(178 days)
No
The description focuses on standard pulmonary function testing measurements and calculations based on established criteria (ATS). There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is intended for "Pulmonary Function Testing," which involves measuring a person's ability to move air into and out of their lungs, and then reporting these measurements. This is a diagnostic function, not a therapeutic one. It provides information about lung function but does not treat or alleviate a medical condition.
Yes.
The device measures volume and flow rates for pulmonary function testing, which are then reported as numerical results. These measurements are used to assess a person's ability to move air into and out of their lungs, diagnosing conditions related to lung function.
No
The device description clearly outlines hardware components such as a "Flow sensing pneumotach and base," "molded from high impact UL rated ABS plastic," and "rechargeable Ni-Cad batteries." It also mentions physical interactions like "Field calibration with a 1 to 9 Liter calibration syringe" and "Cross-contamination control via external filter system." These are all indicative of a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs)." This involves measuring physical parameters (volume and flow rates) directly from the patient's respiratory system.
- 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 Description: The device measures differential pressure as air passes through it, which is a physical measurement of airflow. It does not analyze biological samples.
Therefore, the Flowmate LTE is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended use for the Flowmate LTE is for Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs). The volume and flow rates measured for the entire effort and then reported as numerical results with a printout of the effort if selected.
Product codes
Not Found
Device Description
Flow sensing pneumotach and base that measures differential pressure as air passes through it (the same principle as the Flowmate, PC Flow +, Renaissance, and Flash devices)
Compact design molded from high impact UL rated ABS plastic. rechargeable Ni-Cad batteries for portable operation,
Automatic calculations of test results, and best test selection based on ATS criteria
Testing capabilities include; FVC, FEV1, FEV3, FEV1/FVC%, FEF.2-1.2, FEF25-75%, FEF75-85, PEF, FEF50, FIVC, FEF50/FIF50, PIF, MVV, Methacholine Challenge, and Lung Age
Testing Capabilities: Capacity 10 Liters
Volume Accuracy +/- 3% Max. Flow Rate +/- 16 L/s
Back Pressure Less than 1.5 cm H2O
Population Predicted Normals included: Composite Knudson Crapo (ITS) ECCS HSU
Customization allows user to change report format, input temperature and barometric readings, and select printer driver for printer being used
Reports printed on standard 8 1/2 " x 11" paper
Field calibration with a 1 to 9 Liter calibration syringe
Cross-contamination control via external filter system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs (referenced by Pulmonary Function Testing)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Waveform performance testing showed that the Flowmate LTE exceeded the ATS recommendations for FVC. FEV1. FEF 25-75 and PEF accuracy at all of the 24 waveforms except #17. Waveform #17 takes over 20 seconds to complete. The Flowmate LTE accumulates volume for up to 15 seconds the same as the Flowmate 2500. Therefore, some of Waveform #17's volume was produced after the Flowmate LTE stopped recording data from the effort, which accounts for the variation between the actual delivered volume and the measured volume (See Exhibit 2). Taking the volume at the 15 second mark generated by waveform #17 (5.662 Liters) the accuracy is within the ATS recommendation at - 1.8%.
MVV testing used a 2 Liter volume at flow/rates from 40 to 245 L/M also showed acceptable results compared with the ATS criteria for accuracy and precision to the delivered values (See Exhibit 3).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K863953/A, K900673, K911143, unkown
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
Page 1 of 2
"Dedicated to Improving the Quality of Life"
510(k) SUMMARY
Submitted by: New VED Inc. d.b.a. Spirometrics Medical Equipment Co. 415 Rodman Road Auburn, ME 04210 207-784-0906, Fax 207-784-1481
Contact Person: Donald Henton, Official Correspondent Date Prepared: October 10, 1995
- � Classification Name: Diagnostic Spirometer
- Common or Usual Name: Diagnostic or Screening Spirometer �
- Proprietary Name: Flowmate LTE �
- Establishment Registration Number: 1720605 �
- Classification: Diagnostic Spirometers have been classified as Class II devices. �
- Performance Standard: None applicable �
Spirometrics has been marketing a flow sensing pneumotach with its models Flowmate and PC Flow + . The proposed product is substantially equivalent to the Flowmate 2500 premarket notification number K863953/A, and PC Flow + 3350 premarket notification number K900673 both manufactured by Spirometrics, the Renaissance from Puritan Bennett premarket notification number K911143, and the Flash Portable Spirometry System from Tamarac Systems Corporation premarket notification number unkown.
For a description of the device see Exhibit 1.
Description of the device:
- � Flow sensing pneumotach and base that measures differential pressure as air passes through it (the same principle as the Flowmate, PC Flow +, Renaissance, and Flash devices)
- � Compact design molded from high impact UL rated ABS plastic. rechargeable Ni-Cad batteries for portable operation,
- � Automatic calculations of test results, and best test selection based on ATS criteria
510(k) SUMMARY
510(k) SUMMARY
1
- Testing capabilities include; FVC, FEV1, FEV3, FEV1/FVC%, FEF.2-1.2, � FEF25-75%, FEF75-85, PEF, FEF50, FIVC, FEF50/FIF50, PIF, MVV, Methacholine Challenge, and Lung Age
- Testing Capabilities: Capacity 10 Liters �
Volume Accuracy +/- 3% Max. Flow Rate +/- 16 L/s
Back Pressure Less than 1.5 cm H2O
- Population Predicted Normals included: Composite �
Knudson Crapo (ITS) ECCS
HSU
- Customization allows user to change report format, input temperature and � barometric readings, and select printer driver for printer being used
- � Reports printed on standard 8 1/2 " x 11" paper
- Field calibration with a 1 to 9 Liter calibration syringe �
- Cross-contamination control via external filter system �
Intended use for the Flowmate LTE is for Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs). The volume and flow rates measured for the entire effort and then reported as numerical results with a printout of the effort if selected.
Waveform performance testing showed that the Flowmate LTE exceeded the ATS recommendations for FVC. FEV1. FEF 25-75 and PEF accuracy at all of the 24 waveforms except #17. Waveform #17 takes over 20 seconds to complete. The Flowmate LTE accumulates volume for up to 15 seconds the same as the Flowmate 2500. Therefore, some of Waveform #17's volume was produced after the Flowmate LTE stopped recording data from the effort, which accounts for the variation between the actual delivered volume and the measured volume (See Exhibit 2). Taking the volume at the 15 second mark generated by waveform #17 (5.662 Liters) the accuracy is within the ATS recommendation at - 1.8%.
MVV testing used a 2 Liter volume at flow/rates from 40 to 245 L/M also showed acceptable results compared with the ATS criteria for accuracy and precision to the delivered values (See Exhibit 3).
Our conclusion is that the Flowmate LTE is substantially equivalent to the predicate device the Flowmate. It is also substantially equivalent to the PC Flow +. Renaissance, and Flash Portable Spirometry System.
Page 2 of 2