(274 days)
Not Found
No
The description focuses on electrostatic field technology and cold plasmas for air purification, with no mention of AI or ML.
No.
The device is described as a room air purifier/recirculating air cleaner for filtering and inactivating airborne particles, not for treating a specific medical condition in a patient.
No
Explanation: The device description clearly states its intended use is as a "room air purifier/recirculating air cleaner" for filtering and inactivating airborne particles. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly outlines hardware components and technology (electrostatic field technology, cold plasmas) for air purification, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "room air purifier/recirculating air cleaner" for filtering and inactivating airborne particles. This is an environmental control function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on air purification technology (electrostatic fields, cold plasmas) and capturing airborne particulates. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (biomarkers, pathogens, etc.)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device's function is to improve air quality in a medical setting, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Plasmair Model T2006 is intended as a room air purifier/recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical cleaner. The System's dood for member of to supplement existing building air treatment and/or provide air treatment where none exists.
Product codes
FRF
Device Description
The device uses spatially modulated, amplified multidirectional electrostatic field technology to create cold plasmas for decontamination and capture of airborne particulates.
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)
Electrical safety and performance data included in the submission established that the device meets the performance specifications.
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
Summary of Safety and Effectiveness
| Submitted By: | Laurent Descôtes |
|---|---|
| Date Prepared: | 11 December, 2007 |
| Trade/Proprietary Name: | Plasmair™ Model T2006 |
| Common/Usual Name: | Air Filtration System; HEPA Air Filtration System |
| Classification Name: | Medical recirculating air cleaner. (per 21 CFR 880.5045) |
| Classification: | FDA has classified these devices in Class II. |
| Panel: 80 | |
| Product Code: FRF |
Purpose of Submission
The purpose of this submission is to establish the substantial equivalence of a new device not previously marketed in the USA (Plasmair™ Model T2006) to devices previously cleared through the 510(k) process.
Substantial Equivalence
The new device is substantially equivalent to the Biological Controls, Inc, MICROCON 800MUV (K972064).
Technological Characteristics
The device uses spatially modulated, amplified multidirectional electrostatic field technology to create cold plasmas for decontamination and capture of airborne particulates. These technologies do not raise new questions of Safety or Effectiveness.
Performance Data
Electrical safety and performance data included in the submission established that the device meets the performance specifications.
Conclusion
Airinspace, BV concludes based on the information presented that the Plasmair™ Model T2006 is substantially equivalent to the current legally marketed products in the USA.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or ribbons, which are arranged in a way that suggests a human figure or form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2007
AirInSpace B.V. C/O Mr. Wade Tetsuka Consultant Wade Tetsuka 43795 Lee Mill Square Leesburg, Virginia 20176
Re: K070722
Trade/Device Name: Plasmair " Model T2006 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: II Product Code: FRF Dated: November 21, 2007 Received: November 29, 2007
Dear Mr. Tetsuka:
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.
2
Page 2 - Mr. Tetsuka
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 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-Ling Lu, Ph.D.
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: K070722
Device Name: Plasmair™ Model T2006
The Plasmair Model T2006 is intended as a room air purifier/recirculating air Indications for Use: cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical cleaner. The System's dood for member of to supplement existing building air treatment and/or provide air treatment where none exists.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A Murphy, MD
Kotozzz
Prescription Use:
or
Over-the-Counter Use: X (Per 21 CFR 801.109)
- Confidential -