LOW PH PHENOLIC 256

K983585 · Central Solutions, Inc. · LRJ · Nov 6, 1998 · General Hospital

Device Facts

• Record ID: K983585
• Device Name: LOW PH PHENOLIC 256
• Applicant: Central Solutions, Inc.
• Product Code: LRJ · General Hospital
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6890
• Device Class: Class 1

Indications for Use

This product is not to be used as a terminal sterilant/high-level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used to preclean or decontaminate critical medical devices prior to sterlization or high-level disinfection.

Device Story

Low pH Phenolic 256 is a liquid germicidal detergent for cleaning, disinfecting, and deodorizing hard, non-porous surfaces in healthcare institutions. Used by hospital staff and healthcare personnel to control cross-contamination. Applied to environmental surfaces (e.g., bed frames, examination tables, stethoscopes) and for pre-cleaning medical devices. Operates as a chemical disinfectant; effective against Mycobacterium tuberculosis, Staphylococcus aureus, Salmonella cholerasuis, Pseudomonas aeruginosa, Trichophyton mentagrophytes, and HIV-1 in the presence of 5% organic soil. Healthcare providers apply the solution to surfaces to reduce pathogen transmission risk; benefits include maintaining sanitary clinical environments and preventing cross-contamination.

Clinical Evidence

Bench testing only. Efficacy demonstrated via A.O.A.C. testing in hard water (up to 400 ppm) with 5% organic soil load. Effective as a bactericide, virucide, and fungicide at 20°C with a 10-minute contact time.

Technological Characteristics

Activated synthetic phenolic base disinfectant cleaner. Concentrate contains 14.735% phenolics. pH of concentrate: 2.25 ± 0.50; pH of use-dilution: 3.50 ± 0.50. Specific gravity: 1.089 ± 0.01. Flash point: None. Phosphate-free. Liquid form.

Indications for Use

Indicated for low and intermediate level disinfection of hard, non-porous surfaces in healthcare settings, including wheelchairs, medical beds, patient transfer lifts, crutches, instrument trays, operating tables, dental chairs, medical lamps, and whirlpool units. May be used to preclean or decontaminate critical or non-critical medical devices prior to sterilization or high-level disinfection.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with the text "CENTRAL SOLUTIONS INC" in bold, black letters. Above the text is a black circle with a white teardrop shape inside. To the right of the logo, the text "NOV 6 1998" is printed in a smaller, less bold font.

DISINFECTANT CATEGORY:

FRHOFF RD. KANSAS 66115

Formulation . Development . Production

## 510(k) SUMMARY

1983585

| SUBMITTER: | Central Solutions, Inc.<br>3130 Brinkerhoff Road<br>P.O. Box 15276<br>Kansas City, KS 66115<br>Tel: [phone] | CONTACT PERSON: | Paul Nobrega |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------|
| | | DATE PREPARED: | August 27, 1998 |
| DEVICE TRADE / PROPRIETY NAME: | | Low pH Phenolic 256 | |
| DEVICE COMMON / USUAL NAME: | | General Purpose Disinfectant | |
| CLASSIFICATION NAME: | | Unclassified | |

This product is not to be used as a terminal sterilant/high-level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used to preclean or decontaminate critical medical devices prior to sterlization or high-level disinfection.

Intermediate Level General Purpose Disinfectant

## USE, FUNCTIONS, CONCEPTS, AND PERFORMANCE CHARACTERISTICS OF DEVICE:

Low pH Phenolic 256 is a liquid germicidal detergent formulated to clean, disinfect, and deodorize any washable, non-porous surface in one easy step. Low pH Phenolic 256 is recommended for use by hospitals, nursing homes, and other health care institutions that are dedicated to controlling cross-contamination in their establishments. Low pH Phenolic 256 is for use on any hard, inanimate surfaces such as door handles, medical bed surfaces, springs, wheelchairs, walls, floors, light switches, linen carts, stretcher wheels, toilet bowl surfaces, showers, bathtubs, bed frames, patient transfer lifts, patient scales, examination tables, dental chairs, stethoscopes, bedpans, blood donor chairs, and other hard, non-porous surfaces that need disinfection.

