(309 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven components.
No.
The device is described as a barrier and a one-way valve for CPR, separating the patient and rescuer without active therapeutic claims.
No
Explanation: The device description states its purpose is to "separate the patient and the rescuer during cardiopulmonary resuscitation (CPR)". It facilitates a medical procedure (CPR) by providing a barrier and one-way valve for breathing flow, but it does not analyze or interpret physiological data to determine the nature or cause of a disease or condition. Therefore, it is not a diagnostic device.
No
The device description clearly states it is a "flat sheet" with "integral ear loops" and a "one-way valve," indicating it is a physical, hardware-based medical 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 to separate the patient and rescuer during CPR. This is a physical barrier and a mechanical aid for ventilation.
- Device Description: The description details a physical barrier with a one-way valve. It does not mention any components or processes that analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples.
- Detecting or measuring substances in the body.
- Providing diagnostic information about a disease or condition.
- Any laboratory or clinical testing context.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. The Rescue Breather does not fit this description.
N/A
Intended Use / Indications for Use
The Rescue Breather is intended to separate the patient and the rescuer during cardiopulmonary resuscitation (CPR) on adults and children. It is a single use device and is not sold sterile. The intended use of the Res-Cue Key/Life Key is identical.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The device is a flat sheet measuring 6" by 11" which has integral ear loops to hold it in position during use. The mask provides separation between the skin, mucous membranes and oral secretions of the patient and the rescuer. There is a one-way valve in the middle of the mask which directs breathing flow to the patient.
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
adults and children
Intended User / Care Setting
rescuer
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)
Testing delineated in the ASTM Standard F 920-93 has been conducted. The device meets all specifications relevant to its features.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
DINTERNATIONAL SAFETY INC.
1955520
510(K) SUMMARY
MANUFACTURING DIVISION P.O. BOX 20961 KEIZER. OR. 97307-0961
OCT -8 1996
800-733-90017 503-463-1445
Contact person: Gordon Jackson
Date summary prepared: October 4, 1996
Device name:
Proprietary name: Common or usual name: Classification name:
Rescue Breather™ Cardiopulmonary Resuscitation (CPR) mask. Nonrebreathing valve, Class II, 21 CFR 868.5870.
Legally marketed device for substantial equivalence comparison: Res-Cue Key™ and Life Key™ by Ambu, Inc. cleared under K900260.
Description of the device:
The device is a flat sheet measuring 6" by 11" which has integral ear loops to hold it in position during use. The mask provides separation between the skin, mucous membranes and oral secretions of the patient and the rescuer. There is a one-way valve in the middle of the mask which directs breathing flow to the patient.
Intended Use of Device:
The Rescue Breather is intended to separate the patient and the rescuer during cardiopulmonary resuscitation (CPR) on adults and children. It is a single use device and is not sold sterile. The intended use of the Res-Cue Key/Life Key is identical.
Technological Characteristics:
The Rescue Breather and the Res-Cue Key/Life Key are both sheet-type masks with ear loops for attachment to the patient. Both have one-way valves in the middle of the mask. Neither device has any portion which extends into the patient's mouth. The two devices are composed of different materials. The Rescue Breather is composed of surgical glove quality natural latex and nylon. The Res-Cue Key and Life Key are composed of high and low density polymers.
Performance Data
Testing delineated in the ASTM Standard F 920-93 has been conducted. The device meets all specifications relevant to its features.