(244 days)
Not Found
No
The description details a purely mechanical device for mouth-to-mask resuscitation with no mention of computational or data-driven components.
Yes
The device is described as being used for "mouth-to-mask treatment of respiratory failure," which is a direct therapeutic intervention to support breathing. It uses a one-way valve to allow the rescuer to provide exhaled air and oxygen to the patient, indicating an active role in treating a medical condition.
No
This device is used for mouth-to-mask treatment of respiratory failure by facilitating the delivery of air and oxygen to a patient; it does not diagnose medical conditions.
No
The device description clearly outlines a physical, hardware-based medical device (face mask, valve, oxygen port) used for mouth-to-mask resuscitation. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "mouth-to-mask treatment of respiratory failure." This is a direct intervention on a patient to support breathing, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical device used for delivering air to a patient's lungs. It involves a mask, valve, and oxygen port, all components of a respiratory support device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition through in vitro testing.
The device is clearly designed for providing respiratory assistance, which falls under the category of medical devices used for treatment or support, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
A device used for mouth-to-mask treatment of respiratory failure.
Product codes
Not Found
Device Description
The configuration of this pocket-sized device is a cushioned face mask used to enclose the patients nose and mouth. A one-way valve allows the rescuer to provide exhaled air to the patient. The oxygen port will allow oxygen enhancement of the rescuer's exhaled air. Expired air and/or fluids from the patient is vented away from the rescuer due to the one-way valve and an alternate venting route.
The device comes in one size and is designed for adults but can be used on infants. By rotating the mask 180 degrees and placing the nose portion just below the infants lover lip, the wider portion of the cushion rests on the forehead. The repositioning of the mask and the soft material of the mask cushion allows for a complete seal of the mask cushion to an infants facial contours.
The device is non-sterile. It normally will be packaged in a polybag which may be placed in a zippered nylon pouch.
This device is not intended for use by persons not trained in basic life saving skills or those with only a basic bystander course.
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
The device comes in one size and is designed for adults but can be used on infants.
Intended User / Care Setting
Not intended for use by persons not trained in basic life saving skills or those with only a basic bystander course.
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 CPR MICROMASK with Oxygen Inlet was found equivalent to the Laerdal Medical Pocket Mack for the following:
FLOW RESISTANCE FACE MASK TRANSPARENCY FACE SEALING EFFECT Of VOMITUS AND BARRIER EFFECTIVENESS DEAD SPACE EFFECTS OF TEMPERATURE POSSIBILITY OF MISASSEMBLY HUMAN FACTORS DESIGN AND INSTRUCTIONS SUPPLEMENTAL UXYGEN
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
plasco, inc.
4080 MORRISON DRIVE . . GURNEE, ILLINOIS 60031 . ● 708-662-4400
G 60031 • 708-662
MAR 2 0 1996
510 (k) SUMMARY
Submitted By: 1 .
Gary S. Botsford Plasco, Inc. (Registration No. 1416598) 4080 Morrison Dr. Gurnee, IL 60031 847-662-4400 Fax: 847-662-1084
-
Date Prepared: 3/19/96 2 .
Name of Device: 3. Proprietary Name: CPR MICROMASK with Oxygen Inlet Classification Name: Valve, Non-Rebreathing Common/Usual Name: Exhaled-air Pulmonary Resuscitator with Filter -
4 . Equivalent device: Laerdal Mcdical Pocket Mask, Cat. No. 83-00-03 (K861401)
-
న్. Device dascription.
The configuration of this pocket-sized device is a cushioned face mask used to enclose the patients nose and mouth. A one-way valve allows the rescuer to provide exhaled air to the patient. The oxygen port will allow oxygen enhancement of the rescuer's exhaled air. Expired air and/or fluids from the patient is vented away from the rescuer due to the one-way valve and an alternate venting route.
The device comes in one size and is designed for adults but can be used on infants. By rotating the mask 180 degrees and placing the nose portion just below the infants lover lip, the wider portion of the cushion rests on the forehead. The repositioning of the mask and the soft material of the mask cushion allows for a complete seal of the mask cushion to an infants facial contours.
The device is non-sterile. It normally will be packaged in a polybag which may be placed in a zippered nylon pouch.
This device is not intended for use by persons not trained in basic life saving skills or those with only a basic bystander course.
-
- Device use: A device used for mouth-to-mask treatment of respiratory failure.
- ! . The CPR MICROMASK with Oxygen Inler performs the same function and is technologically equivalent to the Laerdal Medical Pocket Mask, Cat INo. 83-00-03.
1
4080 MORRISON DRIVE . . GURNEE, ILLINOIS 60031 ● 708-662-4400
510(k) SUMMARY - Page 2
Performance Testing: 8. The CPR MICROMASK with Oxygen Inlet was found equivalent to the Laerdal Medical Pocket Mack for the following:
FLOW RESISTANCE FACE MASK TRANSPARENCY FACE SEALING EFFECT Of VOMITUS AND BARRIER EFFECTIVENESS DEAD SPACE EFFECTS OF TEMPERATURE POSSIBILITY OF MISASSEMBLY HUMAN FACTORS DESIGN AND INSTRUCTIONS SUPPLEMENTAL UXYGEN
- The major patient/rescuer contact components complies with lhe Tripartike Biocompatibility Guidance for Medical Devices.