(234 days)
Airistar Air Purification Systems (Model 1000) are intended for use in filtering airborne particles from air for medical purposes.
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.
The provided text describes the Airistar Air Purification Systems (Model 500 & Model 1000) and its 510(k) submission. However, it does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or most of the requested metrics related to a clinical study. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than comprehensive performance study results.
Here's an analysis based on the provided text, highlighting the absence of information for many of your questions:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria (e.g., a certain percentage of particle removal at a specific size, or a CAD performance metric) are explicitly detailed in the document. The general statement is that "Bench testing has confirmed the devices' ability to remove particles efficiently."
| Criteria | Reported Device Performance |
|---|---|
| Particle Removal Efficiency | "confirmed the devices' ability to remove particles efficiently" |
| Ozone Production | "UV lamp produced zero ozone" |
| Safety and Effectiveness | "as safe and effective as the predicate device" |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No clinical test set involving patient data is described. The testing referred to is "bench testing."
- Data Provenance: Not applicable. The testing is described as "bench testing," implying laboratory-based testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No mention of expert ground truth establishment for a test set is present, as the testing was bench testing.
4. Adjudication method for the test set
Not applicable. No test set involving human data requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an air purification system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm; it's a physical air purification device. The "performance" is its physical ability to filter air, which would inherently be "standalone" in its function. The document mentions "bench testing" which is a standalone evaluation of the device's physical capabilities.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mentioned "bench testing," the ground truth would be established by objective measurements from laboratory equipment (e.g., particle counters) following established testing standards for air filtration efficiency. No human-derived ground truth (like expert consensus, pathology, or outcomes data) is relevant or mentioned.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning system.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of what the document does provide regarding "proof" of meeting criteria:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data against specific, quantitative acceptance criteria.
- Substantial Equivalence: The core argument is that the Airistar Air Purification Systems (Model 500 & Model 1000) have the same intended use and either identical technological characteristics or different ones that do not raise new safety or effectiveness concerns compared to the predicate devices (Hepa-Care Air Cleaner K984116, Mobile Particulate Contamination Control System K023693, Advanced Air Cleaner System K012549).
- Bench Testing: The document states that "Bench testing has confirmed the devices' ability to remove particles efficiently." This is a general statement without specific metrics or protocols detailed.
- Ozone Testing: "Underwriters Laboratory testing showed the UV lamp produced zero ozone." This is a specific performance metric, stating a zero-level finding.
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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
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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.
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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.
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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
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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
§ 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).