ASAHI ANGIOGRAPHIC CATHETER

K051561 · Asahi Intecc Co., Ltd. · DQO · Nov 2, 2005 · Cardiovascular

Device Facts

• Record ID: K051561
• Device Name: ASAHI ANGIOGRAPHIC CATHETER
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQO · Cardiovascular
• Decision Date: Nov 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.

Device Story

Asahi Angiographic Catheter is a diagnostic intravascular catheter used to deliver radiopaque contrast medium to specific vascular sites. Device consists of a tube, proximal hub, and strain relief. Tube features stainless steel braid reinforcement and radiopaque material for visualization under fluoroscopy; distal tip is soft with various configurations to accommodate vessel curvature. Operated by physicians in clinical settings to facilitate angiographic imaging. Output is the targeted delivery of contrast media, enabling visualization of the vascular system to assist in clinical diagnosis and decision-making.

Clinical Evidence

Bench testing and biocompatibility testing only. Materials passed ISO-10993 series testing. No clinical data presented.

Technological Characteristics

Diagnostic intravascular catheter; stainless steel braid reinforced tube; radiopaque material; proximal hub; strain relief; soft distal tip. Biocompatibility per ISO-10993. No software or electronic components.

Indications for Use

Indicated for delivery of radiopaque contrast medium to selected sites in the vascular system.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• 4F Infiniti Angiographic Catheter (K960975)
• 5F and 6F Infiniti Angiographic Catheter (K970854)
• Stand & High Flow Femoral- Ventricular Pigtail Catheter (K862006)

Submission Summary (Full Text)

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KOS/561

Traditional 510(k)

The Asahi Angiographic Catheter

Asahi Intecc Co., Ltd. June, 2005

# NOV - 2 2005

## 510(k) Summary of Safety and Effectiveness

| Date Prepared: | June, 2005 |
|----------------------|------------------------------------------------------------------|
| Submitted: | Asahi Intecc Co., Ltd. |
| | 1703 Wakita-cho, Moriyama-ku, Nagoya, |
| | Aichi, 463-0024, Japan. |
| Contact Person: | Yoshi Terai |
| | Director of Asahi Intecc USA Inc. |
| Address: | 1301 Dove Street, |
| | Suite #350 Newport Beach, |
| | CA, 92660, USA |
| Phone Number: | Phone: [phone] |
| Fax Number: | Fax: [phone] |
| Device Trade Name: | Asahi Angiographic Catheter |
| Classification Name: | Diagnostic intravascular catheter (per 21 CFR 870.1200) |
| Classification: | Class II |
| Predicate Device: | K960975: 4F Infiniti Angiographic Catheter |
| | K970854: 5F and 6F Infiniti Angiographic Catheter |
| | K862006: Stand & High Flow Femoral- Ventricular Pigtail Catheter |

#### Device Description:

The Asahi Angiographic Catheter consists, as its basic structure, of a tube to be inserted into vascular, a proximal hub, and strain relief for the joint section of the first 2 parts. The tube is reinforced by stainless steel braid. The distal tip of the catheter is made soft and has variety configuration in order to easily bend in accordance with the vessel curve. The tube is radiopaque in whole length so as to be easily confirmed its position under radioscopy.

#### Intended Use:

The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.

#### Device Technological Characteristics and Comparison to Predicate Device:

The Asahi Angiographic Catheters are 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 angiographic catheters.

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Asahi Intecc Co., Ltd. June, 2005

## Performance Data:

Bench and biocompatibility testing were conducted according to the relevant ISO to Demonstrate that the Asahi Angiographic Catheter met the acceptance criteria and performed similarly to the predicate devices.

performed summary to the ontact materials used to fabricate the Asahi Angiographic Catheters pass the testing required by ISO-10993 series. These materials are currently used in many disposable medical devices.

## Conclusion:

The Asahi Angiographic Catheters are substantially equivalent to the claimed predicates devices and other currently marketed angiographic catheters.

K05156 Premarket Notification [510(k)] Number

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle's head with three stripes extending from the back of the head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the top of the seal.

NOV - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Asahi Intec Co., Ltd. c/o Mr. Yoghi Terai Director 1301 Dove Street, #350 Newport Beach, CA 92660

> K021561 Asahi Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: September 27, 2006 Received: September 27, 2005

### Dear Mr. Terai:

Re:

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. Tamas Borsal

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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,

Duvur R. Wilmer

- 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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Asahi Intecc Co., Ltd. September, 2005

Asahi Angiographic Catheter Traditional 510(k)

## Indications for Use

510(k) Number (if known): K051561

Device Name: Asahi Angiographic Catheter

Indications For Use:

The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and the same of the same of the same of the same of the seat of the states of the states of the states of the states of the states of the states of the states of the states o

Dmna R. Vichnes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko5156 |

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