(161 days)
No
The document describes standard spirometry and oximetry measurements and calculations based on established standards (ATS/ERS). There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is used for diagnostic purposes (lung function testing and oximetry) rather than directly treating or preventing a disease.
Yes
The device is described as taking measurements for lung function and oximetry testing, and it calculates various parameters and deviations, which are all indicative of a diagnostic purpose.
No
The device description explicitly states "MIR Minispir - Spirolab III are instruments for the analysis of respiratory function," indicating they are physical devices, not just software. The performance studies also mention testing of electrical, mechanical durability, and temperature/humidity, which are associated with hardware.
Based on the provided information, the MIR Minispir and Spirolab III spirometers and pulse oximeters are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD devices analyze samples taken from the human body. This typically involves blood, urine, tissue, or other biological specimens.
- The MIR devices measure physiological parameters directly from the patient. Spirometry measures lung function by analyzing airflow and volume during breathing. Oximetry measures oxygen saturation and pulse rate non-invasively through the skin.
These devices are considered medical devices that perform physiological measurements, but they do not fall under the definition of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MIR Minispir spirometer and Spirolab III spirometer and pulse oximeter 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
BZG, DQA
Device Description
MIR Minispir - Spirolab III are instruments for the analysis of respiratory function, which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a calculation of the main spirometric parameters, predicted values and percentage deviations compared to the measured values. Plus Flow/Volume and Volume/time curves and the interpretation of the FVC test following the international spirometry standards (ATS/ERS). What is more Spirolab III with its integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Spirolab III calculates several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
spirometry testing in people of all ages, excluding infants and neonates .
oximetry testing in people of all ages. .
Intended User / Care Setting
Used by either a physician, respiratory therapist or technician.
Can be used in 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
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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 MIR Minispir - Spirolab III 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 Minispir - Spirolab III sare 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.
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
'2061875
Image /page/0/Picture/1 description: The image shows the logo for MIR Medical International Research. The logo consists of a stylized graphic of three connected shapes resembling mountains or tents, followed by the letters "MIR" in bold, sans-serif font. Below the logo, the words "MEDICAL INTERNATIONAL RESEARCH" are printed in a smaller, sans-serif font.
DEC 1 1 2006
Summary of Safety and Effectiveness
1. Applicant Information
| Date Prepared: | November 30, 2006 |
|---|---|
| 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
Trade Name: Minispir - Spirolab III Classification Name: spirometer
3. Identification of legally marketed device to which the submitter claims equivalence:
| Company Name: | MIR Medical International Research |
|---|---|
| Device Name: | MIR Spirolab II |
| 510(k) number: | K052140 |
As Spirometer : Regulation Number 868.1840
As oximeter: 870.2700 Regulation Number
4. Description of the device:
MIR Minispir - Spirolab III are instruments for the analysis of respiratory function, which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a calculation of the main spirometric parameters, predicted values and percentage deviations compared to the measured values. Plus Flow/Volume and Volume/time curves and the interpretation of the FVC test following the international spirometry standards (ATS/ERS). What is more Spirolab III with its integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Spirolab III calculates several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.
1
5. Statement of Intended Use:
The MIR Minispir spirometer and Spirolab III spirometer and pulse oximeter 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.
6. Summary of the technological characteristics of the new device in comparison to those of the predicate device:
Spirometry function (for both Minispir and Spirolab III)
The MIR Spirolab III has the
- . same intended use
- same operating principle .
- same spirometry parameters .
- . same algorithms for spirometry parameters calculation
- . same physical aspect (keyboard, display, size and weight)
- same printer .
as the Spirolab II.
The main differences between Spirolab III and Spirolab II are shortly described as follow:
- . Spirolab III has an integrated oximetric option, so it can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes-BPM).
- Spirolab I II has an additional function key to address directly the operator to the . oximetric functions.
- . The Software of both spirometers use the same algorithms for spirometric values calculations, but the language is different.
- The flow sensor of both Spirolab III and Spirolab II is outside the device. The flow . sensor of Spirolab III is Minispir . However the Minispir's sensor and turbine are the same as those used in the cleared Spirolab II.
MIR Minispir has the
- same intended use .
- . same operating principle
- . same spirometry parameters
- . same algorithms for spirometry parameters calculation
- . same turbine
- . same sensor and mouthpiece holders
as the Spirolab II.
2
Minispir has different size, weight and physical aspect from the cleared Spirolab II. In fact Minispir doesn't have any keyboard and display and it is connected to either a PC or Spirolab III to show the calculated spirometric results.
Oximetry function for (Spirolab III)
The MIR Spirolab III has the same pulse oximetry function as the cleared MIR Spirotel.
The MIR Spirolab III has the
- . same intended use
- same operating principle .
- . same sensors
- same oximetry board .
- same oximetry parameters (SpO2, pulse rate) .
- same algorithms for oximetry parameters calculation .
as the MIR Spirotel.
Spirolab III calculates more oximetry parameters than Spirotel
7. Brief discussion of the clinical and non clinical tests relied on for a determination of SE.
Testing was done to ensure that the MIR Minispir - Spirolab III 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 Minispir - Spirolab III sare 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.
8. Conclusions
Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed devices.
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.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Simon Fowler Sales Manager MIR Medical International Research S.R.L. Via del Maggiolino 125 00155 Roma, ITALY
DEC 1 1 2006
Re: K061875
Trade/Device Name: Minispir - Spirolab III Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG, DQA Dated: December 1, 2006 Received: December 7, 2006
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 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.
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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 (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.
This letter will allow you to begin marketing your device as described in 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Clus
Shia-Lien, Ph.D.
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known):
Device Name: Minispir - Spirolab III
Indications for Use: The MIR Minispir spirometer and Spirolab III spirometer and pulse oximeter 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)
Aum Mulum
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