(182 days)
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Not Found
No
The device description and performance studies focus on mechanical function and visual inspection, with no mention of AI or ML.
No.
Explanation: The device is designed to allow patients to speak and does not directly treat or diagnose a disease or condition.
No
The provided text describes a speaking valve used between a tracheostomy tube and ventilation equipment, which facilitates speech but does not diagnose a condition.
No
The device description clearly describes a physical valve with a silicone diaphragm, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use as a one-way speaking valve between a tracheostomy tube and ventilation equipment." This describes a device used in vivo (within the body) to facilitate speech for patients with tracheostomies.
- Device Description: The description details a mechanical valve placed in-line with a tracheostomy tube and ventilator. It describes a physical mechanism (silicone diaphragm opening and closing) to control airflow.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis of biological specimens.
- No Mention of Specimen Analysis: The description focuses on the mechanical function of the valve and its interaction with airflow and ventilation equipment, not on analyzing any biological samples.
Therefore, this device falls under the category of a medical device used for respiratory support and communication, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use as a one-way speaking valve hetween a tracheostomy tube and ventilation equipment.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Montgomery Tracheostomy Speaking Valves are designed to offer ventilator dependent patients the opportunity to speak without having to wait for the ventilator to cycle, allowing patients to speak during inspiration and expiration without interruption. The valve is placed in-line between the tracheostomy tube and the ventilator and features a thin silicone diaphragm which opens on inspiration and closes on expiration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
JUN 10 1996
SMDA Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Product: Montgomery Tracheostomy Speaking Valve (15mm / 22mm)
Description: Montgomery Tracheostomy Speaking Valves are designed to offer ventilator dependent patients the opportunity to speak without having to wait for the ventilator to cycle, allowing patients to speak during inspiration and expiration without interruption. The valve is placed in-line between the tracheostomy tube and the ventilator and features a thin silicone diaphragm which opens on inspiration and closes on expiration.
Indications For Use: For use as a one-way speaking valve hetween a tracheostomy tube and ventilation equipment.
Predicate Device: Tracheostomy Speaking Valve (15mm / 22mm), Product No. 007 marketed by Passy and Passy (4521 Campus Drive, Irvine, CA).
Testing: Each valve is visually inspected for defects and tested with ISO 5356-1 test qauges for 15mm and 22mm connections prior to packaging.
Submitted by:
Stuart K. Montgomery, President
Date:
April 9, 1996