The Dolphin 2000 Oximetry Sensors are designed for use with BCI pulse oximeter monitors. They represent a redesign and updating of the Aristo Sensor Line.

The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to the disposable Dolphin 2000 Oximol. Joth diodes are embedded in a laminate of tapes predicate devious. The cable assembly. The sensors have an adhesive bandage that is connected to the oable doomapplied to the patient by wrapping it around a finger backling that allows the other to see of disposable Dolphin 2000 Oximetry Sensors are or toe (measurement ofto). I our else for adult, pediatric, infant and neonatal application available, which are indication for the sensors are provided non-sterile for single patient use.

The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespin-. The re-usuale Dolphin 2000 Finger. The finger. The finger clip sensor consists of the style clip that is placed on the end on opposing clip halves, maintained in mild entiter and delection of the molded outer components house the optoelectric compression by a sping mings. The nentain contact with the patient's finger. Clear components within these pads the optical energy to pass through the finger for the windows within those pade perminents on one provided non-sterile.

AI/ML Overview

The Dolphin 2000™ Pulse Oximetry Sensor was evaluated through clinical testing involving breathe-down protocols. Scientific accuracy was demonstrated by statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy (ARMS) for SaO2 values in the range of 70-100% for adults, pediatrics, and infants	Less than 2.0% ARMS in the range of 70-100% SaO2
Accuracy (ARMS) for SaO2 values in the range of 70-100% for neonates	Less than 3% ARMS in the range of 70-100% SaO2

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Sixteen volunteers.
Data Provenance: Prospective, conducted at the University of California at San Francisco ('UCSF') Department of Anesthesiology and the VA Hospital of Wisconsin - Milwaukee, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Two primary medical experts are mentioned for overseeing the studies: John W. or Gallerma at UCSF and Dr. Phillip Clifford, MD. at VA Hospital of Wisconsin - Milwaukee. Their specific qualifications (e.g., years of experience) are not detailed beyond their medical doctor (MD) designation at prominent institutions.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). The "scientific accuracy was demonstrated by statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values," suggesting a direct comparison to a reference standard rather than multi-reader adjudication of the device output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the device's accuracy against a physiological reference, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance testing described is a standalone evaluation of the device's accuracy in measuring SpO2 values. The volunteers were "fully conscious" and their SaO2 values were measured by the device and compared to functional SaO2 values.

7. The Type of Ground Truth Used

Type of Ground Truth: Functional SaO2 values, likely obtained through direct arterial blood gas analysis, which is considered a gold standard for blood oxygen saturation measurement.

8. The Sample Size for the Training Set

The document does not mention a separate training set or its sample size. The description pertains to the validation of the device, implying a pre-existing algorithm or design. Pulse oximeters generally rely on established physiological principles and calibration, rather than machine learning models that require explicit training sets for each device iteration in the way AI algorithms do.

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

Not applicable, as no explicit training set for a machine learning algorithm is described. The device's underlying principles are based on non-invasive optical assessment of tissue oxygenation.

Summary

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14. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K012989

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: Classification Name: Proprietary Name:

oximetry sensor oximeter Dolphin™ 2000 Oximetry Sensors

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Predicate Devices

Sensor Name	Dolphin Model	Aristo Model( PredicateDevice)	Original 510(k)
BCI Reusable Dolphin 2000Oximetry Sensor	2050	222	K960251
BCI Adult DisposableDolphin 2000 OximetrySensor	2351	221-1	K960251
BCI Pediatric DisposableDolphin 2000 OximetrySensor	2352	221-2	K960251
BCI Infant DisposableDolphin 2000 OximetrySensor	2353	221-3	K960251
BCI Neonatal Dolphin 2000Oximetry Sensor	2354	221-4	K960251

Device Description

Device Describition: The Dolphill 2005 Oximetry Soith BCI pulse oximeter monitors. They represent a redesign and updating of the Aristo Sensor Line.

The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to The disposable Dolphin 2005 Oximol. Joth diodes are embedded in a laminate of tapes predicate devious. The cable assembly. The sensors have an adhesive bandage that is connected to the oable doomapplied to the patient by wrapping it around a finger backling that allows the other to see of disposable Dolphin 2000 Oximetry Sensors are or toe (measurement ofto). I our else for adult, pediatric, infant and neonatal application available, which are indication for the sensors are provided non-sterile for single patient use.

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Intended Use

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of The Dolphin 2006 Oximolly Coulse rate. They are fully compatible replacement artenar oxygon battler with major brands of pulse oximeters.

Technological Characteristics Comparison

Technological Onaracterior Sensors are substantially equivalent in intended use, The Dolphin 2000 Oximory Obnoors ars careerormance to commercially available design, principles of operation, the Dolphin 2000 Oximetry Sensors are substantially oximenty sensors. Opeonioury, the Depthin and by Opto Sensors (M) Sch. Bhd.

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of The Dolphin 2006 Oximony onulse rate. They are fully compatible replacement artenar oxygon batarasse with major brands of pulse oximeters.

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 The Dolphin 2000 oximolry conservally-available oximetry monitors listed compatiblity for asc with the laborou, and components of equivalent specifications as used in the predicate devices.

The Dolphin 2000 oximetry sensors, like the predicate devices are available in both The Dolphin 2000 oximelly ochoors, 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

I Biocompatibility

Biocompatibility tests, appropriate for skin-contacting devices for prolonged exposure, Diocompationny tooks, appropriate device components used in the assembly of the Were portion on the saimetry sensors by the respective component manufacturer. Test Dolphill 2000 - pulse oximoury Sensers of toxic, non-irritant, and non-sensitizing.

u Electrical Safety

Electrical Garcty
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 . . EN 60001-141 (1995) Mediour Shoul Squipments for medical electrical systems

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EN 60601-1-2 (1993) Medical electrical equipment part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility requirements and tests
Pulse Oximeters Particular Requirements EN 865 (1997) ..
Standard Specification for Pulse Oximeters ASTM F1415-92 -

Clinical Testing

.The sensors were validated in two breathe-down protocols, one at the University of California at San Francisco ('UCSF') Department of Anesthesiology (John W. or Gallerma at Unit Pand a second 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. Sixteen volunteers participated in Dolphin 2000 Spo2 values to lest (i.e. no motion) while fully conscious at SaO2 values the broathe about promotived to determine the ARMS for each probe. ranging from 10 100% മധവം 2000 Reusable, Adult disposable, Neonatal disposable for BCI resulted in an accuracy determination of less then 2.0% Аямs 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2002

Mr. Bill Curnan Dolphin Medical, Inc. C/0 Curnan Consulting 9433 S. Morning Glory Lane Highlands Ranch, CO 80130

Re: K012989

Roll Dolphin 2000 Oximeter Sensors (Models 2050, 2351, 2352, 2353, and 2354) Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: DQA Dated: February 20, 2002 Received: February 20, 2002

Dear Mr. Curnan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your coetermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobare) to regard to the Medical Device Amendments, or to conninered provided 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). and Cosmotic Too (110) that to novice, subject to the general controls provisions of the Act. The r ou may, dierelove, mains of the Act include requirements for annual registration, listing of general voltrols proficions 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 If your device is classified (500 a00 rols. Existing major regulations affecting your device can indy be subject to suble additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ovancements concerning your device in the Federal Register.

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Page 2 - Mr. Bill 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours,

Kaitlin

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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. Attachment B

Statement of Indications for Use (FDA Form)

510(k):

K012989

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 Use
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K01298

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).