(131 days)
Not Found
No
The summary describes a HEPA-filtered clean hood with embedded firmware and manual controls, with no mention of AI, ML, image processing, or data sets for training/testing.
No.
The device is a HEPA-filtered clean hood designed to control airborne particulates in a medical environment, not directly treat a medical condition or disease. It provides a controlled environment, which is supportive of medical procedures, but it is not a therapeutic device itself.
No
Explanation: The device is described as a HEPA-Filtered clean hood for filtering airborne particles from the air, providing a controlled environment. Its intended use is for medical applications requiring particulate control, not for diagnosing medical conditions.
No
The device description clearly states it is a portable HEPA-Filtered clean hood with physical components like filters, controls, and power requirements, indicating it is a hardware device with embedded firmware, not a software-only device.
Based on the provided information, the M-100 system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "filtering airborne particles from air for medical purposes." This describes a device that acts on the environment (air) to create a controlled space, not a device that is used to examine specimens taken from the human body (in vitro).
- Device Description: The description details a HEPA-filtered clean hood designed to control airborne particulates. This aligns with environmental control for medical procedures, not diagnostic testing of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on analysis of biological samples.
The M-100 system is a device used to create a clean environment for medical procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The M-100 system is intended for use in filtering airborne particles from air for medical purposes.
Product codes (comma separated list FDA assigned to the subject device)
FRF
Device Description
The M-100 is a portable HEPA-Filtered clean hood for use in providing a controlled environment to class 100 (ISO class 3,5) for medical applications that require a high degree of airborne particulate control. The system is controlled by embedded firmware and runs on standard 120volt, 5 amp power. Pushbutton Controls include airflow, light intensity, lift/lower. Manual controls include Filter tilt/angle, brakes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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).
Not Found
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).
0
Airex Inc.
Image /page/0/Picture/2 description: The image shows a logo for AIREX. The word "AIREX" is written in white, bold, sans-serif font on a black rounded rectangle. The logo is surrounded by a grid of circles. The circles above the rectangle are filled in, while the circles below the rectangle are hollow.
MAR 1 2 2003
510(K) SUMMARY
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 a 510(k) Summary.
- Submitted By: 1. Airex Inc. 13704 SE 17th Street Bellevue, WA 98005
-
- Contact Person: William Haslebacher, President, CTO
- Date Prepared: 3. January 26, 2003
-
- Proprietary Name; M-100 Mobile Medical Air Cleaner
-
- Common/ Usual Name: HEPA Filtration system
6. Classification Name: Sec. 880.5045 Medical Recirculating Air Cleaner. A device designed to remove particles from the air for medical purposes
7. Predicate Device:
The M-100 is substantially equivalent to the Micron 800M Air Purifier system by Biological Controls Inc (K974682, January23, 1998) in its design and its intended use.
8. Device Description:
The M-100 is a portable HEPA-Filtered clean hood for use in providing a controlled environment to class 100 (ISO class 3,5) for medical applications that require a high degree of airborne particulate control. The system is controlled by embedded firmware and runs on standard 120volt, 5 amp power. Pushbutton Controls include airflow, light intensity, lift/lower. Manual controls include Filter tilt/angle, brakes.
The M-100 has been designed to meet the following product safety standards;
- UL 2601 Standard for Medical Electrical Equipment Part 1: General Requirements l for Safety
- ISO 14644-1 Classification of Air Cleanliness, Cleanrooms & Associated Controlled Environments, 1999.
1
9. Intended Uses:
The M-100 system is intended for use in filtering airborne particles from air for medical purposes.
10, Technological Comparison to Predicate Device:
The M-100 is similar to the predicate device in that:
- t Both system generate HEPA filtered air for medical purposes
- . Both are portable, mobile
- Both systems are UL approved .
The M-100 differs from the predicate device in that it can be used to direct highly filtered air to a specific location by means of available tilt and axial adjustments to the filter head assembly.
End of 510(k) Summary
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three curved lines representing the bird's head and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
MAR 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William Haslebacher President Airex Incorporated 13704 SE 17th Street Bellevue, Washington 98005
Re: K023693
Trade/Device Name: M-100 Mobile Medical Air Cleaner Regulation Number: 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: II Product Code: FRF Dated: January 28, 2003 Received: January 29, 2003
Dear Mr. Haslebacher:
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.
3
Page 2 -- Mr. Haslebacher
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 (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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Susan Roane
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
4
Airex Inc.
Indications for Use
Page 1 of 1
510(k) Number (if known):
Device Name: M-100 Mobile Medical Air Cleaner
Indications for Use:
The M-100 system is intended for use in filtering airborne particles from air for medical purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chiu S. Lim
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental D
510(k) Number. K023693
K023693addtofileA.doc