AIROCIDE TI02

• K Number: K023830
• Device Name: AIROCIDE TI02
• Manufacturer: KES SCIENCE & TECHNOLOGY, INC
• Date Cleared: 2003-02-04 ( 78 days)
• Product Code: FRA
• Regulation Number: 880.6500
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: K033448 , K052732

Intended Use

Potential applications include removing and mineralizing airborne contaminations of pathogens and/or harmful molds and volatile organic compounds present in rooms or enclosed areas: treatment rooms, hospital wards, intensive care hospital wards, holding areas in jails, operating rooms, homeless shelters, pediatric waiting areas, command and control vehicles, embalming rooms in funeral homes, postal facilities, etc.

Device Description

Not Found

AI/ML Overview

The provided documents, K023830, primarily consist of an FDA 510(k) clearance letter and an "intended use" statement for the AiroCide TiO2 device. This documentation does not contain the detailed information necessary to describe acceptance criteria or a study proving the device meets those criteria, as typically required for performance evaluations of medical devices.

The FDA letter confirms the device's substantial equivalence to a legally marketed predicate device but does not present the specific performance data for the AiroCide TiO2 itself. The "intended use" statement describes potential applications but does not include any performance metrics, study designs, or results.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method.
5. Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This type of information would typically be found in a separate section of the 510(k) submission, such as a "Device Performance" or "Clinical Data" section, which is not present in the provided FDA letters.

Summary

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FFB 0 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

·Mr. John Hayman, Jr. President KES Science & Technology, Incorporated 3625 Kennesaw North Industrial Parkway Kennesaw, Georgia 30144

Re: K023830

Trade/Device Name: AiroCide TiO2 Regulation Number: 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: II Product Code: FRA Dated: November 6, 2003 Received: November 18, 2003

Dear Mr. Hayman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Hayman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runne

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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0025 Kennesan North Industrial Play. Kennessan, BA 30144 USA PHONE [phone] FAX [phone] www.kesmist.com

January 31, 2003

Food and Drug Administration Center for Devices and Radiological Health (HFZ-308) Office of Compliance Information Processing and Office Automation Branch 9200 Corporate Boulevard Rockville, MD 20850-4015

501(k) Notification

Dear Sir/Madam,

AiroCide TiO2 INTENDED USE: Potential applications include removing and mineralizing airborne contaminations of pathogens and/or harmful molds and volatile organic compounds present in rooms or enclosed areas: treatment rooms, hospital wards, intensive care hospital wards, holding areas in jails, operating rooms, homeless shelters, pediatric waiting areas, command and control vehicles, embalming rooms in funeral homes, postal facilities, etc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109) OR

Over-The-Counter Use

Qius S. Lim

(Optional Format 1-2-96)

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K0223830

Regulation Number and Section

§ 880.6500 Medical ultraviolet air purifier.

(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).