(148 days)
The Abracair Air Cleaner is intended for the reduction of aerosolized mold and bacteria within hospitals, nursing homes, medical facilities. The device may be used in occupied spaces within hospital environments such as baby an/or neonatal nurseries, hospital rooms, operating rooms, mortuaries, embalming rooms.
ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24 are devices that use a 6inch xenon flash lamp, doped with titanium within a reflecting chamber to irradiate air as the air passes through a baffled chamber. An internal fan draws air through a input filter at approximately 300 cubic feet per minute (CFM) or 100 CFM determined by model number.
The provided text describes an air cleaner device (ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24) and its premarket notification (510(k) K052732). However, it does not contain details about specific acceptance criteria or an explicit study proving the device meets quantitative performance metrics in a manner that allows for a table of reported device performance or many of the requested study details.
The document indicates that "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug and Cosmetic Act." Instead, it mentions a test conducted by the Research Triangle Institute.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit quantitative acceptance criteria are stated in the document. The device's performance is described qualitatively.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Reduction of Airborne Contaminants | (Not defined quantitatively in document) | "ABRACAIR reduces aerosolized bacteria and fungi." |
| Safety Standards | (Not defined explicitly beyond general conformity) | "Tested to Underwriter Label safety standards and is eligible to bear the Canadian Standards Association (CSA) Mark with the C-US Indicator." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to a single test by the Research Triangle Institute without detailing the experimental setup, number of tests, or samples used.
- Data Provenance: The test was conducted by the "Research Triangle Institute." The country of origin of this specific test data is not explicitly stated but can be inferred to be the USA given the context of the 510(k) submission to the FDA. The study appears to be a prospective test designed to evaluate the device's efficacy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document describes a technical performance test rather than a diagnostic or interpretive study requiring expert ground truth establishment for a test set. Therefore, this information is not applicable or provided. The "ground truth" would be the actual concentration of bacteria and fungi as measured by scientific instruments.
4. Adjudication Method for the Test Set
- Not applicable as this was a technical performance test, not one requiring human interpretation and adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This device is an air cleaner, not an imaging or diagnostic device that typically requires human reader interpretation. The study focused on the device's ability to reduce airborne contaminants, not on human interpretation or diagnosis.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Yes, this was a standalone performance test of the device. The study assessed the efficacy of the ABRACAIR Air Cleaner itself in reducing airborne bacteria and fungi, without any human-in-the-loop component related to its primary intended function.
7. The Type of Ground Truth Used
- The ground truth for the "reduces aerosolized bacteria and fungi" claim would be direct measurement of the concentration of airborne bacteria and fungi (e.g., colony-forming units per unit volume of air) before and after air treatment by the device. This is a scientific measurement, not an expert consensus, pathology, or outcomes data in the medical diagnostic sense.
8. The Sample Size for the Training Set
- Not applicable. This device is an air cleaner, not a machine learning model that typically requires a training set. The "study" described is a direct performance test of the physical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device and study.
In summary: The provided 510(k) summary focuses on general device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results with quantitative acceptance criteria. The performance claim is qualitative ("reduces aerosolized bacteria and fungi") and is supported by a test from Research Triangle Institute, but the specifics of that test (methodology, raw data, statistical analysis, specific metrics, sample sizes, etc.) are not included in this document.
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KD52732
FEB 2 4 2016
510(k) SUMMARY
ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR , Part 807.92, Content and Format of one 510(k) Summery
1. Submitted By:
: .. '
Dr. David Changaris, MD Synlabs. Inc. 204 N. 17th Street Louisville, Kentucky 40203-1212 U.S.A.
2. Contact Person:
Dr. David Changaris 801 Barret Avenue Louisville, Kentucky 40204 Tel: 1-502-584-6852 Fax: 1 -502-584-8379 Cell: 1-502-445-9471
3. Date Prepared:
August 16, 2005
4. Proprietary Name:
ABRACAIR Air Cleaner, QTZ300-60 ABRACAIR Air Cleaner, TI 100-30P
5. Common/Usual Name:
Air Purifier
6. Classification Name:
$ 880.6500 Medical Ultraviolet Air Purifier. A device designed to remove particles from air, as class II devices, product code FRA, and it is reviewed by General Hospital Devices.
7. Predicate Device:
AiroCide TiO2 (K023830) Air Purifier 3707 UVC (K033448)
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8. Device Description:
ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24 are devices that use a 6inch xenon flash lamp, doped with titanium within a reflecting chamber to irradiate air as the air passes through a baffled chamber. An internal fan draws air through a input filter at approximately 300 cubic feet per minute (CFM) or 100 CFM determined by model number.
9. Intended Use:
The ABRACAIR Air Cleaner is used to reduce the concentration of viable airborne bacteria, mold and spores within inhabitated spaces. The use of this device is not intended to treat a speicfic disease or medical condition. It should be used as part of a comprehensive air quality program.
10. Performance Standards:
No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug and Cosmetic Act. However, the ABRACAIR Air Cleaner was tested by the Research Triangle Institute which showed ABRACAIR reduces aerosolized bacteria and fungi. The device has been tested to Underwriter Label safety standards and is eligible to bear the Canadian Standards Association (CSA) Mark with the C-US Indicator.
11. Substantial Equivalence:
The ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24 are substantial equivalence to AiroCide TiO2 (K023830) and Air Purifier 3707, UVC (K033448) in respect to intended use, characteristics and device descriptions.
End of 510(k) Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with three lines representing its wings, and a human profile in the negative space between the wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Changaris Chief Executive Officer Abracair, Incorporated 801 Barret Avenue Louisville, Kentucky 40204
Re: K052732
Trade/Device Name: Abracair models QTZ300-60 and QTZ100-24 Regulation Number: 880.6500 Regulation Name: Medical ultraviolet air purifier Regulatory Class: II Product Code: FRA Dated: December 12, 2005 Received: February 7, 2006
FEB 2 4 2006
Dear Mr. Changaris:
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. David Changaris
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clu L
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known): K052732
Device Name: Abracair models QTZ300-60 and QTZ100-24
Indications For Use: The Abracair Air Cleaner is intended for the reduction of aerosolized mold and bacteria within hospitals, nursing homes, medical facilities. The device may be used in occupied spaces within hospital environments such as baby an/or neonatal nurseries, hospital rooms, operating rooms, mortuaries, embalming rooms.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shali 17. M. Mighyly, MD 2/24/06
logy General Hospital
and Dental Services
/052732
Page 1 of
§ 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).