(140 days)
The BREATHE EASY device is a medical recirculating air cleaner designed to remove airborne particles and allergens, such as: dust, smoke, pollen, mold spores, animal hair and dander, dust mites, and harmful fibers, that may lead to allergic reactions.
The BREATHE EASY is an adjustable, personal system for treating air in a specified area of a room. The BREATHE EASY device contains an air treatment system, including a housing unit with an air inlet and a treated air outlet, a blower and a filter, for removing contaminants from the air flowing along the flow path.
The BREATHE EASY Model AD device contains also an air filtering system with a heater and humidifier for treating ambient air so as to bring it to a preselected respiratory comfort level. The BREATHE EASY device provides a method for guiding the treated air outflow so as to obtain a flow distribution in close proximity to the head of a user, thereby forming a treated air envelope surrounding his respiratory openings.
The BREATHE EASY device is supported on an adjustable support arm, adjustably mounted onto a household furniture (e.g., bed), wall, or wheeled support structure.
The provided text is a 510(k) Summary for the BREATHE EASY device, a medical recirculating air cleaner. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about specific acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested table and information based on the given input. The document focuses on regulatory classification and substantial equivalence, not detailed performance data or clinical study results.
Here's what I can infer from the document regarding a "study":
- Performance Standards: The document explicitly states: "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act."
- Compliance: It also mentions: "However, the BREATHE EASY complies with the IEC 601-1." IEC 601-1 (now IEC 60601-1) is a general standard for the safety and essential performance of medical electrical equipment, not a standard specific to air cleaner efficacy in removing allergens.
In summary, the provided document does not contain the information needed to answer your questions about acceptance criteria and detailed study results.
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OCT 1 3 1998
510(k) Summary
RespirAid Ltd. BREATHE EASY
510(k) Number K981841
Applicant's Name:
RespirAid Ltd. POB 12, Katzrin 12900, Israel
Contact Person:
Shoshana Friedman Push-med Ltd. 117 Ahuzah St. Ra'ananna 43373, Israel Telephone: 972-9-771-8130 Fax: 972-9-771-8131
Date Prepared:
May 24, 1998
Trade Name:
BREATHE EASY (Models AD and CD)
Classification Name:
Medical Recirculating Air Cleaner
Classification:
The FDA has classified medical recirculating air cleaners as class II devices (product code 80 FRF, regulation no. 880,5045) and it is reviewed by General Hospital Devices.
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K981841
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Predicate Device:
- · Enviracaire EV-1 (Enviracaire, Co.) K872359
Indication for Use:
The BREATHE EASY device is a medical recirculating air cleaner designed to remove airborne particles and allergens, such as: dust, smoke, pollen, mold spores, animal hair and dander, dust mites, and harmful fibers, that may lead to allergic reactions.
Device Description:
The BREATHE EASY is an adjustable, personal system for treating air in a specified area of a room. The BREATHE EASY device contains an air treatment system, including a housing unit with an air inlet and a treated air outlet, a blower and a filter, for removing contaminants from the air flowing along the flow path.
The BREATHE EASY Model AD device contains also an air filtering system with a heater and humidifier for treating ambient air so as to bring it to a preselected respiratory comfort level. The BREATHE EASY device provides a method for guiding the treated air outflow so as to obtain a flow distribution in close proximity to the head of a user, thereby forming a treated air envelope surrounding his respiratory openings.
The BREATHE EASY device is supported on an adjustable support arm, adjustably mounted onto a household furniture (e.g., bed), wall, or wheeled support structure.
Performance Standards:
No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act, However, the BREATHE EASY complies with the IEC 601-1.
Substantial Equivalence:
The BREATHE EASY device is substantially equivalent to Enviracaire EV-1 cleared under K872359 in respect to intended use, technological characteristics, performance, and labeling.
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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird, with three parallel lines forming the body and wings. The bird is facing to the right.
. .
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 13 1998
RespirAid Limited C/O Ms. Shoshana Friedman Push-med Limitd 117 Ahuzah St. Ra'ananna 43373 ISRAEL
Re: K981841 Trade Name: BREATHE EASY, Models AD and CD Regulatory Class: II Product Code: FRF Dated: Auqust 24, 1998 Received: September 4, 1998
Dear Ms. Friedman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), 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 895. ਕਿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Friedman
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Contro. and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
.......
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INDICATIONS FOR USE
510(k) Number (if known): K981841
Device Name:
BREATHE EASY
Indications for Use:
The BREATHE EASY device is a medical recirculating air cleaner designed to remove airborne particles and allergens, such as: dust, smoke, pollen, mold spores, animal hair and dander, dust mites, and harmful fibers, that may lead to allergic reactions.
Qlin S. him
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
of Reptaductive, Abdominal, Ear, Nose and Rhroat, and Radiological Devices Division
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use X
§ 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).