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).

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

AI/ML Overview

The provided document is a 510(k) summary for the RespAide™ Valve for CPR Assistance. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Based on the document, here's an analysis of the acceptance criteria and study information:

Description of the Study:

The study conducted was a bench test at Nelson Laboratories to demonstrate substantial equivalence to existing predicate devices. This type of study primarily focuses on performance specifications rather than clinical outcomes with human subjects.

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Meet or exceed all standards for filtration	RespAide™ met and exceeded all standards for filtration
Meet or exceed all standards for differential air flow	RespAide™ met and exceeded all standards for differential air flow
Consistent with industry standards (for filtration and airflow)	RespAide™ met and exceeded all standards consistent with industry standards
One-way valve function (implied by "one-way valve" feature)	(Not explicitly detailed beyond being a feature)
Hydrophobic and hydrophilic filter function (implied)	(Not explicitly detailed beyond being a feature)

Detailed Study Information:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "independent laboratory testing," suggesting a series of tests were performed on a sample of RespAide™ devices.
- Data Provenance: The testing was performed at Nelson Laboratories, an independent laboratory. The country of origin for the data is not explicitly stated but is likely the United States, given the context of the FDA submission. This was a retrospective analysis of the device's performance against established standards.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable in the context of this study. The "ground truth" here is objective physical standards and criteria for filtration and airflow, rather than expert interpretation of medical data (e.g., imaging, pathology). The laboratory tests themselves establish the performance against these objective standards.
Adjudication Method for the Test Set:
- Not applicable. Since the "ground truth" is objective performance against physical standards measured by laboratory equipment, there is no need for expert adjudication in the traditional sense (e.g., 2+1 physician review).
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Data: Not available." This indicates that no studies involving human readers or clinical outcomes were conducted or provided for this submission. The focus was solely on the physical performance characteristics of the device.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a physical medical device (CPR mask) and not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
The Type of Ground Truth Used:
- The ground truth used was objective physical performance standards for filtration and differential air flow, consistent with industry standards. These are measurable physical properties, not clinical outcomes, pathology, or expert consensus on medical findings.
Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The study pertains to a physical product.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As the device is not an AI/ML algorithm, there is no training set or corresponding ground truth to be established in that context.

Summary

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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: 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

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

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 (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

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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

Over-The-Counter Use

Mark Uramie

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

Regulation Number and Section

§ 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).