(211 days)
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Dwyer Magnahelic Gauge
No
The summary describes a simple mechanical manometer for measuring pressure and contains no mention of AI, ML, or related concepts.
No
The device is a manometer intended to measure airway pressure, which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
No
The device is described as a manometer intended to measure airway pressure, which is a measurement tool rather than a diagnostic device that identifies a disease or condition. Its purpose is to provide a numerical reading of pressure, not to interpret that reading in a diagnostic context.
No
The device description explicitly states it is a "disposable manometer," which is a physical hardware device used to measure pressure. It also mentions being attached by flexible tubing, further indicating a hardware component.
Based on the provided information, the Mercury Airway Pressure Manometer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Mercury Airway Pressure Manometer measures airway pressure. This is a physical measurement taken directly from the patient's respiratory system, not a test performed on a sample outside the body.
- Intended Use: The intended use is to measure airway pressure, which is a physiological parameter, not to diagnose a condition based on a biological sample.
Therefore, the device falls under the category of a medical device used for monitoring or measurement of a physiological function, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Mercury Airway Pressure Manometer is a disposable manometer intended to measure airway pressure up to 80 cm H2O. It is designed to be attached by flexible tubing to the Mercury CPR bag or other devices providing expiratory pressure. Bench testing has determined that the Mercury Airway Pressure Manometer measures airway pressures up to 80 cm H2O in a mannner consistent with the Dwver Magnahelic Gauge, a pre-amendment device.
Product codes
monitor, airway pressure (includes gauge)
Device Description
The Mercury Airway Pressure Manometer is a disposable manometer intended to measure airway pressure up to 80 cm H2O. It is designed to be attached by flexible tubing to the Mercury CPR bag or other devices providing expiratory pressure.
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
airway
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)
Bench testing has determined that the Mercury Airway Pressure Manometer measures airway pressures up to 80 cm H2O in a mannner consistent with the Dwver Magnahelic Gauge, a pre-amendment device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a black and white drawing of two figures. One figure is standing behind the other, with their arms around the seated figure. Both figures have a heart shape on their chest. There is also a registered trademark symbol in the image.
Image /page/0/Picture/1 description: The image shows the logo for Mercury Medical. The word "MERCURY" is in large, bold, sans-serif font, with a line underneath it. Below the line, the word "MEDICAL" is in a smaller, sans-serif font, with the registered trademark symbol to the right of the word.
ENCLOSURE I
510(k) SUMMARY
- Mercury Airway Pressure Manometer .
- Airway Pressure Manometer (gauge) .
- monitor, airway pressure (includes gauge) .
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21CFR 807.92.
The Mercury Airway Pressure Manometer is a disposable manometer intended to measure airway pressure up to 80 cm H2O. It is designed to be attached by flexible tubing to the Mercury CPR bag or other devices providing expiratory pressure. Bench testing has determined that the Mercury Airway Pressure Manometer measures airway pressures up to 80 cm H2O in a mannner consistent with the Dwver Magnahelic Gauge, a pre-amendment device.
Kathy L. Hann
Kathy L. Hann
9/22/95
Date
Se