(212 days)
No
The summary describes a standard pulmonary function testing device that measures PEF and FEV1 based on airflow mechanics. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The software validation is described as "moderate" level of concern, which is typical for devices performing measurements and data storage, not complex AI/ML processing.
No
The device is strictly for monitoring and diagnostic purposes to track respiratory conditions; it does not provide any treatment or therapy.
Yes
The device measures physiological parameters (PEF and FEV1) to monitor respiratory conditions like asthma, which is a key characteristic of a diagnostic device.
No
The device description explicitly states it is a "hand-held pulmonary function testing device" composed of a "main unit and removable mouthpiece," indicating it includes physical hardware components beyond just software.
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: This device measures physiological parameters (PEF and FEV1) directly from the patient's breath. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor respiratory conditions by measuring lung function, not by analyzing biological samples.
Therefore, the Smart Peak Flow Meter (Model: B1) is a medical device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV 1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.
Product codes (comma separated list FDA assigned to the subject device)
BZH
Device Description
Smart Peak Flow Meter (Model: B1) is a new type of hand-held pulmonary function testing device that measures peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1). Regular measurement is beneficial to the controlling of pulmonary disease such as asthma. The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision.
The Smart Peak Flow Meter (Model: B1) is mainly composed of the main unit and removable mouthpiece. The use of B1 is very simple, user can master it quickly after reading the product user manual. It adopts mouth blowing method. After mouthpiece installation and powering on, keep breath steady, take a deep breath, hold the breath while put the mouthpiece into mouth, then exhale quickly and forcefully, taking as much time as possible. The results will be shown on the display screen and smart phone App. The mouthpiece should be removed regularly for cleaning.
The device can store 100 sets of data which can be transmitted to smart phone App through Bluetooth transmission mode for permanent storage. User can check the previous measurement records on the smart phone App.
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
adults and children over 5 years of age
Intended User / Care Setting
Home use, with caregiver supervision.
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)
Non-clinical testings have been conducted to verify that the Smart Peak Flow Meter (Model: B1) meets all design specifications which supports the conclusion that it's Substantially Equivalent to the predicate device. The testing results demonstrate that the targeted device complies with the following standards and guidance:
- IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11. Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- Wireless testing was conducted on the Smart Peak Flow Meter (Model: B1). The device complies with FDA's guidance: Guidance Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff.
The body-contacting components of this device are mouthpiece and main unit which have been demonstrated conformance to the following standards:
- ISO 10993-1, Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process.
We have also conducted:
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern. Software validation demonstrated that the software functions as specified in the software requirement specifications.
- Performance test has also been conducted to verify the measurement accuracy, intra instrument repeatability, PEF inter instrument repeatability and performance of flow resistance of the device according to American Thoracic Society Standard of Spirometry (2005 Revision). All of the tested parameters meet the requirements in the standards. The performance of the targeted device is demonstrated to be comparable with the predicate device in the comparison testing, so it is concluded that the targeted device is substantially equivalent to the predicate device.
- Human Factor Engineering Study
- A HFE study was designed to address the use-related risks, usability concerns and clearness of the Instructions for Use (IFU) and Graphic User Interface (GUI) of Smart Peak Flow Meter application and device, while operated by intended users. All study participants (20 out of 20 -100%) completed the critical tasks with ease and confidence.
