(83 days)
No
The device description and performance studies focus on physical barrier properties and biocompatibility, with no mention of AI or ML.
No.
The device functions as a physical barrier to protect the rescuer during CPR, primarily preventing exposure to bodily fluids, rather than directly treating a medical condition or restoring health.
No
The device is described as a physical barrier for mouth-to-mouth resuscitation that protects the rescuer from the patient's bodily fluids. Its intended use is for CPR, which is a life-saving procedure, not a diagnostic one. There is no mention of it detecting or identifying diseases or conditions.
No
The device description clearly describes a physical barrier with a one-way valve and filter, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "physical barrier for mouth to mouth resuscitation." This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical components and function of the device as a barrier and valve for directing airflow during CPR. It does not mention any analysis of biological samples or detection of substances.
- Lack of Diagnostic Elements: There is no mention of the device being used to diagnose a disease, condition, or state of health. It's a tool for performing a medical procedure (CPR).
- Performance Studies: The performance studies mentioned relate to biocompatibility and physical standards (ASTM F920-93, ASTM D6499-00), which are relevant for medical devices but not specifically for IVDs. IVD performance studies would typically involve metrics like sensitivity, specificity, and accuracy in detecting analytes.
In summary, the device's function is to provide a physical barrier during CPR, which falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for 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.
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.
Product codes
CBP
Device Description
Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921.
The CPR Shield with One Way Valve and Barrier Filter, Model 4921 is a mouth to mouth barrier that offers protection to the person performing CPR to a patient from vomitus and oral secretions. The device is to be assumed to be used by persons trained in CPR techniques. 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 administrator to the patient, and directed the exhaled gases away from the rescuer and into the environment. The CPR Shield with One Way Valve and Barrier Filter are equivalent to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility testing has been successfully performed to FDA recognized standards for Cytotoxicity, Skin Irritation and Skin Sensitization. The finished device has been tested to all applicable portions of ASTM F920-93. Additional testing to ASTM D6499-00 Inhibition ELISA was also conducted and found to be acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEC 2 2 2005
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
10 Glenshaw Street
Orangeburg, NY 10962
USA
Phone: 845-365-8200
Fax: 845-365-8201 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Div. of Anesthesiology, (21 CFR 868.5870) Class II |
| Predicate Device | 4-02 Jr. (CPR Mouth Barrier), Eagle Health Supplies
510(k) #: K945177 |
| Device Description/
Comparison | Dynarex CPR Shield with One Way Valve and Barrier Filter,
Model 4921 |
| 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. |
1
Page 2 of 2
510(K) SUMMARY
Table of Comparison
| Characteristic | Dynarex CPR Shield | Eagle Health Supply 4-02
Jr |
|--------------------------------|-------------------------|--------------------------------|
| Mouthpiece Housing
Material | Polystyrene | Polystyrene |
| Mouthpiece Filter
Material | Polypropylene, 70g | Similar |
| Mouthpiece Gasket
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.
2
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
4
Indications for Use
510(k) Number (if known): |