(87 days)
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Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description is not available to infer such capabilities.
No
A therapeutic device is used to treat a condition. This device is indicated for spot-checking of oxygen saturation and pulse rate, which is a diagnostic or monitoring function, not a treatment.
Yes
The device is indicated for "spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR)", which are measurements used in the diagnosis and monitoring of health conditions.
No
The description explicitly states "OxiCare Fingertip Pulse Oximeter, model DB11", which is a hardware device placed on the fingertip to measure SpO2 and pulse rate. This is not a software-only device.
Based on the provided information, the OxiCare Fingertip Pulse Oximeter, model DB11 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 about a person's health.
- Device Function: The OxiCare Fingertip Pulse Oximeter measures functional arterial oxygen saturation (SpO2) and pulse rate (PR) by placing the device on the fingertip. This is a non-invasive measurement taken directly from the body, not from a specimen taken from the body.
Therefore, the OxiCare Fingertip Pulse Oximeter falls under the category of a non-invasive medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The OxiCare Fingertip Pulse Oximeter, model DB11 is indicated for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in hospitals, physician's office, clinical settings and home care environment.
The OxiCare Fingertip Pulse Oximeter, model DB11 is not intended for continuous monitoring.
Product codes
DOA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult and pediatric 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2012
Mr. Nicky Pan Regulatory Affairs Specialist DELBio Incorporation 3F & 6F No. 252 Shangying Road Guishan Industrial Zone Taoyuan County, Taiwan 33341
Re: K122927
Trade/Device Name: Oxicare Fingertip Pulse Oximeter, Model DB11 Regulation Number: 21 CFR 870.2700 . Regulation Name: Oximeter · Regulatory Class: II Product Code: DOA Dated: December 7, 2012 Received: December 7, 2012
Dear Mr. Pan:
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. Iisting 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
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony Lis min
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Oxicare Fingertip Pulse Oximeter
DELBio Incorporation 510(K) Notification
Indications for Use Form
510(k) Number (if known): JKL22927
Device Name: Oxicare Fingertip Pulse Oximeter, model DB11
Indications for Use:
The OxiCare Fingertip Pulse Oximeter, model DB11 is indicated for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in hospitals, physician's office, clinical settings and home care environment.
The OxiCare Fingertip Pulse Oximeter, model DB11 is not intended for continuous monitoring.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Albert E. Moyal Albert E. Moyal 2012.12.19 12:05:46 for LS -02,00,
(Division Sign-Off) Division of Anesthaslology, General Hospital Infection Control, Dental Devices
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510(k) Number: