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.

AI/ML Overview

The provided text is a 510(k) summary for the Sedat Flamingo Angiographic injector/syringe. The document explicitly states: "H. Summary of Clinical Tests (Not Applicable)." and lists "G. Summary of Non-Clinical Tests Mechanical testing was presented."

Therefore, a study demonstrating the device meets acceptance criteria via clinical tests, multi-reader multi-case studies, independent standalone algorithm performance, or using experts to establish ground truth is not applicable based on this document. The device's substantial equivalence was established through non-clinical mechanical testing and comparison to a predicate device.

Here's an breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantified acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it relies on substantial equivalence to a predicate device and mechanical testing.

Acceptance Criterion	Reported Device Performance
Not specified for clinical performance	Not specified for clinical performance
Equivalence in indications for use	Stated as equivalent to Sedat's Dolphin Device (K042449)
Equivalence in design	Stated as equivalent to Sedat's Dolphin Device (K042449)
Equivalence in material	Stated as equivalent to Sedat's Dolphin Device (K042449)
Equivalence in function	Stated as equivalent to Sedat's Dolphin Device (K042449)
Mechanical Performance	Mechanical testing was presented (details not described in summary)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set or data provenance from clinical data is mentioned for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical ground truth or experts were used for this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication method is mentioned for this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical inflation device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical inflation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in a clinical sense. The "ground truth" for this device's performance was established through mechanical testing and comparison to a predicate device's design, materials, and function.

8. The sample size for the training set

Not applicable. No training set is mentioned for this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable. No training set is mentioned for this 510(k) submission.

Summary

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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: +33 472 397 414 Fax: +33 478 518 967

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

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.