SEDAT FLAMINGO

K082755 · Sedat · MAV · Dec 15, 2008 · Cardiovascular

Device Facts

• Record ID: K082755
• Device Name: SEDAT FLAMINGO
• Applicant: Sedat
• Product Code: MAV · Cardiovascular
• Decision Date: Dec 15, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Sedat Flamingo is indicated for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

Device Story

The Sedat Flamingo is a single-use, sterile, manual inflation device used in cardiovascular procedures. It consists of an inflation unit and a 30 cc syringe. The operator manually manipulates a grip handle to drive a piston, pressurizing or depressurizing balloon catheters. Clockwise rotation of the handle achieves controlled inflation; a cam locking mechanism maintains pressure when the user releases the device. A button lock release allows for instantaneous deflation. The device is used by clinicians in a cardiovascular setting to manage balloon catheter pressure, facilitating procedural success.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual inflation device; 30 cc syringe; cam locking mechanism for pressure maintenance; button lock for rapid deflation; single-use; sterile.

Indications for Use

Indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, 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

• Sedat Dolphin Device (K042449)

Submission Summary (Full Text)

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## VII. 510(k) Summary

K082755 Rg. 1 of 2

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular \$807.92, the following summary of information is provided:

## A. Submitted by

## DEC 1 5 2008

Catherine Charles Director of Regulatory Affairs and Quality Assurance Sedat 135. Route Neuve 69540 Irigny -France Telephone: [phone] Fax: [phone]

#### B. Device Name

Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Classification: Product Code:

Sedat Flamingo Angiographic injector/syringe Ballon Inflation Syringe Class II 870.1650 MAV

#### C. Predicate Devices

The subject device is substantially equivalent to Sedat's Dolphin Device (K042449).

## D. Device Description

The Sedat Flamingo inflation device is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the FLAMINGO is achieved by the manipulation of a grip handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the button locks located on device.

#### E. Intended Use

The Sedat Flamingo is indicated for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

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# F. Substantial Equivalence

KOB2755 pg2012

Data were provided which demonstrated the Sedat Flamingo inflation device is to be substantially equivalent to Sedat's Dolphin Device (K042449). The substantial equivalence is based upon equivalence in indications for use, design, material, and function.

- G. Summary of Non-Clinical Tests Mechanical testing was presented.
- H. Summary of Clinical Tests (Not Applicable).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2008

SEDAT c/o Mr. Charles Cousin President. Excaelia 8895 Towne Centre Drive #105-416 San Diego, CA 92122

K082755 Re:

> Trade/Device Name: Sedat Flamingo Common Name: Syringe, Balloon Inflation Regulation Number: 21 CFR 870.1650 Regulatory Class: II Product Code: MAV Dated: November 24, 2008 Received: November 25, 2008

Dear Mr. 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, 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. Charles Cousin

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's) 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,

Bram D. Zuckerman, M.D.
Director

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): KO82755

Device Name: SEDAT Flamingo

Indications for Use:

The Sedat Flamingo is indicated for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

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) Page 1 of 1

| (Division Sign-Off) | |
|--------------------------------|----------|
| Division of Cardiovascular Dev | |
| 510(k) Number | K08 2755 |