(217 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a simple mechanical device (CPR mask with oxygen port) and do not mention any computational or algorithmic components, let alone AI/ML.
No
The device is a CPR mask, primarily functioning as a barrier and for delivering rescue breaths, not for directly treating a disease or condition. While it aids in life-saving procedures, it is not a therapeutic device in itself.
No
The device is designed for mouth-to-mask ventilation and CPR rescue techniques, primarily functioning as a barrier and for air delivery, not for diagnosing medical conditions.
No
The device description explicitly states it is made up of physical components (medical grade PVC, K-resin, elastic strap) and includes performance testing related to physical properties (resistance), indicating it is a hardware device.
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 ventilation and CPR rescue techniques. This is a direct intervention on a patient to support breathing and circulation.
- Device Description: The device is a physical barrier and delivery system for air/oxygen. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on physical characteristics like biocompatibility and resistance to airflow, which are relevant to a medical device used for ventilation, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
In summary, the device is a medical device used for providing respiratory support and acting as a barrier during CPR, which falls under the category of therapeutic or supportive medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Genuine First Aid CPR Face (with oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
Product codes (comma separated list FDA assigned to the subject device)
CBP
Device Description
Genuine First Aid CPR Face Mask and oxygen port, made up of medical grade PVC and one-way valve made up of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim.
Single use. CPR mask includes: One-way filter valve PVC mask with oxygen port Elastic Strap Packaged for easy portability and quick access
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
Adult
Intended User / Care Setting
Persons who have received adequate training. Used for health emergency victims.
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)
Performance testing included Biocompatibility testing (vitro cytotoxicity, skin irritation, delayed-type hypersensitivity) according to ISO10993-1,-5,-10 which all passed. Expiratory resistance and Inspiratory resistance performance testing was done using the test methods described in ISO10651-4:2002.
Expiratory resistance: 3 cmH2O (at 50 L/min)
Inspiratory resistance: 2 cmH2O (at 50 L/min)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Expiratory resistance: 3 cmH2O (at 50 L/min)
Inspiratory resistance: 2 cmH2O (at 50 L/min)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
KI 8846
12-2261
MAR 1 8 2011
Submitter: Genuine First Aid LLC 600 Cleveland Street Suite 400 Clearwater FL 33755, USA Office: (727) 449 2150 (727) 449 2145 Fax: Contact: Desiree Jacques
Contact/Consultant: Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Rd East Stroudsburg, PA 18301 USA (570) 620-0198 (570) 620-0199
Trade Name: Genuine First Aid CPR Mask
Common Name: Emergency CPR Mask
Classification Name: Valve, Non-Rebreathing Product Code: СВР Classification: Class II Panel: Anesthesiology 21CFR 868.5870 Requlatory Classification:
Medisource CPR Mask with Oxygen Port - K081516 Predicate Device:
Device Description:
Genuine First Aid CPR Face Mask and oxygen port, made up of medical grade PVC and one-way valve made up of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim.
Single use. CPR mask includes: One-way filter valve PVC mask with oxygen port Elastic Strap Packaged for easy portability and quick access
Specifications:
Dimensions: (122mm x 100mm x 90mm) mask connector 22mm ID oxygen port 6mm OD Inspiratory resistance: