NOVIGUARD QUICK DRY

K961044 · Dr. Novis Smith & Co., Inc. · LRJ · Jul 3, 1997 · General Hospital

Device Facts

• Record ID: K961044
• Device Name: NOVIGUARD QUICK DRY
• Applicant: Dr. Novis Smith & Co., Inc.
• Product Code: LRJ · General Hospital
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6890
• Device Class: Class 1

Indications for Use

Noviguard is a general purpose disinfectant and is intended to be used on non-critical devices, dental and medical equipment, surfaces such as wheelchairs, dental chairs and medical beds in health care facilities.

Device Story

Noviguard Quick Dry is a surface disinfectant formulated with phenol and ortho-phenyl phenol complexed with oleyltrimethylenediamine (Adogen 572) and polyvinylpyrrolidone (PVP) in an ethanol solvent. Upon application, the ethanol evaporates rapidly, leaving a thin, high-concentration phenolic film on the surface. This film provides a rapid initial kill of microorganisms and acts as a slow-release barrier for sustained disinfection. The device is intended for use by healthcare personnel on non-critical medical and dental equipment and surfaces to maintain a disinfected state after initial cleaning. It offers a wider spectrum of antimicrobial activity and longer-lasting protection compared to standard phenolic disinfectants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disinfectant solution containing phenol, ortho-phenyl phenol, oleyltrimethylenediamine (Adogen 572), and PVP in ethanol. Operates via chemical disinfection and formation of a residual antimicrobial film. Liquid form for surface application. No electronic components or software.

Indications for Use

Indicated for use as a general purpose disinfectant on non-critical medical/dental devices and surfaces (e.g., wheelchairs, dental chairs, medical beds) in healthcare facilities.

Regulatory Classification

Identification

A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.

Predicate Devices

• Lysol

Submission Summary (Full Text)

{0}

JUN 20 '97 10:54AM PEACOCK LABS.PHILA.PA 19143
P.3/6

6-2

DR NOVIS SMITH & CO
1034 Laurel Oak Road
Voorhees, NJ 08043
800-668-4482
PA [phone]
Fax [phone]

510(k) SUMMARY
Prepared June 19, 1997

This 510(k) Summary for Noviguard Quick Dry has been prepared by Dr. Novis Smith who can be reached at the place of business noted in the letterhead and is the contact person.

Noviguard Quick Dry is a specially formulated general purpose disinfectant based on phenol and ortho phenyl phenol which are complexed reversibly with a oleyltrimethylenediamine (Adogen 572) and another basic polymer(PVP) to form a thin film which contains a high concentration of the phenolic disinfectant when dried. (This permits the use of low levels of phenol in the use solution to be about 0.5% yet when the very thin film dries the percentage of phenol is about 25% as the complex.) The phenol is retained and escapes as if in a slow release situation over week or more. the higher molecular weight components which also are disinfectants remain and maintain an effective disinfecting barrier. This whole formulation is dissolved in ethanol which permits the solution to dry within seconds for fast even application to surfaces. Ethanol does not attack most normally found surfaces in homes or hospitals.

We claim equivalence to Lysol which is based on just ortho-phenyl phenol. These are both products with at use concentrations of about 1% or less of active components. Both have been designed for the hospital and the home for primary disinfecting of exposed surfaces against a wide range of organisms. Noviguard Quick Dry is intended to be used as a general purpose disinfectant after cleanup has been accomplished or on surfaces nominally clean to maintain these surfaces in a disinfected state. This is achieved by using two phenols which act more rapidly and have a wider number of organisms which Noviguard would be effective against and in combination with the film forming polymer and oleyl trimethylenediamine. This unique combination permits the application of small amounts of disinfectant to surfaces and yet obtains maximum effectiveness since a rapid effective kill occurs and a longer lasting disinfecting action is maintained.

K 96 10 44
JUL - 3 1997

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Dr. Novis Smith
President
Dr. Novis Smith & Company, Incorporated
701 Haddon Avenue
Collingswood, New Jersey 08108

JUL - 3 1997

Re: K961044
Trade Name: Noviguard Quick Dry
Regulatory Class: Unclassified
Product Code: LRJ
Dated: May 20, 1997
Received: May 21, 1997

Dear Dr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{2}

Page 2 - Mr. Smith

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{3}

3-5
STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K961044

Device Name: Noviguard Quick Dry

Indications For Use:

Noviguard is a general purpose disinfectant and is intended to be used on non-critical devices, dental and medical equipment, surfaces such as wheelchairs, dental chairs and medical beds in health care facilities.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K961044
Prescription Use ☐ OR Over-the-Counter Use ☑