Efficacy tests have demonstrated that this product is an effective bactericide, and virucide in the presence of organic soil (5% blood serum). When used as directed, Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Mycobacterium tuberculosis (BCG) at 20℃, Staphylococcus aureus, Salmonella cholerasuis, and Pseudomonas aeruginosa. Low pH Phenolic 256 is fungicidal against the pathogenic fungi, Trichophyton mentagrophytes (Athlete's Foot Fungus) when used as directed on hard surfaces found in bathrooms, shower stalls, locker rooms, or other clean, non-porous, hard surfaces commonly contacted by bare feet. This product, when used on environmental, inanimate, non-porous surfaces, exhibits effective virucidal activity against HIV-1 (associated with AIDS). HIV-1 (AIDS Virus) on pre-cleaned environmental surfaces/objects previously soiled with blood/body fluids in health care settings in which there is an expected likelihood of soiling of inanimate surfaces/objects with blood or body fluids, and in which the surfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for transmission of human immunodeficiency virus Type-1 (HIV-1) (associated with AIDS).

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Image /page/1/Picture/0 description: The image shows the logo for Central Solutions, Inc. The logo consists of a stylized letter "C" with a water droplet inside. The text "CENTRAL SOLUTIONS, INC." is written in bold, sans-serif font below the logo.

3130 BRINKERHOFF RD. P.O. BOX 15276 KANSAS CITY, KANSAS 66115 [phone]

Formulation • Development • Production

# 510(k) Summary - Page 2

## SCIENTIFIC PHYSICAL CHARACTERISTICS OF DEVICE:

| Product Designation: | Activated Synthetic Phenolic Base Disinfectant Cleaner |
|---------------------------|---------------------------------------------------------------------------------|
| Appearance (Concentrate): | Clear light amber liquid |
| Odor: | Slight alcohol |
| Percent of Phenolics: | Concentrate: 14.735% |
| pH (concentrate): | 2.25 ± 0.50 |
| pH (use-dilution): | 3.50 ± 0.50 |
| Specific Gravity (25°C): | 1.089 ± 0.01 |
| Flash Point: | None |
| Detergency: | Excellent |
| Phosphate Content: | None |
| Testing: | A.O.A.C. in Hard Water up to 400 ppm in the presence of<br>5% organic soil load |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

Mr. Paul J. Nobrega Registration Specialist Dental Solutions, Incorporated 3130 Brinkerhoff Road P.O. Box 15276 Kansas City, Kansas 66115

Re : K983585 Trade Name: Low pH Phenolic 256/Cen-pHene Regulatory Class: Unclassified Product Code: LRJ Dated: Auqust 27, 1998 October 13, 1998 Received:

Dear Mr. Nobrega:

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 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). 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 requlations 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 requirements, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Nobrega

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

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (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" (21CFR 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/dsma/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

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## Page _ 1 _ of _ 1

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|------------------------------|
| 510 (K) NUMBER (IF KNOWN) | K983585 |
| DEVICE NAME | LOW PHPHENOLIC 258/CEN-PHENE |

#### INDICATIONS FOR USE :

Is a general for repose as interfact For use in health care settings for low and intermediate level disinfection of hard, non-porsus, increase in the contra suffaces of wheelchairs, medical beds, patient transfer iffs, cruiches, instrument trays, operating tables, surfaces of Pricolonalic, modical paintal chairs, medical lamps, whilipool bathing units, and other medical devices that require low or internediate level disinfection. This product may be used to preclaan or decontaminate attical or non-citical medical devices prior to sterilization or high-loved disintedion. The effectiveness of this product has been documented at a temperature of 68°F (20°C), with a ten minute contact time on the surface being treated.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The Counter-Use Prescription Use (Per 21 CFR 801 。 109) (Optional Format 1 - 2 -96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _