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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dolphin ONE Pulse Oximetry Forehead Sensor:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Accuracy (ARMS)	< 2.0 ARMS in the range of 70-100% SaO2

Note: The document only explicitly states one clear acceptance criterion (accuracy) and its corresponding performance. Other tests (biocompatibility, environmental, pulse rate, skin temperature) are mentioned as having been "complied with" or having "no reports of biocompatibility issues," but specific quantitative acceptance criteria for those tests are not detailed in the provided text.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Volunteers participated in the breathe-down protocol," but does not provide the number of volunteers.
Data Provenance: Prospective clinical testing. The study was conducted at the "VA Hospital of Wisconsin - Milwaukee," indicating data from the USA.

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

Number of Experts: One expert is explicitly named: "Dr. Phillip Clifford, MD." It is unclear if he was the sole expert establishing ground truth or if others were involved but not named.
Qualifications of Expert(s): "Dr. Phillip Clifford, MD." His specific specialty (e.g., anesthesiologist, pulmonologist) or years of experience are not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. The ground truth seems to have been established by Dr. Clifford at the VA Hospital.

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

No, an MRMC comparative effectiveness study was not done. The document describes a standalone clinical validation study comparing the device's readings to functional SaO2 values. There is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The clinical validation describes directly comparing the device's SpO2 values to functional SaO2 values, indicating an assessment of the device's performance independent of human interpretation or AI assistance.

7. Type of Ground Truth Used

Functional SaO2 values. The text states, "Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpO2 values to functional SaO2 values." This suggests a reference method (likely involving blood gas analysis) was used to determine the true arterial oxygen saturation.

8. Sample Size for the Training Set

The document does not mention a training set. Pulse oximeters are typically hardware devices that implement established physiological principles; they do not usually involve machine learning models that require a "training set" in the conventional AI sense. The testing described is for validation of the device's accuracy.

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

As no training set is mentioned or implied for this type of device, this question is not applicable.

Summary

{0}------------------------------------------------

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: 813-431-1444 Fax: 501-646-5851

Sponsor Company Name and Address and Contact Person

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

Tammy Conway, QA Manager Phone: 310-349-2308 Fax: 310-978-1816

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 inK030629
Dolphin ONE ReusableOximetry 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.

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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above a wavy base.

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

ਵੱ

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.

{3}------------------------------------------------

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 (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 may ovean other generational 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 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

{4}------------------------------------------------

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

Page 1 of

510(k) Number: K040380

00080

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).