(116 days)
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.
The Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories are designed to measure noninvasive arterial blood oxygen saturation and pulse rate.
The provided text does not contain detailed information about specific acceptance criteria for performance, nor does it describe a study that explicitly proves the device meets such criteria. The document is a 510(k) summary for the Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories, focusing on regulatory clearance based on substantial equivalence to predicate devices, and compliance with general safety and performance standards.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based only on the provided text, indicating where information is missing:
Acceptance Criteria and Device Performance Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured and the target) | Reported Device Performance (Result and evaluation against criterion) |
|---|---|
| Not explicitly stated in the provided document. | Not explicitly stated in the provided document. |
2. Sample size used for the test set and data provenance
- Test set sample size: Not specified in the provided document.
- Data provenance: Not specified in the provided document.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Not applicable as the document does not describe a clinical study with expert ground truth establishment.
4. Adjudication method for the test set
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, the document does not mention an MRMC comparative effectiveness study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This device is a pulse oximeter, a medical device that directly measures SpO2 and pulse rate. The concept of "standalone algorithm performance" (without human-in-the-loop) in the context of AI is not directly applicable here. The device's performance would be evaluated as a standalone product. The document states it was "validated through testing" to support compliance with standards, implying standalone performance testing. However, no specific details on these tests are provided.
7. The type of ground truth used
- Not explicitly stated for performance testing. In a pulse oximeter validation, ground truth for oxygen saturation would typically be established by co-oximetry (blood gas analysis) from arterial blood samples. The document mentions compliance with standards like "EN 865 Pulse Oximeters - Particular Requirements" and "ISO 9919 Pulse Oximeters - Particular Requirements," which generally outline the methodology for establishing accuracy against a reference method.
8. The sample size for the training set
- Not applicable, as this document describes a physical medical device, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what the document does provide regarding validation:
The document states: "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."
The referenced standards include:
- EN 865 Pulse Oximeters - Particular Requirements
- ISO 9919 Pulse Oximeters - Particular Requirements
These international standards typically define the methods and requirements for testing pulse oximeter accuracy, particularly against arterial blood gas co-oximetry, and specify acceptable bias and accuracy root mean square (ARMS) limits. However, the results of such testing and the specific acceptance criteria met are not detailed in this 510(k) summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, as well as adherence to recognized voluntary standards.
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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, Inc1215 West Century DriveLouisville, CO |
|---|---|
| Contact: | Michael A. Chilbert, Ph.D., P.E.Phone: 608-221-1551 Fax: 608-223-2496 |
| Proprietary: | Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories |
| Common: | Pulse Oximeter, Ear Oximeter |
| Classification: | Oximeter, 74 DQA, 21CFR870.2700, Class IIEar 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 608-221-1551 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 (301) 594-4646. 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" (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 (301) 443-6597 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 |
6
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.
(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 Cardiovascular, Respiratory, and |
| Neurological Devices |
| 510(k) Number: |
| Prescription Use(Per 21CFR801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ---------------------------------------- | ---- | -------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K021955 |
§ 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).