OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 by OXYPULSE

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.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the OxiBlue and OxiPro Fingertip Pulse Oximeters. It states that the devices are substantially equivalent to legally marketed predicate devices.

Based on the provided text, the following information can be extracted:

A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria or device performance data in a table format. It focuses on the substantial equivalence determination rather than specific performance metrics.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the given document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the given document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the given document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not provided in the given document. The device is a pulse oximeter, which typically measures physiological parameters directly rather than relying on human interpretation, so an MRMC study related to AI assistance is not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the given document. The device itself is a standalone measurement tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the given document. For pulse oximeters, ground truth is typically established against co-oximetry blood gas analysis.
The sample size for the training set:
This information is not provided in the given document.
How the ground truth for the training set was established:
This information is not provided in the given document.

Summary of missing information:

The provided document is an FDA 510(k) clearance letter, which primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device. It does not contain the detailed technical study results, performance metrics, or validation methodology that would typically be found in a clinical study report or a more comprehensive technical submission. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and sample sizes is not available in this specific document.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

Indication for use

510(k) Number (if Imown in K100815

Device Name: OxiBlue Fingertip Pulse Oximeter and OxiPro Fingertip Pulse Oximeter

Indications for Use:

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

Page 1 of 1

10(k) Number: KC 100815

II-2

Regulation Number and Section

§ 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).