DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS by DATEX-OHMEDA, INC.

The Datex-Ohmeda 3900/3900P Pulse Oximeters measure arterial oxygem saturation and pulse rate noninvasively using Datex-Ohmeda disposable and reusable finger and ear sensors.

Additionally, the Datex-Ohmeda 3900/3900P Pulsc Oximeters measure Relative Perfusion Index™ pulsatile value, which is an indicator of relative perfusion at the sensor site.

Device Description

The Datex-Ohmeda 3900/39001' Pulse Oxincters are noninvasive, arterial oxygen sammation and pulse rate monitors. Roth models feature two casy-to-read displays that present patient data and status information. The numeric LEDs (light-emitting diodos) show the SpOs and pulse rate values. The LDC (liquid crystal display) shows the plethysnographic waveform, the carrent Relative Porfusion Index™ pulsatile value (17,70), the current high and low SpO, and pulse rate linit settings and alarin messages as appropriate. You can choose, through a series of menu options, to send current or trend (SpO, or PL™ pulsatile value) data to the built-in printer (39001' only) or to a computer. The menn options also include setting the date and time, and labeling individual data records.

AI/ML Overview

The provided text does not contain detailed information about a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) summary for the Datex-Ohmeda 3900/3900P Pulse Oximeters, primarily focused on establishing substantial equivalence to a predicate device (Datex-Ohmeda 3800 Pulse Oximeter) and outlining the device's features and compliance with general standards.

However, based on the information provided, I can infer what typical acceptance criteria for a pulse oximeter would involve and what the document generally states about performance and validation.

Implied Acceptance Criteria and Reported Device Performance (Inferred from device type and general compliance)

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance (from text)
Accuracy of SpO2 Measurement	To accurately measure arterial oxygen saturation (SpO2) across a defined range (e.g., 70-100%).	"The Datex-Ohmeda 3900/3900P Pulse Oximeters measure arterial oxygen saturation... noninvasively." (Implied accuracy, but no specific values like RMSd or bias are provided). The device is stated to be "substantially equivalent" to a legally marketed predicate device, implying similar performance.
Accuracy of Pulse Rate Measurement	To accurately measure pulse rate across a defined range.	"The Datex-Ohmeda 3900/3900P Pulse Oximeters measure... pulse rate noninvasively." (Implied accuracy, but no specific values are provided).
Functional Performance	Reliable display of plethysmographic waveform, Relative Perfusion Index, and alarm functions.	"Features two easy-to-read displays that present patient data and status information. The numeric LEDs... show the SpO2 and pulse rate values. The LCD... shows the plethysmographic waveform, the current Relative Perfusion Index™ pulsatile value..., the current high and low SpO2 and pulse rate limit settings and alarm messages..."
Safety and Electrical Compliance	Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.	The device "comply[s] with the following standards: CSA C22.2 #GD1, IEC 601-1, Part 1 and Amendments 1 and 2, IEC 601-1-1, Part 1, IEC 601-1-2, Part 1, IEC 601-1-4, Part 1, ISO 9919 (1992), EN 2601-1." This directly indicates compliance with these safety and performance standards.
Software Validation	Software performs as intended and is free from critical defects.	"Additionally, the software for the Datex-Ohmeda 3900/3900P Pulse Oximeters was developed following a robust software development process and was fully specified and validated by Datex-Ohmeda."
Device Interoperability	Compatibility with specific sensors, printer output, and analog output.	"Compatibility with several types of Datex-Ohmeda sensors for flexibility," "send current or trend... data to the built-in printer (3900P only) or to a computer," "Two analog output channels, SpO2 and pulse rate, that can be connected to a chart recorder or polysomnography machine."

Here's an analysis of the specific points requested, based only on the provided text. Many aspects are not explicitly stated, as 510(k) summaries often focus on conclusions of testing rather than detailed methodologies.

