The Dolphin 2000™ Datex Compatible Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with major brands af pulse oximeter monitors. They represent a design change to the existing Dolphin Aristo Datex Compatible Sensors and the Dolphin 2000 Nellcor 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 fo 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. Disposable sensors are connected to the host oximeter through the use of an adapter cable.

The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespinstyle clip that is placed on the end of a finger clip sensor consistes 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 fingeoloolear windows within these pads permit the optical energy to pass through the finge for the measurements.

AI/ML Overview

The provided text describes the Dolphin 2000 Oximetry Sensors, a device for continuous monitoring of arterial oxygen saturation and pulse rate. The document focuses on regulatory submission (510(k) summary) rather than a detailed scientific study. Therefore, some of the requested information (like specific sample sizes for training sets, adjudication methods, or MRMC study details) is not explicitly present.

However, based on the provided text, here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biocompatibility: Non-toxic, non-irritant, non-sensitizing for skin contact materials	Tests demonstrated materials to be non-toxic, non-irritant, and non-sensitizing.
Electrical Safety: Compliance with EN 60601-1 and ASTM F1415-92	Tested and found to comply with applicable clauses of EN 60601-1 (1990) and ASTM F1415-92.
Clinical Accuracy (SpO2): Expected range of 70-100% SaO2	Demonstrated "scientific accuracy" by statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values. Data was analyzed to determine the ARMS (Accuracy Root Mean Square) for each probe, but specific ARMS values or numerical accuracy thresholds are not provided.
Substantial Equivalence: In intended use, design, principles of operation, materials, and performance to predicate devices	The device is stated to be "substantially equivalent in intended use, design, principles of operation, materials, and performance to commercially available oximetry sensors."
Labeled Accuracy: Equivalent to predicate devices	The labeled accuracy of the Dolphin 2000 sensors is stated to be "equivalent to those of the predicate devices."

2. Sample Size for the Test Set and Data Provenance

Sample Size for the Test Set: Not explicitly stated. The text mentions "volunteers participated in the breathe-down protocol." The exact number of volunteers is not provided.
Data Provenance: The clinical testing was conducted at the VA Hospital of Wisconsin - Milwaukee. This indicates an origin within the United States. The nature of the study ("breathe-down protocols") implies a prospective design for the clinical accuracy evaluation.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Number of Experts: One expert is explicitly mentioned: "Dr. Phillip Clifford, MD." It is unclear if there were other experts involved in establishing the ground truth or overseeing the study.
Qualifications: "Dr. Phillip Clifford, MD." implies a medical doctor, likely involved in patient care and clinical research, but specific specialization or years of experience are not provided.

4. Adjudication Method (Test Set)

The text does not provide details on an adjudication method. For a clinical study measuring physiological parameters, expert adjudication in the typical sense (e.g., for image interpretation) is less common than adherence to standardized protocols and direct measurement.

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

No, an MRMC comparative effectiveness study is not described. The study focused on the standalone performance of the device against a "functional SaO2" ground truth.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The "breathe-down protocols" aimed to validate the device's accuracy by statistically comparing its SpO2 values to functional SaO2 values. This is a direct measurement of the device's performance.

7. Type of Ground Truth Used

The ground truth for the clinical accuracy study was functional SaO2 values. These are typically obtained from a co-oximeter, considered a gold standard for blood oxygen saturation measurement, by drawing arterial blood samples during the breathe-down protocol.

8. Sample Size for the Training Set

The document does not describe the development of an algorithm in the traditional sense that would require a "training set." This device is an oximeter sensor, where the underlying principle of operation (non-invasive optical assessment of tissue oxygenation) is well-established rather than a machine learning algorithm that is "trained" on data. Therefore, the concept of a "training set" as it applies to AI/ML devices is not relevant here.

9. How Ground Truth for the Training Set Was Established

As explained above, the concept of a "training set" for this type of device (an oximetry sensor) is not applicable in the context of the provided document. The device's fundamental operating principles are based on known physics, and its performance is validated through clinical testing against a reference standard (functional SaO2).

Summary

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K ob0524

16. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Dolphin 2000™ Datex Compatible Oximeter sensors 2/16/06

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

Tammy Conway, QA Manager phone: (310) 978-0516 fax: (310) 978-1816

Manufacturing Facility Names and Addresses

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

OSI Systems Pvt. Ltd. B1, Vikram Puri Secunderbad, Andhra Pradesh, 5000076, India

Common, Classification & Proprietary Names

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

Predicate Devices

Model #	PredicateModel #	Predicate510(k) #	PredicateModel #	Predicate510(k) #
2030 Sensor	Model 2010	K030952
2331 Sensor	2351	K012989	251-1	K970769
2332 Sensor	2352	K012989	251-2	K970769
2333 Sensor	2353	K012989	251-3	K970769
2334 Sensor	2354	K012989	251-4	K970769
2413 & 2423 Extension Cables	2421	K030952

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Device Description

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 ovailable 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, configured, 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.

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Performance Testing

. Biocompatibility

The sensors in this application utilize only previously approved skin contact materials. 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-irritant, and non-sensitiing.

Electrical Safety .

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

-EN 60601-1 (1990) Medical electrical equipment - part 1: General requirements for safety
-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.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "U.S. Department of Health and Human Services, USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing the bird's body and wings. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 15 2006

Dolphin Medical Incorporated C/O Mr. Bill Curnan Regulatory Specialist 9433 S. Morning Glory Lane Highlands Ranch, Colorado 80130

Re: K060524

Trade/Device Name: Dolphin 2000 Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 6, 2006 Received: May 22, 2006

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 (fix 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 gemeral controls provisions of the Act. The general controls provisions of the Act in turn 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 offecting 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 ground in 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 prectice 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, (S 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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):

Device Name: 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

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

11:11:11

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sian-
Division: . stology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K060524

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).