MIR SPIROBANK SPIROMETER by MIR MEDICAL INTL. RESEARCH SRL

Device is a spirometer for lung-function testing. For testing lung-function in all people from children to adults, generally used by a physician or by a respiratory therapist or technician. Device is portable and thus can be used at home, in the factory, in the hospital, in the doctor's office.

Device Description

Device is a spirometer for lung-function testing. Device is portable.

AI/ML Overview

This document is an FDA 510(k) clearance letter for the MIR Spirobank Spirometer, dated December 21, 1998. It primarily confirms the device's substantial equivalence to predicate devices and allows it to be marketed.

However, this document does NOT contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

The document states:

Device Name: MIR Spirobank Spirometer (Page 2)
Intended Use: "Device is a spirometer for lung-function testing. For testing lung-function in all people from children to adults, generally used by a physician or by a respiratory therapist or technician. Device is portable and thus can be used at home, in the factory, in the hospital, in the doctor's office." (Page 2)
Regulatory Class: II (two) (Page 1)
Product Code: 73 BZG (Page 1)

Therefore, I cannot provide the requested information based on the provided text. This type of information is typically found in the 510(k) submission itself, often in sections detailing device performance testing or clinical studies, which are not part of this clearance letter.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an abstract bird with three human profiles forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1998

Mr. Simon Fowler MIR Medical International Research Vicolo Maddalena 22/A 00041 Albano Laziale, Roma ITALY

Re: K983909 MIR Spirobank Spirometer Regulatory Class: II (two) Product Code: 73 BZG Dated: October 30, 1998 November 3, 1998 Received:

Dear Mr. Fower:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Simon Fowler

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10:51 FAX12/18/98



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510(k) Number (if knovin);
Davico Name:	100 bar




Device is a spirometer for lu 1g-function testing
For testing lung-function in all people from children to adults, generally used by
a physician or by a respirato y therapist or technician.
Device is portable and thus can be used at home, in the factory, in the hospital,in the doctor's office.

File tef FDADOC3




		(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE.ON ANOTHER PAGE IF
NEEDED)
		Concurrence of CDRH, Office of Device Evaluation (ODE)


Marle Kra


Prescription Use_(Per 21 CFR 801.109)		Over-The-Counter Use_
ivision Sign-Off)		(Optional Format 1-2-96)
ivision of Cardiovascular, Respiratory,
nd Neurological Devices10(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).