(165 days)
Ohmeda 3770 / 3775 Handheld Pulse Oximeters
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No
The document describes a standard pulse oximeter and does not mention any AI or ML technologies.
No.
The device is described as a "monitor" and an "oximeter," which are diagnostic tools, not therapeutic devices used for treatment.
Yes
The device is a pulse oximeter that monitors oxygen saturation and pulse rate, which are physiological parameters used for diagnostic purposes (e.g., assessing respiratory function or circulatory health).
No
The device description explicitly states it is a "Pulse Oximeter" and operates on battery power using "finger and ear sensors," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Datex-Ohmeda TuffSat 3000 Pulse Oximeter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the TuffSat 3000 is a non-invasive device that measures oxygen saturation and pulse rate directly from the patient's finger or ear. It does not analyze samples taken from the body.
Therefore, it falls under the category of a non-invasive medical device rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing Datex-Ohmeda disposable and reusable finger and ear sensors labeled for patients ranging from neonates to adults.
Product codes
74 DQA
Device Description
The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is a noninvasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing Datex-Ohmeda disposable and reusable finger and ear sensors labeled for patients ranging from neonates to adults.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
neonates to adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Datex-Ohmeda TuffSat 3000 Pulse Oximeter was validated through rigorous testing performed both in-house and at a Nationally Recognized Testing Lab. This testing supports the compliance of the Datex-Ohmeda TuffSat 3000 Pulse Oximeter to the above mentioned standards.
Additionally, the software for the Datex-Ohmeda TuffSat 3000 Pulse Oximeter was developed following a robust software development process and was specified and validated by Datex-Ohmeda.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ohmeda 3770 / 3775 Handheld Pulse Oximeters
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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MAR 3 1 2000
Summary of Safety and Effectiveness
October 15, 1999
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Datex-Ohmeda
Tuffsat 3000 Pulse Oximeter. |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Proprietary: | Datex-Ohmeda TuffSat 3000 Pulse Oximeter |
| Common: | Oximeter |
| Classification: | Oximeter Class II – 21 CFR870.2700 – 74 DQA |
The 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA of 1990 and 1992.
The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is substantially equivalent to the following currently marketed devices:
- . Ohmeda 3770 / 3775 Handheld Pulse Oximeters
The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is a noninvasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing Datex-Ohmeda disposable and reusable finger and ear sensors labeled for patients ranging from neonates to adults.
There is no change in the fundamental scientific technology nor the intended use of the device from that of the predicate device.
The Datex-Ohmeda TuffSat 3000 Pulse Oximeter was designed to comply with applicable portions of the following standards:
| 1.* IEC 601-1 | Medical Electrical Equipment - General Requirements for Safety |
|---|---|
| 2. IEC 601-1-1 | Safety Requirements for Medical Electrical Systems |
| 3.* IEC 601-1-2 | Electromagnetic compatibility - Requirements and tests |
| 4. CAN/CSA C22.2 #601 | Medical Electrical Equipment - General Requirements for Safety |
| 5. UL 2601-1 | Medical Electrical Equipment - General Requirements for Safety |
| 6. ISO 9919 | Pulse Oximeters for Medical Use - Requirements |
| 7. EN 865 | Pulse Oximeters - Particular Requirements |
| 8.* ASTM 1415 | Standard Specification for Pulse Oximeters |
| 9. EN 1441 | Medical Devices - Risk Analysis |
| 10. IEC 601-1-4 | Programmable Electrical Medical Systems |
- Report / certificate included in this submission
The Datex-Ohmeda 3770 / 3775 Handheld and TuffSat 3000 Pulse Oximeters are substantially equivalent in design concepts, technologies and materials. The Datex-Ohmeda TuffSat 3000 Pulse Oximeter was validated through rigorous testing performed both in-house and at a Nationally Recognized Testing Lab. This testing supports the compliance of the Datex-Ohmeda TuffSat 3000 Pulse Oximeter to the above mentioned standards.
Additionally, the software for the Datex-Ohmeda TuffSat 3000 Pulse Oximeter was developed following a robust software development process and was specified and validated by Datex-Ohmeda.
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Image /page/1/Picture/1 description: The image is a black and white logo. The logo is circular and contains an image of an eagle. The words "Department of Health & Human Services - USA" are written around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2000
Mr. Dale Thanig Datex-Ohmeda, Inc. 1315 West Century Drive Louisville, CO 80027-9560
K993512 Re : Datex-Ohmeda TuffSat 3000 Pulse Oximeter Regulatory Class: II (two) Product Code: 74 DQA February 29, 2000 Dated: Received: March 1, 2000
Dear Mr. Thanig:
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 against 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 Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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. Dale Thaniq
This letter will allow you to beqin 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 requlation 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
teame Awertedn fe;
James E. Dillard III 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): _K993512
Datex-Ohmeda TuffSat 3000 Pulse Oximeter Device Name:
Indications for Use:
The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing Datex-Ohmeda disposable and reusable finger and ear sensors labeled for patients ranging from neonates to adults.
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 OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Luan A Weiteihn
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510K Number: K 993572
OR
Prescription Use (Per 21CFR801.109)
Over-The-Counter