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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and a study for the Smart Peak Flow Meter (Model: B1).

1. A table of acceptance criteria and the reported device performance

Criteria	Acceptance Criteria (from ATS 2005 Standard)	Reported Device Performance
PEF Accuracy	±10% or ±18 L/min (whichever is greater)	Meets the requirements in the standards (ATS 2005)
FEV1 Accuracy	±3% or ±0.05 L (whichever is greater)	Meets the requirements in the standards (ATS 2005)
Intra-instrument Repeatability	Not explicitly stated, but implied to meet ATS 2005	Meets the requirements in the standards (ATS 2005)
Inter-instrument Repeatability	Not explicitly stated, but implied to meet ATS 2005	Meets the requirements in the standards (ATS 2005)
Flow Resistance	Not explicitly stated, but implied to meet ATS 2005	Meets the requirements in the standards (ATS 2005)
Software Functionality	Software functions as specified in software requirement specifications	Software validation demonstrated functionality
Biocompatibility	Conformance to ISO 10993-1	Passed tests as per ISO 10993-1
Electrical Safety	Conformance to IEC 60601-1 and IEC 60601-1-11	Passed tests as per IEC 60601-1 and IEC 60601-1-11
EMC	Conformance to IEC 60601-1-2	Passed test as per IEC 60601-1-2
Wireless Functionality	Compliance with FDA's guidance for RF Wireless Technology	Complies with FDA's guidance
Human Factors	Ease of use, safety, and effectiveness for intended users	100% of participants completed critical tasks with ease and confidence; device and application are as safe and effective as predicate device

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Performance Test (Accuracy, Repeatability, Flow Resistance): The document states "All of the tested parameters meet the requirements in the standards," but it does not specify the sample size used for the performance testing.
Human Factor Engineering Study:
- Sample Size: 20 participants
- Data Provenance: Not specified, but likely a prospective study conducted for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document refers to conformance with the American Thoracic Society (ATS) Standard 2005 Revision for performance testing. For such standards, the "ground truth" is typically defined by the standard's specifications and measurement methods using reference equipment. No information is provided about human expert involvement in establishing a ground truth for the performance test itself. For the human factors study, the "ground truth" would be the observed user interaction and satisfaction, not expert medical opinion.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The performance testing relies on comparison to standardized measurements against the ATS 2005 standard, not human adjudication of medical findings. The Human Factor study measures user performance and feedback, not a diagnostic outcome requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a "Smart Peak Flow Meter" for spirometry, which directly measures physiological parameters (PEF and FEV1). It does not involve "human readers" or AI assistance in interpreting images or data in a way that an MRMC study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The primary performance tests (accuracy, repeatability, flow resistance) are effectively standalone tests of the device's measurement capabilities against a standard. The human factors study evaluates the user interface and overall device usability for human users, making it a human-in-the-loop evaluation for that aspect. However, the core measurement functionality is standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests (PEF and FEV1 accuracy) is based on the American Thoracic Society (ATS) Standard 2005 Revision. This standard defines the acceptable range and methodology for measuring these physiological parameters, likely involving calibrated reference equipment.

8. The sample size for the training set

Not applicable. The device is a measurement device for spirometry, not a machine learning or AI-driven diagnostic tool that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of this device.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K191239

Device Name Smart Peak Flow Meter (Model: B1)

Indications for Use (Describe)

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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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, HaizhuDistrict, 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.

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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.

