ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE

K141339 · Asahi Intecc Co., Ltd. · DQX · Oct 23, 2014 · Cardiovascular

Device Facts

• Record ID: K141339
• Device Name: ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide wires are not to be used in the neurovasculature.

Device Story

ASAHI RG3 is a PTCA guidewire designed to facilitate insertion of balloon dilatation catheters and other interventional devices into narrowed or obstructed blood vessels. Device consists of a tapered core wire and coil, soldered together; distal end features hydrophilic polymer coating; proximal end features silicone oil coating. Coil is partially radiopaque for visualization under fluoroscopy. Used in clinical settings (e.g., cath lab) by physicians to navigate vasculature. Guidewire provides a track for balloon catheters to reach target lesion sites, enabling vessel dilation and treatment of obstructions. Benefits include improved access to coronary and peripheral vasculature for minimally invasive procedures.

Clinical Evidence

Bench testing only. Performance data includes tensile strength, torque strength, torqueability, tip flexibility, coating adhesion/integrity, and catheter compatibility. Biocompatibility verified through material comparison to predicate devices.

Technological Characteristics

Tapered core wire and coil construction; soldered assembly. Distal end: hydrophilic polymer coating. Proximal end: silicone oil coating. Radiopaque coil segments for fluoroscopic visualization. Length: 330 cm; diameter: 0.26 mm. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) requiring balloon dilatation catheter placement. Contraindicated for use in the neurovasculature.

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 Prowater Guidewire, Asahi Grand Slam (K031277)
• ASAHI PTCA Guide Wire ASAHI Gaia (K133865)

Submission Summary (Full Text)

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

December 3, 2014

Asahi Intecc Co., Ltd. % Candace Cederman Senior Regulatory Affairs Consultant CardoMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228

Re: K141339

> Trade/Device Name: ASAHI PTCA Guidewire System, ASAHI RG3 Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire System Regulatory Class: Class II Product Code: DQX Dated: September 25, 2014 Received: September 26, 2014

Dear Candace Cederman:

This letter corrects our substantially equivalent letter of September 25, 2014.

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

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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.fda.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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

For 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):

Device Name:

ASAHI PTCA Guidewire ASAHI RG3

Indications for Use:

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide wires are not to be used in the neurovasculature.

#### 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)

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# ASAHI INTECC CO.,LTD.

1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel.[phone] Fax.[phone] Branch offices: Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore, Beijing Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi

#### 510(k) Summary [as required by 21 CFR 807.92(c)]

## ASAHI PTCA Guide Wire ASAHI RG3

#### 510(k)

| 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 PTCA Guidewire System, ASAHI RG3 |
| DEVICE<br>CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION<br>NAME: | Catheter, Guide, Wire |
| PRODUCT CODE | DQX- Catheter Guide Wire |
| PREDICATE<br>DEVICES: | K031277, Asahi Prowater Guidewire, Asahi Grand Slam<br>K133865, ASAHI PTCA Guide Wire ASAHI Gaia |
| DATE PREPARED: | May 16th, 2014 |

#### INTENDED USE:

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

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#### DESCRIPTION:

The product, ASAHI PTCA Guide Wire ASAHI RG3 (hereinafter ASAHI RG3 and ASAHI RG3 Soft), is intended to facilitate the insertion of an inflatable balloon catheter and other devices for treating narrowing and obstruction of the blood vessels.

The basic structure of the ASAHI RG3 and ASAHI RG3 Soft consists of a taper core wire and a coil. The taper core wire and the coil are soldered. The coil is radiopaque in part length so its position can be easily confirmed under radioscopy. In addition to this, coatings are applied on the surface of the product. The distal end of ASAHI RG3 and ASAHI RG3 Soft are coated with hydrophilic polymer. On the other hand, the proximal end of the taper core of ASAHI RG3 and ASAHI RG3 Soft wire is coated with silicone oil.

#### COMPARISON TABLE WITH PREDICATE DEVICES:

Comparisons of the ASAHI PTCA Guide Wire ASAHI RG3 and predicate devices show that the technological characteristics of the ASAHI RG3 such as the intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate devices. The ASAHI PTCA Guide Wire ASAHI RG3 has an overall length of 330 cm and a nominal outer diameter of 0.26 mm.

#### NON CLINICAL TESTING / PERFORMANCE DATA:

Non clinical laboratory testing was performed on the ASAHI RG3 to determine substantial equivalence. The following testing/assessments were performed:

- Tensile Strength ●
- Torque Strength
- o Torqueablity
- Tip Flexibility ●
- Coating Adhesion/Integrity ●
- Catheter Compatibility ●

#### BIOCOMPATIBILITY:

The ASAHI RG3 Guidewire was compared to the predicate devices. Based on similariites of the materials used in the subject devcie to its predicates, the biocompatibiity of the ASAHI RG3 was verified to be the same as those of the predicates.

#### CONCLUSION:

The ASAHI RG3 GuideWire has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended, and is as safe and effective as the predicate devices.

Therefore, the ASAHI PTCA Guide Wire ASAHI RG3 is substantially equivalent to the predicate devices.