(85 days)
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No
The summary describes a standard pulse oximeter and does not mention any AI or ML capabilities, image processing, or details about training/test sets which are common indicators of AI/ML use in medical devices.
No
The device is described as measuring and displaying SpO2 and pulse rate, which are diagnostic functions, not therapeutic.
Yes
The device measures and displays functional arterial oxygen saturation (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status. This falls under the definition of a diagnostic device as it provides information for diagnosis or monitoring.
No
The description explicitly refers to "Fingertip Pulse Oximeter," which is a hardware device that measures SpO2 and pulse rate. The transmission methods (USB or Bluetooth) also imply a physical device.
Based on the provided information, this device 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 OxiBlue and OxiPro Fingertip Pulse Oximeters measure functional arterial oxygen saturation (SpO2) and pulse rate by placing the device on a patient's finger. This is a non-invasive measurement taken directly from the body, not a test performed on a sample outside the body.
Therefore, these devices fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The OxiBlue Fingertip Puls) Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arterial overan saturation (SpO2) and pulse rate of patients in home care. It is intended for adu't and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiBlue can transmit in the either a USB cable or wireless Bluetooth technology.
The OxiPro Fingertip Pulse Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arter. V oxygen saturation (SpO2) and pulse rate of patients in home care. It is intended for adu' and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiPro can transmit Pro vio : USB cable, and does not include Bluetooth technology.
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
finger
Indicated Patient Age Range
adu't and pediatric patients
Intended User / Care Setting
home care
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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Oxypulse C/O Mr. James A. Dunning President Qualpro Consulting, LLC One Macdonal Center, 1 North Macdonald Suite # 8 Mesa, Arizona 85201
JUN 1 62010
Re: K100815
Trade/Device Name: OxiBlue Fingertip Pulse Oximeter and OxiPro Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 18, 2010 Received: March 23, 2010
Dear Mr. Dunning:
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 fabeling 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indication for use
510(k) Number (if Imown in K100815
Device Name: OxiBlue Fingertip Pulse Oximeter and OxiPro Fingertip Pulse Oximeter
Indications for Use:
The OxiBlue Fingertip Puls) Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arterial overan saturation (SpO2) and pulse rate of patients in home care. It is intended for adu't and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiBlue can transmit in the either a USB cable or wireless Bluetooth technology.
The OxiPro Fingertip Pulse Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arter. V oxygen saturation (SpO2) and pulse rate of patients in home care. It is intended for adu' and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiPro can transmit Pro vio : USB cable, and does not include Bluetooth technology.
Prescription Use × (Part 21 CFR 801 Subpar: D)
AND/OR
Over-The-Cou8nter Use ( (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE I THO'N THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
C . . currence of CDRH, Office of Device Evaluation (ODE)
L. Schult
Division Sign-Off) iivision of Anesthesiology, General Hospital fection Control, Dental Devices
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10(k) Number: KC 100815
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