RUSCH EMERGENCY MASK

K993528 · Rusch, Inc. · CBP · May 31, 2000 · Anesthesiology

Device Facts

• Record ID: K993528
• Device Name: RUSCH EMERGENCY MASK
• Applicant: Rusch, Inc.
• Product Code: CBP · Anesthesiology
• Decision Date: May 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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. 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.

Device Story

Rusch Emergency Mask is a single-use, lightweight PVC mask system for emergency life support. Input: manual ventilation or supplemental oxygen. Operation: mask placed over victim's face to create seal; one-way valve with 3M Filtrate filter protects rescuer during mouth-to-mask ventilation; universal breathing tube connects to resuscitation bags; integral oxygen port connects to emergency oxygen systems. Output: delivered ventilation/oxygen to patient. Used in emergency settings by trained personnel. Transparent structure allows visual monitoring of patient. Benefits: provides barrier protection for rescuer, enables simultaneous mouth/nose ventilation, and folds into pocket-sized case for portability.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, full-sized PVC mask. Features: universal breathing tube, one-way valve with 3M Filtrate filter, head straps, oxygen port. Foldable design for portability. Transparent material for visual monitoring. Non-powered, mechanical device.

Indications for Use

Indicated for adult, child, and infant victims of health emergencies requiring oxygen support or CPR. Intended for use by trained, qualified individuals for mouth-to-mask ventilation.

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 (K933048)

Submission Summary (Full Text)

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K993528

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: [phone] [phone] 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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#### 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 [phone]. Additionally, for questions on the promotion and [phone] haddevice, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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)