(30 days)
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.
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. The oximetry sensor is available in a disposable or reusable configuration, and with one configuration for the extension cable (8 feet).
The provided text describes a 510(k) submission for the OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100. It asserts substantial equivalence to a predicate device and lists compliance with various standards. However, it does not contain a detailed study report with specific acceptance criteria and performance data for the device itself. The document mainly focuses on regulatory compliance and substantial equivalence to a previously cleared device.
Therefore, many of the requested details about acceptance criteria, specific performance results, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from the provided text.
Here's an analysis of what can be inferred or is explicitly stated, with limitations noted:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided document. The document states that the device has been "designed to comply with ... standards" (section 1), implying that performance criteria would be defined by these standards, but it doesn't list specific performance metrics or the device's results against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided document. The text mentions "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" (section 1). However, it does not provide details about the sample size, data provenance, or the nature of this "testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not present in the provided document. Pulse oximeters typically compare their readings to invasive blood gas measurements. The document does not describe human expert involvement in establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not present in the provided document. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the device is described as a "Stand-Alone Pulse Oximeter" (sections 0, 1, 4). The performance discussed (albeit vaguely) refers to the device's direct measurement capabilities. Thus, any performance claims would inherently be "standalone" performance. The text states: "The OSI Medical Dolphin Pulse Oximeter and Accessories is a portable stand-alone device... to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." (section 0).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in the provided document for the "additional testing." For pulse oximeters, the accepted ground truth for accuracy is typically arterial blood gas analysis (co-oximetry). While the document states the device "has been designed to comply with ... standards" (section 1), these standards would implicitly dictate the ground truth methodology for performance testing, but the document does not elaborate on the specific ground truth used for its own testing.
8. The sample size for the training set:
This information is not present in the provided document. Pulse oximeters primarily rely on hardware and signal processing algorithms based on known physiological principles (e.g., Beer-Lambert law), rather than machine learning models that require a "training set" in the common AI sense. While there is "software" for the device, the document states it was "fully specified and validated" (section 1), not "trained."
9. How the ground truth for the training set was established:
This information is not present in the provided document, for the reasons outlined in point 8.
In summary, the provided submission focuses on regulatory compliance and substantial equivalence to predicate devices, rather than a detailed report of a new clinical study with explicit acceptance criteria and corresponding performance data for the device itself.
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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.
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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
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- 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
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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.
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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
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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 |
|---|---|
| ------------------------------------------ | ------------------------------------------- |
§ 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).