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.

Device Description

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 used by persons trained in CPR techniques. The device 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 atmosphere.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921. It describes the device and claims substantial equivalence to a predicate device, the Eagle Health Supplies 4-02 Jr. (CPR Mouth Barrier), 510(k) #: K945177.

This document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance metrics. Instead, it focuses on demonstrating substantial equivalence through a comparison of physical characteristics and successful biocompatibility testing. Therefore, I cannot generate a table of acceptance criteria and reported device performance from this document for the types of studies you've requested (e.g., MRMC, standalone algorithm performance), because this type of information is not present.

The document mainly highlights:

Device Description and Intended Use: The Dynarex CPR Shield is a physical barrier for mouth-to-mouth resuscitation, offering protection to the person performing CPR.
Predicate Device: Eagle Health Supply 4-02 Jr.
Comparison of Characteristics: A table comparing material composition (Mouthpiece Housing, Mouthpiece Filter, Mouthpiece Gasket, Protective Face Shield), Sterility, and Packaging between the Dynarex CPR Shield and the predicate device, showing them to be similar or equivalent.
Biocompatibility Testing: The device underwent biocompatibility testing to FDA recognized standards for Cytotoxicity, Skin Irritation, and Skin Sensitization. It also passed tests related to ASTM F920-93 and ASTM D6499-00 inhibition ELISA.

Based on the provided information, I can answer some of your points by stating that the information is not available in the document, as the submission relies on substantial equivalence rather than a new performance study against specific acceptance criteria for AI or diagnostic performance.

Here's a breakdown of what can be derived from the document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI or diagnostic accuracy studies. For this type of device (CPR shield), acceptance criteria are primarily related to material safety (biocompatibility) and functional equivalence to a predicate device.
  - Biocompatibility: Passed FDA recognized standards for Cytotoxicity, Skin Irritation, and Skin Sensitization.
  - Functional Equivalence: Demonstrated through material and design similarity to the predicate device and the presence of a one-way valve and barrier filter for protection.
- Reported Device Performance:
  - Biocompatibility: "successfully performed to FDA recognized standards for Cytotoxicity, Skin Irritation and Skin Sensitization." "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."
  - Functional: "The CPR Shield includes a one-way valve that directs the breathing gas flow from the CPR administrator to the patient, and directs the exhalled gases away from the rescuer and into the outside atmosphere."
(Note: No numerical performance metrics for diagnostic accuracy or AI are applicable or available in this document as it is not an AI/diagnostic device.)
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device and submission. The "test set" here refers to the samples used in biocompatibility testing, not a diagnostic or AI performance study. Details on the number of samples or data provenance for biocompatibility testing are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert consensus on images, pathology results) is not relevant for this CPR shield submission. The "truth" for biocompatibility is determined by laboratory testing against established standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered diagnostic device, and no MRMC study was conducted or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth is established by standardized laboratory tests evaluating cellular toxicity, irritation, and sensitization responses as per recognized FDA standards (e.g., ISO 10993 series, or the specific ASTM standards mentioned).
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary

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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 Corporation10 Glenshaw StreetOrangeburg, NY 10962USAPhone: 845-365-8200Fax: 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, NonrebreathingDiv. of Anesthesiology, (21 CFR 868.5870) Class II
Predicate Device	4-02 Jr. (CPR Mouth Barrier), Eagle Health Supplies510(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 formouth to mouth resuscitation.

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Page 2 of 2

510(K) SUMMARY

Table of Comparison

Characteristic	Dynarex CPR Shield	Eagle Health Supply 4-02Jr
Mouthpiece HousingMaterial	Polystyrene	Polystyrene
Mouthpiece FilterMaterial	Polypropylene, 70g	Similar
Mouthpiece GasketMaterial	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 (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

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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

Page 1 of __

K052743

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).