(226 days)
The Rusch Emergency Mask is designed to assist in providing immediate life support to health emergency victims requiring oxygen support(inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The device is intended for mouth to mask ventilation by trained individuals trained in the use of the device and qualified to use the device. The device is intended to be used on adult,child and infant population.
The Rusch Emergency Mask is one-piece, single use, full-sized light weight PVC mask system which includes a universal breathing tube, one way filtered valve, head straps and oxygen port. The design of the ER mask permits it to fold into a convenient pocket sized case for portability yet deploy instantly for use as a CPR Mask when removed from its package. The mask can be supplied with or without examination gloves. The soft PVC cushion promotes a seal to the face allowing ventilation through both the mouth and nose simultaneously. The transparent structure permits visual identification. The mouth piece and the one way valve with 3M Filtrate TM filter provide the rescuer protection when using "mouth-tomouth" rescue techniques. The proximal end of the breathing tube can be attached to a universal resuscitation bag port while the integral oxygen tube allows for connection to an emergency oxygen system.
The provided document for the Rusch Emergency Mask (K993528) does not contain information regarding
acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a
predicate device (Laerdal Pocket Mask™ K933048). It describes the device's intended use and
technological characteristics, but does not present any performance study data, clinical trials, or
metrics that would allow for the construction of a table of acceptance criteria and reported device
performance.
Therefore, I cannot provide the requested information. The document merely confirms that the FDA
reviewed the 510(k) notification and determined the device to be substantially equivalent to a
legally marketed predicate device, allowing it to proceed to market. This determination is based on
the device's design, intended use, and technological characteristics being comparable to the
predicate, rather than on specific performance acceptance criteria met through a dedicated study.
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MAY 3 1 2000
(EI)
Attachment E
Substantial Equivalence 510(k)Summary
Rusch Emergency Mask
To Whom it may concern
Date: October 14, 1999
Submitter/ Contact - Name and Address
Ronald J. Young Director, Manufacturing Operations Rusch Inc. 2450 Meadowbrook Parkway Duluth, GA 30096
Telephone: (770) 623-0816 (770) 623-1829 Fax:
Device Details:
Trade Name: Rusch Emergency Mask
Common Name: Emergency CPR Mask
Classification Name: Mask, Oxygen, Non-Rebreathing
Predicate Legally Marketed Device: Laerdal Pocket Mask™ K933048
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Intended Use
The Rusch Emergency Mask is designed to assist in providing immediate life support to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques.
Description Of The Device
The Rusch Emergency Mask is one-piece, single use, full-sized light weight PVC mask system which includes a universal breathing tube, one way filtered valve, head straps and oxygen port. The design of the ER mask permits it to fold into a convenient pocket sized case for portability yet deploy instantly for use as a CPR Mask when removed from its package. The mask can be supplied with or without examination gloves.
The soft PVC cushion promotes a seal to the face allowing ventilation through both the mouth and nose simultaneously. The transparent structure permits visual identification. The mouth piece and the one way valve with 3M Filtrate TM filter provide the rescuer protection when using "mouth-tomouth" rescue techniques. The proximal end of the breathing tube can be attached to a universal resuscitation bag port while the integral oxygen tube allows for connection to an emergency oxygen system.
Technological Characteristics of the Device
The device is equivalent is design and construction to the Laerdal Pocket Mask™ K933048
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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 and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Public Health Service
MAY 3 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ronald Young Director, Manufacturing Operations Rusch Inc. 2450 Meadowbrook Parkway Duluth, GA 30096
K993528 Re: Rusch Emergency Mask Regulatory Class: II (two) 73 CBP Product Code: Dated: May 9, 2000 Received: May 15, 2000
Dear Mr. Young:
We have reviewed your Section 510(k) notification of intent to market we nave reviews from and we have determined the device is che device forcions and to a the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrosure, co regarif may 28, 1976, the enactment date of the Include ocale ocamers, 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. The general controls enc general ocheroze 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 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: 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ronald Young
This letter will allow you to begin marketing your device as described inis receir will ation you co icgation. The FDA finding of substantial in your 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 rtgaracton (evices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and (301) 394 1010 haddevice, 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). first 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,
Mula n Mulleen
James E. Dillard, III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 5 of __
510(k) Number (if known):
Device Name:_Rusch_Emergency_Mask
Indications For Use:
The Rusch Emergency Mask is designed to assist in providing immediate life support to health emergency victims requiring oxygen support(inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The device is intended for mouth to mask ventilation by trained individuals trained in the use of the device and qualified to use the device. The device is intended to be used on adult,child and infant population.
Signed
Director Manufacturing Operations
Date 01/19/00
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark n Milkuse
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993528/
prescription use
(Optional Format 3-10-98)
§ 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).