(88 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is a standard spirometer.
No
The device measures spirometer readings (FEV1 and FVC), which are diagnostic measurements, not a form of therapy.
Yes
The device is described as a spirometer that takes readings of a patient, and provides output readings (FEV1 and FVC), which are used for diagnosis related to lung function. It also mentions a predicate device which is a spirometer, further supporting its diagnostic function.
No
The device description explicitly states it is a "hand-held portable electronic spirometer," which indicates a hardware component is involved in taking the readings.
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 described device is a spirometer that measures lung function (FEV1 and FVC) during exhalation. This is a direct measurement of a physiological process within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to take spirometer readings, which is a pulmonary function test.
- Anatomical Site: The anatomical site is the lung, indicating a direct interaction with the respiratory system.
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
The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC.
Product codes
73 BZG
Device Description
A hand-held portable electronic spirometer measuring FEV1 and FVC
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
Not Found
Intended User / Care Setting
Places where a qualified clinican desires to take these lung measurements - FEV1 and FVC.
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
None applicable
Key Metrics
Not Found
Predicate Device(s)
Spirometrics Model 2600 Micro Spirometer - K901057
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows a logo with the word "Micro" in a bold, sans-serif font, positioned above the word "Direct" in a similar but slightly less bold font. The word "Micro" is set against a solid black rectangular background, while "Direct" is placed on a white background. The overall design is simple and emphasizes the two words, likely representing a company or brand name.
NOV - 1 1996
Non-Confidential Summary of Safety and Effectiveness August 1, 1996
page 1 of 2
| Micro Direct, Inc.
840 Pownal Rd.
| Auburn, ME 04210 | Tel - (207) 786-7808 | Fax - (207) 786-7280 |
|---|---|---|
| Official contact: | David R. Staszak, President | |
| Proprietary or Trade Name: | Micro Spirometer | |
| Common/Usual Name: | Diagnostic Spirometer | |
| Classification Name: | 73 BZG - Diagnostic Spirometer | |
| Intended device: | Diagnostic spirometer | |
| Predicate devices: | Spirometrics Model 2600 Micro Spirometer - K901057 | |
| Device description: | A hand-held portable electronic spirometer measuring FEV1 | |
| and FVC |
Indicated use:
The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC.
Targeted population:
Patients requiring lung function evaluations.
Environment of use:
Places where a qualified clinican desires to take these lung measurements - FEV1 and FVC.
Comparison to predicate devices:
| Attribute | Intended
device | Spirometrics
Model 2600 | |
|----------------------------------------------------------------------------------------------|--------------------|----------------------------|--------------|
| Use
Intended as a spirometer | Yes | Yes | |
| Intended to measure
lung function FEV1 and FVC | Yes | - | page 3 of 29 |
| Attribute | Intended
device | Spirometrics
Model 2600 | |
| Use (continued)
Indicated for measuring
patients lung function | Yes | Yes | |
| Indicated for use by a clinican
in environments such as the
home or hospital | Yes | Yes | |
| Manufactured by Micro Medical | Yes | Yes | |
| Exact same unit as supplied to
and marketed by Spirometrics and
approved under K901057 | Yes | - - | |
| Design
Transducer - flow sensing turbine | Yes | Yes | |
| No output | Yes | Yes | |
| Flow range lps BTPS 0-12 | Yes | Yes | |
| Volume range liters 0-9.99 | Yes | Yes | |
| Measures - FVC - FEV1 | Yes | Yes | |
| Accuracy + / - 3 | Yes | Yes | |
| Display LCD | Yes | Yes | |
| Transducer cleaned after use | Yes | Yes | |
| Utilizes paper mouthpiece | Yes | Yes | |
| Materials
Same materials as K901057 | Yes | Yes | |
| Performance Testing
None applicable | Yes | Yes | |
1
Non-Confidential Summary of Safety and Effectiveness August 1, 1996
page 2 of 2
Comparison to predicate devices: (continued)
Differences
There is no difference between the intended device and the listed predicate device.