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: HO
• Reference & Predicate Devices: N/A

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.

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).