(210 days)
No
The device description details a simple system using a pressure sensor and microcontroller to process real-time gas flow data and display results on an LCD. There is no mention of AI, ML, or any complex algorithms beyond basic signal processing for flow and volume calculation. The performance studies focus on standard spirometry metrics and comparison to a predicate device, not on AI/ML model performance.
No
The device is a monitoring device, not a device that provides therapy or treatment.
Yes
This device monitors physiological parameters (PEF and FEV1) to track respiratory conditions like asthma, which is a key function of diagnostic devices. Although it's for home monitoring, it provides data crucial for diagnosing or managing a condition.
No
The device description explicitly states it is composed of a "Main Unit" containing hardware components like a segment LCD, a pressure sensor, and a Microcontroller Unit, in addition to a Mouthpiece. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Device Function: This device measures physiological parameters (PEF and FEV1) directly from the patient's breath. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to monitor respiratory conditions by measuring airflow from the patient's lungs, not by analyzing biological samples.
Therefore, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
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 (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. The device is for Over-The-Counter Use.
Product codes
BZH
Device Description
The Peak flow meter is composed of Main Unit and Mouthpiece.
Mouthpiece: Mouth blowing.
Main Unit: Containing a segment LCD, a pressure sensor and a Microcontroller Unit.
The pressure sensor records the gas flow rate in real time and delivers to MCU for processing, to get the flow volume of gas and volume, after the measurement, LCD displays the measurement results.
Principle for working: Patient puts the mouthpiece in the mouth and vigorously blows the gas through it. The pressures sensor records the gas flow rate in real time and delivers to central processor for processing to estimate the flow volume of gas at the present time and the maximum value of the whole process which is the Peak Expiration Flow rate (PEF). At the same time, the central processor measures the time of the entire process using high-precision crystal from some to zero of the flow, and then calculates the flow volume integration on time. Taking the volume in the first second is the forced expiratory volume of 1 second (FEV1).
In the process of test, the buzzer gives a tone to indicate the beginning and of the measurement, after the measurement, LCD displays the measurement results.
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 / Over-The-Counter Use
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 tests have been conducted to verify that the Peak Flow Meter (SMPF-2S, SMPF-3A) 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 equipment and medical electrical systems used in the home healthcare environment.
Biocompatibility: The body-contacting components of this device (mouthpiece and main unit) have been demonstrated conformance to ISO 10993-1, Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process.
Software Validation: 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: Performance test has also been conducted to verify the measurement accuracy, intra instrument repeatability, PEF inter instrument repeatability and performance 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.
Human Factors Study: Human Factor Engineering Study was conducted according to IEC 62366. The study results of this human factor engineering study demonstrate that the 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
May 26, 2021
Shanghai Sonmol Medical Equipment Co., Ltd. % Raymond Luo Technical Manager Shanghai Sungo management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K203196
Trade/Device Name: Peak Flow Meter Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter For Spirometry Regulatory Class: Class II Product Code: BZH Dated: April 26, 2021 Received: April 26, 2021
Dear Raymond Luo:
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.
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
1
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 medical devices and radiation-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,
Rachana Visaria, Ph.D. Assistant 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) K203196
Device Name Peak Flow Meter
Indications for Use (Describe)
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. The device is for Over-The-Counter Use.
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
Date of preparation: 5/25/2021
1. Applicant
Name: Shanghai Sonmol Medical Equipment Co., Ltd. Address: Room 116-118, Building 21, No.500 Jiajian Road, Jiading District Shanghai, China
Official Contact Person Information
Shanghai Sungo Management Consulting Company Limited Name: Raymond Luo Tel: 0086-21-68828050 Mail: fda.sungo@gmail.com
2. Device
The proprietary name of the new device: Peak Flow Meter The generic name of the device: Peak-Flow Meter For Spirometry Classification regulation: 21 CFR 868.1860 Classification: Class II. Product code: BZH
3. Predicate device and reference device
Predicate device
| Sponsor | Guangzhou Homesun Medical Technology Co., Ltd |
|---|---|
| Device Name and Model | Smart Peak Flow Meter (Model: B1) |
| 510(k) Number | K191239 |
| Product Code | BZH |
| Regulation Number | 21 CFR 868.1860 |
| Regulation Class | II |
Reference device
| Sponsor | Clement Clarke Int. Ltd |
|---|---|
| Device Name and Model | Mini-Wright Digital (Model: 3120001) |
| 510(k) Number | K053156 |
| Product Code | BZH |
| Regulation Number | 21 CFR 868.1860 |
| Regulation Class | II |
4
4. Intended use of the device:
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. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.
