ASAHI SUOH PTCA GUIDE WIRE

K083904 · Asahi Intecc Co., Ltd. · DQX · Jan 29, 2009 · Cardiovascular

Device Facts

• Record ID: K083904
• Device Name: ASAHI SUOH PTCA GUIDE WIRE
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 29, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percultaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.

Device Story

Steerable guide wire; 0.014-inch diameter; 180 cm or 300 cm length. Stainless steel core wire; platinum-nickel and stainless steel coil; soldered construction. Distal radiopaque tip for visualization; hydrophilic coating on distal portion; PTFE coating on proximal section. Used by physicians during PTCA/PTA procedures to navigate vasculature and guide balloon catheters. Facilitates catheter placement; improves procedural efficiency.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical and functional testing demonstrated performance as intended.

Technological Characteristics

Stainless steel core; platinum-nickel/stainless steel coil; soldered joints. Hydrophilic distal coating; PTFE proximal coating. 0.014-inch diameter. Radiopaque tip. Manual operation.

Indications for Use

Indicated for facilitating balloon dilatation catheter placement during PTCA and PTA procedures. 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

• JoWire Neo's PTCA Guide Wire (K022762)
• JoWire Asahi PTCA Guide Wire (K031277)
• Asahi PTCA Guide Wire (K052339)

Submission Summary (Full Text)

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#### 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.

K083904

| 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] |

JAN 29 2009

| TRADE NAME: | Asahi SUOH 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 |
| | PREDICATE DEVICE: JoWire Neo's PTCA Guide Wire - 510(k) K022762<br>JoWire Asahi PTCA Guide Wire - 510(k) K031277<br>Asahi PTCA Guide Wire - 510(k) K052339 |

## Description of the Device Subject to Premarket Notification:

The Asahi SUOH 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 length. The extension wire is connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless steel core wire with a platinum-nickel and stainless steel coil. The core wire and coil are soldered. 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 easily bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.

. .. Asahi Intecc December 25, 2008

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## INDICATION FOR USE:

The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percultaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.

### TECHNICAL CHARACTERISTICS:

The Asahi SUOH PTCA Guide Wire is made of the same materials that have been used in other predicate devices that are labeled for the same indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.

### PERFORMANCE DATA:

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. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the Asahi SUOH PTCA Guide Wire performs as intended.

## SUMMARY/CONCLUSION:

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

Asahi Intecc December 25, 2008

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The logo is black and white.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2009

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

K083904

Re:

Trade/Device Name: Asahi SUOH PTCA Guide Wire Common Name: Catheter guide wire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: December 25, 2008 Received: December 29, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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# Page 2 - Mr. Yoshi Terai

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

ht

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 1NDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Asahi SUOH PTCA Guide Wire

Indications for Use:

The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.

Prescription Use X (Part 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)

Concurrence

Division Sign-Citt) isloh of Cardiovascular Devices (k) Number Kog39ey

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