(87 days)
Not Found
No
The device description details a purely mechanical, manually operated inflation device with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an inflation device used to operate balloon catheters during cardiovascular procedures, not a therapeutic device itself.
No
The device is an inflation device used to pressurize and depressurize balloon catheters during cardiovascular procedures. Its function is to create and maintain pressure, not to diagnose a condition or disease.
No
The device description clearly states it is a physical device consisting of an inflation device and a syringe, operated manually. It is not software-only.
Based on the provided information, the Sedat Flamingo is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "to create, maintain and monitor pressure in the balloon catheter during cardiovascular procedures." This describes a device used in vivo (within the body) to manipulate a medical device (a balloon catheter) during a procedure.
- Device Description: The description details a mechanical device for inflating and deflating balloon catheters. It does not mention any components or functions related to testing samples of human origin (like blood, urine, tissue, etc.) in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Reagents or assays.
Therefore, the Sedat Flamingo is a medical device used for a therapeutic or procedural purpose within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Sedat Flamingo is indicated for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.
Product codes
MAV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
1
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).
2
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
3
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
4
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 |