- The study results of this human factor engineering study demonstrate that the Smart Peak Flow Meter device and application are as safe and as effective as its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
PEF: ±10% or ±18L/min (Take the larger one)
FEV1: ±3% or ±0.05L (Take the larger one)
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2019
Guangzhou Homesun Medical Technology Co., Ltd % Tracy Che Registered engineer Feiying Drug & Medical Consulting Technical Service Group B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No. 22 Guimiao Rd. Shenzhen, 518000 CN
Re: K191239
Trade/Device Name: Smart Peak Flow Meter (Model: B1) Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter For Spirometry Regulatory Class: Class II Product Code: BZH Dated: November 5, 2019 Received: November 8, 2019
Dear Tracy Che:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Michael Ryan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191239
Device Name Smart Peak Flow Meter (Model: B1)
Indications for Use (Describe)
This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV 1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information
| 510 (k) owner's name: | Guangzhou Homesun Medical Technology Co., Ltd |
|---|---|
| Address: | Floor 7th, TianxiangBusiness Building, No.28, Li Fu Road, Haizhu |
| District, Guangzhou, GD. China | |
| Contact person: | Jinqun Li |
| Phone number: | +86 020 34003801 |
| Fax number: | +86 020 34003801 |
| Email: | ljq@huxijia.com |
| Date of summary prepared: | December 4, 2019 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name/Model: | Smart Peak Flow Meter (Model: B1) |
|---|---|
| Regulation name: | Peak-flow meter for spirometry |
| Regulation number: | 21 CFR 868.1860 |
| Product code | BZH |
| Review panel: | Anesthesiology |
| Regulation class: | Class II |
(4) Predicate and reference device
| Image: bullet point | Predicate device |
|---|---|
| --------------------- | ------------------ |
| Sponsor | Beijing M&B Electronic Instruments Co., Ltd. |
|---|---|
| Device Name and Model | MSA100BT Peak Flow Meter |
| 510(k) Number | K170281 |
| Product Code | BZH |
| Regulation Number | 21 CFR 868.1860 |
| Regulation Class | II |
| Reference device 1 | |
| Sponsor | KORR MEDICAL TECHNOLOGIES, INC. |
4
| Device Name and Model | ACCUTRAX, MODEL EPF840 Electronic Peak Flow Meter |
|---|---|
| 510(k) Number | K982995 |
| Product Code | BZH |
| Regulation Number | 21 CFR 868.1860 |
| Regulation Class | II |
| ◇ Reference device 2 | |
| Sponsor | Clement Clarke Int. Ltd |
| Device Name and Model | Mini-Wright Digital |
| 510(k) Number | K053156 |
| Product Code | BZH |
| Regulation Number | 21 CFR 868.1860 |
| Regulation Class | II |
(5) Description/ Design of device
Smart Peak Flow Meter (Model: B1) is a new type of hand-held pulmonary function testing device that measures peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1). Regular measurement is beneficial to the controlling of pulmonary disease such as asthma. The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision.
The Smart Peak Flow Meter (Model: B1) is mainly composed of the main unit and removable mouthpiece. The use of B1 is very simple, user can master it quickly after reading the product user manual. It adopts mouth blowing method. After mouthpiece installation and powering on, keep breath steady, take a deep breath, hold the breath while put the mouthpiece into mouth, then exhale quickly and forcefully, taking as much time as possible. The results will be shown on the display screen and smart phone App. The mouthpiece should be removed regularly for cleaning.
The device can store 100 sets of data which can be transmitted to smart phone App through Bluetooth transmission mode for permanent storage. User can check the previous measurement records on the smart phone App.
(6) Indications for use
This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.
(7) Technological characteristics and substantial equivalence
5
| Item | Targeted
device | Predicate device | Reference device
1 | Reference device
2 | Remark |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Trade name | Smart Peak
Flow Meter
(Model: B1) | MSA100BT Peak
Flow Meter | ACCUTRAX,
MODEL EPF840
Electronic Peak
Flow Meter | Mini-Wright
Digital | / |
| 510
(k)
number | K191239 | K170281 | K982995 | K053156 | / |
| Regulation
number | 21 CFR
868.1860 | 21 CFR 868.1860 | 21 CFR 868.1860 | 21 CFR 868.1860 | Same |
| Regulation
description | Peak-flow
meter for
spirometry | Peak-flow meter
for spirometry | Peak-flow meter
for spirometry | Peak-flow meter
for spirometry | Same |
| Classificatio
n name | Meter, Peak
Flow,
Spirometry | Meter, Peak Flow,
Spirometry | Meter, Peak Flow,
Spirometry | Meter, Peak Flow,
Spirometry | Same |
| Product
code | BZH | BZH | BZH | BZH | Same |
| Class | II | II | II | II | Similar |
| Indications
for use/
Intended use | This device is
intended to
monitor a
patient's Peak
Expiratory
Flow (PEF)
and Forced
Expiratory
Volume in one
second (FEV1)
at home. The
device is
intended for
monitoring
respiratory
conditions
such as
asthma. | This device is
intended for
monitoring PEF
(Peak Expired
Flow Rate) and
FEV1 (Forced
Expiratory
Volume in one
second) for
patient home use.
