(65 days)
The Spirobank G spirometer 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 lung function and can make spirometry testing in people of all ages, excluding infants and neonates. It can be used in any setting.
Spirobank G is a spirometer designed to facilitate the total valuation of lung function. It is 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 spirometric parameters. Its connectivity capability (USB, Bluetooth) makes it suitable also for telemedicine applications.
The Spirobank G is a spirometer intended for lung function testing. The provided document focuses on demonstrating substantial equivalence to predicate devices (Spirobank and Spirobank II) rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a novel AI-powered device.
However, based on the information provided, we can infer the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety & Environmental Compliance (EN 60601-1:1990) | In compliance with the guideline and standards referenced. |
| Electromagnetic Compatibility (EN 60601-1-2:1993) | In compliance with the guideline and standards referenced. |
| Electrical Safety | Performs within its specifications. |
| Mechanical Durability | Performs within its specifications. |
| Safety (Operator and Patient) | Performs within its specifications. |
| Temperature/Humidity Performance | Performs within its specifications. |
| Spirometry Accuracy (ATS Standards) | Results obtained were within the range of accuracy required by ATS. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the spirometry accuracy testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Spirometry testing was performed according with American Thoracic Society (ATS) Standards."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For spirometry, the "ground truth" typically refers to precise measurements from a highly calibrated reference spirometer or simulated lung. Expert review would typically be for interpretation of results rather than establishing the raw spirometry ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a spirometer, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described is effectively a standalone performance evaluation of the device itself (hardware and embedded software) against established standards. The spirometer performs its measurements and calculations without continuous human intervention during the measurement process.
7. The Type of Ground Truth Used
For spirometry accuracy: The implied ground truth is the "range of accuracy required by ATS" standards, which would be based on comparison to highly accurate reference spirometry measurements or simulated lung volumes/flow profiles.
For safety and environmental criteria: Ground truth is compliance with the specific technical standards (e.g., EN 60601-1:1990, EN 60601-1-2:1993).
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Spirobank G is a medical device that measures physiological parameters based on established physical principles, not a machine learning model that requires a "training set" in the conventional sense. Its "training" would involve calibration and engineering design based on physical and physiological principles.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons stated above.
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Image /page/0/Picture/0 description: The image shows the logo for MIR Medical International Research. The logo consists of a stylized, interconnected "M" shape on the left, 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, completing the company's name.
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string is "K072979". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized.
Summary of Safety and Effectiveness
1. Applicant Information
| Date Prepared: | October 03, 2007 |
|---|---|
| Submitter: | MIR Medical International Research |
| Address: | Via del Maggiolino, 12500155 Roma - Italy |
| Contact Person: | Simon Fowler |
| Phone Number: | +39.0622754777 |
DEC 2 6 2007
2. Device Information
Trade Name: Spirobank G Classification Name: spirometer
3. Identification of legally marketed device to which the submitter claims equivalence:
| Company Name: | MIR. |
|---|---|
| Device Name: | Spirobank |
| 510(k) number: | K983909 |
| Company Name: | MIR. |
|---|---|
| Device Name: | Spirobank II |
| 510(k) number: | KK061712 |
4. Description of the device:
Spirobank G is a spirometer designed to facilitate the total valuation of lung function. It is 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 spirometric parameters.
Its connectivity capability (USB, Bluetooth) makes it suitable also for telemedicine applications.
5. Statement of Intended Use:
The Spirobank G spirometer 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 lung function and can make spirometry testing in people of all ages, excluding infants and neonates. 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:
Spirobank G has the same functions (graphic display, USB, Bluetooth), the same hardware (ICs, memory end microcontroller) and the same turbines (reusable and disposable) as Spirobank II though maintaining the design of the enclosure of the original Spirobank.
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7. Brief discussion of the clinical and nonclinical tests relied on for a determination of SE.
Testing was done to ensure that Spirobank G 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 Spirobank G is in compliance with the guideline 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
DEC 2 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Simon Fowler Sales Manager M.I.R. Medical International Research Via del Maggiolino, 125 Roma, Italy 00155
Re: K072979
Trade/Device Name: Spirobank G Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: November 20, 2007 Received: November 26, 2007
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 (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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert S. Betz for
Chin-Lin, 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: K072979
Device Name: Spirobank G
Indications for Use: The Spirobank G spirometer 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 lung function and can make spirometry testing in people of all ages, excluding infants and neonates.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Min Whold
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K072979
§ 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).