The Dolphin 2000 Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with Nellcor pulse oximeter monitors. They represent a design change to the Dolphin 2000 BCI Compatible Sensors.

The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate of tapes that is connected to the cable assembly. The sensors have an adhesive bandage backing that allows the sensor to be applied to the patient by wrapping it around a finger or toe (measurement site). Four sizes of disposable Dolphin 2000 Oximetry Sensors are available, which are indicated for use for adult, pediatric, infant and neonatal application sites. The Dolphin 2000 disposable sensors are provided non-sterile for single patient use.

The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespinstyle clip that is placed on the end of a finger. The finger clip sensor consists of the emitter and detector components mounted in opposing clip halves, maintained in mild compression by a spring hinge. The molded outer components house the optoelectric components within contoured pads that maintain contact with the patient's finger. Clear windows within these pads permit the optical energy to pass through the finger for the measurements. The Dolphin 2000 re-usable sensors are provided non-sterile.

AI/ML Overview

The Dolphin 2000 Oximetry Sensors were validated in clinical testing to demonstrate their accuracy in measuring arterial oxygen saturation (SpO2).

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (Clinical Validation)	Reported Device Performance (Clinical Validation)
ARMS for Reusable, Adult Disposable, and Pediatric/Infant Disposable probes	< 2.0% in the range of 70-100% SaO2	< 2.0% ARMS in the range of 70-100% SaO2
ARMS for Neonatal Disposable probes	< 3.0% in the range of 70-100% SaO2	< 3.0% ARMS in the range of 70-100% SaO2

2. Sample Size and Data Provenance:

Test Set Sample Size: Not explicitly stated how many volunteers participated, but the study implies a group of "Volunteers."
Data Provenance: Prospective (breathe-down protocol in a clinical setting), conducted at the VA Hospital of Wisconsin - Milwaukee, USA.

3. Number of Experts and Qualifications:

Number of Experts: One expert is explicitly named: Dr. Phillip Clifford, MD.
Qualifications: "Dr. Phillip Clifford, MD." implies a medical doctor, likely with expertise in physiology or critical care relevant to oximetry. Specific years of experience or specialization are not detailed.

4. Adjudication Method:

Not applicable as the ground truth (functional SaO2) was established by direct measurement from arterial blood gas analysis, not expert consensus or review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone accuracy of the device against a physiological ground truth.

6. Standalone Performance:

Yes, a standalone study was performed. The device's SpO2 values were statistically compared to functional SaO2 values obtained from volunteers during a breathe-down protocol.

7. Type of Ground Truth Used:

Physiological Ground Truth: Functional SaO2 values, likely obtained through co-oximetry via arterial blood gas analysis, are implied as the comparison standard ("statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values").

8. Sample Size for the Training Set:

The document does not explicitly mention a separate "training set" or its size. The described "Clinical Testing" focuses on validation. It is common for such medical devices to be developed and refined using internal data, but details of that process are not provided in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established:

As a separate training set is not explicitly mentioned, the method for establishing its ground truth is not detailed in this document.

Summary

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MAY 1 9 2003

14. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Dolphin 2000™ Pulse Oximetry Sensor 3/14/02

Submitter ( Consultant name and Address)

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

Phone: 720-939-6482 Fax: 786-551-8221

Sponsor Company Name and Address and Contact Person

Dolphin Medical Inc. 12525 Chadron Avenue Hawthorne, CA 90250

Paul Lee, Regulatory Affairs Specialist (310) 349-2416 phone: fax: (310) 644-1727

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:

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Predicate Devices

Sensor Name	Dolphin Model	Dolphin 2000Predicate Modelfound in K012989 #	Nellcor Predicatefound in K863784 &K991823
Nellcor ReusableDolphin 2000 OximetrySensor	2010	2050	DS-100A
Nellcor Adult DisposableDolphin 2000 OximetrySensor	2311	2351	D-25
Nellcor PediatricDisposable Dolphin2000 Oximetry Sensor	2312	2352	D-20
Nellcor InfantDisposable Dolphin2000 Oximetry Sensor	2313	2353	I-20
Nellcor NeonatalDolphin 2000 OximetrySensor	2314	2354	N-25
Adapter Cable	2421	2425	N/A

Device Description

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Intended Use

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate. They are fully compatible replacement sensors intended for use with major brands of pulse oximeters.

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 listed above. 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

. 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 by the respective component manufacturer. Test results demonstrated the materials to be nontoxic, non-irritant, and non-sensitizing.

프 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 svstems
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 -

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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 and less than 3% Arms in the range of 70-100 for Neonates.

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Image /page/4/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 an emblem featuring a stylized eagle with three stripes extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2003

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

Re: K030952

Trade/Device Name: Nellcor Compatible Dolphin 2000 Oximetry Sensors (Models 2010, 2311, 2312, 2313, and 2314) and Adapter Cable Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 5, 2003 Received: May 6, 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Knox

Susan Runner, DDS, MA Interim 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): KU30952

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.

prescription device √

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Division Sign-Off) Division of Anesthes, " By, General Hospital, Infection Control, De .. ial De

510(k) Number:

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).