A table of acceptance criteria and the reported device performance
See table above. The document doesn't provide specific quantitative acceptance criteria or detailed results like mean differences, standard deviations, or RMSd values for SpO2 or pulse rate accuracy, which are typical for pulse oximeter studies. It mostly focuses on functional features and compliance with general standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The document only mentions that the device was "validated through rigorous testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable as the text describes a medical device (pulse oximeter) that measures physiological parameters directly, not an AI or diagnostic imaging system that relies on expert interpretation for ground truth. For pulse oximeters, ground truth for SpO2 typically comes from co-oximetry of arterial blood samples.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies where multiple human readers interpret data, and their findings need to be reconciled to establish a ground truth for an AI or diagnostic application. This is not the type of study described or implied for a pulse oximeter.
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 MRMC study was done or is applicable. This is a medical device (pulse oximeter) that provides direct measurements, not an AI assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, essentially. The "rigorous testing" and "validation" mentioned for the 3900/3900P Pulse Oximeters would inherently constitute standalone testing of the device's performance in measuring SpO2 and pulse rate. The device operates independently to provide these measurements.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
While not explicitly stated, for pulse oximeters, the ground truth for arterial oxygen saturation (SpO2) is typically established by co-oximetry of arterial blood samples. This is the standard method for validating optical plethysmographic SpO2 measurements. Pulse rate ground truth would likely come from ECG or a reference heart rate monitor.
The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/machine learning model that requires a distinct "training set." The device's internal algorithms are based on established physiological principles and spectrophotometry, not learned from a dataset in the way a neural network would be. The "validation" refers to verifying its performance against established standards, not training an AI.
How the ground truth for the training set was established
Not applicable for the same reasons as #8.

Summary

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6 1998

5 November 1998

K983684

Oatex-Ohmeda
1315 West Century Drive
Louisville, CO 80027-9560

telephone
303-666-1001

Customer Service 800-345-2700

Product Support 800 345-2755

w datex-ohmeda.com

510(k) Summary of Safety and Effectiveness Information for the Datex-Subject:s ( )hmeda 3900/3900P Pulse Oximeters Proprietary: Datex-Ohmeda 3900/3900P Pulse Oximeters Common: Oximeler Classification:Oximeter Class II - 21CFR870.2700 - 74 DQA

The 510(k) summery of salety and effoctiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.

The Datex-Ohmeda 3900/39001' Pulse Oximeters are substantially equivalent to the following carrently marketed device:

t Datex-Ohmeds 3800 Pulse Oximeter.
The Datex-Ohmeda 3900/390011 Pulse Oxincters are noninvasive, arterial oxygen sammation and pulse rate monitors. Roth models feature two casy-to-read displays that present patient data and status information. The numeric LEDs (light-emitting diodos) show the SpOs and pulse rate values. The LDC (liquid crystal display) shows the plethysnographic waveform, the carrent Relative Porfusion Index™ pulsatile value (17,70), the current high and low SpO, and pulse rate linit settings and alarin messages as appropriate. You can choose, through a series of menu options, to send current or trend (SpO, or PL™ pulsatile value) data to the built-in printer (39001' only) or to a computer. The menn options also include setting the date and time, and labeling individual data records.

Features:

TiuTrak™ data sampling system. .
Perf Trak™ waveform display, an antomatic scale of the plethysmographic waveform ● to provide a relative indication of the sensor site perfusion level.
. Relative Perfusion Indox™ pulsatile value (PL™) to indicate oximelty signal strength and site perfusion. This value appears on the LCD during monitoring.
Large SpO2 digital display for clear differentiation from the pulse rate value. .
Backlit and adjustable vicwing-angle display for excellent visibility in subdued . lighting conditions.
. Direct access to user-sclectable high and low alarm limits for SpO2 and pulse rate.
. An audible pulse indicator with an adjustable volume; the automatic pitch modulation reflects changing SpO2 level.
Visual and andible (adjustable volume) alarms.
Ability to save user-selected alarm limits and volume settings for use between power-. up cycles.
. An alann-silence feature that silences andible alarms for 120 seconds.
An all-mute feature that silences andible alarms until deactivated. This ability to ● mute all alarms can be disabled.

