(287 days)
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No
The provided 510(k) summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses solely on standard spirometry measurements.
No
The device is described as measuring respiratory parameters, which is a diagnostic function, not a therapeutic one. It assesses conditions rather than treating them.
Yes
The device is described as measuring lung functions (FVC, FEVI, PEF, FEV1%) in patients with respiratory conditions like Asthma and COPD, which are measurements used to diagnose and monitor these conditions.
No
The device is described as a "Vitalograph Micro Spirometer," which is a hardware device used to measure lung function. The summary does not mention any software component that functions independently as a medical device.
Based on the provided information, the Vitalograph Micro Spirometer 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.
- Spirometer Function: A spirometer measures lung function by assessing the volume and flow of air during breathing. This is a direct measurement of a physiological process within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use describes measuring lung function parameters (FVC, FEVI, PEF, FEV1%) in patients with respiratory conditions. This aligns with the function of a spirometer and not an IVD.
Therefore, the Vitalograph Micro Spirometer is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vitalograph Micro Spirometer is intended to measure, FVC, FEVI, PEF and FEV1% in patients with respiratory conditions such as Asthma, COPD, etc.
Product codes
73 BZH
Device Description
Vitalograph Micro Spirometer
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 2000
Mr. Phil Hemes Vitalograph Inc. 8347 Quivira Road Lenexa, KS 66215
Re : K991412 Vitalograph Micro Requlatory Class: II (two) Product Code: 73 BZH Dated: Auqust 13, 1999 Received: November 24, 1999
Dear Mr. Hemes:
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 reqistration, 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 requlations 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 requlation may result in In addition, FDA may publish further announcements regulatory action. 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. Phil Hemes
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,
Jecino H. Watashmun for,
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Atalograph Micro Spirometer
Indications for Use
The Vitalograph Micro Spirometer is intended to measure, FVC, FEVI, PEF and FEV1% in patients with respiratory conditions such as Asthma, COPD, etc.
JoAwetashereci
Division Sign Off
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1991412 510(k) Number
prescription use ✓
TC