The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting – home, factory, pharmacy, hospital or physician's office.

Device Description

MIR Spirotel is a simple to operate precise pocket spirometer and pulse oximeter (weight only 100g). It measures the most important functional respiratory parameters and monitors the oxygen saturation and pulse rate.

AI/ML Overview

The provided document is a 510(k) summary for the MIR Spirotel device, which combines a spirometer and a pulse oximeter. It details the device's characteristics, intended use, and comparison to predicate devices, but it does not contain detailed acceptance criteria or a multi-reader multi-case (MRMC) comparative effectiveness study.

However, it does mention standalone performance testing. Here's what can be extracted and inferred based on the provided text:

Acceptance Criteria and Reported Device Performance

The document generally states compliance with standards rather than specific numerical acceptance criteria.

Acceptance Criteria Category	Reported Device Performance (as stated or inferred)
Spirometry Performance	"Testing was performed according with American Thoracic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS."
Pulse Oximetry Performance	"For oximetry testing a desaturation trial was conducted. The results obtained were within specification."
Safety and Environmental Compliance	"Safety and environmental testing was conducted in accordance with EN 60601-1:1990... The MIR Spirotel is in compliance with the guideline and standards referenced and that it performs within its specifications." (Covers EMC, electrical, mechanical durability, safety, temperature/humidity).

Study Details

The document describes performance testing for both spirometry and pulse oximetry.

1. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified for either spirometry or pulse oximetry. The document only mentions "clinical testing."
Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document only states that spirometry testing was against "American Thoracic Society (ATS) Standards" and oximetry results were "within specification," implying comparison to a reference standard, but it doesn't detail human expert involvement in establishing ground truth for the test data itself.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified. The testing described focuses on device performance against established standards rather than diagnostic agreement adjudicated by multiple experts.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a measurement tool (spirometer and pulse oximeter), not an AI-based diagnostic interpretation tool.
Effect size improvement without AI: Not applicable, as no MRMC study was conducted, and the device itself is a measurement tool, not an AI for human reader assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes. The described clinical testing for both spirometry and pulse oximetry appears to be standalone performance testing of the device itself against established standards or specifications. The document states:
- "Testing of device performance included clinical testing of both spirometry and pulse oximetry functions."
- "Spirometry testing was performed according with American Thorotic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS."
- "For oximetry testing a desaturation trial was conducted. The results obtained were within specification."

6. The type of ground truth used:

Spirometry: Inferred to be a reference standard compliant with "American Thoracic Society (ATS) Standards." This typically involves a highly accurate and calibrated spirometer as a reference.
Pulse Oximetry: Inferred to be a reference standard for oxygen saturation measurement during a "desaturation trial." This usually involves co-oximetry (blood gas analysis) for accurate SpO2 reference values.

7. The sample size for the training set:

Not applicable/Not specified. The Spirotel described here is a hardware device for measurement, not an AI/machine learning algorithm that requires a training set in the conventional sense.

8. How the ground truth for the training set was established:

Not applicable. (See point 7).

Summary

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JUL 19 2005

K043528

Image /page/0/Picture/2 description: The image shows the logo for MIR Medical International Research. The logo consists of a stylized graphic element resembling three interconnected arches, followed by the letters "MIR" in bold, sans-serif font. Below the graphic and letters, the words "MEDICAL INTERNATIONAL RESEARCH" are printed in a smaller, sans-serif font.

Summary of Safety and Effectiveness

1. Applicant Information

Date Prepared:	July 8, 2004
Submitter:	MIR Medical International Research
Address:	Via del Maggiolino, 12500155 Roma - Italy
Contact Person:	Simon Fowler
Phone Number:	+39 06.22.754.777

2. Device Information

Spirotel Trade Name: Classification Name: spirometer and oximeter

3. Identification of legally marketed device to which the submitter claims equivalence:

Company Name:	SDI Diagnostics, Inc.
Device Name:	Spirotel, Model 29-1020.
510(k) number:	K031643

BCI, Inc. Company Name: 3420 "Digit" Pulse Oximeter. Device Name: K013171 510(k) number:

4. Description of the device:

5. Statement of Intended Use:

The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting home, factory, pharmacy, hospital or physician's office.

6. Summary of the technological characteristics of the new device in comparison to those of the predicate device:

MIR Spirotel combines in a single device the functions of a spirometer and a pulse oximeter. It is derived from the SDI Diagnostics Spirotel, to which the pulse oximetry function has been

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added, through an OEM Oximeter Board, which uses the same technology found in the legally marketed BCI 3420 "Digit" Pulse Oximeter.

7. Brief discussion of the clinical and nonclinical tests relied on for a determination of SE.

Testing was done to ensure that the MIR Spirotel 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 Saley and Cirillonmental teoling was ormatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The salery (oporator and the MIR Spirotel is in compliance with the guideline and standards referenced and that it performs within its specifications.

Testing of device performance included clinical testing of both spirometry and pulse oximetry functions.

Spirometry testing was performed according with American Thoracic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS.

For oximetry testing a desaturation trial was conducted. The results obtained were within 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 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three heads, representing the department's focus on health, well-being, and human services. The figure is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2005

Mr. Simon Fowler Sales Manger Medical International, Research SRL (MIR) Via Del Maggiolino 125 Roma, ITALY 00155

Re: K043528

Trade/Device Name: SPIROTEL Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG, DQA Dated: June 30, 2005 Received: July 5, 2005

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 for association 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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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 or any I oderal butther and st requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fat 6077; laboring (21 CFR Part 820); and if applicable, the electronic form in the quand, 25wd provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) I this loter with acation. The FDA finding of substantial equivalence of your device to a legally promatication "The 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 If you desire 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 other general micronianter and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suite y. Michie M-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: Spirotel

Indications for Use: The Spirotel spirometer and pulse oximeter is intended to be Indications for Use. The Spiroter Spirometer and paraction of a physician or paramedic
used by a physician or by a patient under the instruction of a physician or paramedic used by a physician of by a patient ander the measured to be used as a singleto test lung function in people of all ages. It is also intended to be used as a singleto test lung function in people of all agos: it is also incometer
patient device and can be used in any setting – home, factory, pharmacy, hospital or physician's office.

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)

MLLY

(Division Sign-Off) Division of Anesthesiotogy, General Hospital Infection Control, Dental Device

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).