DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420

K040380 · Dolphin Medical, Inc. · DQA · Aug 31, 2004 · Cardiovascular

Device Facts

• Record ID: K040380
• Device Name: DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420
• Applicant: Dolphin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 31, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Dolphin ONE Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

Device Story

Dolphin ONE Model 420 is a reusable forehead pulse oximetry sensor; used with compatible Dolphin ONE pulse oximeter monitors. Sensor consists of emitter and photodiode detector mounted in a sealed pouch; held in place by disposable adhesive disc and headband. Operates via spectrophotometry; measures light absorption to determine arterial oxygen saturation (SpO2) and pulse rate. Used in clinical settings; operated by healthcare professionals. Output displayed on monitor; assists clinicians in patient oxygenation assessment. Benefits include continuous, noninvasive monitoring of vital signs.

Clinical Evidence

Clinical validation performed via breathe-down protocols at VA Hospital of Wisconsin - Milwaukee. Study included conscious volunteers at rest with SaO2 ranging from 70-100%. Accuracy determined by comparing sensor SpO2 values to functional SaO2 values. Results showed accuracy of < 2.0 ARMS for adults and pediatrics > 30 kg.

Technological Characteristics

Reusable forehead sensor; emitter and photodiode detector; sealed pouch construction. Materials are non-toxic, non-irritant, and non-sensitizing. Complies with ASTM 1415 for environmental, pulse rate, and skin temperature requirements. Non-sterile.

Indications for Use

Indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate in adults and pediatrics > 30 kg.

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 ONE Reusable Oximetry Forehead Sensor Model 320 (K030629)

Submission Summary (Full Text)

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AUG 3 1 2004

K040380

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 14.0

# Dolphin ONE 1 Pulse Oximetry Forehead Sensor 1/23/04

## Submitter (Consultant Name and Address)

Jon Werner 14240 N 42nd St #205 Tampa, FL 33613

Phone: [phone] Fax: [phone]

#### Sponsor Company Name and Address and Contact Person

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

Tammy Conway, QA Manager Phone: [phone] Fax: [phone]

#### Manufacturing Facility Name and Address

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

### Common, Classification & Proprietary Names

Oximetry Sensor Common Name: Classification Name: Oximeter Dolphin ONETM Oximetry Sensors Proprietary Name:

#### Predicate Devices

| Sensor | Dolphin Model | Dolphin ONE Predicate Model found in<br>K030629 |
|--------------------------------------------------|---------------|-------------------------------------------------|
| Dolphin ONE Reusable<br>Oximetry Forehead Sensor | 420 | 320 |

#### Device Description

The Dolphin ONE Forehead Oximetry Sensor is a reusable sensor for use with approved Dolphin ONE pulse oximeter monitors.

The reusable forehead sensor is for use on the forehead and held in place with a disposable adhesive disc and headband. The emitter and detector are mounted in a sealed pouch (same materials as in the reusable Y sensor above) constructed in a flat cylindrical shape. The sensor is provided non-sterile.

#### Intended Use

The Dolphin ONE Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

#### Technonological Characteristics Comparison

The Dolphin ONE Oximetry Sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to commercially available oximetry sensors.

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All of the Dolphin ONE Oximetry Sensors and the predicate devices operate on the identical principles of All of the Dulphill ONE Oxinony Online and produced as not as a series and detectors (photodiode).

The Dolphin ONE Oximetry Sensors are designed, and manufactured for full compatibility for The Dolphili ONE OXImon of Concert and Connects. They are constructed of similar materials ase with the labords, equivalent specifications as used in the predicate devices.

The labeled accuracy of the Doiphin ONE Sensors is equivalent to those of the predicate devices.

#### Performance Testing

- Biocompatibility .
- The Dolphin ONE Model 420 Forehead Sensor utilizes the same sensor body, cable, and keyed The Dolphin ONE MOGOF LEO PORTONE Sensors approved in #K030629 and have been sold worldwide with no reports of biocompatibility issues. The material changes from the Model 320 Sensor have either been approved in other Dolphin Medical Sensor Models or have certifications to demonstrate the materials to be non-toxic, non-initant, and non-sensitizing.
- Validation Testing . The Dolphin ONE Oximetry Sensors have been tested and found to comply with environmental specifications, pulse rate specifications, and skin temperature requirements as per ASTM 1415.

#### Clinical Testing

The sensors were validated in breathe-down protocols at the VA Hospital of Wisconsin - Milwaukee, (Dr. Phillip Clifford, MD) Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpO2 values to functional SaO2 values. Volunteers participated in the breathe-down protocol at rest (i.e. no runtion) while fully conscious at SaO2 values ranging from 70-100%. Data was analyzed to determine the ARMS for each probe. Clinical validation for the Dolphin ONE Forehead Sensor resulted in an accuracy determination of less than 2.0 ARMS in the range of 70-100% SaO2 for adults and pediatrics > 30 kg.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2004

Dolphin Medical, Incorporated C/O Mr. Jon Werner Regulatory Consultant 14240 N. 42nd Street Tampa, Florida 33613

Re: K040380

Ko 10:500
Trade/Device Name: Dolphin Medical Dolphin ONE Adult Reusable Forehead Senor Model 420 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 20, 2004 Received: August 23, 2004

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Dear Mr. Werner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 merslate commerce prior to tray and been reclassified in accordance with the provisions of Antendinents, or to de rood alla metic Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Counting, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or 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 (I MA), it may of subject to tack and federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh 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 I lease be auvrsou mat 1 Dr. o letermination that your device complies with other requirements mean that I DA mas made a acteriand regulations administered by other Federal agencies. of the Act of ally I ederal statues and reguirements, including, but not limited to: registration You must comply with an all all the Prec 8 requirements (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Pat 007), labality systems (QS) regulation (21 CFR Part 820); and if requirents as set form 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) This letter will anon 700 be Finding of substantial equivalence of your device to a premarket notification - 11 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), If you desire specific at 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 may ovean other generational 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 Runns

Chiu Lin, Ph.D. 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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# Indications for Use

510(k) Number (if known): K040380

Device Name: Dolphin Medical Dolphin ONE Adult Reusable Forehead Sensor Model 420

Indications For Use:

The Dolphin ONE Model 420 oximetry sensor is indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aun Secom

(Division Sign-Qff) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

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510(k) Number: K040380

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