(28 days)
DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach is to be used as a generalpurpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and chrome. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach are intended for use in healthcare settings for environmental control of bacteria and viruses, and prevention of cross-contamination. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach tuberculocidal efficacy requires two minutes contact time at room temperature (68-779F, 20-25°C).
DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach
The provided documents are a letter from the FDA regarding a 510(k) submission for a hospital cleaner disinfectant. These documents do not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for a medical device.
Instead, the documents describe the FDA's determination of substantial equivalence for a product named "DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach" and state its intended use as an intermediate level disinfectant for non-critical devices and hard surfaces in healthcare settings.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving a device meets these criteria based on the provided text. The documents are related to regulatory clearance (510(k)), not performance study details.
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Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 30 1998
Mr. Gregory S. Cross Environmental Chemist Caltech™ Industries, Incorporated 2420 Schuette Drive Midland, Michigan 48642
Re : K983869 DISPATCH® Hospital Cleaner Disinfectant Trade Name: Towels with Bleach Requlatory Class: Unclassified Product Code: LJR Dated: October 20, 1998 November 2, 1998 Received:
Dear Mr. Cross:
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 Regulations, 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 Reqister. Please note: this response to your premarket notification 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 requlations.
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Page 2 - Mr. Cross
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debting of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marice 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 (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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Diredtor 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): K983869
Device Name: _ DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach
Indications For Use:
DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach is to be used as a generalpurpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and chrome. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach are intended for use in healthcare settings for environmental control of bacteria and viruses, and prevention of cross-contamination. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach tuberculocidal efficacy requires two minutes contact time at room temperature (68-779F, 20-25°C).
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.