ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000

K083146 · Asahi Intecc Co., Ltd. · DQX · Nov 21, 2008 · Cardiovascular

Device Facts

• Record ID: K083146
• Device Name: ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 21, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Asahi Regalia XS 1.0 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 Regalia XS 1.0 Peripheral Guide Wire is a steerable guidewire (0.014 inch diameter; 180 cm or 300 cm length) used to facilitate placement and exchange of diagnostic/therapeutic devices during peripheral vascular procedures. Device features stainless steel core wire; soldered coil; radiopaque distal tip for visibility; flexible distal section; hydrophilic-coated distal section; PTFE-coated proximal section. Operated by physicians in clinical settings. Extension wire connects to proximal end outside body. Device provides mechanical support and navigation for interventional tools within peripheral vessels.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Stainless steel core wire; soldered coil; radiopaque distal tip; polyurethane/hydrophilic distal coating; PTFE proximal coating. 0.014 inch diameter. Manual operation.

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 PTCA Guide Wire Fielder (K052022)
• Asahi Treasure Guide Wire (K061984)

Submission Summary (Full Text)

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#### 9.0 510(K) SUMMARY

Kor3146

This 510(k) summary 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 | NOV 21 2008 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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 Regalia XS 1.0 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 PTCA Guide Wire Fielder - K052022<br>Asahi Treasure Guide Wire - K061984 | |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Asahi Regalia XS 1.0 Peripheral Guide Wire is steerable quide 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 wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

# INDICATION FOR USE:

The Asahi Regalia XS 1.0 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.

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## TECHNICAL CHARACTERISTICS:

The Asahi Regalia XS 1.0 Peripheral Guide Wire is made of the same materials that have been used in other predicate devices that are labeled for the similar indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.

### PERFORMANCE DATA:

This submission represents a change to the existing product labeling. Additional performance testing is not applicable.

#### SUMMARY/CONCLUSION:

The Asahi Regalia XS 1.0 Peripheral 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 ] 2008

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

Re: K083146

Trade/Device Name: Asahi Regalia XS 1.0 Peripheral Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: October 2, 2008 Received: October 23, 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.

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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 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 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. 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 rcference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 responsibilitics 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.

Duna R. Lochner

A Bram 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): Koß 3/46

Device Name: Asahi Regalia XS 1.0 Peripheral Guide Wire

Indications for Use:

The Asahi Regalia XS 1.0 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Holmes

on of Catalovascular Devices

(dic) Number K083146

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