Datex. Ohmeda

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Image /page/1/Picture/4 description: The image shows a black circle with a white letter D inside. There is a small black square in the upper right corner of the circle. The letter D is positioned in the lower left quadrant of the circle.

1315 West Century Drive Louisville, CO 80027-9560

Telephone 303-666-7(x)1

Customer Service 800-345-2700

Product Support 800-345-2755

Website www.datex-ohmeda.com Festures (continued):

Antomatic tiered alarm messages -- high, modium, low priorities, and system status. ◆
Alarin and status-information messages appear on the LCD. D
Language options that display the monitor's screen toxt and, in most cases, printed . or transmilled data in the selected language.
Short, medium, or long (3, 6, on 12 seconds, respectively) SpO2 response averaging ◆ modes.
Fractional or functional SpO2 calibration modes. .
Automatic storage of up to 24 hours of SpO2, pulse-rate, and PLTM pulsatile value . તેમાં મું.
The data in trend memory, along with castom patient labels, alarm limit violations, . and time stamps, can be transmitted through the RS-232 connector and to the 39001' printer.
Viewable SpO2 or PL'iM pulsatile value trend data. ♥
. Custom patient labels that appear on printer, fax, modem, and scrial communication outpul
. Two analog output channels, SpO2 and pulse rate, that can be commented to a chart recorder or polysommography machine.
. An automatic self-test and calibration check at start-up. After start up, the oximeter continuously performs background self-tosts.
. Rechargeable, sealed, lead-acid battery backup operation, including low buttery status reporting.
. Compatibility with several types of Datex- Chimeda sensors for flexibility

The Datex-Oloneda 3900/39001' Pulse Oximoters comply with the following standards:

1. CSA C22.2 #GD1
ri IEC 601-1, Part 1 and Amendments 1 and 2
1. IEC 601-1-1, Part 1
IEC 601-1-2, Part 1 র্ক
1. IFC 601-1-4, Part 1
1. ISO) 9919 (1992)
1. 【几 2601-1

The Datex-Ohmedia 3800 Pulse Oximoter and the Datex-Ohmode 3900/39002 Paise Oximelers are substantially equivalent in design commons, tochnologies and nuterials. The Datex-Ohmeda 3900/3900P Pulse Oximents were validated through rigorous testing that, in part, support the compliance of the 3900/3900P Pulse Oximeters to the above mentioned arendards. Additionally, the software for the Datex-Olumeda 3900/3900P Pulse Oximeters was developed following a robust software development process and was fully specified and validated by Datex-Ohmeda.

The Datex-Olimeda 3900/3900P Pulse Oximoters are the next generation in the Datex-Ohmeda 3800 Pulse Oximeter family of products.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 6 1998

Mr. Tom Kroenke Datex-Ohmeda Configured Monitors Business Unit 1315 West Century Drive Louisville, CO 80027-9560

Re: K983684 Datex-Ohmeda 3900/3900P Pulse Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: October 29, 1998 Received: October 30, 1998

Dear Mr. Kroenke:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Tom Kroenke

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas . Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K983684
Device Name:	Datex-Ohmeda 3900/3900P Pulse Oximeters

Indications For Use:

The Datex-Ohmeda 3900/3900P Pulse Oximeters measure arterial oxygem saturation and pulse rate noninvasively using Datex-Ohmeda disposable and reusable finger and ear sensors.

Additionally, the Datex-Ohmeda 3900/3900P Pulsc Oximeters measure Relative Perfusion Index™ pulsatile value, which is an indicator of relative perfusion at the sensor site.

US federal and Canadian laws restrict the sale of this device by or on the order of a licensed medical practitioner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number. K983684

Prescription Use (Per 21CFR801.109) OR Over-The-Counter Use

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).