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K Number
K052743
Device Name
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
Manufacturer
DYNAREX CORP.
Date Cleared
2005-12-22

(83 days)

Product Code
CBP
Regulation Number
868.5870
Type
Traditional
Panel
AN
Reference & Predicate Devices
K945177
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

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:

  1. 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.)

  2. 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.

  3. 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.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of submission.

  5. 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.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.

  7. 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).

  8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.

  9. How the ground truth for the training set was established: Not applicable.

§ 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).