(28 days)
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Not Found
No
The 510(k) summary describes a disinfectant towel and does not mention any AI or ML components.
No
The device is a disinfectant for non-critical surfaces and equipment, not a device used to treat or diagnose patients.
No
Explanation: The device is described as a cleaner/disinfectant and is intended for environmental control of bacteria and viruses on surfaces, not for diagnosing medical conditions.
No
The device is a physical product (towels with bleach) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning and disinfecting surfaces and non-critical medical devices. This is an environmental control measure, not a diagnostic test performed on biological samples.
- Device Description: It's described as "Hospital Cleaner Disinfectant Towels with Bleach," which is consistent with a cleaning product, not a diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
Therefore, DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach is a disinfectant product for environmental use in healthcare settings, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
LJR
Device Description
DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and bottom. Inside the circle is a stylized image of a human figure with three wavy lines extending from the head, resembling a bird or a flowing design.
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
2
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)