(155 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard spirometry measurements and calculations based on pressure and flow.
No
The device is used for lung-function diagnosis by measuring and analyzing breath flow, volume, and pressure, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "lung-function diagnosis."
No
The device description explicitly states that the system comprises hardware components including a hand-held pneumotach with a sensor and USB interface, in addition to the software.
Based on the provided information, the Flowhandy ZAN100 USB is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Flowhandy ZAN100 USB Function: The Flowhandy ZAN100 USB measures and analyzes breath flow, volume, and pressure directly from the subject's breathing. It does not analyze specimens taken from the body.
Therefore, the Flowhandy ZAN100 USB falls under the category of a medical device used for physiological measurement, specifically spirometry, rather than an IVD.
N/A
Intended Use / Indications for Use
The Flowhandy ZAN100 USB is an open, personal-computer-based spirometry system with optional shutter for measuring and analyzing breath flow, volume, and pressure in adult and pediatric subjects for use by pulmonologists, allergists, general practitioners, and occupationalmedicine practitioners in lung-function diagnosis.
Product codes
73-BZG, BZG
Device Description
The Flowhandy ZAN100 USB is a pneumotachometer spirometry system. The system comprises a Windows personal computer (sold separately) for data collection, analysis, storage, and display; proprietary Betterflow ZAN100 USB software program for the PC; and a Flowlandy, hand-held pneumotach with reusable variable-orifice core, differential pneumatic pressure sensor, and USB interface. An optional computer-controlled shutter may be added to the air passageway to interrupt flow to allow pressure measurements using the on-board pressure sensor.
The ZAN100 measures the pressure drop across the known orifice to indicate the rate of breath flow both in and out of the air passageway. Knowing the flow rate of air from a subject allows the calculation of the most recognized spirometric values for the subject. Closing off the passageway with the optional shutter enables the pressure sensor to take important pressure measurements for the subject's breathing as well.
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
adult and pediatric subjects
Intended User / Care Setting
pulmonologists, allergists, general practitioners, and occupationalmedicine practitioners
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
Safety: The Flowhandy was examined and bench tested by third-party examiners to demonstrate conformance to three recognized international consensus standards for safety of medical electrical equipment: EN 60601-1 for general medical-device safety of medical electrical safety, and EN 60601-1-2 for electromagnetic compairity.
Effectiveness: In-house and third-party testing demonstrate that Flowhandy measurement performance meets or exceeded published American Thoracic Society requirements and the claimed performance meeting requirements under stated and anticipated operating conditions.
Clinical: CE marking and years of successful operation in Europe demonstrate that patients and clinicians can safely and effectively use the Flowhandy under actual-use conditions and that the users guide, product physical design, and other human-factor characteristics of the Flowlandy system are appropriate for the product's intended use.
Key Metrics
Volume resolution:
§ 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
510(k) Number K052176
Date
Flowhandy ZAN100 USB 510(k) Summary
Submitter
| Company: | ZAN Messgeräte GmbH
Schlimpfhofer Strasse 14, D-97723 Oberthulba, Germany
Tel +49 97 36 81810, Fax +49 97 36 818120 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jim Lewis
Ferraris Respiratory Inc, 908 Main Street, Louisville CO 80027, USA
Tel 303 666 5555, Fax 303 666 5588 |
| Prepared: | August 2005 |
| Device Name | |
| Trade: | Flowhandy ZAN100 USB |
| Common: | Spirometer |
| Classification: | Diagnostic spirometer, 21 CFR 868.1840; Class II |
| Product code: | 73-BZG |
| Predicate Devices | |
| Trade Name: | MasterScreen Pneumo |
| 510(k) Number: | K933839 |
| Manufacturer: | Erich Jaeger Gmbh |
Device Description
The Flowhandy ZAN100 USB is a pneumotachometer spirometry system. The system comprises a Windows personal computer (sold separately) for data collection, analysis, storage, and display; proprietary Betterflow ZAN100 USB software program for the PC; and a Flowlandy, hand-held pneumotach with reusable variable-orifice core, differential pneumatic pressure sensor, and USB interface. An optional computer-controlled shutter may be added to the air passageway to interrupt flow to allow pressure measurements using the on-board pressure sensor.
The ZAN100 measures the pressure drop across the known orifice to indicate the rate of breath flow both in and out of the air passageway. Knowing the flow rate of air from a subject allows the calculation of the most recognized spirometric values for the subject. Closing off the passageway with the optional shutter enables the pressure sensor to take important pressure measurements for the subject's breathing as well.
Indications for Use
The Flowhandy ZAN100 USB is an open, personal-computer-based spirometry system with optional shutter for measuring and analyzing breath flow, volume, and pressure in adult and pediatric subjects for use by pulmonologists, allergists, general practitioners, and occupationalmedicine practitioners in lung-function diagnosis.
1
Summary of Technological Characteristics
The Flowhandy uses the pressure difference in the air stream across a variable-orifice diaphragm to measure a subject's airflow rate (pneumotachometry) throughout established breathing maneuvers to provide spirometric analysis. The instantaneous flow rate values are acquired on a personal computer, where the data is analyzed, stored, and displayed. The optional shutter is a solenoid-activated valve for interrupting airflow.
Technical Specifications
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- Operating temperature range: 10 to 40 °C Operating humidity: 20 to 90%, non-condensing Storage temperature: 0 to 40 °C Storage humidity: 10 to 90%, non-condensing Material: POM (polyoxymethylene) Enclosure rating: IPX1 Type of applied part: BF (subject floating) Flow sensing Measuring principle: Pressure difference with variable diaphragm (pneumotachometry) Dimensions: 100x90x45 mm Weight: 250 a Power supply: 5 VDC, 0.2 Wmax (powered from USB port) Pressure transducer: Semiconductor; 0 to 1.4 kPa; 0.1% accuracy Volume resolution: