DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS
Device Facts
| Record ID | K983684 |
|---|---|
| Device Name | DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS |
| Applicant | Datex-Ohmeda, Inc. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Nov 6, 1998 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
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.
Device Story
Noninvasive pulse oximeter; monitors arterial oxygen saturation (SpO2) and pulse rate. Inputs: optical signals from disposable/reusable finger or ear sensors. Processing: TiuTrak™ data sampling; Perf Trak™ waveform scaling; Relative Perfusion Index™ (PI™) calculation for signal strength/perfusion. Outputs: numeric LED displays for SpO2/pulse; LCD for plethysmographic waveform, PI™ value, alarm messages, and trend data. Features: adjustable alarm limits, audible pulse indicator with pitch modulation, 24-hour trend storage, RS-232 data transmission, and analog outputs for chart recorders/polysomnography. Used in clinical settings; operated by healthcare professionals. Benefits: provides real-time physiological monitoring and perfusion assessment to support clinical decision-making.
Clinical Evidence
Bench testing only. Compliance with safety standards (CSA C22.2 #601, IEC 601-1 series, ISO 9919) and internal validation of software development processes.
Technological Characteristics
Noninvasive optical sensing; LED/LCD displays; RS-232 connectivity; analog output channels. Powered by AC with rechargeable sealed lead-acid battery backup. Software-controlled with automatic self-test and calibration. Complies with IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-1-4, and ISO 9919 (1992).
Indications for Use
Indicated for noninvasive monitoring of arterial oxygen saturation and pulse rate in patients requiring such measurements, as ordered by a licensed medical practitioner.
Regulatory Classification
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.
Predicate Devices
- Datex-Ohmeda 3800 Pulse Oximeter
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/4 description: The image shows a black circle with a white shape inside that resembles the letter 'D'. There is also a small black square in the upper right corner of the circle. The black circle is the dominant feature, with the white 'D' shape creating a contrast within it. The overall design appears simple and graphic.
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
{1}------------------------------------------------
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
- 3. IEC 601-1-1, Part 1
- IEC 601-1-2, Part 1 র্ক
- 5. IFC 601-1-4, Part 1
- 6. ISO) 9919 (1992)
- 7. 【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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
## 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
