RESPAIDE

K980052 · Emergency Filtration Products, Inc. · CBP · Aug 5, 1998 · Anesthesiology

Device Facts

• Record ID: K980052
• Device Name: RESPAIDE
• Applicant: Emergency Filtration Products, Inc.
• Product Code: CBP · Anesthesiology
• Decision Date: Aug 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

RespAide™ is a CPR assistance mask featuring a one-way valve with hydrophobic and hydrophilic filters; includes a pillow mask, mouthpiece, latex gloves, antiseptic wipe, and biohazard bag. Designed for use by laypersons or professionals during emergency cardiac or respiratory arrest. The device acts as a barrier to reduce pathogen transmission risk between the rescuer and the patient, overcoming hesitancy to perform CPR. The one-way valve directs air flow to the patient while filtering exhaled air. Used in diverse settings like homes, public spaces, and transit. The healthcare provider or rescuer places the mask over the patient's mouth/nose to facilitate rescue breathing.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing at Nelson Laboratories regarding filtration and differential air flow performance.

Technological Characteristics

One-way valve with hydrophobic and hydrophilic filters; pillow mask; ISO fittings. Includes accessory kit (nylon stuff sack, latex gloves, antiseptic wipe, biohazard bag). Mechanical device; no electronic or software components.

Indications for Use

Indicated for use in cardiac or respiratory arrest to assist in cardiopulmonary resuscitation (CPR). Suitable for use by consumers in various settings including offices, automobiles, boats, swimming pools, industry, and airlines.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Predicate Devices

• Laerdal pocket mask

Submission Summary (Full Text)

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K980052

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: [phone]; Fax: [phone] E-Mail: [e-mail]

#### 510 (K) Summary

Emergency Filtration Products, Inc. 321 North Mall Dr., Suite H103 St. George, UT 84790 [phone], [phone] 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

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- 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.

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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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

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Thomas J. Øallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation . ________________________________________________________________________________________________________________________________________________ Center for Devices and Radiological Health

Enclosure

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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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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AK-1

Prescription Use

OR

Over-The-Counter Use

Mark Uramie

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices