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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Minispir device, which functions as both a spirometer and a pulse oximeter. The submission aims to demonstrate substantial equivalence to a predicate device (Minispir, K082766).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly refers to industry standards as acceptance criteria rather than explicitly listing them.

Acceptance Criteria (Standard/Guideline)	Reported Device Performance
Spirometry: American Thoracic Society (ATS) Standards	"Spirometry testing was performed according with American Thoracic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS."
Oximetry: Required Accuracy (details not specified)	"A clinical investigation has been carried out to validate the new oximetry board. The results demonstrated required accuracy."
Safety and Environmental: EN 60601-1:2006 and EN 60601-1-2:2007 (EMC, electrical, mechanical durability, safety (operator and patient), temperature/humidity)	"Testing was done to ensure that the Minispir would perform safely and accurately within the environments for which it is to be marketed... The results demonstrates that the Minispir is in compliance with the guidelines and standards referenced and that it performs within its specifications."

2. Sample Size Used for the Test Set and Data Provenance:

Spirometry: No specific sample size for a test set is mentioned. The document states "Spirometry testing was performed according with American Thoracic Society (ATS) Standards." This implies a set of tests conforming to ATS guidelines, but the number of subjects or tests is not provided.
Oximetry: A "clinical investigation" was carried out for oximetry, but no sample size for this investigation is provided.
Data Provenance: Not explicitly stated, but given the applicant is "MIR Medical International Research" located in "Roma - Italy," it is reasonable to infer the studies might have been conducted in Italy or other European locations. The document does not specify if the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts or a ground truth established by experts for either spirometry or oximetry testing.
For spirometry, the ground truth is implicitly defined by the ATS Standards, which govern the expected physical characteristics and accuracy of the device.
For oximetry, the "clinical investigation" validated the accuracy, but the method for establishing the true oxygen saturation for comparison (the "ground truth") is not detailed. Typically, this would involve a co-oximeter or arterial blood gas analysis, but this is not stated.

4. Adjudication Method:

Not applicable/Not mentioned. The testing described for spirometry and oximetry appears to be direct device performance measurement against a standard or a reference, rather than a subjective assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study typically assesses the improvement in human reader performance (e.g., radiologists interpreting images) with AI assistance. The Minispir is a diagnostic device for measuring physiological parameters, not an AI-powered image interpretation tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the studies described are essentially standalone performance evaluations.
- Spirometry: The device's spirometry function was tested against ATS standards, meaning the algorithm's measurements were compared to the accuracy requirements.
- Oximetry: A "clinical investigation... to validate the new oximetry board" also implies evaluation of the device's output (SpO2, pulse rate) directly against a reference, without human intervention in the measurement process itself, although a human operates the device.

7. Type of Ground Truth Used:

Spirometry: Indirectly, the "ground truth" is derived from the American Thoracic Society (ATS) Standards. These standards define the expected accuracy and performance range for spirometers, so the device's measurements are compared against these established technical and physiological benchmarks rather than individual patient-specific "ground truth" established by an expert or pathology.
Oximetry: For the clinical investigation, the ground truth for oximetry (SpO2 and pulse rate) would typically be established by a reference method such as an arterial blood gas analyzer or a co-oximeter. However, the document only states that "results demonstrated required accuracy" without specifying the reference method used to establish this truth.

8. Sample Size for the Training Set:

The document does not provide any information about a training set. This is consistent with the nature of the device, which relies on established physiological measurement principles and algorithms rather than machine learning models that require training data. The algorithms for spirometry and oximetry are stated to be the "same algorithms" as the predicate device, implying they are well-established.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set is mentioned or implied for a device of this nature.

Summary

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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:

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

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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.

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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.

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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); 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

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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

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510(k) Number:

Regulation Number and Section

§ 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).