(30 days)
N/A
N/A
No
The description focuses on standard pulse oximetry technology and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is a pulse oximeter, which is a diagnostic device used for monitoring, not treating, a condition.
Yes
The device is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which falls under diagnostic monitoring to assess a patient's physiological state.
No
The device description explicitly states it is a "portable stand-alone device" that includes "electronic hardware and software," a "connecting cable," and "oximetry sensor(s)." It also details physical dimensions, weight, and power source, all indicating a hardware component is integral to the device's function.
Based on the provided text, the OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories is not an IVD (In Vitro Diagnostic) device.
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 description clearly states that the device is a "continuous noninvasive monitoring" device that measures "functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate" by using a sensor placed on the body. It measures light absorption through the skin.
- No Sample Analysis: The device does not analyze samples taken from the body. It directly measures physiological parameters on the body.
Therefore, the OSI Medical Dolphin Stand-Alone Pulse Oximeter falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using an SpO2 sensor. The OSI Medical Dolphin Pulse Oximeter and Accessories are indicated for use with adult, pediatric, and neonatal patients who are well or poorly perfused in hospitals, hospital-type facilities and home environments.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA
Device Description
The OSI Medical Dolphin Pulse Oximeter and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
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 alarms, 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 function of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable.
The OSI Medical Dolphin Pulse Oximeter is available in one configuration as a portable stand-alone oximeter that is 10 cm / 3.94 inches high. 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8.8 lbs. The unit is powered either with a voltage input of 100-240 Vac, 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module, 300mA System Module) and a charge time of about 4.5 hours to 80% capacity.
The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor.
The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in length.
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 oximetry sensor is available in a disposable or reusable configuration, and with one configuration for the extension cable (8 feet).
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, pediatric, and neonatal
Intended User / Care Setting
Not Found
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)
Additional testing has been performed on the OSI Medical Dolphin Stand-Alone Pulse Oximeter to validate the performance of the motion artifact rejection under the worst-case scenario, involving the disposable sensors, and has been included in this submission. Additionally, the software for the OSI Medical Dolphin Pulse Oximeter was fully specified and validated by OSI Medical.
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
§ 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
FEB 0 8 2002
January 3, 2002
Summary of Safety and Effectiveness Information for the OSI Medical Dolphin Stand-Subject: Alone Pulse Oximeter and Accessories. OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories. Proprietary: Common: Oximeter. Oximeter Class II - 21 CFR 870.2700 - 74 DQA Classification:
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 1992.
The OSI Medical Dolphin Pulse Oximeter and Accessories is substantially equivalent to the following currently marketed device(s):
- OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036, . #K012533, and #K012626.
- Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories. .
The OSI Medical Dolphin Pulse Oximeter and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpOz value, the high and low SpO2 and pulse rate alarms, 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 function of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable.
The OSI Medical Dolphin Pulse Oximeter is available in one configuration as a portable stand-alone oximeter that is 10 cm / 3.94 inches high. 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8.8 lbs. The unit is powered either with a voltage input of 100-240 Vac, 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module, 300mA System Module) and a charge time of about 4.5 hours to 80% capacity.
The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor.
The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in length.
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.
1
The oximetry sensor is available in a disposable or reusable configuration, and with one configuration for the extension cable (8 feet).
The OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories have been designed to comply with the following standards:
- CSA C22.2 No. 601.1 1.
- IEC 601-1, Part 1 and Amendments 1 and 2 2.
- IEC 601-1-1, Part 1 3.
- IEC 601-1-2, Part 1 ধ
-
- ISO 9919: 1992
-
- EN 865: 1997
-
- FDA Guidance Document for Pulse Oximeters: 9/7/1992
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- ASTM 1415:1992, and Draft 10.1
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- UL2601-1: Second Edition, 1997
-
- IEC 6068-2-6
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- IEC 6068-2-27
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- IEC 6068-2-64
-
- ISTA Procedure 2A
The Masimo Set®/Quartz 2500 Pulse Oximeter and the OSI Medical Dolphin Stand-Alone Pulse Oximeter are substantially equivalent in design concepts, technologies and materials. Additional testing has been performed on the OSI Medical Dolphin Stand-Alone Pulse Oximeter to validate the performance of the motion artifact rejection under the worst-case scenario, involving the disposable sensors, and has been included in this submission. Additionally, the software for the OSI Medical Dolphin Pulse Oximeter was fully specified and validated by OSI Medical.
OSI Medical, Inc. 13801 McCormick Drive Tampa, FL 33626 Tel: 813-818-7488 Fax:813-818-7588
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 8 2002
Mr. Jon Werner QA Manager OSI Medical 13801 McCormick Drive Tampa, FL 33626
Re: K020075
Dolphin Stand-Alone Pulse Oximeter and Accessories Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: January 8, 2002 Received: January 9, 2002
Dear Mr. Werner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de noos mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Sheri L. Musgnung
Please be advised that FDA's issuance of a substantial equivalence determination and mean Please oe advised that IDA s issuates of a backers with other requirements of the Act that FDA has made a decermination that your contristered by other Federal agencies. You must or ally recetal statutes and regulations and as a limited to: registration and listing (21 comply with an the Act 3 requirements) n.c. and 801 ); good manufacturing practice requirements as set CFK Fat 807), facemig (21 OF R Part 820); and if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow you to ough finding of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire spoonte acrison for in vitro diagnostic devices), please contact the Office of additionally 21 Of IC For at 646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1010. office of Compliance at (301) 594-4639. Also, please note the your deviced, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation ontined, "Thisorange responsibilities under the Act may be obtained from the Other general miormation of Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
K. Don Tille
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR INTENDED USE FOR 2100 PULSE OXIMETER
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100
February 4, 2002
Indications for Use:
Indicallors In Ose.
The OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and public of any hominaste monitoring of theilence bygon only and the end Accessories are indicated for use with adult, by an Spoz sensor, The OOT Medion Dolphill Faloo Oximo conditions and for patients who are well or poorly perfused in hospitals, hospital-type facilities and home environments.
Accessories:
Digital Dolphin Disposable Sensors Digital Dolphin Disposuble Octions
Digital Dolphin 210 Reusable Finger Clip intended for adults / pediatrics greater than 66.14 Ibs. (30kg). Digital Dolphin 110 Extension Cable
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number: | K020075 |
|---|---|
| ---------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR over-the-counter Use |
|---|---|
| ------------------------------------------ | ------------------------------------------- |