T.B.Q. RTU

K980369 · STERIS Corporation · LRJ · Feb 17, 1998 · General Hospital

Device Facts

• Record ID: K980369
• Device Name: T.B.Q. RTU
• Applicant: STERIS Corporation
• Product Code: LRJ · General Hospital
• Decision Date: Feb 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6890
• Device Class: Class 1

Indications for Use

T.B.Q. RTU is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in manimate surfaces with a 10 minute contact time at 20°C by housekeeping, mirses, and emergency medical personnel.

Device Story

T.B.Q. RTU is a liquid chemical germicide spray utilizing quaternary ammonium chloride compounds. It is used by housekeeping, nurses, and emergency medical personnel in clinical settings to disinfect hard inanimate surfaces and reusable non-critical medical devices, or to pre-clean/decontaminate critical devices prior to sterilization. The device requires a 10-minute contact time at 20°C to inactivate bacteria, fungi, and viruses. It functions as a chemical disinfectant; no electronic or software components are involved.

Clinical Evidence

Bench testing only. Effectiveness established via AOAC Germicidal Use-Dilution Test (S. aureus, S. choleraesuis, Ps. aeruginosa), AOAC Tuberculocidal Test, AOAC Fungicidal Test (T. mentagrophytes), Virucidal Qualification Test (Herpes simplex, Vaccinia, Adenovirus Type 5), and EPA-approved dilution method against HIV-1.

Technological Characteristics

Liquid chemical germicide; active ingredients: quaternary ammonium chloride compounds. Form factor: pump spray. No electronic components, software, or connectivity. Sterilization/disinfection achieved via chemical action.

Indications for Use

Indicated for reprocessing non-critical medical devices and medical equipment surfaces, and for pre-cleaning or decontaminating critical medical devices prior to sterilization or high-level disinfection. Used by housekeeping, nurses, and emergency medical personnel.

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

• Tor Germicidal Cleaner (Huntington Laboratories)
• Quat-Syl 256 (National Laboratories)
• Futron 25 (Hysan Corp.)

Submission Summary (Full Text)

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## 510(k) Summary

FEB 17 1998

Trade Name: T.B.Q. RTU

Common/Usual Name: General Purpose Disinfectant

Submitter/Manufacturer:

STERIS Corp. Calgon Vestal Division 5035 Manchester Avenue St. Louis, MO 63110 Establishment Registration Number: 1940768

Contact: Mike Ebers, Manager Regulatory Affairs [phone]

Description: T.B.Q. RTU is a liquid chemical geamicide pump spray unilizing quatinary ammonium chloride compounds as active ingredients.

Intended Use: T.B.Q. RTU is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in manimate surfaces with a 10 minute contact time at 20°C by housekeeping, mirses, and emergency medical personnel.

Substantial Equivalence to: (1)Tor Germicidal Cleaner, Huntington Laboratories, (2) Quat-Syl 256, National Laboratories, (3) Futron 25, Hysan Corp.

Comparison to Listed Substantially Equivalent Products: Listed products are also liquid chemical germicides utilizing quatinary ammonium chloride compounds as active ingredients to inactivate specific bacteria, fungi, and viruses on hard inanimate surfaces.

Safety Data: Acute Oral LDgo (Rats) > 1,900 mg/kg

Acute Inhalation LC<o =>2.2 ml/ft

Dermal Irritation (Rabbit) = Primary Irritation Index of 0.09 (Draize Scale), Barely Perceptible Initation .

Eye Irritation (Rabbit) = No initation

Dermal Sensitization (Guinea Pig) = Negative as sensitizer

Effectiveness Data: Germicidal: Passes AOAC Germicidal Use-Dilution Test against S. aureus, S. choleraesuis and Ps. aeruginosa

Tuberculocidal: Passes AOAC Tuberculocidal Test

Fungicidal: Passes AOAC Fungicidal Test against T. mentagrophytes.

Virucidal: Passes Virucidal Qualification Test against Herpes simplex, Vaccinia and Adenovinus Type S

Passes EPA approved Dilution Method against the HIV-1 (AIDS) vinus.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 1998

Mr. Michael G. Sarli Regulatory Specialist Steris Corporation 5035 Manchester Avenue St. Louis, Missouri 63110

K980369 Re : T.B.O. RTU Trade Name: Requlatory Class: Unclassified Product Code: LRJ Dated: January 14, 1998 Received: January 30, 1998

Dear Mr. Sarli:

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 The general controls provisions of the Act 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 Requlations, 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

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Page 2 - Mr. Sarli

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" (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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## 510(k) Number (if known):K980369

Device Name: I B.Q. RTU

Indications For Use: T.B.Q. RTU is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preciesn or decomationate cattical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.

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Conquirence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Dental, Inf ction Control. and General Hoop 510(k) Number

Prescription Use (per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)