Smart Peak Flow Meter

K191239 · Guangzhou Homesun Medical Technology Co., Ltd. · BZH · Dec 6, 2019 · Anesthesiology

Device Facts

• Record ID: K191239
• Device Name: Smart Peak Flow Meter
• Applicant: Guangzhou Homesun Medical Technology Co., Ltd.
• Product Code: BZH · Anesthesiology
• Decision Date: Dec 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Hand-held pulmonary function testing device; measures PEF and FEV1. Input: patient exhalation through removable mouthpiece. Principle: pressure sensor transforms airflow into electrical signal; flow integration calculates volume. Output: results displayed on device screen and transmitted via Bluetooth to smartphone app. Used at home by patients (adults/children >5 with supervision). Healthcare providers review stored data from app to monitor respiratory conditions. Benefits: enables regular home monitoring of lung function to assist in asthma management.

Clinical Evidence

Bench testing only. Performance verified against ATS 2005 standards for PEF and FEV1 accuracy, repeatability, and flow resistance. Biocompatibility testing per ISO 10993-1. Software validation per FDA guidance (moderate level of concern). Human factors engineering study (n=20) confirmed 100% success rate in critical tasks, demonstrating usability and safety.

Technological Characteristics

Hand-held device; 111x39x40mm; 50g. Materials: PP (mouthpiece). Sensing: pressure sensor. Power: 3.7V 300mAh lithium polymer battery. Connectivity: Bluetooth wireless. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ATS 2005. Sterility: non-sterile.

Indications for Use

Indicated for monitoring PEF and FEV1 in adults and children >5 years (with caregiver supervision) at home for respiratory conditions like asthma.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

• MSA100BT Peak Flow Meter (K170281)

Reference Devices

• ACCUTRAX, MODEL EPF840 Electronic Peak Flow Meter (K982995)
• Mini-Wright Digital (K053156)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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# 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<br>District, Guangzhou, GD. China |
| Contact person: | Jinqun Li |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Email: | [e-mail] |
| 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.

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

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| Item | Targeted<br>device | Predicate device | Reference device<br>1 | Reference device<br>2 | Remark |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Trade name | Smart Peak<br>Flow Meter<br>(Model: B1) | MSA100BT Peak<br>Flow Meter | ACCUTRAX,<br>MODEL EPF840<br>Electronic Peak<br>Flow Meter | Mini-Wright<br>Digital | / |
| 510<br>(k)<br>number | K191239 | K170281 | K982995 | K053156 | / |
| Regulation<br>number | 21 CFR<br>868.1860 | 21 CFR 868.1860 | 21 CFR 868.1860 | 21 CFR 868.1860 | Same |
| Regulation<br>description | Peak-flow<br>meter for<br>spirometry | Peak-flow meter<br>for spirometry | Peak-flow meter<br>for spirometry | Peak-flow meter<br>for spirometry | Same |
| Classificatio<br>n name | Meter, Peak<br>Flow,<br>Spirometry | Meter, Peak Flow,<br>Spirometry | Meter, Peak Flow,<br>Spirometry | Meter, Peak Flow,<br>Spirometry | Same |
| Product<br>code | BZH | BZH | BZH | BZH | Same |
| Class | II | II | II | II | Similar |
| Indications<br>for use/<br>Intended use | This device is<br>intended to<br>monitor a<br>patient's Peak<br>Expiratory<br>Flow (PEF)<br>and Forced<br>Expiratory<br>Volume in one<br>second (FEV1)<br>at home. The<br>device is<br>intended for<br>monitoring<br>respiratory<br>conditions<br>such as<br>asthma. | This device is<br>intended for<br>monitoring PEF<br>(Peak Expired<br>Flow Rate) and<br>FEV1 (Forced<br>Expiratory<br>Volume in one<br>second) for<br>patient home use.<br>The device is<br>designed for<br>pediatric to adult<br>patients. The<br>device is intended<br>for monitoring<br>respiratory<br>conditions such as<br>asthma. | This AccuTrax<br>EPF80 device is<br>intended for<br>monitoring PEF<br>and FEV1 for<br>patient home and<br>work use. The<br>EPF840 is<br>designed for<br>pediatric to adult<br>patients. When<br>the EPF840 is<br>used to watch<br>lung conditions<br>such as asthma,<br>the user should be<br>under the care of<br>a licensed health<br>care professional.<br>A licensed health | The Mini-Wright<br>Digital is a<br>handheld, battery<br>operated,<br>electronic Peak<br>Flow Meter and<br>FEV1 monitoring<br>device with an<br>internal memory<br>capable of storing<br>240 sets of<br>readings. This<br>product will be<br>sold as an OTC<br>device with<br>appropriate<br>instructions.<br>When used to<br>monitor<br>conditions such as<br>asthma, this<br>device should be<br>used under the<br>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<br>appropriate | intended for use | |
| | | | treatment plan. | with pediatric and | |
| | | | This treatment<br>plan will tell you | adult patients in<br>both home and<br>clinical settings. | |
| | | | what action to<br>take when there<br>are changes in<br>your PEF/FEV1<br>numbers. | | |
| Patient<br>population | Pediatric to<br>adult patients. | Pediatric to adult<br>patients. | Pediatric to adult<br>patients. | Pediatric to adult<br>patients. | Same |
| Prescription<br>or OTC | OTC | OTC | Prescription | OTC | Same |
| Basic unit specification | | | | | |
| Power<br>supply | 3.7V-300mAh<br>lithium<br>polymer<br>battery | AAA 1.5x2<br>alkaline batteries | Primary source:<br>Alkaline 9-volt<br>battery<br>RTC backup:<br>Lithium 3V<br>battery CR2032 | Lithium coin<br>CR2032 (included,<br>not changeable) | Different<br>Note 1 |
| Dimensions | 111*39*40mm | 126*54*28mm | 88*112*48mm | 29*44*114mm | Different<br>Note 2 |
| Weight | 50g | 120g (including<br>batteries and<br>mouthpiece) | 184g with battery | 54g | Different<br>Note 2 |
| Materials | PP<br>(Mouthpiece) | PP (Mouthpiece) | ABS, Cycolac<br>2502 (GE<br>Plastics)<br>(flowhead) | / | Same |
| Components | Mainly<br>composed of<br>main unit and<br>removable<br>mouthpiece. | Mainly composed<br>of main<br>equipment,<br>mouthpiece,<br>turbine sensor. | Mainly composed<br>of flowhead and<br>unit body. | Mainly composed<br>of meter and<br>adapter | Similar |
| Compliance<br>with<br>voluntary<br>standards | IEC 60601-1,<br>IEC<br>60601-1-2,<br>IEC<br>60601-1-11 | IEC 60601-1,<br>IEC 60601-1-2,<br>ATS 2005. | ATS standard | ATS 1994 | Similar |
| | ATS 2005. | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Performance specification | | | | | |
| Measuring<br>method | Flow: Pressure<br>Sensor.<br>Volume: Flow<br>Integration | Flow:<br>Turbine<br>sensor<br>Volume: Flow<br>integration | Flow:<br>Air<br>pressure reducing<br>mess in a flow<br>head is applied to<br>a pressure<br>transducer<br>Volume: Flow<br>integration | Pressure sensor | Different<br>Note 3 |
| Measuring<br>range<br>of<br>PEF | 50-840L/min | 50-900L/min | 875L/min (max) | 60-850L/min | Similar |
| Measuring<br>range<br>of<br>FEV1 | 0.01-9.99L | 0.01-9.99L | 8.5L (max) | 0.6-8L | Same |
| Accuracy | PEF: ±10% or<br>±18L/min<br>(Take the<br>larger one)<br>FEV1: ±3% or<br>±0.05L (Take<br>the larger one) | PEF: ±20L/min or<br>±10% of the<br>reading;<br>FEV1: ±0.05L or<br>±3% of the<br>reading. | PEF: ±10% or<br>±24L/min<br>whichever is<br>greater<br>FEV1: ±5% or<br>±0.100L<br>whichever is<br>greater | PEF: ±6%<br>FEV1: ±3.5%<br>(@25°1013mbar<br>50%HR) | Similar<br>Note 4 |
| Measuring<br>resolution | PEF: 1L/min<br>FEV1: 0.01L | PEF: 1L/min<br>FEV1: 0.01L | / | PEF: 5L/min<br>FEV1: 0/05L | Same |
| Memory | 100 historical<br>data | 250 recordings | 480 tests | 240 FEV1 and 240<br>PEF | Different<br>Note 5 |
| Data safety | Data<br>rememorized<br>by flash<br>memory. | Data<br>rememorized by<br>flash memory. | / | / | Same |
| Data<br>transmission | Bluetooth<br>wireless<br>transmission | BLE wireless<br>transmission | / | / | Same |
| Working<br>conditions | Temperature:<br>10°C~+40°C,<br>Humidity: 0%<br>RH~80%RH,<br>Atmospheric<br>pressure: | Temperature:<br>10°C~+40°C,<br>Humidity: 25 %<br>RH~85%RH,<br>Atmospheric<br>pressure: | Temperature:<br>15°C~35°C | Temperature:<br>15°C~35°C | Similar |
| | | | | | |
| Storage<br>conditions | 70KPa ~<br>106KPa | 86KPa ~<br>106KPa | / | Temperature:<br>-10℃~+50℃,<br>Humidity: 15 to<br>95% | Similar |
| | Temperature:<br>-20°C ~<br>+55°C, | Temperature:<br>-10°C~+55°C,<br>Humidity: 15 % | / | | |
| | Humidity: 0%<br>RH~80%RH, | RH~93%RH,<br>Atmospheric<br>pressure: | / | | |
| | Atmospheric<br>pressure: | 50KPa ~<br>106KPa | / | | |
| | 70KPa ~<br>106KPa | | /…