MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER

K020075 · Dolphin Medical, Inc. · DQA · Feb 8, 2002 · Cardiovascular

Device Facts

• Record ID: K020075
• Device Name: MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER
• Applicant: Dolphin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 of adult, pediatric and neonatal patients in hospitals, hospital-type facilities and home environments. The OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are indicated for use with adult, pediatric and neonatal patients who are well or poorly perfused.

Device Story

Portable stand-alone pulse oximeter (Model 2100) calculates functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate. Device uses two LEDs in a sensor to measure light absorption of blood; oxygenated and deoxygenated hemoglobin absorb light differently. Monitor processes detector signals to calculate SpO2 and pulse rate; displays plethysmographic waveform, numerical values, trends, and alarms. Used in hospitals, hospital-type facilities, and home environments by clinicians or patients. Powered by AC or internal sealed lead-acid battery. Provides continuous monitoring to assist healthcare providers in assessing patient oxygenation status, potentially benefiting patients by enabling timely intervention for hypoxemia.

Clinical Evidence

Bench testing only. Compliance with standards including ISO 9919:1992, EN 865:1997, and FDA Pulse Oximeter Guidance (1992). Performance of motion artifact rejection validated via bench testing.

Technological Characteristics

Portable stand-alone monitor (10x27.5x25 cm, 4 kg). Dual-LED optical sensing principle. Powered by 100-240 Vac or sealed lead-acid battery. Connectivity via extension cable to disposable/reusable sensors. Complies with IEC 601-1, ISO 9919, EN 865, and ASTM 1415 standards. Software-based signal processing.

Indications for Use

Indicated for continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate in adult, pediatric, and neonatal patients, including those who are well or poorly perfused, in hospital and home environments.

Regulatory Classification

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.

Predicate Devices

• OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories (K002036)
• OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories (K012533)
• OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories (K012626)
• Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories

Submission Summary (Full Text)

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K020075

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
- 5. ISO 9919: 1992
- 6. EN 865: 1997
- 7. FDA Guidance Document for Pulse Oximeters: 9/7/1992
- 8. ASTM 1415:1992, and Draft 10.1
- 9. UL2601-1: Second Edition, 1997
- 10. IEC 6068-2-6
- 11. IEC 6068-2-27
- 12. IEC 6068-2-64
- 13. 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: [phone] Fax:[phone]

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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 [phone]. office of Compliance at [phone]. 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 [phone] or [phone] 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

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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices

| 510(k) Number: | K020075 |
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| Prescription Use<br>(Per 21 CFR 801.109) | <div> OR over-the-counter Use </div> |
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