The device is
designed for
pediatric to adult
patients. The
device is intended
for monitoring
respiratory
conditions such as
asthma. | This AccuTrax
EPF80 device is
intended for
monitoring PEF
and FEV1 for
patient home and
work use. The
EPF840 is
designed for
pediatric to adult
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 | The Mini-Wright
Digital is a
handheld, battery
operated,
electronic Peak
Flow Meter and
FEV1 monitoring
device with an
internal memory
capable of storing
240 sets of
readings. This
product will be
sold as an OTC
device with
appropriate
instructions.
When used to
monitor
conditions such as
asthma, this
device should be
used under the
direction of a | Similar |
| | | | importance of the | physician or | |
| | | | measures reported | licensed health | |
| | | | by the AccuTrax | care professional. | |
| | | | 840, and how to | The device is | |
| | | | decide on an
appropriate | intended for use | |
| | | | treatment plan. | with pediatric and | |
| | | | This treatment
plan will tell you | adult patients in
both home and
clinical settings. | |
| | | | what action to
take when there
are changes in
your PEF/FEV1
numbers. | | |
| Patient
population | Pediatric to
adult patients. | Pediatric to adult
patients. | Pediatric to adult
patients. | Pediatric to adult
patients. | Same |
| Prescription
or OTC | OTC | OTC | Prescription | OTC | Same |
| Basic unit specification | | | | | |
| Power
supply | 3.7V-300mAh
lithium
polymer
battery | AAA 1.5x2
alkaline batteries | Primary source:
Alkaline 9-volt
battery
RTC backup:
Lithium 3V
battery CR2032 | Lithium coin
CR2032 (included,
not changeable) | Different
Note 1 |
| Dimensions | 1113940mm | 1265428mm | 8811248mm | 2944114mm | Different
Note 2 |
| Weight | 50g | 120g (including
batteries and
mouthpiece) | 184g with battery | 54g | Different
Note 2 |
| Materials | PP
(Mouthpiece) | PP (Mouthpiece) | ABS, Cycolac
2502 (GE
Plastics)
(flowhead) | / | Same |
| Components | Mainly
composed of
main unit and
removable
mouthpiece. | Mainly composed
of main
equipment,
mouthpiece,
turbine sensor. | Mainly composed
of flowhead and
unit body. | Mainly composed
of meter and
adapter | Similar |
| Compliance
with
voluntary
standards | IEC 60601-1,
IEC
60601-1-2,
IEC
60601-1-11 | IEC 60601-1,
IEC 60601-1-2,
ATS 2005. | ATS standard | ATS 1994 | Similar |
| | ATS 2005. | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Performance specification | | | | | |
| Measuring
method | Flow: Pressure
Sensor.
Volume: Flow
Integration | Flow:
Turbine
sensor
Volume: Flow
integration | Flow:
Air
pressure reducing
mess in a flow
head is applied to
a pressure
transducer
Volume: Flow
integration | Pressure sensor | Different
Note 3 |
| Measuring
range
of
PEF | 50-840L/min | 50-900L/min | 875L/min (max) | 60-850L/min | Similar |
| Measuring
range
of
FEV1 | 0.01-9.99L | 0.01-9.99L | 8.5L (max) | 0.6-8L | Same |
| Accuracy | PEF: ±10% or
±18L/min
(Take the
larger one)
FEV1: ±3% or
±0.05L (Take
the larger one) | PEF: ±20L/min or
±10% of the
reading;
FEV1: ±0.05L or
±3% of the
reading. | PEF: ±10% or
±24L/min
whichever is
greater
FEV1: ±5% or
±0.100L
whichever is
greater | PEF: ±6%
FEV1: ±3.5%
(@25°1013mbar
50%HR) | Similar
Note 4 |
| Measuring
resolution | PEF: 1L/min
FEV1: 0.01L | PEF: 1L/min
FEV1: 0.01L | / | PEF: 5L/min
FEV1: 0/05L | Same |
| Memory | 100 historical
data | 250 recordings | 480 tests | 240 FEV1 and 240
PEF | Different
Note 5 |
| Data safety | Data
rememorized
by flash
memory. | Data
rememorized by
flash memory. | / | / | Same |
| Data
transmission | Bluetooth
wireless
transmission | BLE wireless
transmission | / | / | Same |
| Working
conditions | Temperature:
10°C~+40°C,
Humidity: 0%
RH80%RH,+40°C,
Atmospheric
pressure: | Temperature:
10°C
Humidity: 25 %
RH85%RH,35°C | Temperature:
Atmospheric
pressure: | Temperature:
15°C
15°C35°C | Similar |+50℃,
| | | | | | |
| Storage
conditions | 70KPa ~
106KPa | 86KPa ~
106KPa | / | Temperature:
-10℃
Humidity: 15 to
95% | Similar |
| | Temperature:
-20°C ~
+55°C, | Temperature:
-10°C~+55°C,
Humidity: 15 % | / | | |
| | Humidity: 0%
RH80%RH, | RH93%RH,
Atmospheric
pressure: | / | | |
| | Atmospheric
pressure: | 50KPa ~
106KPa | / | | |
