NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210

K032947 · Dolphin Medical, Inc. · DQA · Oct 17, 2003 · Cardiovascular

Device Facts

• Record ID: K032947
• Device Name: NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210
• Applicant: Dolphin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

Device Story

Dolphin 2000 Y Oximetry Sensor is a reusable, non-sterile pulse oximetry sensor compatible with Nellcor monitors. It utilizes optical emitters (LEDs) and detectors (photodiode) to perform non-invasive assessment of tissue oxygenation. The sensor is applied to the ear, finger, hand, or neonatal foot, secured by a disposable bandage or ear clip. It functions as a peripheral component to a host pulse oximeter, which processes the optical signals to calculate and display arterial oxygen saturation (SpO2) and pulse rate. Used in clinical settings, the device provides real-time data to healthcare providers for patient monitoring. The output assists clinicians in assessing patient oxygenation status, enabling timely clinical interventions. Benefits include continuous, non-invasive monitoring of vital signs across all patient age groups.

Clinical Evidence

Clinical validation performed via breathe-down protocols at the VA Hospital of Wisconsin - Milwaukee. Study included adult, pediatric, infant, and neonatal subjects. Accuracy (ARMS) was measured against functional SaO2 values (70-100% range). Results: <2.0% ARMS for adults, pediatrics, and infants; <3% ARMS for neonates; <3.5% ARMS for ear clip applications.

Technological Characteristics

Non-invasive optical sensor using LEDs and photodiodes. Materials tested for biocompatibility (non-toxic, non-irritant, non-sensitizing). Complies with EN 60601-1, EN 60601-1-1, EN 60601-1-2, and ASTM F1415-92. Reusable Y-shape design with disposable bandage or ear clip. Non-sterile.

Indications for Use

Indicated for continuous monitoring of arterial oxygen saturation and pulse rate in adult, pediatric, infant, and neonatal populations.

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 2010 (K030952)
• Nellcor D-YS (K991823)
• Nellcor D-YSE (K991823)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a series of handwritten alphanumeric characters, seemingly a code or identifier. The characters are 'K032947' and are written in a simple, slightly tilted manner. The handwriting appears somewhat casual, with variations in stroke thickness and character alignment.

# OCT 1 7 2003

## 14. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## Dolphin 2000™ Pulse Oximetry Y Sensor 9/09/03

#### Submitter ( Consultant name and Address)

Bill Curnan 9433 S. Morning Glory Lane Highlands Ranch, CO 80130

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:

[phone] fax:

#### Manufacturing Facility Name and Address

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

#### Common, Classification & Proprietary Names

Common Name: oximetry sensor Classification Name: oximeter Dolphin™ 2000 Oximetry Sensors Proprietary Name:

### Predicate Devices

| Sensor | Dolphin<br>Model | Dolphin 2000<br>Predicate Model<br>found in K030952 # | Nellcor Predicate<br>found in<br>K991823 |
|------------------------------------------------------------------|------------------|-------------------------------------------------------|------------------------------------------|
| Dolphin 2000 Nellcor<br>Compatable Reusable<br>Oximetry Y Sensor | 2210 | 2010 | D-YS<br>D-YSE |

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### Device Description

The Dolphin 2000 Y Oximetry Sensor is a fully compatible re-usable replacement sensor for use with Nellcor pulse oximeter monitors.

The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in place with a disposable bandage. The sensor can also be used on the adult ear with the ear clip accessory. The emitter and detector are mounted in a sealed pouch (same material as in the re-usable clip sensor above) constructed in a Y shape. The sensor is provided non-sterile.

### Intended Use

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

### Technological Characteristics Comparison

The Dolphin 2000 Oximetry Sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to commercially available oximetry sensors.

All of the Dolphin 2000 oximetry sensors and the predicate devices operate on the identical principles of non-invasive optical assessment of tissue oxygenation using emitters (LEDs) and detectors (photodiode).

The Dolphin 2000 oximetry sensors are designed, and manufactured for full compatibility for use with the labeled, commercially-available oximetry monitors. They are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The Dolphin 2000 oximetry sensors, like the predicate devices are available in both disposable and re-usable styles, labeled for use in adult, pediatric, infant and neonatal populations.

The labeled accuracy of the Dolphin 2000 sensors is equivalent to those of the predicate devices.

### Performance Testing

#### 프 Biocompatibility

Biocompatibility tests, appropriate for skin-contacting devices for prolonged exposure, were performed on the each of the device components used in the assembly of the Dolphin 2000™ pulse oximetry sensors. Test results demonstrated the materials to be non-toxic, non-imitant, and non-sensitizing.

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#### t Electrical Safety

The Dolphin 2000 Oximetry Sensors have been tested and found to comply with the applicable clauses of the following standards:

- Medical electrical equipment part 1: General EN 60601-1 (1990) . requirements for safety
- EN 60601-1-1 (1993) Medical electrical equipment part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems
- EN 60601-1-2 (1993) Medical electrical equipment part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility requirements and tests
- ASTM F1415-92 Standard Specification for Pulse Oximeters -

### 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 2000 SpO2 values to functional SaO2 values. Volunteers participated in the breathe-down protocol at rest (i.e. no motion) 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 2000 Reusable, Adult disposable, and Neonatal disposable probes resulted in an accuracy determination of less then 2.0% ARMs in the range of 70-100% Sa02 for adults, pediatrics, and infants, less than 3% Arms in the range of 70-100 for Neonates, and less than 3.5 % for ear clip applications..

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them that resemble wings or feathers.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 17 2003

Mr. Bill Curnan Regulatory Specialist Dolphin Medical Incorporated 9433 S. Morning Glory Lane Littleton, Colorado 80130

Re: K032947

Trade/Device Name: Nellcor Compatible Dolphin 2000 Y Oximetry Sensor (Model 2210) Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA

Dated: September 19, 2003 Received: September 22, 2003

Dear Mr. Curnan:

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. Curnan

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,

Patricia Cucinotta

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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## Statement of Indications for Use (FDA Form)

510(k): ҚОЗΖ947

Device:

## DOLPHIN 2000 Oximetry Sensors

## Indications for Use:

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: