(15 days)
Not Found
Not Found
No
The summary describes a standard IV catheter with a passive safety mechanism and does not mention any AI or ML capabilities.
No.
The device is described as an IV Catheter used for administering fluids and drugs, and withdrawing blood, indicating it is an access device, not one that provides therapy itself.
No
The device description states its use for "administration of fluids and drugs and for withdrawal of blood," which are therapeutic or procedural functions, not diagnostic ones.
No
The intended use and device description (although not found, the intended use is sufficient) clearly describe a physical IV catheter with a safety mechanism, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access to the peripheral vascular system for administering fluids and drugs and withdrawing blood. This is a direct interaction with the patient's body for therapeutic and diagnostic purposes, not for testing samples in vitro (outside the body).
- Device Description: While the description is "Not Found," the intended use clearly points to an in-vivo device.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other components typically associated with IVD devices.
Therefore, the NUOVOguard IV Catheter is a medical device used for accessing the vascular system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
NUOVOguard IV Catheter in sizes 14G to 26G is used to provide access into the peripheral vascular system for the administration of fluids and drugs and for withdrawal of blood. The NUOVOguard provides a passive safety tip clip to protect from the accidental needle stick injury after cannulations
Product codes
FOZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
FEB - 5 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
United States Safety Syringes Company, Incorporated c/o Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K090122
Trade/Device Name: Intravascular Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: January 14, 2009 Received: January 21, 2009
Dear Mr. Devine:
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 vour 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.
1
Page 2 -- Mr. Devine
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.
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) 276-0115. 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 Biometric's (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,
Anthony 29, 2024 for
Ginette Y. Michaud, M.D.
Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation . Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known): KOGO(a2
Device Name: US SAFETY SYRINGES CO. NUOVOguard IV Catheter
Indications for Use:
NUOVOguard IV Catheter in sizes 14G to 26G is used to provide access into the peripheral vascular system for the administration of fluids and drugs and for withdrawal of blood. The NUOVOguard provides a passive safety tip clip to protect from the accidental needle stick injury after cannulations
Prescription Use 2 (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Diviston Sign-Off)
fa
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K090122