PRO-PORTION CLEANER/DISINFECTANT

K991509 · Sultan Chemists, Inc. · LRJ · Jul 14, 1999 · General Hospital

Device Facts

• Record ID: K991509
• Device Name: PRO-PORTION CLEANER/DISINFECTANT
• Applicant: Sultan Chemists, Inc.
• Product Code: LRJ · General Hospital
• Decision Date: Jul 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6890
• Device Class: Class 1

Indications for Use

Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to a health care setting where low and intermediate level disinfection of hard, non-porous surfaces is required. It is intended to be used in a dental office as an instrument ultrasonic cleaning solution. In order to disinfect, a contact time of 10 minutes at 69°F / 20°C is required. This product may be used to pre-clean or decontaminate of critical or noncritical medical devices prior to sterilization. Must be followed by appropriate terminal sterilization or high-level disinfection process.

Device Story

Pro-Portion is a phenolic-based, ready-to-use liquid cleaner/disinfectant; intended for hard, non-porous surfaces in dental offices and healthcare settings. Functions as an ultrasonic cleaning solution for instruments; requires 10-minute contact time at 20°C for disinfection. Used by dental staff to pre-clean or decontaminate critical/semi-critical devices prior to terminal sterilization or high-level disinfection. Not for use on devices entering sterile body areas or contacting mucous membranes. Benefits include efficient cleaning and intermediate-level disinfection of dental units, lights, and various materials including plastics, stainless steel, and glass.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Phenolic-based liquid cleaner/disinfectant; 10.5% phenolics in concentrate; pH 9.1-11.1 (concentrate), 6.8-8.2 (use-dilution); specific gravity 0.9-1.1; flash point: none; phosphate-free. Compatible with polycarbonate, PVC, polypropylene, polystyrene, vinyl, stainless steel, Plexiglas, and glass.

Indications for Use

Indicated for use in healthcare settings, specifically dental offices, for low and intermediate level disinfection of hard, non-porous surfaces and as an ultrasonic cleaning solution for instruments. Contraindicated for use as a terminal sterilant or high-level disinfectant on devices introduced into the bloodstream, normally sterile areas, or contacting intact mucous membranes.

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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# 510 K Summary K 991509

### Physical Characteristics

| Product designation: | A phenolic cleaner/disinfectant |
|---------------------------|---------------------------------|
| Appearance (concentrate): | Clear light amber liquid |
| Odor: | Slight alcohol |
| Percent of Phenolics: | Concentrate 10.5% |
| pH (concentrate): | 9.1 - 11.1 |
| pH (use-dilution): | 6.8 - 8.2 |
| Specific Gravity (25°C): | .9-1.1 |
| Flash Point: | None |
| Detergency: | Excellent |
| Phosphate Content: | None |

Image /page/0/Picture/4 description: The image shows a logo for "TUV CERT ISO 9001 REGISTERED". The logo features the "TUV" acronym in a stylized font above the word "CERT", which is enclosed in a rounded rectangle. Below "CERT" is the text "ISO 9001 REGISTERED". The entire logo is surrounded by two concentric oval shapes.

Image /page/0/Picture/5 description: The image shows a logo with the letters 'OSAP' stacked on top of each other. The letters are white and are set against a black square background. The logo is simple and modern in design.

Image /page/0/Picture/6 description: This image shows the logo and contact information for Sultan Chemists, Inc. The logo includes the company name in bold, stylized font, with a black triangle behind it. The address is listed as 85 West Forest Ave., Englewood, NJ 07631. The phone number is [phone], the toll-free number is [phone], and the fax number is [phone].

Image /page/0/Picture/7 description: The image shows the letters DMA in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are black and the background is white.

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Image /page/0/Picture/8 description: The image shows a logo with the letters "ADEA" in a stylized, bold font. The letters are interconnected, with the "A" and "D" sharing a vertical line, and the "E" and "A" also sharing a line. The overall design is modern and geometric, with a sense of unity and connection between the letters.

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## 510 K Summary K 991509

Sultan Chemists Submitter: 85 W. Forest Avenue Englewood, NJ 07631

| Contact Person: | Les Heimann |
|------------------------|---------------------------------------|
| Date Prepared: | June 16, 1999 |
| Propriety Name: | Pro-Portion ™ cleaner/ disinfectant |
| Common Usual Name: | General Purpose Cleaner/ Disinfectant |
| Disinfectant Category: | Intermediate level |

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 or semi-critical medical devices prior to sterilization/high-level disinfection. To be effective a ten-minute contact time at room temperature (69°F / 20°C) is required.

#### Use, Functions, Concepts, and Performance Characteristics

Pro-Portion is a broad spectrum, multi-purpose ready to use, effective cleaner and disinfectant for use on the surfaces of inanimate objects. Pro-portion will efficiently clean and disinfect, when used as directed, such items as laminated counter tops, dental units, dental instruments, lights, and other inanimate surfaces, including those made of plastics (such as: polycarbonate, polyvinylchloride, polypropylene and polystyrene), nonporous vinyl and upholstery, stainless steel, painted surfaces, Plexiglas, glass, and other hard non-porous surfaces.

Image /page/1/Picture/6 description: The image shows a logo for "TUV CERT ISO 9001 REGISTERED". The logo consists of the "TUV" acronym stacked on top of the word "CERT", all enclosed within an oval shape. Below the oval, the text "ISO 9001 REGISTERED" is printed in a smaller font size. The logo appears to be a certification mark, indicating that the organization has been registered under the ISO 9001 standard.

Image /page/1/Picture/7 description: The image shows a logo with the letters "OSAP" stacked on top of each other. The letters are white and are set against a black square background. The logo appears to be a simple, graphic design.

#### 510 K Summary

ultan
Sultan Chemists, Inc.
85 West Forest Ave., Englewood, NJ 07631
Phone: [phone] • Toll Free: [phone]
Fax: [phone] • http://www.sultanintl.com

Image /page/1/Picture/10 description: The image shows two sets of bold, sans-serif letters. On the left, the letters "DMA" are displayed, with the "A" appearing slightly smaller and nestled between the "D" and "M". To the right, the letters "ADCA" are shown, with a similar style and thickness as the first set of letters. The letters are all in black, contrasting with the white background.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 14 1999

Mr. Les Heimann Vice President of Quality Sultan Chemists, Incorporated 85 West Forest Avenue 07631 Englewood, NJ

Re : K991509 Pro-Portion™ Cleaner/Disinfectant Trade Name: Requlatory Class: Unclassified Product Code: LRJ Dated: April 24, 1999 Received: April 30,1999

Dear Mr. Heimann:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Mr. Heimann Page 2 -

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 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 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 diaqnostic 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

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Page of

| 510(k) Number (if known): | K991509 |
|---------------------------|---------|
|---------------------------|---------|

Pro-Portion™ Device Name:

Indications For Use:

Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to a health care setting where low and intermediate level disinfection of hard, non-porous surfaces is required. It is intended to be used in a dental office as an instrument ultrasonic cleaning solution. In order to disinfect, a contact time of 10 minutes at 69°F / 20°C is required.

This product may be used to pre-clean or decontaminate of critical or noncritical medical devices prior to sterilization. Must be followed by appropriate terminal sterilization or high-level disinfection process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qlin S. Lin

(Division Sign-Off)
Division of Dental Infection Control,
and General Hospital Devices
510(k) Number
K941509

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)