5. Device Description:
5.1 Composition
The Peak flow meter is composed of Main Unit and Mouthpiece.
Mouthpiece: Mouth blowing.
Main Unit: Containing a segment LCD, a pressure sensor and a Microcontroller Unit.
The pressure sensor records the gas flow rate in real time and delivers to MCU for processing, to get the flow volume of gas and volume, after the measurement, LCD displays the measurement results.
5.2 Principle for working
Patient puts the mouthpiece in the mouth and vigorously blows the gas through it. The pressures sensor records the gas flow rate in real time and delivers to central processor for processing to estimate the flow volume of gas at the present time and the maximum value of the whole process which is the Peak Expiration Flow rate (PEF). At the same time, the central processor measures the time of the entire process using high-precision crystal from some to zero of the flow, and then calculates the flow volume integration on time. Taking the volume in the first second is the forced expiratory volume of 1 second (FEV1).
In the process of test, the buzzer gives a tone to indicate the beginning and of the measurement, after the measurement, LCD displays the measurement results.
5.3 Model differences
The two models are identical except the following aspects.
| ITEMS | SMPF-2S | SMPF-3A |
|---|---|---|
| Indications for use/ Intended use | Measuring forced expiratory volume of 1 second (FEV1), peak expiration flow rate (PEF) | Measuring peak expiration flow rate (PEF) |
| Measuring range of FEV1 | 0.5L ~ 8L | none |
| Accuracy | Volume: ±3% or ±0.05L | |
| (whichever is greater) | ||
| Flow rate : ±10% or ±18L/min | ||
| (whichever is greater) | Flow rate : ±10% or ±18L/min | |
| (whichever is greater) | ||
| Measuring resolution | Volume: 0.01L | |
| Flow: 1L/min | Flow: 1L/min |
6. Technological characteristics and substantial equivalence
5
Shanghai Sonmol Medical Equipment Co., Ltd. (K203196 )
| ITEMS | Current Device | Predicate Device | Reference Device | Comparison |
|---|---|---|---|---|
| Trade name | Peak Flow Meter (SMPF-2S) | Smart Peak Flow Meter (Model: B1) | Mini-Wright Digital | |
| 510 (k) number | K203196 | K191239 | K053156 | |
| Regulation number | 21 CFR 868.1860 | 21 CFR 868.1860 | 21 CFR 868.1860 | identical |
| Regulation description | Peak-flow meter for spirometry | Peak-flow meter for spirometry | Peak-flowmeter for spirometry | identical |
| Classification name | Meter, Peak Flow, Spirometry | Meter, Peak Flow, Spirometry | Meter, Peak Flow, Spirometry | identical |
| Product code | BZH | BZH | BZH | identical |
| Class | II | II | II | identical |
| 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. The device is for Over-The- | ||||
| Counter 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. | 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 | ||||
| physician or licensed health care | ||||
| professional. The device is intended for use | ||||
| with pediatric and adult patients in both | ||||
| home and clinical settings. | Identical to | |||
| the predicate | ||||
| device | ||||
| Patient population | Pediatric to adult patients. | Pediatric to adult patients. | Pediatric to adult patients. | identical |
6
Shanghai Sonmol Medical Equipment Co., Ltd. (K203196 )
| Prescription or | OTC | OTC | OTC | identical | ||
|---|---|---|---|---|---|---|
| OTC | ||||||
| Basic Unit Specification | ||||||
| Power supply | DC3V (2 AAA Alkaline batteries) | 3.7V-300mAh lithium Polymer battery | Lithium coin CR2032 (included, not changeable) | Note 1 | ||
| Dimensions | 1424856mm | 1113940mm | 2944114mm | Note 2 | ||
| Weight | 52g | 50g | 54g | Note 2 | ||
| Materials | ABS | PP (Mouthpiece) | / | Note 3 | ||
| Components | Main Unit and Mouthpiece and the mouthpiece is unremovable. | Mainly composed of main unit and Removable mouthpiece. | Mainly composed of meter and adapter | Note 4 | ||
| Compliance | IEC 60601-1, | IEC 60601-1, | ATS 1994 | Identical to | ||
| With | IEC 60601-1-2, | IEC 60601-1-2, | the predicate | |||
| voluntary | IEC 60601-1-11, | IEC 60601-1-11, | device | |||
| standards | ATS 2005 | ATS 2005 | ||||
| Performance specification | ||||||