(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

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Item	Targeteddevice	Predicate device	Reference device1	Reference device2	Remark
Trade name	Smart PeakFlow Meter(Model: B1)	MSA100BT PeakFlow Meter	ACCUTRAX,MODEL EPF840Electronic PeakFlow Meter	Mini-WrightDigital	/
510(k)number	K191239	K170281	K982995	K053156	/
Regulationnumber	21 CFR868.1860	21 CFR 868.1860	21 CFR 868.1860	21 CFR 868.1860	Same
Regulationdescription	Peak-flowmeter forspirometry	Peak-flow meterfor spirometry	Peak-flow meterfor spirometry	Peak-flow meterfor spirometry	Same
Classification name	Meter, PeakFlow,Spirometry	Meter, Peak Flow,Spirometry	Meter, Peak Flow,Spirometry	Meter, Peak Flow,Spirometry	Same
Productcode	BZH	BZH	BZH	BZH	Same
Class	II	II	II	II	Similar
Indicationsfor use/Intended use	This device isintended tomonitor apatient's PeakExpiratoryFlow (PEF)and ForcedExpiratoryVolume in onesecond (FEV1)at home. Thedevice isintended formonitoringrespiratoryconditionssuch asasthma.	This device isintended formonitoring PEF(Peak ExpiredFlow Rate) andFEV1 (ForcedExpiratoryVolume in onesecond) forpatient home use.The device isdesigned forpediatric to adultpatients. Thedevice is intendedfor monitoringrespiratoryconditions such asasthma.	This AccuTraxEPF80 device isintended formonitoring PEFand FEV1 forpatient home andwork use. TheEPF840 isdesigned forpediatric to adultpatients. Whenthe EPF840 isused to watchlung conditionssuch as asthma,the user should beunder the care ofa licensed healthcare professional.A licensed health	The Mini-WrightDigital is ahandheld, batteryoperated,electronic PeakFlow Meter andFEV1 monitoringdevice with aninternal memorycapable of storing240 sets ofreadings. Thisproduct will besold as an OTCdevice withappropriateinstructions.When used tomonitorconditions such asasthma, thisdevice should beused under thedirection 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 anappropriate	intended for use
			treatment plan.	with pediatric and
			This treatmentplan will tell you	adult patients inboth home andclinical settings.
			what action totake when thereare changes inyour PEF/FEV1numbers.
Patientpopulation	Pediatric toadult patients.	Pediatric to adultpatients.	Pediatric to adultpatients.	Pediatric to adultpatients.	Same
Prescriptionor OTC	OTC	OTC	Prescription	OTC	Same
Basic unit specification
Powersupply	3.7V-300mAhlithiumpolymerbattery	AAA 1.5x2alkaline batteries	Primary source:Alkaline 9-voltbatteryRTC backup:Lithium 3Vbattery CR2032	Lithium coinCR2032 (included,not changeable)	DifferentNote 1
Dimensions	1113940mm	1265428mm	8811248mm	2944114mm	DifferentNote 2
Weight	50g	120g (includingbatteries andmouthpiece)	184g with battery	54g	DifferentNote 2
Materials	PP(Mouthpiece)	PP (Mouthpiece)	ABS, Cycolac2502 (GEPlastics)(flowhead)	/	Same
Components	Mainlycomposed ofmain unit andremovablemouthpiece.	Mainly composedof mainequipment,mouthpiece,turbine sensor.	Mainly composedof flowhead andunit body.	Mainly composedof meter andadapter	Similar
Compliancewithvoluntarystandards	IEC 60601-1,IEC60601-1-2,IEC60601-1-11	IEC 60601-1,IEC 60601-1-2,ATS 2005.	ATS standard	ATS 1994	Similar
	ATS 2005.



Performance specification
Measuringmethod	Flow: PressureSensor.Volume: FlowIntegration	Flow:TurbinesensorVolume: Flowintegration	Flow:Airpressure reducingmess in a flowhead is applied toa pressuretransducerVolume: Flowintegration	Pressure sensor	DifferentNote 3
MeasuringrangeofPEF	50-840L/min	50-900L/min	875L/min (max)	60-850L/min	Similar
MeasuringrangeofFEV1	0.01-9.99L	0.01-9.99L	8.5L (max)	0.6-8L	Same
Accuracy	PEF: ±10% or±18L/min(Take thelarger one)FEV1: ±3% or±0.05L (Takethe larger one)	PEF: ±20L/min or±10% of thereading;FEV1: ±0.05L or±3% of thereading.	PEF: ±10% or±24L/minwhichever isgreaterFEV1: ±5% or±0.100Lwhichever isgreater	PEF: ±6%FEV1: ±3.5%(@25°1013mbar50%HR)	SimilarNote 4
Measuringresolution	PEF: 1L/minFEV1: 0.01L	PEF: 1L/minFEV1: 0.01L	/	PEF: 5L/minFEV1: 0/05L	Same
Memory	100 historicaldata	250 recordings	480 tests	240 FEV1 and 240PEF	DifferentNote 5
Data safety	Datarememorizedby flashmemory.	Datarememorized byflash memory.	/	/	Same
Datatransmission	Bluetoothwirelesstransmission	BLE wirelesstransmission	/	/	Same
Workingconditions	Temperature:10°C~+40°C,Humidity: 0%RH~80%RH,Atmosphericpressure:	Temperature:10°C~+40°C,Humidity: 25 %RH~85%RH,Atmosphericpressure:	Temperature:15°C~35°C	Temperature:15°C~35°C	Similar

Storageconditions	70KPa ~106KPa	86KPa ~106KPa	/	Temperature:-10℃~+50℃,Humidity: 15 to95%	Similar
	Temperature:-20°C ~+55°C,	Temperature:-10°C~+55°C,Humidity: 15 %	/
	Humidity: 0%RH~80%RH,	RH~93%RH,Atmosphericpressure:	/
	Atmosphericpressure:	50KPa ~106KPa	/
	70KPa ~106KPa		/
	106KPa		/
			/
			/
Biocompatibility	Passed thetests as perISO 10993-1	Passed the tests asper ISO 10993-1	/	/	Same
Electricalsafety	Passed thetests as perIEC60601-1and IEC60601-1-11	Passed the test asper IEC 60601-1	/	/	Similar
EMC	Passed the testas per IEC60601-1-2	Passed the test asper IEC60601-1-2	/	/	Same
Sterility	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Same

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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

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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

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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.

Regulation Number and Section

§ 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).