TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES

K021955 · Datex-Ohmeda, Inc. · DQA · Oct 8, 2002 · Cardiovascular

Device Facts

• Record ID: K021955
• Device Name: TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
• Applicant: Datex-Ohmeda, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Datex-Ohmeda 3800 Series and 3900 Series Oximeters with TruTrak Plus are indicated for spotchecking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion. These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.

Device Story

Pulse oximeter system measuring noninvasive arterial blood oxygen saturation and pulse rate; utilizes TruTrak Plus technology to improve performance during patient motion. Device processes optical signals from sensors; provides real-time monitoring output for clinicians or home users. Used in hospital and non-hospital environments; supports clinical decision-making regarding patient respiratory status and oxygenation. Benefits include reliable monitoring during motion, reducing false alarms and improving patient care continuity.

Clinical Evidence

Bench testing only. Device validated for compliance with voluntary standards including EN 865 and ISO 9919 for pulse oximeters, and EN/IEC 60601-1 series for electrical safety and electromagnetic compatibility.

Technological Characteristics

Pulse oximeter system; optical sensing principle. Complies with EN 865, ISO 9919, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, EN/IEC 60601-1-4, CSA 22.2 601.1, and UL 2601-1. Includes programmable electrical medical systems. Form factor supports spot-checking and continuous monitoring.

Indications for Use

Indicated for spot-checking and continuous monitoring of functional oxygen saturation and pulse rate in adult, pediatric, and neonatal patients, including during clinical patient motion, in hospital and non-hospital settings.

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

• Ohmeda 3800 Pulse Oximeter (K962127)
• Datex-Ohmeda 3900/3900P Pulse Oximeters (K983684)
• Datex-Ohmeda M-OSAT Pulse Oximeters and Accessories (K011670)

Submission Summary (Full Text)

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16021955

007 0 8 2002

June 11, 2002

Subject: 510(k) Summary of Safety and Effectiveness Information for the Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories.

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992 as part 807.92.

| Submitter: | Datex-Ohmeda, Inc<br>1215 West Century Drive<br>Louisville, CO |
|-----------------|--------------------------------------------------------------------------------------------|
| Contact: | Michael A. Chilbert, Ph.D., P.E.<br>Phone: [phone]    Fax: [phone] |
| Proprietary: | Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories |
| Common: | Pulse Oximeter, Ear Oximeter |
| Classification: | Oximeter, 74 DQA, 21CFR870.2700, Class II<br>Ear oximeter, 74 DPZ, 21CFR870.2710, Class II |

The Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories are substantially equivalent to the FDA 510(k) cleared and currently marketed Ohmeda 3800 Pulse Oximeter (K962127), the Datex-Ohmeda 3900/3900P Pulse Oximeters (K983684), and the Datex-Ohmeda M-OSAT Pulse Oximeters and Accessories (K011670)

The Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories are designed to measure noninvasive arterial blood oxygen saturation and pulse rate. They can be used for Adult, pediatric or neonatal monitoring in clinical settings and at home.

The Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories were designed to comply with the applicable portions of the following voluntary standards:

EN 475 Medical Devices - Electrically Generated Alarm Signals EN 865 Pulse Oximeters - Particular Requirements ISO 9919 Pulse Oximeters - Particular Requirements EN/IEC 60601-1 Medical Electrical Equipment: General Requirements For Safety EN/IEC 60601-1-1 Coll. Standard: Safety Requirements For Medical Electrical Systems EN/IEC 60601-1-2 Coll. Standard: Electromagnetic Compatibility - Requirements & Tests EN/IEC 60601-1-4 Collateral Standard: Programmable Electrical Medical Systems CSA 22.2 601.1 Medical Electrical Equipment, Part 1: General Requirements for Safety UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety

The Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories has been validated through testing that, in part, support the compliance of the device to the above mentioned standards.

Contact:

Michael A. Chilbert, Ph.D., P.E. Manager, Regulatory Affairs

Datex-Ohmeda, Inc P.O. Box 7550 Madison, WI 53707-7550 www.datex-ohmeda.com

Telephone [phone] Toll Free 800-345-2700 Facsimile 608-222-9147

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

# OCT 0 8 2007

Michael A. Chilbert, Ph.D., P.E. Manager, Regulatory Affairs Datex-Ohmeda, Incorporated Anesthesia and Drug Delivery Business Unit 1315 West Century Drive Louisville, Colorado 80027

Re: K021955

> Trade/Device Name: TruTrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Pulse Oximeter and Accessories Regulation Number: 21 CFR 870.2700 & 21 CFR 870.2710 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA & DPZ Dated: September 6, 2002 Received: September 9, 2002

Dear Dr. Chilbert:

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 – Dr. Chilbert

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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) 63&-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely,

Timothy A. Ulatowski

Timothy A Ulatowski 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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| 510(k) Number (if known): | K021955 |
|---------------------------|-----------------------------------------------------------------------------------------------------|
| Device Name: | TruTrak Plus Enhancements to the Datex-Ohmeda 3800 Series and 3900 Series Oximeters and Accessories |

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Indications For Use:

The Datex-Ohmeda 3800 Series and 3900 Series Oximeters with TruTrak Plus are indicated for spotchecking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion. These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|----------------------------------------------|
| Division of Cardiovascular, Respiratory, and |
| Neurological Devices |
| 510(k) Number: |

| Prescription Use<br>(Per 21CFR801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|----------------------------------------|----|--------------------------------------------------|
|----------------------------------------|----|--------------------------------------------------|

| (Division Sign-Off) | |
|-----------------------------------------------|---------|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K021955 |