(48 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is limited to a standard spirometer.
No
A spirometer is used for testing and diagnosis of lung function, not for treating a condition.
Yes
The device is a spirometer for lung-function testing, which is a diagnostic procedure used to assess respiratory health and identify potential lung conditions.
No
The description explicitly states the device is a "spirometer," which is a hardware device used for measuring lung function. While it is described as portable, there is no indication that the device itself is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a spirometer for lung-function testing. This involves measuring physiological parameters related to breathing (like forced vital capacity, forced expiratory volume in one second, etc.) directly from the patient's body, not from a sample taken from the body.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples.
Therefore, this device falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
73 BZG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
children to adults
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
| 0002 | ||
|---|---|---|
| 10:51 FAX | ||
| 12/18/98 | ||
| Page | ||
| 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 Devices | ||
| 10(k) Number __ | ||