(314 days)
Not Found
Not Found
No
The summary describes standard spirometry functions and data management without mentioning AI or ML.
No
The device is used for diagnostic tests (measuring functional parameters, calculating indices, and providing automatic diagnosis) rather than for treating a condition.
Yes
The device performs "functional automatic diagnosis" and uses an "11 scale classification" based on "ATS recommendations," which indicates it is used to identify or characterize medical conditions.
No
The description explicitly mentions an "LCD display of the device" and a "Memory bank of the device," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the Spirobank indicates it performs pulmonary function tests (FVC, VC, IVC, MVV, etc.). These tests involve measuring the volume and flow of air inhaled and exhaled by a patient. This is a direct measurement of a physiological function, not an analysis of a biological specimen.
Therefore, the Spirobank is a medical device used for physiological measurement, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Spirobank can carry out the FVC, VC & IVC, MVV and respiratory profile tests, measuring more than 20 functional parameters, and also calculate repeatability and test acceptability indices. The functional automatic diagnosis consists of an 11 scale classification, as laid down in the ATS recommendations.
The tests can be performed in adults and pediatrics, in the hospital, clinic and at home.
Results are displayed on the LCD display of the device, and printed on an external printer, transferred to a PC. Memory bank of the device can store several hundred test results which may be transferred to a PC, printed on an external printer, or reviewed on the device at a later date.
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
Not Found
Indicated Patient Age Range
adults and pediatrics
Intended User / Care Setting
hospital, clinic and at home.
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 1998
Mr. Michael Davidson Futuremed America, Inc. 15700 Devonshire Street Granada Hills, CA 91344-7225
Re: K973456 "SPIROBANK" Portable PC Based Spirometer Requlatory Class: II (two) Product Code: 73 BZG Dated: April 24, 1998 Received: April 27, 1998
Dear Mr. Davidson:
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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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. Michael Davidson
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 regulation (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,
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
| Page | ___ of ___ |
|---|---|
| ------ | ------------ |
| 510(k) Number (if known): | (K) 973456 |
|---|---|
| Device Name: | SPIROBANK |
Indications For Use:
Spirobank can carry out the FVC, VC & IVC, MVV and respiratory profile tests, measuring more than 20 functional parameters, and also calculate repeatability and test acceptability indices. The functional automatic diagnosis consists of an 11 scale classification, as laid down in the ATS recommendations.
The tests can be performed in adults and pediatrics, in the hospital, clinic and at home.
Results are displayed on the LCD display of the device, and printed on an external printer, transferred to a PC. Memory bank of the device can store several hundred test results which may be transferred to a PC, printed on an external printer, or reviewed on the device at a later date.
R. Ramgoolie
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE.ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
York Madra 7-20-98
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use_ 10200xpace = 201, 1091 510(k) Number_ (Optional Format 1-2-98)