The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

Device Description

The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of (SpO2) and pulse rate for adult, pediatric and neonatal patients. arterial hemoqlobin

The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate alarm limits, alarms, trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the function of arterial hemoglobin (SpQz) and pulse rate, and provide for the connection to the connecting cable.

The Dolphin Medical Pulse Oximeter Model 2100 is available in one configuration as a portable standalone oximeter that is 10 cm / 3.94 inches high, 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8.8 lbs. The unit is powered either with a voltage input of 100-240 Vac, 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module, 300mA System Module) and a charge time of about 4.5 hours to 80% capacity.

The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor.

The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in length.

The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.

The oximetry sensor is available in either a disposable configuration, and with one configuration for the extension cable (8 feet).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Dolphin Medical 2100 Pulse Oximeter. It mentions compliance with several standards and refers to "clinical data" but does not contain explicit acceptance criteria or a detailed study description with performance metrics in the format requested.

The document largely focuses on device description, predicate device comparison, and regulatory compliance rather than presenting specific performance data from a clinical study against predefined acceptance criteria.

Therefore, many of the requested fields cannot be accurately populated from the provided text.

Here's what can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Present in Document	Not Present in Document
(e.g., Accuracy of SpO2 within ±2% in specified range)	(e.g., SpO2 accuracy: Mean difference ± SD = 0.5% ± 1.2%)
(e.g., Pulse Rate Accuracy within ±3 bpm)	(e.g., Pulse Rate accuracy: Mean difference ± SD = 1 bpm ± 2 bpm)
(e.g., Bias and precision values for SpO2 and pulse rate)	(e.g., A statistical analysis of "clinical data" was provided to the FDA, but the specific metrics are not detailed in this summary.)

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not specified in the provided text. The document refers to "clinical data" being provided to the FDA, but the number of subjects or data points is not mentioned in this 510(k) summary.
Data Provenance: Not specified in the provided text. It's unclear if the data was collected retrospectively or prospectively, or its country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable/Not Provided. For pulse oximeters, the "ground truth" for SpO2 is typically established through co-oximetry measurements from arterial blood samples, not by expert consensus on visual assessment. The document does not describe the methodology for ground truth establishment.

4. Adjudication method for the test set

Not Applicable/Not Provided. As ground truth for pulse oximeters is usually instrumental (co-oximetry), an adjudication method by human experts is not typically used for this type of device performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a pulse oximeter, a medical device for measuring physiological parameters (SpO2 and pulse rate). MRMC studies are typically relevant for diagnostic imaging AI devices where human readers interpret images. This device does not involve human interpretation with or without AI assistance in the way an MRMC study would measure.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, by nature of the device. A pulse oximeter inherently performs "standalone" measurement. The device calculates SpO2 and pulse rate from sensor signals. The performance evaluation would assess the accuracy of these algorithmic measurements against a reference standard (e.g., co-oximetry). The document states, "the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the function of arterial hemoglobin (SpQz) and pulse rate". The software update mentioned is in "the Dolphin ONE OEM-601 Module, the component that functions as the oximetry engine," which implies algorithmic performance.

7. The type of ground truth used

Not explicitly stated, but likely co-oximetry. For pulse oximeters, the gold standard for measuring arterial oxygen saturation (SaO2) is ex vivo co-oximetry performed on arterial blood samples. This is implicitly the required ground truth for pulse oximeter accuracy studies, as per FDA guidance for pulse oximeters, which the device claims to comply with ("FDA Guidance Document for Pulse Oximeters: 9/7/1992").

8. The sample size for the training set

Not applicable/Not provided. This document describes a medical device, not a machine learning model that would typically have a distinct "training set" in the sense of AI. While the device contains software ("internal software validation of the OEM-601 Module"), the development process for such software historically would involve engineering validation and potentially calibration data, but not a "training set" for an AI algorithm as understood in modern AI development.

9. How the ground truth for the training set was established

Not applicable/Not provided. (See point 8).

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Dolphin Medical 2100 Pulse Oximeter and Accessories 4/16/03

Submitter Company Dolphin Medical - FL 13801 McCormick Dr Tampa, FL 33626

Contact: Jon Werner Phone: 813-818-7488 x208 Fax: 813-818-7488

Sponsor Company

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

Contact: Tammy Conway Phone: 310-349-2308 Fax: 310-978-1816

Manufacturing Facility

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

Common, Classification & Proprietary Names

Common Name: Oximeter Classification Name: Oximeter Class II - 21 CFR 870.2700 - 74 DQA Proprietary Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories.

Intended Use

The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

Predicate Device

The Dolphin Medical Pulse Oximeter and Accessories is substantially equivalent to the following currently marketed device(s):

Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036, . #K012533, #K012626, #K020075, #K021959 and #K024235.
The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of (SpO2) and pulse rate for adult, pediatric and neonatal patients. arterial hemoqlobin

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The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in length.

The oximetry sensor is available in either a disposable configuration, and with one configuration for the extension cable (8 feet).

The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories have been designed to comply with the following standards:

1. CSA C22.2 No. 601.1
IEC 601-1, Part 1 and Amendments 1 and 2 2.
IEC 601-1-1, Part 1 3.
1. IEC 601-1-2, Part 1
1. ISO 9919: 1992
1. EN 865: 1997
1. FDA Guidance Document for Pulse Oximeters: 9/7/1992
1. ASTM 1415:1992. and Draft 10.1
UL2601-1: Second Edition, 1997 9.
1. IEC 60068-2-6
1. IEC 60068-2-27
1. IEC 60068-2-64
1. ISTA Procedure 2A

The Dolphin Medical Stand-Alone Pulse Oximeter. Model No. 2100 and Accessories are identical to the Dolphin Medical Stand-Alone Pulse Oximeter Model No. 2100 and Accessories previously reviewed under #K024235 with only one exception. The software was updated in the Dolphin ONE OEM-601 Module, the component that functions as the oximetry engine. A review of the FDA guidance document "Deciding When to Submit a 510(k) for Change to an Existing Device," (January 10, 1997) was performed to determine if a 510(k) submission is necessary for the modified device. Based on the review of the product documentation and an evaluation of the 510(k) decision tree, it is our assessment that the product does not raise any new patient safety issues but does require a 510(k) review of the clinical data to establish safety and effectiveness for purposes of substantial equivalence. As a result, the clinical data and the internal software validation of the OEM-601 Module have been provided for your review.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Mr. Jon Werner QA Manager Dolphin Medical Incoporated 13801 McCormick Drive Tampa, Fl 33626

Re: K031465

Trade/Device Name: Model 2100 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 11, 2003 Received: September 12, 2003

Dear Mr. Werner:

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. Jon Werner

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 vours.

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 INTENDED USE FOR 2100 PULSE OXIMETER

KO31465 510(k) Number (if known):

Device Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100

May 2, 2003

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesia, General Hospital, Infection Control, and Dental Devices (DAGID)

510(k) Number:	K031465
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Prescription Use(Per 21 CFR 801.109)
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over-the-counter Use
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(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:	K031465
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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).