ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE

K110584 · Asahi Intecc Co., Ltd. · MOF · Aug 22, 2011 · Cardiovascular

Device Facts

• Record ID: K110584
• Device Name: ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: MOF · Cardiovascular
• Decision Date: Aug 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

ASAHI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

Device Story

Steerable guide wire (0.014" diameter; 200cm/300cm lengths) used in neurovascular procedures; facilitates placement/exchange of cerebral catheters. Construction: stainless steel core wire; platinum-nickel and stainless steel coils; radiopaque distal tip; hydrophilic coating on distal portion; PTFE coating on proximal section (300cm model). Operated by physicians during intravascular therapy. Provides mechanical guidance through neurovasculature; radiopaque tip allows visualization under imaging. Benefits patient by enabling precise navigation of therapeutic devices to target neurovascular sites.

Clinical Evidence

Bench testing only. No clinical data. Testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence, catheter compatibility, and particulate testing. Biocompatibility evaluated via systemic toxicity, hemolysis, intracutaneous, cytotoxicity, sensitization, pyrogen, plasma recalcification, coagulation, thromboresistance, and complement activation studies.

Technological Characteristics

0.014" diameter steerable guide wire. Materials: stainless steel core, platinum-nickel and stainless steel coils, solder. Coatings: hydrophilic (distal), PTFE (proximal). Radiopaque tip. Sterilized. Mechanical sensing/actuation via manual manipulation by clinician. No software or electronic components.

Indications for Use

Indicated for use in the neuro vasculature to facilitate placement and exchange of therapeutic devices (e.g., cerebral catheters) during intravascular therapy.

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

• Micro Therapeutics, Inc. / EV3 - SilverSpeed Hydrophilic Guidewire (K993257)
• Asahi - JoWire Neo's PTCA Guide Wire (K022762)
• BSC/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire (K971254)

Reference Devices

• Asahi - ASAHI SION PTCA Guide Wire (K100578)

Submission Summary (Full Text)

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AUG 2 2 2011

KI10584

## 510(K) SUMMARY

## 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 CHIKAI Neurovascular 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 DEVICE: | 1. Micro Therapeutics, Inc. / EV3 - SilverSpeed Hydrophilic Guidewire -<br>510(k) K993257<br>2. Asahi - JoWire Neo's PTCA Guide Wire - 510(k) K022762<br>3. BSC/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire -510(k)<br>K971254<br>Additional referenced 510(k) cleared device:<br>4. Asahi - ASAHI SION PTCA Guide Wire - 510(k) K100578 |

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

The ASAHI CHIKAI Neurovascular Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200 cm and 300 cm lengths. The extension wire is connected to the end of the guide wire outside the body for 200 cm wire. 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 the coil assembly is soldered to the core wire. The coil assembly construction is similar to the 510k cleared ASAHI SION PTCA guide wire with K100578. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.

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K110584

510(K) SUMMARY

#### INDICATION FOR USE:

ASAHI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

#### TECHNICAL CHARACTERISTICS:

Comparisons of the ASAHI CHIKAI Neurovascular 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 ASAHI CHIKAI Neurovascular 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 CHIKAI Neurovascular 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.

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

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.

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 Microcatheter Additional bench testing Particulate testing

Biocompatibility/evaluation: Systemic Toxicity Study In Vitro Hemolysis Study

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# 510(K) SUMMARY

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 CHIKAI Neurovascular Guide Wire characteristics are substantially equivalent to the specified predicate device 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 Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

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

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

AUG 2 2 2011

Re: K110584

Trade/Device Name: Asahi Chikai Neurovascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Neurovascular catheter guide wire Regulatory Class: Class II Product Code: MOF Dated: August 4, 2011 Received: August 5, 2011

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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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.html 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.lda.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,

Erich Fromm

Malvina B. Eydelman, M. Director

Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Kl(10584

Device Name: ASAHI CHIKA! Neurovascular Guide Wire

Indications for Use:

ASAHI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

Prescription Use_ X

(Parl 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _

(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)

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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KI 10584 510(k) Number