| | 70KPa ~
106KPa | | / | | |
| | 106KPa | | / | | |
| | | | / | | |
| | | | / | | |
| Biocompatibility | Passed the
tests as per
ISO 10993-1 | Passed the tests as
per ISO 10993-1 | / | / | Same |
| Electrical
safety | Passed the
tests as per
IEC
60601-1
and IEC
60601-1-11 | Passed the test as
per IEC 60601-1 | / | / | Similar |
| EMC | Passed the test
as per IEC
60601-1-2 | Passed the test as
per IEC
60601-1-2 | / | / | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same |
6
7
8
A Note 1:
The targeted device uses lithium battery for power supply which is different from the predicate device, but the lithium battery has been tested according to IEC 62133, so this difference should not raise any problems. And the reference devices also use lithium battery for power.
A Note 2:
Although the appearance, weight and dimensions are different between the targeted and predicate device, these differences are insignificant and do not raise any problems.
A Note 3:
The targeted device adopts pressure sensor to transform air flow into electrical signal. while the predicate device adopts turbine sensor to transform air flow into pulse signal. Although the measuring method is different, the difference will not raise any problems, as both devices were demonstrated to have electromagnetic compatibility, electrical safety and measurement accuracy by testing. And the reference devices also adopt pressure sensor/transducer, so this measuring method is similar.
A Note 4:
The accuracy of the targeted device's PEF is similar to that of the predicate device.
A Note 5:
The difference in memory does not raise any problems.
Conclusion:
Based on the above analysis, the Smart Peak Flow Meter (Model: B1) is substantially equivalent to
9
the predicate device.
(8) Non-clinical studies and tests performed
Non-clinical testings have been conducted to verify that the Smart Peak Flow Meter (Model: B1) meets all design specifications which supports the conclusion that it's Substantially Equivalent to the predicate device. The testing results demonstrate that the targeted device complies with the following standards and guidance:
- A IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
-
IEC 60601-1-11. Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- A Wireless testing was conducted on the Smart Peak Flow Meter (Model: B1). The device complies with FDA's guidance: Guidance Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff.
The body-contacting components of this device are mouthpiece and main unit which have been demonstrated conformance to the following standards:
-
A ISO 10993-1, Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process.
We have also conducted: -
A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern. Software validation demonstrated that the software functions as specified in the software requirement specifications.
-
A Performance test has also been conducted to verify the measurement accuracy, intra instrument repeatability, PEF inter instrument repeatability and performance of flow resistance of the device according to American Thoracic Society Standard of Spirometry (2005 Revision). All of the tested parameters meet the requirements in the standards. The performance of the targeted device is demonstrated to be comparable with the predicate device in the comparison testing, so it is concluded that the targeted device is substantially equivalent to the predicate device.
-
A Human Factor Engineering Study
10
A HFE study was designed to address the use-related risks, usability concerns and clearness of the Instructions for Use (IFU) and Graphic User Interface (GUI) of Smart Peak Flow Meter application and device, while operated by intended users. All study participants (20 out of 20 -100%) completed the critical tasks with ease and confidence.
The study results of this human factor engineering study demonstrate that the Smart Peak Flow Meter device and application are as safe and as effective as its predicate device.
(10) Conclusion
Based on the above analysis and tests performed, it can be concluded that the performance and function of Smart Peak Flow Meter (Model: B1) are Substantially Equivalent to the predicate device.