(59 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard spirometry and oximetry measurements without mentioning any advanced analytical capabilities.
No
The device is described as a spirometer and pulse oximeter intended to "test lung function" and measure "respiratory parameters" and "oxygen saturation," which are diagnostic functions, not therapeutic.
Yes
The device is described as "intended to test lung function" and performs "spirometry testing" and "oximetry testing," which are diagnostic procedures to assess a patient's health status.
No
The device description explicitly states that the Minispir is a spirometer and pulse oximeter connected to a Personal Computer using a USB cable, indicating it includes hardware components.
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 description clearly states that the device measures respiratory parameters (lung function) and oxygen saturation/heart rate. These are measurements taken directly from the patient's body (in vivo), not from a sample outside the body.
- Intended Use: The intended use is to "test lung function" and perform "oximetry testing," which are direct physiological measurements.
Therefore, while it's a medical device used for diagnosis and monitoring, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Minispir and Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician. The devices are intended to test lung function and can make: - spirometry testing in people of all ages, excluding infants and neonates. . - oximetry testing in people of all ages. They can be used in any setting.
Product codes
BZQ, DQA
Device Description
Minispir is a spirometer and pulse oximeter (optional) connected to a Personal Computer using a USB cable. The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart pulse rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
all ages, excluding infants and neonates for spirometry testing; all ages for oximetry testing.
Intended User / Care Setting
physician, respiratory therapist or technician; any setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was done to ensure that the Minispir 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 60601-1:2006 and EN 60601-1-2:2007. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrates that the Minispir is in compliance with the guidelines and standards referenced and that it performs within its specifications. Spirometry testing was performed according with American Thoracic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS. A clinical investigation has been carried out to validate the new oximetry board. The results demonstrated required accuracy.
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
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Medical International Research (MIR). The logo consists of a stylized "M" formed by three overlapping shapes, followed by the letters "MIR" in bold, sans-serif font. Below the logo, the full name "MEDICAL INTERNATIONAL RESEARCH" is printed in a smaller, sans-serif font.
510 (k) Summary
1. Applicant Information
Date Prepared: March 16, 2012 Submitter: MIR Medical International Research Address: Via del Maggiolino, 125 00155 Roma - Italy Contact Person: Gerda Van Houts
039-06-22754777
2. Device Information
Phone Number:
Trade Name: Minispir Classification Name: spirometer and oximeter
3. Identification of legally marketed device to which the submitter claims equivalence:
Company Name: MIR Medical International Research Device Name: Minispir 510(k) number: K082766
As Spirometer : Regulation Number 868.1840
As oximeter: Regulation Number 870.2700
4. Description of the device:
Minispir is a spirometer and pulse oximeter (optional) connected to a Personal Computer using a USB cable. The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart pulse rate.
5. Statement of Intended Use:
The Minispir III spirometer and pulse oximeter is intended to be used by either a physician, respiratory therapist or technician.
The device is intended to test lung function and can make:
- spirometry testing in people of all ages, excluding infants and neonates. .
- oximetry testing in people of all ages. .
It can be used in any setting.
2012
1
6. Summary of the technological characteristics of the new device in comparison to those of the predicate device:
The new Minispir uses a new PCB (with a new microprocessor) and a different oximetry module. Also the external aspect and dimensions have slightly changed.
Spirometry function
The new Minispir has the
- . same intended use
- same operating principle .
- . same turbine sensor
- same spirometry parameters .
- same algorithms for spirometry parameters calculation .
as the predicate Minispir.
Oximetry function
The new Minispir has the
- . same intended use
- same operating principle .
- . same sensors
- same oximetry parameters (SpO2, pulse rate) .
- same algorithms for oximetry parameters calculation .
as the predicate Minispir.
Minispir uses a different oximetry module.
7. Brief discussion of the clinical and non clinical tests relied on for a determination of SE.
Testing was done to ensure that the Minispir 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 60601-1:2006 and EN 60601-1-2:2007. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrates that the Minispir is in compliance with the guidelines and standards referenced and that it performs within its specifications.
Spirometry testing was performed according with American Thoracic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS.
A clinical investigation has been carried out to validate the new oximetry board. The results demonstrated required accuracy.
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird figure. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
4 2012
M.I.R. Medical International Research Ms. Gerda Van Houts Export Area Manager Via Del Maggiolino 125 Rome, Italy 00155
Re: K122384
Trade/Device Name: Minispir- Spirolab III Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZQ, DQA Dated: September 11, 2012 Received: September 14, 2012
Dear Ms. Van Houts:
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.
3
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,
Nh 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
4
Indications for Use
510(k) Number (if known):
Device Name: Minispir -Spirolab III
Indications for Use: The Minispir and Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician.
The devices are intended to test lung function and can make:
- spirometry testing in people of all ages, excluding infants and neonates. .
- oximetry testing in people of all ages. ●
They can be used in any setting.
Prescription Use X (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)
L. Shulto
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devic
Page 1 of 1
510(k) Number: