OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR

K012626 · Osi Medical, Inc. · DQA · Nov 2, 2001 · Cardiovascular

Device Facts

• Record ID: K012626
• Device Name: OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR
• Applicant: Osi Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 2, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories and 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 indicated for use with adult, pediatric and neonatal patients in hospital, clinical, and home environments.

Device Story

Portable stand-alone pulse oximeter (Model 2100) monitors SpO2 and pulse rate; inputs signals from LEDs within oximetry sensors via connecting cable; sensor measures light absorption of blood using two LEDs; monitor calculates ratio of oxygenated to total hemoglobin; displays plethysmographic waveform, SpO2, pulse rate, alarm limits, trends, and status messages; used by clinicians or patients in hospital, clinical, or home settings; provides real-time physiological data to assist in patient monitoring and clinical decision-making; benefits include noninvasive assessment of oxygenation status.

Clinical Evidence

Bench testing only. Compliance with standards including ISO 9919:1992, EN 865:1997, and FDA Pulse Oximeter Guidance (1992). Biocompatibility and performance validation performed for disposable sensors.

Technological Characteristics

Portable stand-alone monitor; 10cm x 27.5cm x 25cm; 4kg; powered by 100-240 Vac or sealed lead-acid battery. Uses two-wavelength LED oximetry sensing. Complies with IEC 601-1, ISO 9919, EN 865, and ASTM 1415. Disposable and reusable sensor options. Connectivity via proprietary extension cable.

Indications for Use

Indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult, pediatric, and neonatal patients in hospital, clinical, 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)

Submission Summary (Full Text)

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K012626

## NOV 0 2 2001

August 8, 2001

| Subject: | Summary of Safety and Effectiveness Information for the OSI Medical Dolphin Stand-<br>Alone Pulse Oximeter and Accessories. |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| Proprietary: | OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories. |
| Common: | Oximeter. |
| Classification: | Oximeter Class II - 21 CFR 870.2700 – 74 DQA |

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 for adult, pediatric and neonatal patients.

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 (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:

- 1. CSA C22.2 No. 601.1
- IEC 601-1, Part 1 and Amendments 1 and 2 2.
- 3. IEC 601-1-1, Part 1
- 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
- UL2601-1: Second Edition, 1997 9.
- 10. IEC 6068-2-6
- 11. IEC 6068-2-27
- 12. IEC 6068-2-64
- 13. ISTA Procedure 2A

The OSI Medical Dolphin Stand-Alone Pulse Oximeter with disposable sensors is substantially equivalent The OSI Medical Dolphill Galle-Alone Pulse Online of 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.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three curved lines representing its wings, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 0 2 2001

Mr. Jon Werner OSI Medical, Inc. 13801 McCormick Drive Tampa, FL 33626

K012626 Re:

R012020
OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: August 8, 2001 Received: August 13, 2001

Dear Mr. Werner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to may 20, 2017 11:12 accordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrorore, manel a the Act include requirements for annual registration, listing of general obtarvill profice, 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 11 70dr de subject to such additional controls. Existing major regulations affecting your device can may or subject to back are as Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be arribed and i Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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#### Page 2 - Mr. Jon Werner

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF IT rat 007); adoning (21 CFR Part 820); and if applicable, the electronic roral in and quinn control provisions (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 lotter will and my of your e FDA finding of substantial equivalence of your device to a legally market notification: "The stars 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 specific ad 1309.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF N Far 804. Additionally, for questions on the promotion and advertising of Compination at (301) 591 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisorana wour responsibilities under the Act may be obtained from the Oiner general information of Small and 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. Darl Tellem
James F. Dillard III

ames E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## NOV 0 2 2001 INDICATIONS FOR INTENDED USE FOR 2100 PULSE OXIMETER

K012626

PR-032100.D

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100

August 8, 2001

Indications for Use:

Indications for Use:
The OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories and indicated for the continuous The OSI Medical Dolphin Standanon ense oxines of and Aboooolobin (SpO) and pulse rate (measured noninvasive monitoring of functional or use Oximeter and Accessories are inicated for use with adult,
by an SpO2 sensor). The OSI Medical Dolphin Pulse Oximeter and home by an SpO2 sensor). The OSI Medical Dolphil Pulse Oxineler and Acoboonoo and Industral 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 Digital Dolphin Disposable Sensors
Digital Dolphin 210 Reusable Finger Clip intended for adults / pediatrics greater than 66.14 lbs. (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.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | (Division Sign-Off) |
| | Division of Cardiovascular, Respiratory, and Neurological Devices |
| 510(k) Number: | K012624 |
| Prescription Use <span style="text-decoration: underline;">✓</span> | OR over-the-counter Use <span style="text-decoration: underline;"></span> |