NUOVOGUARD

K090122 · U.S. Safety Syringes Co., Inc. · FOZ · Feb 5, 2009 · General Hospital

Device Facts

• Record ID: K090122
• Device Name: NUOVOGUARD
• Applicant: U.S. Safety Syringes Co., Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Feb 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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

Device Story

The NUOVOguard IV Catheter is a peripheral vascular access device designed for fluid/drug administration and blood withdrawal. It features a passive safety tip clip mechanism that engages after cannulation to prevent accidental needle stick injuries. The device is intended for use by healthcare professionals in clinical settings. It functions as a standard peripheral catheter with an integrated safety feature to protect the operator during and after the insertion procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Peripheral IV catheter; sizes 14G to 26G; includes passive safety tip clip mechanism for needle stick prevention. No specific material standards or software components described.

Indications for Use

Indicated for patients requiring peripheral vascular access for fluid/drug administration or blood withdrawal. Available in sizes 14G to 26G.

Regulatory Classification

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.

Submission Summary (Full Text)

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## 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.

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## 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 [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 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 [phone] or [phone] 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

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## 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)
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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K090122