(213 days)
Not Found
Not Found
No
The summary describes a fluid delivery system for contrast media injection and blood pressure monitoring, with no mention of AI, ML, image processing, or data analysis that would typically indicate AI/ML involvement.
No.
The device is used to inject contrast media and monitor blood pressure, which are diagnostic and procedural functions rather than direct therapeutic actions.
No
The device is used to inject contrast media and monitor blood pressure during angiography and coronarography procedures. While it provides physiological information, its primary function is not to diagnose a disease but rather to facilitate a procedure and provide real-time monitoring.
No
The device description explicitly states it is a "universal and compact automatic set consisting of an injection handle and a fluid delivery system," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for injecting contrast media and monitoring blood pressure during angiographic and coronarographic procedures. These are procedures performed on the patient, not tests performed on samples taken from the patient.
- Device Description: The description details an automatic set for fluid delivery and injection, consistent with a device used in a clinical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. Nautiflux's function is procedural and monitoring, not diagnostic testing of samples.
N/A
Intended Use / 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.
Product codes
DQO, DXO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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
Non-Clinical Tests: "Performance testing was presented."
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: (33) 4 72 39 74 14 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).
1
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.
2
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 (240) 276-0120. 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 (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
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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510(k) Premarket Notification Nautiflux
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్లాల్ల
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