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.

Device Description

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.

AI/ML Overview

This document describes a 510(k) submission for a device called "Low pH Phenolic 256" (also referred to as "Cen-pHene"), which is a liquid germicidal detergent designed for intermediate-level disinfection. The submission does not describe an AI/ML powered medical device, therefore questions regarding sample size for test/training set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and data provenance are not applicable.

Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this disinfectant are defined by its efficacy against specific microorganisms under specified conditions. The reported device performance indicates it met these criteria.

Acceptance Criteria (Microorganism & Condition)	Reported Device Performance
Bactericidal Efficacy (in presence of organic soil - 5% blood serum):
- Mycobacterium tuberculosis (BCG) at 20℃, 10-minute contact time	Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Mycobacterium tuberculosis (BCG) at 20℃.
- Staphylococcus aureus (in presence of 5% blood serum)	Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Staphylococcus aureus.
- Salmonella cholerasuis (in presence of 5% blood serum)	Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Salmonella cholerasuis.
- Pseudomonas aeruginosa (in presence of 5% blood serum)	Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Pseudomonas aeruginosa.
Virucidal Efficacy:
- HIV-1 (associated with AIDS) on pre-cleaned environmental surfaces/objects previously soiled with blood/body fluids in health care settings relevant to potential for transmission of HIV-1.	Exhibits effective virucidal activity against HIV-1 (associated with AIDS).
Fungicidal Efficacy:
- Trichophyton mentagrophytes (Athlete's Foot Fungus) on hard surfaces found in bathrooms, shower stalls, locker rooms, or other clean, non-porous, hard surfaces commonly contacted by bare feet.	Is fungicidal against Trichophyton mentagrophytes (Athlete's Foot Fungus) when used as directed on hard surfaces, as found in bathrooms, shower stalls, locker rooms, or other clean, non-porous, hard surfaces commonly contacted by bare feet.
Physical Characteristics:
- 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 Standard	Tested according to A.O.A.C. in Hard Water up to 400 ppm in the presence of 5% organic soil load.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the explicit "sample size" in terms of number of treated surfaces or biological replicates for the efficacy tests. The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a chemical disinfectant, not an AI/ML powered medical device that requires expert ground truth for interpretation. Efficacy is determined through standardized microbiological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Efficacy is determined through standardized microbiological testing, not human-based adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a chemical disinfectant, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a chemical disinfectant, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's efficacy is the reduction or inactivation of specified microorganisms (bacteria, viruses, fungi) to acceptable levels, as determined by standardized laboratory microbiological testing methods (specifically, A.O.A.C. methods as stated).

8. The sample size for the training set

Not applicable. This is a chemical disinfectant, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a chemical disinfectant, not an AI/ML model that requires a training set and associated ground truth establishment.

Summary

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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:	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:

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 (913) 621-6542

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 of5% organic soil load

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Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.

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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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

INDICATIONS FOR USE :

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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 _

Regulation Number and Section

§ 880.6890 General purpose disinfectants.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.