(279 days)
Not Found
No
The summary describes a standard pulse oximeter with connectivity features and the ability to calculate statistical parameters. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
A therapeutic device is used for treatment. This device is a pulse oximeter, which is a diagnostic device used to measure and monitor oximetry, not to treat a condition.
Yes
The device is a pulse oximeter intended to "test oximetry" and calculate "statistical parameters derived from the SpO2 and pulse rate," which are measurements used for diagnostic purposes.
No
The device description explicitly mentions hardware components and connectivity capabilities (USB, Bluetooth, modem, RS232), and the performance studies include testing for electrical, mechanical durability, and temperature/humidity, all indicative of 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 MIROxi pulse oximeter measures SpO2 (blood oxygen saturation) and pulse rate by placing a sensor on the patient's body (typically a finger). This is a non-invasive measurement taken directly from the patient, not from a sample taken from the patient.
- Intended Use: The intended use describes measuring oximetry in people of all ages. This aligns with the function of a pulse oximeter, which is a physiological monitoring device.
Therefore, the MIROxi pulse oximeter falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MIROxi pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test oximetry in people of all ages.
It can be used in any setting.
Product codes
DQA
Device Description
MIROxi is a pulse oximeter, designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 statistical parameters derived from the SpO2 and pulse rate.
Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
all ages
Intended User / Care Setting
by a physician or by a patient under the instruction of a physician or paramedic.
any setting.
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)
Testing was done to ensure that the MIROxy would perform safely and accurately within the environments for which it is to be marketed.
Safety and environmental testing was conducted in accordance with EN 60601-1:1990 and EN 60601-1-2:1993. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrates that the device is in compliance with the standards referenced and that it performs within its specifications.
The accuracy of SpO2 and pulse rate has been validated by in vitro testing using an optical simulator, under normal conditions.
The results obtained were within the specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Kof1033
Image /page/0/Picture/1 description: The image shows the logo for Medical International Research (MIR). The logo consists of a stylized, interconnected "M" shape above the letters "MIR" in bold, sans-serif font. Below the logo, the full name "MEDICAL INTERNATIONAL RESEARCH" is written in a smaller, sans-serif font.
JAN 1 5 2009
510(k) Summary
1. Applicant Information
| Date Prepared: | January 25, 2007 |
|---|---|
| Submitter: | MIR Medical International Research |
| Address: | Via del Maggiolino, 125 |
| 00155 Roma - Italy | |
| Contact Person: | Simon Fowler |
| Phone Number: | +39 06.22.754.777 |
2. Device Information
MIROxi Trade Name: Classification Name: Oximeter
3. Identification of legally marketed device to which the submitter claims equivalence:
| Company Name: | MIR |
|---|---|
| Device Name: | Spirobank II |
| 510(k) number: | K061712 |
4. Description of the device:
MIROxi is a pulse oximeter, designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 statistical parameters derived from the SpO2 and pulse rate.
Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.
5. Statement of Intended Use:
The MIROxi pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test oximetry in people of all ages.
It can be used in any setting
6. Summary of the technological characteristics of the new device in comparison to those of the predicate device:
MIROxi is directly derived from the Spirobank II. Whereas Spirobank II performs both spirometry and oximetry, MIROxi performs only oximetry testing.
MIROxi uses the same oximetry board and oximetry sensors as the predicate device, and it also calculates the same statistical parameters (derived from the SpO2 and pulse rate).
1
7. Brief discussion of the clinical and nonclinical tests relied on for a determination of SE.
Testing was done to ensure that the MIROxy would perform safely and accurately within the environments for which it is to be marketed.
Safety and environmental testing was conducted in accordance with EN 60601-1:1990 and EN 60601-1-2:1993. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrates that the device is in compliance with the standards referenced and that it performs within its specifications.
The accuracy of SpO2 and pulse rate has been validated by in vitro testing using an optical simulator, under normal conditions.
The results obtained were within the specification.
8. Conclusions
Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed device.
This summary on 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr Simon Fowler Sales Manager MIR Medical International Research Via del Maggiolino, 125 Roma ITALY 00155
JAN 1 5 2009
Re: K081033
Trade/Device Name: MIROxi Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 17, 2008 Received: December 23, 2008
Dear Mr Fowler:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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
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Page 2 - Mr. Fowler
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described m your Section 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Southe H. Michie Cunts.
Ginette Y. Michaud, M.D. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
():
4
Indications for Use
510(k) Number (K ).
Device Name: MIROxi
Indications for Use: The MIROxi pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test oximetry in people of all ages.
It can be used in any setting.
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)
And D. Dold
Page 1 of 1
(Division Sign Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number