(321 days)
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No
The description details standard pulse oximetry technology based on light absorption and calculation, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is a pulse oximeter, which is a diagnostic monitoring device used to measure physiological parameters (SpO2 and pulse rate), not to provide therapy or treatment.
Yes
The device is a pulse oximeter that monitors functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are physiological parameters used to diagnose a patient's condition.
No
The device description explicitly states that the Voyager consists of a CF card, a connecting cable, and is sold with reusable and disposable sensors. It also mentions "electronic hardware and software" within the monitor component. While software is a key part, it is not the sole component of the medical device.
No, this device 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 Dolphin Medical Voyager Pulse Oximeter and Accessories measure functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate non-invasively by shining light through tissue (like a finger or earlobe). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "non-continuous noninvasive monitoring".
Therefore, based on the provided information, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).
Product codes
DQA
Device Description
The Pocket PC based Dolphin Medical Voyager Pulse Oximeter and Accessories, is fully functional handheld device to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate through a Compact Flash (CF) Card.
The Voyager consists of a CF card, and a connecting cable and is sold with the Dolphin ONE reusable and disposable sensors and the Dolphin Voyager Software as accessories. The user is required to load the Dolphin Voyager Software on a Pocket PC. The Voyager is intended for battery use only using the internal Pocket PC battery. The oximeter must not be used when connected to any other device, or when placed in the recharging cradle provided by the Pocket PC manufacturer. The Dolphin Voyager software will disable the oximetry function and display a message "Unit Charging - Do Not Use" when external power is detected.
The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable.
The connecting cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration driver to the oximetry sensor from the the monitor receives the detector signal from the oximetry sensor.
The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.
Mentions image processing
Not Found
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
The Dolphin Medical Voyager and Accessories were clinically validated in two breathe-down protocols at the VA Hospital of Wisconsin - Milwaukee (Dr. Philip Clifford, MD). Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpOz values to functional SaO2 values. Fourteen volunteers participated in the breathe-down protocol at rest (i.e. no motion) while fully conscious at SaQ2 values ranging from 70-100%. Data was analyzed to determine the Aggs for each probe. Clinical validation for the Adult Reusable and Adult Disposable resulted in an accuracy determination of less than 2.0% Arms for adults and pediatrics > 30 kg in the range of 70-100% SaQ2. The Neonatal Disposable resulted in an accuracy determination of less than 2.2% for pediatrics 30 kg in the range of 70-100% SaQ2.
Accuracy determination of less than 2.2% for pediatrics
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
7 2002 NOV
KC14218
November 6, 2002
Summary of Safety and Effectiveness Information for the Dolphin Medical Voyager Pulse Subject: Oximeter and Accessories Dolphin Medical Voyager Pulse Oximeter and Accessories Proprietary: Common: Oximeter Oximeter Class II - 21 CFR 870.2700 - 74 DQA Classification:
The Pocket PC based Dolphin Medical Voyager Pulse Oximeter and Accessories, is fully functional handheld device to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate through a Compact Flash (CF) Card.
The Dolphin Medical Voyager Pulse Oximeter and Accessories is substantially equivalent to the following currently marketed device(s):
- Dolphin Medical Stand Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036. .
- QRS Diagnostic Spiroxcard Diagnostic Spirometer and Pulse Oximeter #K001995. .
The Voyager consists of a CF card, and a connecting cable and is sold with the Dolphin ONE reusable and disposable sensors and the Dolphin Voyager Software as accessories. The user is required to load the Dolphin Voyager Software on a Pocket PC. The Voyager is intended for battery use only using the internal Pocket PC battery. The oximeter must not be used when connected to any other device, or when placed in the recharging cradle provided by the Pocket PC manufacturer. The Dolphin Voyager software will disable the oximetry function and display a message "Unit Charging - Do Not Use" when external power is detected.
The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable.
The connecting cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration driver to the oximetry sensor from the the monitor receives the detector signal from the oximetry sensor.
The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.
The Dolphin Medical Voyager Pulse Oximeter and Accessories is substantially equivalent in design concepts, technologies and materials to the Dolphin Stand-Alone Pulse Oximeter. Formal testing has been performed for the device including Safety and Emissions, and performance validation which has been included in this submission.
1
The Dolphin Medical Voyager and Accessories were clinically validated in two breathe-down protocols at the VA Hospital of Wisconsin - Milwaukee (Dr. Philip Clifford, MD). Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpOz values to functional SaO2 values. Fourteen volunteers participated in the breathe-down protocol at rest (i.e. no motion) while fully conscious at SaQ2 values ranging from 70-100%. Data was analyzed to determine the Aggs for each probe. Clinical validation for the Adult Reusable and Adult Disposable resulted in an accuracy determination of less than 2.0% Arms for adults and pediatrics > 30 kg in the range of 70-100% SaQ2. The Neonatal Disposable resulted in an accuracy determination of less than 2.2% for pediatrics