(211 days)
Not Found
Not Found
No
The description focuses on the mechanical components and filtration capabilities of a CPR assistance mask, with no mention of AI or ML technologies.
Yes
The device is classified as a "Respiratory assisted device" and is used to assist in cardiopulmonary resuscitation (CPR), which is a therapeutic intervention for cardiac or respiratory arrest.
No
The device is described as an air filtering CPR assistance mask used to facilitate CPR and reduce pathogen transmission, not to diagnose medical conditions.
No
The device description clearly outlines physical components such as a mask, valve, filters, gloves, and bags, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in CPR by providing a barrier and filtration during mouth-to-mouth resuscitation. This is a direct intervention on a patient, not a test performed on a sample taken from the body.
- Device Description: The description details a mask, valve, filters, and accessories for performing CPR. It does not mention any components or processes related to analyzing biological samples.
- Classification: The device is classified as a "Respiratory assisted device" under CFR 868.5870, which is a classification for devices used to assist breathing, not for in vitro diagnostic testing.
- Performance Studies: The performance studies mentioned focus on filtration and airflow, which are relevant to a respiratory assistance device, not an IVD.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. The RespAide™ does not perform this function.
N/A
Intended Use / Indications for Use
RespAide™ is designed to be used in an emergency situation where CPR assistance is required. RespAide™ offers to the administrator of CPR the comfort that the risk of transmission of various pathogens is greatly reduced and, therefore, the hesitancy factor for providing CPR is overcome. RespAide™ should be made available to all consumers for office, automobiles, boats, swimming pools, industry, airlines, and anywhere an incident of respiratory or cardiac arrest may occur.
Non Re-Breathing Valve, 73 CBP, Class II under CFR 868.5870 Respiratory assisted device - used in cardiac or respiratory arrest to assist in cardiopulmonary resuscitation (CPR).
Product codes
73 CBP
Device Description
Emergency Filtration Products, Inc. wishes to introduce to the market the RespAide™ air filtering CPR assistance mask, a device similar to the Laerdal pocket mask. Both products are one way valve, CPR assistance masks.
RespAide™ features include the following:
- One Way Valve with Hydrophobic and Hydrophilic Filters .
- Pillow Mask
- ISO Fittings
- Nylon Stuff Sack .
- Mouthpiece .
- Latex Gloves ●
- Antiseptic Wipe ●
- Biohazard Bag for disposal after use
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
Substantial equivalence is based on independent laboratory testing performed at Nelson Laboratories where RespAide™ met and exceeded all standards for filtration and differential air flow consistent with industry standards.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the date August 5, 1998. The month is abbreviated to AUG. The day is 5 and the year is 1998. The text is in a simple, sans-serif font and is black on a white background.
mergency Filtration F
Manufacturers of the RespAlde™ CPR Mask 321 North Mall Drive, Suite H-103, St. George, UT 84790 500 North Rainbow, Suite 300, Las Vegas, NV 89107 Tel: 435-656-3697; Fax: 435-656-5610 E-Mail: efpinc@infowest.com
510 (K) Summary
Emergency Filtration Products, Inc. 321 North Mall Dr., Suite H103 St. George, UT 84790 (435)656-3697, (435)656-5610 FAX
Michael J. Crnkovich, President 1/2/98 Date Prepared
Device Name: Common Name: Classification Name: RespAide™ Valve for CPR Assistance Non re-breathing valve 21 CFR 868.5870 73 CBP, Class II
Emergency Filtration Products, Inc. wishes to introduce to the market the RespAide™ air filtering CPR assistance mask, a device similar to the Laerdal pocket mask. Both products are one way valve, CPR assistance masks.
RespAide™ features include the following:
- One Way Valve with Hydrophobic and Hydrophilic Filters .
- Pillow Mask
- ISO Fittings
1
- Nylon Stuff Sack .
- Mouthpiece .
- Latex Gloves ●
- Antiseptic Wipe ●
- Biohazard Bag for disposal after use
Intended Use
RespAide™ is designed to be used in an emergency situation where CPR assistance is required. RespAide™ offers to the administrator of CPR the comfort that the risk of transmission of various pathogens is greatly reduced and, therefore, the hesitancy factor for providing CPR is overcome. RespAide™ should be made available to all consumers for office, automobiles, boats, swimming pools, industry, airlines, and anywhere an incident of respiratory or cardiac arrest may occur.
Technological Characteristics
None.
Substantial Equivalence
Substantial equivalence is based on independent laboratory testing performed at Nelson Laboratories where RespAide™ met and exceeded all standards for filtration and differential air flow consistent with industry standards.
Clinical Data
Not available.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1998
Mr. Doug Beplate Emergency Filtration Products, Inc. 321 North Mall Drive, Suite H-103 St. George, UT 84790
K980052 Re: RespAide Regulatory Class: II (two) Product Code: 73 CBP Dated: July 20, 1998 Received: July 23, 1998
Dear Mr. Beplate:
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 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 general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions aqainst 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices:
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Mr. BePlate - page 2
General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 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,
321 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21
Thomas J. Øallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation . ________________________________________________________________________________________________________________________________________________ Center for Devices and Radiological Health
Enclosure
4
Kruspe
510(k) Number (if known): K980052
Device Name: RespAide
Indications For Use: Non Re-Breathing Valve, 73 CBP, Class II under CFR 868.5870 Respiratory assisted device - used in cardiac or respiratory arrest to assist in cardiopulmonary resuscitation (CPR).
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