(16 days)
Not Found
No
The description details standard pulse oximetry technology based on light absorption and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is a diagnostic tool that measures oxygen saturation and pulse rate; it does not provide any treatment or therapy.
Yes
The device is indicated for "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements used in the diagnosis and management of various medical conditions.
No
The device description explicitly states it is a "portable stand-alone device, connecting cable, and oximetry sensor(s)" and includes details about its physical dimensions, weight, power source, and hardware components (screen, electronic hardware, LEDs, detector). While it contains software, it is not solely software.
Based on the provided text, 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 OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are described as a device that performs continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. This is done by measuring light absorption through the skin, not by analyzing a sample taken from the body.
- Intended Use: The intended use clearly states "continuous noninvasive monitoring."
- Device Description: The description details how the device uses LEDs and light absorption to calculate SpO2 and pulse rate, which is a non-invasive method.
Therefore, since the device does not analyze samples taken from the body, it does not fit the definition of 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 (measured by an SpO2 sensor). The OSI Medical Dolphin Pulse Oximeter and Accessories are intended for use with adult and pediatric patients in hospitals, clinics, extended care facilities, and home environments.
The OSI Medical's sensor(s) are intended/indicated for use only with the OSI Medical Dolphin Stand-Alone Pulse Oximeter, and consist of the following:
Digital Dolphin Disposable Sensors intended for adults / pediatrics greater than 66.14 Ibs. (30kg). Digital Dolphin Reusable Sensors Intended for adults / pediatrics greater than 66.14 Ibs. (30kg). Digital Dolphin 110 Extension Cable
The OSI Medical extension cable is intended/indicated for use only with the OSI Medical sensor(s) and the OSI Medical Dolphin Stand-Alone Pulse Oximeter.
Product codes
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 alarm limits, 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 functional oxygen saturation of arterial hemoglobin (SpQz) 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 and pediatric patients greater than 66.14 Ibs. (30kg).
Intended User / Care Setting
hospitals, clinics, extended care facilities, and home environments.
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 for the disposable sensors including biocompatibility and performance validation which has been included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 2 2 2001
August 1, 2001
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. .
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 alarm limits, 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 functional oxygen saturation of arterial hemoglobin (SpQz) 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
- IEC 601-1. Part 1 and Amendments 1 and 2 2.
-
- IEC 601-1-1, Part 1
-
- IEC 601-1-2, Part 1
-
- ISO 9919: 1992
-
- EN 865: 1997
-
- FDA Guidance Document for Pulse Oximeters: 9/7/1992
-
- ASTM 1415:1992, and Draft 10.1
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- UL2601-1: Second Edition, 1997
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- IEC 6068-2-6
-
- IEC 6068-2-27
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- IEC 6068-2-64
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- ISTA Procedure 2A
The OSI Medical Dolphin Stand-Alone Pulse Oximeter with disposable sensors is substantially equivalent in design concepts, technologies and materials to the OSI Medical Dolphin Stand-Alone Pulse Oximeter, with reusable sensors. Additional testing has been performed for the disposable sensors including biocompatibility and performance validation which has been included in this submission.
000012
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, each head facing a different direction.
AUG 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jon Werner OA Manager OSI Medical, Inc. 13801 McCormick Drive Tampa, FL 33626
Re: K012533
OSI Medical Digital Dolphin Disposable Optical Sensor, Model 510 Regulation Number: 870.2700 Regulatory Class: II (two) Product Code: 74 DQA Dated: August 3, 2001 Received: August 6, 2001
Dear Mr. Werner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 stired in 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, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Sourisions 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
3
Page 2 - Mr. Jon Werner
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) 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,
Deck Teh
. Dillard III ames 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
K012533 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100
August 1, 2001
Indications for Use:
Indications for Use:
The OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are indicated for the continuous The OSI Medical Dolphin Stand-Alone Califical Che Aberoglobin (SpO-) and pulse rate (measured noninvasive monitoring of lunctional oxygen saturalion of united for use with addition ase with addition and home by an SpO2 sensor). The OST Medical Dolphill Pulse Unition and Noscother Pacilities and home environments.
The OSI Medical's sensor(s) are intended/indicated for use only with the OSI Medical Dolphin Stand-Alone Pulse Oximeter, and consist of the following:
Digital Dolphin Disposable Sensors intended for adults / pediatrics greater than 66.14 Ibs. (30kg). Digital Dolphin Reusable Sensors Intended for adults / pediatrics greater than 66.14 Ibs. (30kg). Digital Dolphin 110 Extension Cable
The OSI Medical extension cable is intended/indicated for use only with the OSI Medical sensor(s) and the OS/ Medical Dolphin Stand-Alone Pulse Oximeter.
(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: K012533
Prescription Use
(Per 21 CFR 801.109)
OR
over-the-counter Use__
000009