NAUTIFLUX

K060010 · Sedat · DQO · Aug 4, 2006 · Cardiovascular

Device Facts

• Record ID: K060010
• Device Name: NAUTIFLUX
• Applicant: Sedat
• Product Code: DQO · Cardiovascular
• Decision Date: Aug 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

Nautiflux is recommended for use in angiographic and coronarographic procedures to inject contrast media and to allow the physician to monitor the blood pressure.

Device Story

Nautiflux is a universal, compact automatic set comprising an injection handle and fluid delivery system. Used in angiographic and coronarographic procedures; operated by physicians. Device injects contrast media into patient vasculature and enables blood pressure monitoring. System facilitates diagnostic imaging workflows.

Clinical Evidence

No clinical data; performance testing was presented.

Indications for Use

Indicated for use in angiographic and coronarographic procedures for contrast media injection and blood pressure monitoring.

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.

Submission Summary (Full Text)

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# Koboolo

## 5. 510(K) SUMMARY

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

#### A. Submitted by

Catherine Charles Sedat 135, Route Neuve 69540 Irigny France Telephone: [phone] Date Prepared: December 29, 2005.

AUG - 4 2006

### B. Device Name

| Trade or Proprietary Name: | Nautiflux |
|----------------------------|--------------------------------------------------|
| Common or Usual Name: | Angiographic and coronarographic set |
| Classification Name: | Diagnostic intravascular catheter/piston syringe |

#### C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

#### D. Device Description

Nautiflux is a universal and compact automatic set consisting of an injection handle and a fluid delivery system for use in angiographic and coronarographic procedures.

## E. Intended Use

Nautiflux is recommended for use in angiographic and coronarographic procedures to inject contrast media and to allow the physician to monitor the blood pressure.

## F. Substantial Equivalence

Data was provided which demonstrated the Nautiflux to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.

## G. Summary of Non-Clinical Tests

Performance testing was presented.

- H. Summary of Clinical Tests (Not Applicable).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2006

SEDAT c/o Excaelia 8895 Towne Centre Drive 105-416 San Diego, CA 92121 Attn: Ms. Laetitia Cousin

Re: K060010

> Trade Name: Nautiflux Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO, DXO Dated: August 1, 2006 Received: August 2, 2006

Dear Ms. Cousin:

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. Iisting 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 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.

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Page 2 - Ms. Laetitia Cousin

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,

Bram D. Zuckerman, M.D.
Director
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Premarket Notification Nautiflux

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#### 4. INDICATIONS FOR USE

510(k) Number (if known): KO 600 (6

Device Name: Nautiflux

Indications for Use:

Nautiflux is recommended for use in angiographic and coronarographic procedures to inject contrast media and to allow the physician to monitor the blood pressure.

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)

(Division Sign-Off)
Division of Cardiovascula:

510(k) Number K061110