DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921

K052743 · Dynarex Corp. · CBP · Dec 22, 2005 · Anesthesiology

Device Facts

• Record ID: K052743
• Device Name: DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
• Applicant: Dynarex Corp.
• Product Code: CBP · Anesthesiology
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2

Intended Use

The Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 492. Intended use is a device used as a physical barrier for mouth to mouth resuscitation.

Device Story

The Dynarex CPR Shield is a single-use, non-sterile physical barrier device designed for mouth-to-mouth resuscitation. It consists of a polystyrene mouthpiece housing, a polypropylene filter, a latex-free rubber gasket, and a PVC face shield. The device incorporates a one-way valve that directs the rescuer's exhaled gas flow into the patient while diverting the patient's exhaled gases and oral secretions away from the rescuer. It is intended for use by individuals trained in CPR techniques to provide protection against disease transmission during emergency resuscitation. The device is disposed of after a single use.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed for cytotoxicity, skin irritation, and skin sensitization per FDA-recognized standards. Additional testing conducted per ASTM F920-93 and ASTM D6499-00 (Inhibition ELISA).

Technological Characteristics

Materials: Polystyrene (housing), Polypropylene (filter), Rubber/latex-free (gasket), PVC (face shield). Non-sterile. Single-use. Mechanical one-way valve for non-rebreathing function. Complies with ASTM F920-93 and ASTM D6499-00.

Indications for Use

Indicated for use as a physical barrier during mouth-to-mouth resuscitation by individuals trained in CPR techniques to protect the rescuer from a patient's vomitus and oral secretions.

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

• 4-02 Jr. (CPR Mouth Barrier), Eagle Health Supplies (K945177)

Submission Summary (Full Text)

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DEC 2 2 2005

K052743

## 510(K) SUMMARY

Page 1 of 2

#### THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF THE SAFE MEDICAL DEVICES ACT OF 1990.

| Submitter | Dynarex Corporation<br>10 Glenshaw Street<br>Orangeburg, NY 10962<br>USA<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | James Hurlman |
| Date of Summary | 09-29-2005 |
| Trade Name | CPR Shield with One Way Valve and Barrier Filter, Model 4921 |
| Common Name | Valve, Nonrebreathing |
| Classification Name | Valve, Nonrebreathing<br>Div. of Anesthesiology, (21 CFR 868.5870) Class II |
| Predicate Device | 4-02 Jr. (CPR Mouth Barrier), Eagle Health Supplies<br>510(k) #: K945177 |
| Device Description/<br>Comparison | Dynarex CPR Shield with One Way Valve and Barrier Filter,<br>Model 4921 |
| Intended Use | The Dynarex CPR Shield with One Way Valve and Barrier Filter,<br>Model 492. Intended use is a device used as a physical barrier for<br>mouth to mouth resuscitation. |

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# 510(K) SUMMARY

#### Table of Comparison

| Characteristic | Dynarex CPR Shield | Eagle Health Supply 4-02<br>Jr |
|--------------------------------|-------------------------|--------------------------------|
| Mouthpiece Housing<br>Material | Polystyrene | Polystyrene |
| Mouthpiece Filter<br>Material | Polypropylene, 70g | Similar |
| Mouthpiece Gasket<br>Material | Rubber, Latex Free | Similar |
| Protective Face Shield | PVC | PVC |
| Sterility | Non Sterile | Non Sterile |
| Packaging | Sealed Polyethylene Bag | Similar |

The CPR Shield with One Way Valve and Barrier Filter, Model 4921 is a mouth to mouth The CPR Shield with Offe Way Valve and Damor Pinoth the patient from vomitus and
barrier that offers protection to the person performing CPR to a patient program the barner that offers protection to the persons trained in CPR techniques. The oral secretions. The device is to be assul by porcere it is labeled as a single use device and should be disposed of after one use.

The CPR Shield includes a one-way valve that directs the breathing gas flow from the CPR The CFR Shield ficiauss a one way varro the exhalled gases away from the resouer and into administrator to the patient, and directed the United gasses and your way Valve and Barrier Filter are equivalent to the predicate devices.

The biocompatibility testing has been successfully performed to FDA recognized standards The blocompatibility testing has been succediary portuges has been tested to
for Cytotoxicity, Skin Irritation and Skin Sensitization. The finished on Jahibition for Cytoloxicity, Skir intration and ORIF Conomization of ASTM D6499-00 Inhibition
all applicable portions of ASTM F920-93. Additional testing to ASTM D6499-00 Inhibition ELISA was also conducted and found to be acceptable.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract design of an eagle, which is the symbol of the United States. The eagle is depicted with its wings spread and its head turned to the right.

Public Health Service

DEC 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Hurlman Manager, Quality Assurance & Regulatory Affairs Dynarex Corporation 10 Glenshaw Street Orangeburg, New Jersey 10962

- Re: K052743
Trade/Device Name: Dynarex CPR Face Shield with One Way Valve and Barrier Filter Regulation Number: 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: September 29, 2005 Received: October 3, 2005

Dear Mr. Hurlman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register.

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Page 2 - Mr. Hurlman

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that I Dr. 3 losualited on that your device complies with other requirements mean that IDA has made a decernmares and regulations administered by other Federal agencies. of the Act of ally rederal states and regarments, including, but not limited to: registration 1 ou indist comply with and the Pisoeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 007), lastims (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begal mading of substantial equivalence of your device to a premitser notification. - The PDF mixers 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), If you desire specific aurros for yoliance at [phone]. Also, please note the regulation prease comact une Office or Sompany premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other generaliational and Consumer Assistance at its toll-free Drisber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Smriti Y. Michai Omd

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): |< 0 52 7 4/3

Dynarex CPR Face Shield with One Way Valve and Barrier Filter Device Name: Indications For Use:

This device is used as a physical barrier for mouth to mouth resuscitation

The use of this device does not guarantee complete protection from disease transmission.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clara Rigdon

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K052743