(165 days)
The Spirobank II spirometer and pulse oximeter 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 .
- oximetry testing in people of all ages. .
It can be used in any setting.
MIR Spirobank II is a spirometer and pulse oximeter, 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, and monitors the oxygen saturation and pulse rate. It also calculates several additional statistical parameters derived from the SpO2 and the pulse rate. Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.
The MIR Spirobank II is a spirometer and pulse oximeter. It was deemed substantially equivalent to MIR Spirobank (K983909) and MIR Spirotel (K043528).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Spirometry performance according to ATS Standards | Results obtained were within the range of accuracy required by ATS. |
| Oximetry performance within specification | Results obtained were within specification. |
Note: The specific numerical acceptance criteria for ATS standards and oximetry specifications are not detailed in the provided summary.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the clinical testing of spirometry and oximetry functions. It only states that "Testing of device performance included clinical testing of both spirometry and pulse oximetry functions."
The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the summary.
4. Adjudication method for the test set
This information is not provided in the summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not mentioned. This device is a diagnostic tool (spirometer and oximeter) and does not involve AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a standalone spirometer and pulse oximeter. The testing described (spirometry and oximetry) inherently evaluates the device's performance in a standalone capacity without direct human-in-the-loop AI assistance. The measurements are taken by the device, and the results are then interpreted by a physician or patient under physician instruction.
7. The type of ground truth used
- Spirometry: The ground truth for spirometry testing was based on compliance with American Thoracic Society (ATS) Standards. This implies that the device's output parameters were compared against accepted physiological ranges and accuracy requirements defined by the ATS.
- Oximetry: The ground truth for oximetry testing was established through a "desaturation trial." This typically involves inducing controlled desaturation and comparing the device's readings to known, accurate reference measurements (e.g., from a co-oximeter or arterial blood gas analysis), although the specific reference method is not detailed.
8. The sample size for the training set
This information is not provided in the summary. This device is a traditional medical device and not explicitly an AI/ML-based device that would typically involve a separate training set in the machine learning context. The "training" for such devices is usually the engineering design and calibration processes based on known physiological principles and standards.
9. How the ground truth for the training set was established
As noted in point 8, the concept of a "training set" as understood in AI/ML is not directly applicable here. The device's algorithms and performance are established through adherence to recognized medical standards and engineering specifications rather than through supervised learning from a labeled training dataset.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for Medical International Research. The logo consists of a stylized graphic above the text "MIR MEDICAL INTERNATIONAL RESEARCH". The graphic is a rounded, stylized shape that resembles three interconnected arches. The text is in a simple, sans-serif font.
OEC - 1 2006
Summary of Safety and Effectiveness
1. Applicant Information
| Date Prepared: | November 30, 2006 |
|---|---|
| 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
Trade Name: Spirobank II Classification Name: spirometer and oximeter
3. Identification of legally marketed device to which the submitter claims equivalence:
| Company Name: | MIR. |
|---|---|
| Device Name: | Spirobank |
| 510(k) number: | K983909 |
MIR. Company Name: Devicc Name: Spirotel K043528 510(k) number:
4. Description of the device:
MIR Spirobank II is a spirometer and pulse oximeter, 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, and monitors the oxygen saturation and pulse rate. It also calculates several additional statistical parameters derived from the SpO2 and the pulse rate.
Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.
5. Statement of Intended Use:
The Spirobank II spirometer and pulse oximeter 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
{1}------------------------------------------------
oximetry testing in people of all ages.
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:
of the MIR Spirobank II combines in a single device the functions both of a spirometer and of a pulse oximeter.
It uses the same spirometry sensor and algorithm and calculates the same parameters as Spirobank, but uses a completely new spirometry PCB.
Spirodains, but asses a compress jimetry PCB as the Spirotel. But in addition to the spot SpO2 ron the pulse rate, it also calculates several additional statistical parameters derived from the SpO2 and the pulse rate.
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 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 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.
Specifically of SpO2 and pulse rate and the statistical parameters which the device calculates, have been verified in-house.
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.
{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 eagle with three overlapping wings, representing the department's mission to protect the health of all Americans. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA", which is arranged in a circular fashion around the logo.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2006
Mr. Simon Fowler M.I.R Medical International Research SRL Via del Maggiolino, 125 00155 Roma. ITALY
Re: K061712 Trade/Device Name: Spirobank II Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG, DQA Dated: November 21, 2006 Received: November 27, 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.
{3}------------------------------------------------
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 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,
Chiu 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
{4}------------------------------------------------
Indications for Use
510(k) Number (K061712):
Device Name: Spirobank II
Indications for Use: The Spirobank II spirometer and pulse oximeter 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 .
- oximetry testing in people of all ages. .
It 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(Eva
f Anesthesiology, General Hospital,
...on Control, Dental Devices
Page 1 of 1
ﮩ
§ 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).