ASAHI PTCA GUIDE WIRE CONFIANZA PRO

K041531 · Asahi Intecc Co., Ltd. · DQX · Aug 3, 2004 · Cardiovascular

Device Facts

• Record ID: K041531
• Device Name: ASAHI PTCA GUIDE WIRE CONFIANZA PRO
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Asahi PTCA Guide wire Confianza Pro is intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasty (PTCA) and percutancous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

Device Story

Steerable guide wire; 0.014" diameter; 180 cm or 300 cm length; stainless steel core wire; soldered core and coil; radiopaque distal tip; hydrophilic/silicone distal coating; PTFE proximal coating. Used by physicians during PTCA/PTA procedures to navigate vasculature and facilitate balloon catheter placement. Device provides mechanical support and guidance for interventional tools; benefits patient by enabling precise access to coronary and peripheral lesions.

Clinical Evidence

Bench testing and biocompatibility testing only; no clinical data presented. Testing demonstrated performance equivalent to predicate devices.

Technological Characteristics

Stainless steel core wire; soldered core and coil construction; radiopaque distal tip; hydrophilic/silicone distal coating; PTFE proximal coating; 0.014" diameter; 180/300 cm lengths. Mechanical device; no energy source or software.

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)

Submission Summary (Full Text)

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Asahi Intecc Co., Ltd. June 2004

AUG - 3 2004

K041531

510(k) Summary of Safety and Effectiveness

| Date Prepared: | April 30, 2004 |
|----------------------|-------------------------------------------------|
| Submitted: | Asahi Intecc Co., Ltd. |
| | 1703 Wakita-cho, Moriyama-ku, Nagoya, |
| | Aichi, 463-0024, Japan |
| Contact Person: | Yoshi Terai |
| | Director of Asahi Intecc US Office |
| Phone Number: | Phone : [phone] |
| Fax Number: | Fax : [phone] |
| Device Trade Name: | Asahi Wire Asahi PTCA Guide Wire Confianza Pro |
| Classification Name: | Catheter Guide Wire, Class II (21 CFR 870.1330) |
| Predicate Device: | JoWire Neo's PTCA Guide Wire K022762 |
| | JoWire Asahi PTCA Guide Wire K031277 |

Device Description:

'I'he Asahi PTCA Guide Wire Confianza Pro is steerable guide wire with a maximum 0.014" and available in 180 cm and 300 cm length. The extension wire is diameter of 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 end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

Intended Use:

The Asahi PTCA Guide wire Confianza Pro is intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasty (PTCA) and percutancous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel

Device Technological Characteristics and Comparison to Predicate Device:

The Asahi PTCA Guide Wire Conflanza Pro is made of the same materials, available in the same diameters and lengths, have the same design and indications for use as the predicate devices and other currently marketed PTCA Guide Wires.

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Performance Data:

Perormation Data.
Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Confianza Pro met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing.

Conclusion:

The Asahi PTCA Guide Wire Confianza Pro is substantially equivalent to the claimed predicates devices and other currently marketed PTCA Guide Wires.

KC41531

Premarket Notification [510(k)] Number

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name around the perimeter. Inside the circle is a stylized image of an eagle, which is a common symbol of the United States. The eagle is depicted with its wings spread, and it appears to be in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2004

Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai Director of Asahi Intecc US Office 1703 Wakita-cho, Moriyama-ku, Nagoya Aichi, 463-0024, Japan

Re: K041531

Trade Name: Asahi PTCA Wire Confianza Pro Regulation Number: 21 CFR 870.1330 Regulation Name: Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: July 15, 2004 Received: July 22, 2004

Dear Mr. Terai:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 Prease be advised ullat I Dri 3 issuated of a oudevice complies with other requirements of the Act that IDA has made a decorminations administered by other Federal agencies. You must of any I cuttal statutes and regarations and limited to: registration and listing (21 comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CFR Fart 807), adoling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation oom or provisions (stime ) our device as described in your Section 510(k) This letter will anow you to oegin maneting of substantial equivalence of your device to a legally premarket nothleation: "The PDF intelling of easification 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 If you desire specific at 1301) 594-4646. Additionally, for questions on the comact the Office of Ochiphants at (200), please contact the Office of Compliance at (301) 594promotion and acrorability or grulation entitled, "Misbranding by reference to premarket 4057. Allso, productions and 807.97) you may obtain. Other general information on your nontreation (21 OF Act may be obtained from the Division of Small Manufacturers, Itsponsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours;

Dura R. Sohner

Bram D
Director
Division

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

510(k) Number (if known): ___K041531_

Asahi PTCA Guide Wire Confianza Pro ---------Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

The intended use and indications for use of the modified device as described in this labeling have not change. The fundamental scientific technology of the modified device has not changed.

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

-10(k) Number_K041531

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