ASAHI PTCA GUIDE WIRE

K070945 · Asahi Intecc Co., Ltd. · DQX · Jan 9, 2008 · Cardiovascular

Device Facts

• Record ID: K070945
• Device Name: ASAHI PTCA GUIDE WIRE
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

Device Story

Steerable guide wire; stainless steel core; radiopaque tip for visibility; available in straight or pre-shaped configurations. Distal portion features hydrophilic coating; proximal section features PTFE coating. Used by physicians in clinical settings to navigate coronary or peripheral vasculature to facilitate balloon catheter placement. Device provides mechanical support and guidance; does not involve electronic processing or AI. Benefits include improved trackability and vessel navigation during angioplasty.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical and functional testing demonstrated that the device performs as intended and is equivalent to predicate devices.

Technological Characteristics

Stainless steel core; radiopaque tip; hydrophilic and PTFE coatings. Maximum diameter 0.014 inches (0.36mm). Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for facilitating placement of balloon dilation catheters 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 (K032615)
• Asahi PTCA Guide Wire Confianza (K041531)
• Asahi PTCA Guide Wire, J Shape Series (K043422)
• Asahi PTCA Guide Wire, Fielder (K052022)
• Asahi PTCA Guide Wire (K052339)
• Asahi PTCA Guide Wire, Fielder J (K062186)
• Asahi PTCA Guide Wire, Fielder FC (K063819)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY & EFFECTIVENESS

#### 510(K) SUMMARY

510(k) summary information is being submitted in accordance with the ils 510(R) Summing of SMDA 1990 and 21 CFR 807.92.

PLICANT

Asahi Intecc Co., Ltd. 1703 Wakita-cho, Moriyama-ku Nagoya, Aichi 463-0024 Japan

FFICIAL ORRESPONDENT Yoshi Terai President, CEO Asahi Intecc USA, Inc. 1301 Dove Street, Suite 350 Newport Beach, CA 92660 Tel: [phone] FAX [phone] e-mail: [e-mail]

ASAHI PTCA Guide Wire

Class 2 per 21 CFR §870.1330

Catheter Guide Wire

TRADE NAME:

Guide Wire

DQX

COMMON NAME: CLASSIFICATION

NAME: DEVICE

CLASSIFICATION: Product Code

大 PREDICATE DEVICE:

| K022762 | JoWire Neo's PTCA Guide Wire |
|---------|---------------------------------------|
| K031277 | JoWire Asahi PTCA Guide Wire |
| K032615 | Asahi PTCA Guide Wire |
| K041531 | Asahi PTCA Guide Wire Confianza |
| K043422 | Asahi PTCA Guide Wire, J Shape Series |
| K052022 | Asahi PTCA Guide Wire, Fielder |
| K052339 | Asahi PTCA Guide Wire |
| K062186 | Asahi PTCA Guide Wire, Fielder J |
| K063819 | Asahi PTCA Guide Wire, Fielder FC |

CONFIDENTIAL Asahi Intecc March 20, 2007

K070945

July - 9 2008

K070945

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# scription of the Device Subject to Premarket Notification:

ScRIPTION OF THE DEVICE GUDEOT TO H Reviment a maximum diameter of in Asan PTCA Guide Wiles are steerable gulde with a maximaling to wire 114 inches (0.56mm) and available in Too children wire is constructed from the more is constructed from connected to the end of the guide wille batside the body. The wild besign. The with the stight stainless steel core with varying core ichgitis and diamotors for backless of the dights innd
or wire and coil are soldered or welded depending upon specific encluded at onl of ewire and coll are soldered of welded deportung upon open open on and is and is
and is a radiopaque tip to achieve visibility, and is available straight and is made soft to easily bend with the vessel curve or, available as are shaped " "The ade soit to easily bend with the vooool ed to the distal portion of the guide wire. The mating (nydropmine and Silicone) is applica to the title guilter of the galler series noximal section of the galde wire is outlou with hydrophilic coating applied to the distal there is poryal and the proximal section of this guide wire is coated with PTFE.

### INDICATION FOR USE:

The ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon rilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and thatator outhers wantely (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

## Technical Characteristics:

The ASAHI PTCA Guide Wires are of the same materials as the predicate devices with the exception of the modified coating material. The dimensional specifications and design of the device ensures compatibility for the intended use.

## PERFORMANCE DATA:

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

#### SUMMARY/CONCLUSION:

The ASAHI PTCA Guide Wire characteristics with the modified PTFE coating are substantially equivalent to the currently marketed Asahi guidewires for the same indication for use.

Bench testing demonstrates that the device functions as intended.

CONFIDENTIAL Asahi Intecc March 20, 2007

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

JAN - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ASAHI Intecc Co., LTD. c/o Mr. Yoshi Terai President, CEO 1301 Dove Street, Suite 350 Newport Beach, CA 92660

Re: K070945

Trade Name: Asahi PTCA Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: December 26, 2007 Received: December 27, 2007

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

R. luchner

/ 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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# INDICATIONS FOR USE STATEMENT_

INDICATIONS FOR USE STATEMENT

10(k) Number (if known): K070945

evice Name: ASAHI PTCA Guide Wires :

ndications for Use:

The ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon lice Honnin FOA Ouring percutaneous transluminal coronary angioplasty (PTCA) and mation catherers annig lanny (PTA). The Asahi PTCA Guide Wires are not to e used in the cerebral blood vessel.

escription Use X art 21 CFR 801 Subpart D) AND/OR

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

EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF EDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

unna P. lo. Lunes

Division Sign Division of Cardiovascular Devices

510(k) Number K070945

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