platinumnickel coil. The coil part (distal end) of the guide wire is radiopaque to achieve visibility. The distal end of the coil part is a straight configuration and is easily bendable with the vessel curvature.

A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.

CONFIDENTIAL Asahi Intecc October 14, 2010

. 1)

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### INDICATION FOR USE:

The Asahi Astato XS 20 Peripheral Guide Wire 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.

### TECHNICAL CHARACTERISTICS:

This submission represents minor dimensional specifications and the addition of a PTFE coating. All other specifications are equivalent to those listed for the currently cleared predicate devices.

Comparisons of the ASAHI Astato XS 20 Peripheral Guide Wire and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices. The ASAH! Astato XS 20 Peripheral Guide Wire is similar in design - device dimensional specifications, and intended use, manufacturing process, operating principle, shelf life and sterilization process are the same and materials that have been used in other predicate devices in that its core wire, tip coils and solders remain the same.

#### PERFORMANCE DATA:

:

Enclosed within this submission is performance data that demonstrates that the Asahi Astato XS 20 Peripheral Guide Wire meets all predetermined performance criteria. 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.

And In vitro bench testing and shelf-life testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence and catheter compatibility as listed below were conducted on the ASAHI Astato XS 20 Peripheral Guide Wire. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Astato XS 20 Peripheral Guide Wire performs as intended.

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 in PTA Balloon Catheter Particulate testing

Biocompatibility: Systemic Toxicity Study In Vitro Hemolysis Study

CONFIDENTIAL Asahi Intecc October 14, 2010

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Intracutaneous Study Cytotoxicity Study Sensitization Study Pyrogen Study Plasma Recalcification Time Coagulation Study In Vivo Thromboresistance Study C3a Complement Activation Study SC5b-9 Complement Activation Study

### SUMMARY/CONCLUSION:

The Asahi Astato XS 20 Peripheral Guide Wire characteristics are substantially equivalent to the specified predicate device and other currently marketed devices for the same indication for use.

CONFIDENTIAL Asahi Intecc October 14, 2010

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705

NOV 1 9 2010

Re: K103057

Trade/Device Name: Astato XS 20 Peripheral Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DOX Dated: October 14, 2010 Received: October 15, 2010

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 deville 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.

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Page 2 - Mr. Yoshi Terai

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 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 vours.

vuna R.V. Ames

A 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):

K10503 t

NOV 1 9 2010

Device Name: ASAHI Astato XS 20 Peripheral Guide

Indications for Use:

2.

……

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The ASAH! Astato XS 20 Peripheral Guide Wire 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

una R. V. Aumer

(Division Sign-Off) Division of Cardiovascular Devices

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