(151 days)
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Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or descriptions of training/test sets, which are typical indicators of AI/ML technology in medical devices. The device description is also not available.
No
The device is used for "spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR)", which is a measurement or diagnostic function, not a therapeutic one.
Yes
The device is used for spot-checking functional arterial oxygen saturation (SpO2) and pulse rate (PR), which are physiological parameters measured to assess a patient's health status. This falls under the definition of a diagnostic device as it aids in identifying or monitoring medical conditions.
No
The device description explicitly states "Fingertip Pulse Oximeter (DB12)", which is a hardware device. The summary does not mention any software component or its function.
Based on the provided information, the Fingertip Pulse Oximeter (DB12) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Fingertip Pulse Oximeter function: The intended use describes the device as being used for "spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult patients". This is done non-invasively by placing the device on the fingertip and measuring light absorption through the skin. It does not involve analyzing specimens taken from the body.
Therefore, the Fingertip Pulse Oximeter (DB12) falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeter (DB12) is used for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult patients in hospitals, physician's office, clinical settings and home care environment.
The Fingertip Pulse Oximeter (DB12) is not intended for continuous monitoring.
Product codes
DQA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospitals, physician's office, clinical settings and home care environment.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
February 28, 2014
DELBio Incorporation C/O Ms. Erica Li Quality Assurance Manager Delta Products Corporation 4405 Cushing Parkway Fremont City, CA 94538
Re: K133090
Trade/Device Name: Oxicare Fingertip Pulse Oximeter, Model DB12 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 28, 2014 Received: January 29, 2014
Dear Ms. Li:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Ms. Erica Li
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Sincerely vours.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Oxicare Fingertip Pulse Oximeter
DELBio Incorporation 510/K) Notification
Indications for Use Form
510(k) Number (if known): K133090
Device Name: Oxicare Fingertip Pulse Oximeter, model DB12
Indications for Use:
The Fingertip Pulse Oximeter (DB12) is used for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult patients in hospitals, physician's office, clinical settings and home care environment.
The Fingertip Pulse Oximeter (DB12) is not intended for continuous monitoring.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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