(234 days)
Not Found
No
The description focuses on mechanical filtration and basic software for programming run times and fan speeds, with no mention of AI or ML technologies.
No
The device is an air filter that removes airborne particles for medical purposes, but it does not directly treat a disease or condition in a patient.
No.
The device is described as an air purification system designed to filter airborne particles, not to diagnose medical conditions or diseases.
No
The device description clearly indicates that the device is a physical air purification system with hardware components (filters, fan, power switch, control knobs, display panel). While one model includes software for programming and display, the core function and components are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "filtering airborne particles from air for medical purposes." This describes a physical process of air purification, not a diagnostic test performed on biological samples.
- Device Description: The description details an air purification system with filters, fans, and controls. It does not mention any components or processes related to analyzing biological specimens (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Using reagents or calibrators.
The device is clearly described as an air cleaner designed to improve air quality for medical purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Airistar Air Purification Systems (Model 1000) are intended for use in filtering airborne particles from air for medical purposes.
K072185
Device Name: Airistar Air Purification Systems - Model 500 & Model 1000
Indications For Use: Intended for use in filtering airborne particles from air for medical purposes.
Product codes
FRF
Device Description
The Airistar Air Purification Systems - Model 1000 are medical air cleaners designed to help remove particulate matter from the air. These systems are for home use and use in hospitals, nursing homes, schools, offices, etc.
The Model 500 Airistar Air Purification System contains software and a display panel to program runs times and fan speeds, the panel also displays filter life indicator bar. The Model 1000 Airistar Air Purification System is operated via a power switch and control knobs to adjust the fan speed. Both models have 3 fan speeds and contain a 6 Stage filter system.
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
home use and use in hospitals, nursing homes, schools, offices, etc.
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
Bench testing has confirmed the devices' ability to remove particles efficiently. The filters have been tested and listed by Underwriters Laboratory testing showed the UV lamp produced zero ozone.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing has confirmed the devices' ability to remove particles efficiently. The filters have been tested and listed by Underwriters Laboratory testing showed the UV lamp produced zero ozone.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
Airistar Technologies, L.L.C. 2330 Ernie Krueger Circle Waukegan, IL 60087 847-775-8018 847-775-8019 (fax) 800-755-8006 (toll-free) info@airistar.com Traditional 510(k) Premarket Submission Contact: Roy Kibbe, President Date prepared: March 12, 2008
Air Filtration Systems - Air Cleaners - Air Purifiers Common Name: Proprietary Name: Airistar Air Purification System (Model 500 & Model 1000)
Classification:
Regulation # 880.5045; Class 2 Product Code FRF
Description: The Airistar Air Purification Systems - Model 1000 are medical air cleaners designed to help remove particulate matter from the air. These systems are for home use and use in hospitals, nursing homes, schools, offices, etc.
The Model 500 Airistar Air Purification System contains software and a display panel to program runs times and fan speeds, the panel also displays filter life indicator bar. The Model 1000 Airistar Air Purification System is operated via a power switch and control knobs to adjust the fan speed. Both models have 3 fan speeds and contain a 6 Stage filter system.
Intended Use: Airistar Air Purification Systems (Model 1000) are intended for use in filtering airborne particles from air for medical purposes.
Predicate Devices: The Airistar Air Purification System is substantially equivalent to the following predicate devices.
Hepa-Care Air Cleaner, Model HC400F & HC400E-UV by Abatement Technologies, Inc. 510(k) #: K984116
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, Airex, Inc. 510(k) #: K023693
Advanced Air Cleaner System, Healthway Products, 510(k) #: K012549
1
Safety and Effectiveness and Summary and Conclusion Regarding Substantial Equivalence:
By definition, a device is substantially equivalent when the device has the same intended use and the Dy delimition, a al characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
The minor differences between the Airistar Air Purification Systems (Model 500 & Model 1000) and the predicate devices cited do not raise any additional questions regarding safety and effectiveness. The intended use of the Airistar Air Purification Systems (Model 500 & Model 1000) is the same as the intended use of the predicate devices.
The device, as designed, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device.
Bench testing has confirmed the devices' ability to remove particles efficiently. The filters have been tested and listed by Underwriters Laboratory testing showed the UV lamp produced zero ozone.
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 symbol, composed of three curved lines, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Airistar Technologies LLC C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313
MAR 2 7 2008
Re: K072185
Trade/Device Name: Airistar Air Purification Systems - Model 500 & Model 1000 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: II Product Code: FRF Dated: March 13, 2008 Received: March 14, 2008
Dear Mr. Job:
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. Job
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,
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
4
Indications for Use
K072185 510(k) Number (if known):
Device Name: Airistar Air Purification Systems - Model 500 & Model 1000
Indications For Use: Intended for use in filtering airborne particles from air for medical purposes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheila A Murphy
(Division Sign-Off)
Page 1 of 1
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K022185