(99 days)
Not Found
No
The summary describes a standard electronic PEF/FEV monitor with data storage and retrieval capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies. The testing described is based on comparing measurements to a waveform generator, not on training or evaluating an AI/ML model.
No
The device is described as a monitor for PEF and FEV, used to watch lung conditions. It does not provide treatment or directly affect the body's structure or function, but rather provides data for a healthcare professional to determine a treatment plan.
Yes
The device is intended for "monitoring PEF and FEV", which are indicators of lung function. It collects and stores data (PEF/FEV test results, symptom scoring, inhaler usage) for analysis by a physician to "watch lung conditions such as asthma". The output requires a "licensed health care professional's advise... to understand the meaning and importance of the measures reported... and how to decide on an appropriate treatment plan," indicating its role in informing clinical decisions about a patient's condition.
No
The device description explicitly states "The EPF840 is an electronic PEF/FEV; monitor," indicating it is a hardware device that measures PEF and FEV. The performance studies also describe testing the "electronic peak flowmeter" using a waveform generator, further confirming it is a physical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended for monitoring PEF and FEV, which are measurements of lung function. These measurements are taken directly from the patient's breath, not from a sample of bodily fluid or tissue that is tested in vitro (outside the body).
- Device Description: The device is an electronic monitor that measures airflow. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures typically associated with IVD devices that analyze biological samples.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device measures a physiological parameter directly from the patient.
N/A
Intended Use / Indications for Use
This AccuTrax EPF840device is intended for monitoring PEF and FEV; for patient home and work use. The EPF840 is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the EPF840 is used to watch lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advise is required to understand the meaning and importance of the measures reported by the AccuTrax 840, and how to decide on an appropriate treatment plan. This treatment plan will tell you what action to take when there are changes in your PEF/FEV; numbers.
Product codes (comma separated list FDA assigned to the subject device)
AN-BZH, 73 BZH
Device Description
The EPF840 is an electronic PEF/FEV; monitor. It can store PEF/FEV; test results, symptom scoring, and inhaler usage with a time and date stamp. The physician may retrieve data for analysis and trending using a personal computer. The physician may customize color zone indicators to the patient's needs.
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
pediatric to adult patients
Intended User / Care Setting
patient home and work use. The user should be under the care of a licensed health care professional. A licensed health care professional's advise is required.
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
The ACCUTRAX EPF840 electronic peak flowmeter was tested at an independent laboratory using a precision waveform generator. The peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) measurements from the EPF840 were compared against the generated values. Both PEF and FEV1 values were well within the required ATS accuracy specifications using the 24 standard waveforms and the 26 flow-time waveforms. Inter-device and intra-device variability testing demonstrated the EPF840 to comply with all variability requirements.
Both the EPF840 and the predicate device was tested using Waveform #24 using a range of scale factors. The generator multiplies each flow by the scale factor. PEF reported by the EPF 840 is compared to the values reported by the generator. The scale factors tested are 0.8, 1.0, 1.2, 1.6, 2.0, 2.4, 2.8, 3.0, 4.0, and 5.7.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Data:
The ACCUTRAX EPF840 electronic peak flowmeter was tested at an independent laboratory using a precision waveform generator. The peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) measurements from the EPF840 were compared against the generated values. Both PEF and FEV1 values were well within the required ATS accuracy specifications using the 24 standard waveforms and the 26 flow-time waveforms. Inter-device and intra-device variability testing demonstrated the EPF840 to comply with all variability requirements. Our evaluation showed the EPF840 to be accurate and extremely repeatable in all tests
Both the EPF840 and the predicate device was tested using Waveform #24 using a range of scale factors. The generator multiplies each flow by the scale factor. PEF reported by the EPF 840 is compared to the values reported by the generator. The scale factors tested are 0.8, 1.0, 1.2, 1.6, 2.0, 2.4, 2.8, 3.0, 4.0, and 5.7.
Both devices operated within the 10% specification of the ATS standard for peak flow.
Clinical Data:
Determination of substantial equivalence is not based on assessment of clinical data.
Performance testing at LDS Hospital (Salt Lake City, UT) demonstrates that the EPF840 meets the ATS standard recommendations.
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.
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
§ 868.1860 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).
0
4 1998 DEC
1998 k
II 510(k) Summary
2.0 General
In accordance with the Safe Medical Devices Act of 1990 (SMDA), this section is a summary of the safety and effectiveness information for this premarket notification upon which an equivalence determination could be based (510(k) summary) [21 CFR & 807.31.
2.1 Submitter Information
| Applicant: | KORR Medical Technologies, Inc. |
|---|---|
| Contact: | Scott A. Kofoed |
| Address: | 3090 East 3300 South Suite 3B |
| Salt Lake City, UT 84109 | |
| Phone: | (801) 483-2080 |
| Fax: | (801) 483-2123 |
| Date Prepared: | Friday, August 21, 1998 |
| Trade name: | ACCUTRAX Electronic Peak Flow Meter |
| Common Name: | Peak Flow Meter |
| Model: | EPF840 |
| Classification name: | Meter, Peak Flow, Spirometry |
|---|---|
| Product Code: | AN-BZH |
CFR Section: .................................................................................................................................................................
Classification: ...................................................... Class II
Predicate Device: ................. Vitalograph 2110 Electronic Flow Meter
510(k) Number: K943678
2.2 Device Description
The EPF840 is an electronic PEF/FEV; monitor. It can store PEF/FEV; test results, symptom scoring, and inhaler usage with a time and date stamp. The physician may retrieve data for analysis and trending using a personal computer. The physician may customize color zone indicators to the patient's needs.
1
2.3 Intended Use
This AccuTrax EPF840device is intended for monitoring PEF and FEV; for patient home and work use. The EPF840 is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the EPF840 is used to watch lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advise is required to understand the meaning and importance of the measures reported by the AccuTrax 840, and how to decide on an appropriate treatment plan. This treatment plan will tell you what action to take when there are changes in your PEF/FEV; numbers.
The product literature contains the text, "CAUTION: Federal Law restricts this device to sale by or on the order of a physician."
2
KORR Medical Technologies, Inc. Section II: 510(k) Summary
Peak Flow Meter - 510(k) premarket notification 08/25/98
| | Parameter
Compared | ACCUTRAX Model EPF840 | Predicate Device
(2110) | Difference Between | |
|----------------------------|------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| 1 | Manufacture | KORR Medical Technologies | Vitalograph | | |
| 2 | Model Name | AccuTrax Model EPF840 electronic
Peak Flow Meter | 2110 electronic PEF/FEV₁ Diary | | |
| 3 | FDA Number | (pending) | K943678 | | |
| 4 | Parameters Measured | PEF FEV1 | PEF FEV1 | No difference | |
| 5 | Flowhead | | | | |
| | Flow detection
principle | Air pressure reducing mess in a flow
head is applied to a pressure
transducer. | Air pressure reducing mess in a flow
head is applied to a pressure
transducer. | No difference | |
| | Back pressure |