(42 days)
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Not Found
No
The summary describes a chemical disinfectant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
Kleenaseptic is intended for disinfecting equipment surfaces and non-critical devices, not for therapeutic use on patients.
No
Kleenaseptic is a disinfectant used for cleaning and disinfecting equipment surfaces and non-critical devices, not for diagnosing diseases or conditions.
No
The device description clearly states it is a "ready-to-use, spray-on" disinfectant, indicating it is a chemical product, not software.
Based on the provided information, Kleenaseptic is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that Kleenaseptic is a "general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices." This is an environmental disinfectant, not a product used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces its use as a "spray-on isopropyl alcohol/quaternary ammonium general purpose disinfectant used for the cleaning and disinfection of equipment surfaces and non-critical devices."
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays for testing
Therefore, Kleenaseptic falls under the category of a disinfectant for surfaces and equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Kleenaseptic is a ready-to-use, spray-on general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important.
Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C).
Product codes
LRJ
Device Description
Kleenaseptic is a ready-to-use, spray-on isopropyl alcohol/quaternary ammonium general purpose disinfectant used for the cleaning and disinfection of equipment surfaces and non-critical devices prior to terminal sterilization/high-level disinfection in healthcare environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
hospitals and other critical care areas
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)
The basis for determination of substantial equivalence for Kleenaseptic, a general purpose disinfectant, is its EPA registration as demonstrated by the assignment of EPA registration number 46781-7 and the EPAstamped approved label.
This submission is in conformance with the FDA "Guidance on the Content and Format of 510(k) Submission for General Purpose Disinfectants'', October 1993. The Guidance allows for a 510(k) in order to carry out the intent of the Memorandum of Understanding (MOU) between the EPA and FDA dated June 4, 1993 and amended June 2, 1994. The MOU is an interim agreement between the two agencies regulating the same products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 "SYBRON DENTAL SPECIALTIES, INC." The word "SYBRON" is in large, bold, sans-serif font. Below it, "DENTAL SPECIALTIES, INC." is in a smaller, sans-serif font. The text is black against a white background.
SUMMARY OF SAFETY
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7425 - Phone (714) 516-7488 - Facsimile Wendy A. Urtel - Contact Person
Date Summary Prepared: March 1998
Device Name:
- . Trade Name - Kleenaseptic
- Common Name General Purpose Disinfectant ●
- . Classification Name - Unclassified
Device Description:
Kleenaseptic is a ready-to-use, spray-on isopropyl alcohol/quaternary ammonium general purpose disinfectant used for the cleaning and disinfection of equipment surfaces and non-critical devices prior to terminal sterilization/high-level disinfection in healthcare environments.
Intended Use of the Device:
Kleenaseptic is a general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important.
Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C).
Substantial Equivalence:
The basis for determination of substantial equivalence for Kleenaseptic, a general purpose disinfectant, is its EPA registration as demonstrated by the assignment of EPA registration number 46781-7 and the EPAstamped approved label.
This submission is in conformance with the FDA "Guidance on the Content and Format of 510(k) Submission for General Purpose Disinfectants'', October 1993. The Guidance allows for a 510(k) in order to carry out the intent of the Memorandum of Understanding (MOU) between the EPA and FDA dated June 4, 1993 and amended June 2, 1994. The MOU is an interim agreement between the two agencies regulating the same products.
SYBRON DENTAL SPECIALTIES, INC. 1717 W COLLINS AVENUE, ORANGE. CALIFORIA 92667 (114) 516-7400 A SUBSIDIARY OF SYBHON INTERNATIONAL
Primal on Resulted Paper
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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
!
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Metrex Research Corporation C/O Ms. Wendy A. Urtel Requlatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92667
Re : K981023 Trade Name: Kleenaseptic Requlatory Class: . Unclassified . . . Product Code: LRJ Dated: March 17, 1998 March 19, 1998 Received:
Dear Ms. Urtel:
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 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 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 through 542 of
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Page 2 - Ms. Urtel
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 finding 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 regulation (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" (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
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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Indications for Use
510(k) Number:
Device Name: Kleenaseptic
Indications for Use:
Kleenaseptic is a ready-to-use, spray-on general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important.
Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chun S. Lim
(Division Sign-Off) Division of Denal, Infection Control, and General Hospital Devices
510(k) Number K981023
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)