OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'

K014218 · Dolphin Medical, Inc. · DQA · Nov 7, 2002 · Cardiovascular

Device Facts

• Record ID: K014218
• Device Name: OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'
• Applicant: Dolphin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).

Device Story

Handheld pulse oximeter system; utilizes Pocket PC platform with Compact Flash (CF) card interface. Inputs: optical signals from LED-based sensors (reusable/disposable). Operation: sensor measures light absorption differences between oxygenated/deoxygenated blood; CF card/software calculates SpO2 and pulse rate. Output: screen displays plethysmographic waveform, SpO2, pulse rate, trends, status messages. Used in clinical settings; operated by healthcare professionals. Device requires battery power; software disables oximetry during charging to ensure safety. Benefits: provides noninvasive, real-time physiological monitoring for patient assessment.

Clinical Evidence

Clinical validation performed via two breathe-down protocols (n=14 volunteers) at VA Hospital of Wisconsin. Accuracy (Arms) compared against functional SaO2 (70-100% range). Results: <2.0% Arms for adults/pediatrics >30kg; <2.2% for pediatrics <30kg; <3.5% for neonates.

Technological Characteristics

System comprises CF card, connecting cable, and LED-based sensors. Operates on Pocket PC (Windows CE). Complies with EN60601-1, EN60601-1-1, UL 2601-1, CSA C22.2 #601, EN 865, ISO 9919, and various MIL-STD-810E environmental/shock/vibration standards. Connectivity: CF card interface. Power: Internal battery only; charging disabled during operation.

Indications for Use

Indicated for non-continuous, noninvasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adults, pediatrics, and neonates. Used with Pocket PC (Windows CE).

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

• Dolphin Medical Stand Alone Pulse Oximeter, Model No. 2100 and Accessories (K002036)
• QRS Diagnostic Spiroxcard Diagnostic Spirometer and Pulse Oximeter (K001995)

Submission Summary (Full Text)

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7 2002 NOV

KC14218

November 6, 2002

Summary of Safety and Effectiveness Information for the Dolphin Medical Voyager Pulse Subject: Oximeter and Accessories Dolphin Medical Voyager Pulse Oximeter and Accessories Proprietary: Common: Oximeter Oximeter Class II - 21 CFR 870.2700 - 74 DQA Classification:

The Pocket PC based Dolphin Medical Voyager Pulse Oximeter and Accessories, is fully functional handheld device to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate through a Compact Flash (CF) Card.

The Dolphin Medical Voyager Pulse Oximeter and Accessories is substantially equivalent to the following currently marketed device(s):

- Dolphin Medical Stand Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036. .
- QRS Diagnostic Spiroxcard Diagnostic Spirometer and Pulse Oximeter #K001995. .

The Voyager consists of a CF card, and a connecting cable and is sold with the Dolphin ONE reusable and disposable sensors and the Dolphin Voyager Software as accessories. The user is required to load the Dolphin Voyager Software on a Pocket PC. The Voyager is intended for battery use only using the internal Pocket PC battery. The oximeter must not be used when connected to any other device, or when placed in the recharging cradle provided by the Pocket PC manufacturer. The Dolphin Voyager software will disable the oximetry function and display a message "Unit Charging - Do Not Use" when external power is detected.

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 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 connecting cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration driver to the oximetry sensor from the the monitor receives the detector signal from the oximetry sensor.

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 Dolphin Medical Voyager Pulse Oximeter and Accessories is substantially equivalent in design concepts, technologies and materials to the Dolphin Stand-Alone Pulse Oximeter. Formal testing has been performed for the device including Safety and Emissions, and performance validation which has been included in this submission.

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The Dolphin Medical Voyager and Accessories were clinically validated in two breathe-down protocols at the VA Hospital of Wisconsin - Milwaukee (Dr. Philip Clifford, MD). Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpOz values to functional SaO2 values. Fourteen volunteers participated in the breathe-down protocol at rest (i.e. no motion) while fully conscious at SaQ2 values ranging from 70-100%. Data was analyzed to determine the Aggs for each probe. Clinical validation for the Adult Reusable and Adult Disposable resulted in an accuracy determination of less than 2.0% Arms for adults and pediatrics > 30 kg in the range of 70-100% SaQ2. The Neonatal Disposable resulted in an accuracy determination of less than 2.2% for pediatrics < 30 kg and less than 3.5% for neonates in the range of 70-100% SaO2.

The Dolphin Medical Voyager Pulse Oximeter and Accessories have been designed to comply with the following standards:

- 1. EN60601-1 Medical Electrical Equipment; Part 1: General requirements for safety (includes Amendments 1 and 2)
- EN 60601-1-1: Medical Electrical Equipment; Part 1: General requirements for safety 1. 2. Collateral standard: Safety requirements for medical electrical systems.
- UL 2601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety 3.
- EN 865 Pulse Oximeter Particular requirements ব
- CSA C22.2 #601 Medical Electrical Equipment Part 1: General Requirements for Safety 5.
- EN 60601-1-2: Medical Electrical Equipment; Part 1: General requirements for safety 2. 6. a. Collateral standard: Electromagnetic compatibility - Requirements and tests
- 7. ISO 9919: Pulse Oximeters for medical use Requirements
- 8. IEC 60068-2-6: Environmental testing Part 2: Tests Test Fc: Vibration (sinusoidal)
- 9. IEC 60068-2-27: Environmental testing. Part 2: Test Ea and guidance: Shock
- 10. IEC 60068-2-64: Environmental testing Part 2: Test methods Test Fh: Vibration, a. broad-band random (digital control) and guidance
- 11. ISTA Procedure 2A: Integrity-Plus Test Procedure, Performance Test for Individual i. Package-Product 150lb (68.2kg) or Less
- 12. MIL-STD-810E, 501.3 Operating and Storage High Temperature
- 13. MIL-STD-810E. 502.3 Operating and Storage Low Temperature
- 14. MIL-STD-810E. 503.3 Temperature Shock
- 15. MIL-STD-810E, 507.3 Procedure III: Humidity

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human figure with three wavy lines extending from the head, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

od and Drug Administratio 00 Corporate Boulevard Rockville MD 20850

Mr. Jon Werner Ouality Assurance Manager Dolphin Medical, Incorporated OSI Medical, Incorporated 13801 McCormick Drive Tampa, Florida 33626

Re: K014218

Trade/Device Name: Dolphin Medical Voyager Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 10, 2002 Received: August 12, 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, and Cosmetic Act (Act) that do not 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 – Mr. Werner

.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Susan Runne
Timothy A. Ulatowski

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Premarket Notification Intended Use and Indications for Use Statement

510(k) Number (if known):

Device Name: Dolphin Medical Voyager Pulse Oximeter

November 6, 2002

Intended Use:

The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
William A. Wot

(Division Sign-Off)

Division of Anesthesia, General Hospital, Infection Control, and Dental Devices (DAGID)

510(k) Number: K014218

Prescription Use (Per 21 CFR 801.109)

OR

over-the-counter Use