DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER

K024235 · Dolphin Medical, Inc. · DQA · Mar 17, 2003 · Cardiovascular

Device Facts

• Record ID: K024235
• Device Name: DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
• Applicant: Dolphin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor).

Device Story

Portable stand-alone pulse oximeter; calculates SpO2 and pulse rate via noninvasive optical sensing. Input: light absorption signals from two LEDs in sensor; processed by internal electronics/software to determine hemoglobin oxygenation ratio. Output: plethysmographic waveform, SpO2 value, pulse rate, alarm limits, trends, status messages on screen. Used in clinical settings; operated by healthcare professionals. Benefits: continuous monitoring of patient oxygenation status; provides real-time alerts for physiological changes.

Clinical Evidence

Bench testing only. Compliance with ISO 9919:1992, EN 865:1997, and ASTM 1415:1992 standards. Additional performance validation testing performed for Y sensor models (320, 360).

Technological Characteristics

Portable stand-alone monitor; 10cm x 27.5cm x 25cm; 4kg. Powered by 100-240 Vac or sealed lead-acid battery. Uses dual-LED optical sensing principle. Complies with IEC 601-1, IEC 601-1-1, IEC 601-1-2, ISO 9919, EN 865, ASTM 1415, and UL2601-1.

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.

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)
• Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories (K012533)
• Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories (K012626)
• Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories (K020075)
• Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories (K021959)

Submission Summary (Full Text)

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Dolphin Medical 2100 Pulse Oximeter and Accessories 12/10/02

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## Submitter Company

Dolphin Medical - FL 13801 McCormick Dr Tampa, FL 33626

Contact: Jon Werner Phone: [phone] x216 Fax: [phone]

## Sponsor Company

Dolphin Medical, Inc. 12525 Chadron Avenue Hawthorne, CA 90250

Contact: Tammy Conway Phone: [phone] Fax: [phone]

### Manufacturing Facility

Opto Sensors (M) Sdn. Bhd. No. 6 Jalan Angkasa Mas 1 Tebrau Industrial Estate II 81100 Johor Bahru. Malaysia

### Common, Classification & Proprietary Names

Common Name: Oximeter Oximeter Class II - 21 CFR 870.2700 - 74 DQA Classification Name: Proprietary Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories.

#### Intended Use

The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor).

#### Predicate Device

The Dolphin Medical 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, #K012533, #K012626, #K020075 and #K021959.
- -

The Dolphin Medical Pulse Oximeter Model 2100 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.

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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 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 (SpQs) and pulse rate, and provide for the connection to the connecting cable.

The Dolphin Medical Pulse Oximeter Model 2100 is available in one configuration as a portable standalone 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) 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 either a disposable configuration, and with one configuration for the extension cable (8 feet).

The Dolphin Medical 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
- 2. IEC 601-1, Part 1 and Amendments 1 and 2
- 3. IEC 601-1-1, Part 1
- IEC 601-1-2, Part 1 4.
- ISO 9919: 1992 5.
- EN 865: 1997 6.
- 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 60068-2-6
- 11. IEC 60068-2-27
- 12. IEC 60068-2-64
- 13. ISTA Procedure 2A

The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories is substantially equivalent in design concepts, technologies and materials to the Dolphin Medical Stand-Alone Pulse Oximeter Model No. 2100 and Accessories previously reviewed. Additional performance validation testing has been performed for the Y sensor models (320, 360) and has been included in this submission.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular design with the department's name around the perimeter. Inside the circle is a stylized caduceus symbol, which is often associated with healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Public Health Service

MAR 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K024235

Trade/Device Name: Dolphin Medical Stand Alone Pulse Oximeter, Model No. 2100 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 7, 2003 Received: March 10, 2003

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Runner, DDS, MA

Interim Director V 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) Number (if known):

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

December 10, 2002

Indications for Use:

The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpQ2) and pulse rate (measured by an SpO2 sensor).

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

> KO24235 510(k) Number:

Prescription Use (Per 21 CFR 801.109)

OR

over-the-counter Use

v. General Hospital.

510(k) Number .