| Measuring | Flow: Pressure Sensor. | |||||
| Volume: Flow Integration | Flow: Pressure Sensor. | |||||
| Volume: Flow Integration | Pressure sensor | identical | ||||
| range of PEF | 60L/min ~ 840 L/min | 50-840L/min | 60-850L/min | Note 5 | ||
| Measuring | ||||||
| range of FEV1 | 0.5L ~ 8L | 0.01-9.99L | 0.6-8L | Note 6 | ||
| Accuracy | PEF: ±10% or ±18L/min | |||||
| (Take the larger one) | ||||||
| FEV1: ±3% or ±0.05L | ||||||
| (Take the larger one) | PEF: ±10% or ±18L/min | |||||
| (Take the larger one) | ||||||
| FEV1: ±3% or ±0.05L | ||||||
| (Take the larger one) | PEF: ±6% | |||||
| FEV1: ±3.5% | ||||||
| (@25°1013mbar 50%HR) | Identical to | |||||
| the predicate | ||||||
| device | ||||||
| Measuring | PEF: 1L/min | |||||
| FEV1: 0.01L | PEF: 1L/min | |||||
| FEV1: 0.01L | PEF: 5L/min | |||||
| FEV1: 0/05L | Identical to | |||||
| the predicate | ||||||
| device |
7
Shanghai Sonmol Medical Equipment Co., Ltd. (K203196 )
| Memory | none | 100 historical data | 240 FEV1and 240 PEF | Note 7 |
|---|---|---|---|---|
| Data safety | none | Data rememorized by flash memory. | / | |
| Data | ||||
| transmission | none | Bluetooth wireless transmission | / | |
| Working | ||||
| conditions | Temperature: 10°C~+40°C, | |||
| Humidity: 0% RH~80%RH, | ||||
| Atmospheric pressure:70KPa~106KPa | Temperature: 10°C~+40°C, | |||
| Humidity: 0% RH~80%RH, | ||||
| Atmospheric pressure:70KPa~106KPa | Temperature: 15°C~35°C | identical | ||
| Storage | ||||
| conditions | Temperature:-10°C ~ +55°C; | |||
| Humidity: ≤95%RH | ||||
| Atmospheric pressure: | ||||
| 500hPa~1060hPa | Temperature:-20°C ~ +55°C, | |||
| Humidity: 0%RH~80%RH, | ||||
| Atmospheric pressure: | ||||
| 70KPa~106KPa | Temperature: -10°C~+50°C, Humidity: 15 | |||
| to 95% | Note 8 | |||
| Biocompatibility | Passed the tests as per ISO 10993-1 | Passed the tests as per ISO 10993-1 | / | identical |
| Electrical | ||||
| safety | Passed the tests as per IEC 60601-1 and | |||
| IEC 60601-1-11 | Passed the tests as per IEC 60601-1 and | |||
| IEC 60601-1-11 | / | identical | ||
| EMC | Passed the test as per IEC60601-1-2 | Passed the test as per IEC60601-1-2 | / | identical |
| Sterility | Non-sterile | Non-sterile | Non-sterile | identical |
Note I : Although the power supply is different from the tests were conducted for electrical safety and EMC to ensure the conformity with stadards.
Note 2: Although the appearance, weight and dimensions are different between the targeted and predicate
device, these differences are insignificant and do not raise new questions of safety and effectiveness.
Note 3: Although the material used for the device is different, the test was done on patient contacting comport biocompatibility.
Note 4. The mouthpiece of the current device is no new risk raised as this is reuse device for single user and the cleaning process is validated.
Note 5: The Maximum Measuring range of PEF is identicale device and the Minimum Measuring range of PEF is icentical to the reference device.
Note 6: The FEV1 Measuring range of current device is similar to the reference device.
Note 7: The current device does not have the function of data memory or wireless transmission. So, there is no additional risk raised from cybersecurity standpoint.
Note 8: The storage condition is different, the test was done according to IEC60601-1-11 to provide conformance.
8
7. Non-clinical studies and tests performed
Non-clinical tests have been conducted to verify that the Peak Flow Meter (SMPF-2S, SMPF-3A) 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 equipment and medical electrical systems used in the home healthcare environment
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 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, so it is concluded that the targeted device is substantially equivalent to the predicate device.
Human Factor Engineering Study was conducted according to IEC 62366. The study results of this human factor engineering study demonstrate that the Peak Flow Meter device and application are as safe and as effective as its predicate device.
8. Conclusion
Based on the above analysis and tests performed, it can be concluded that Peak Flow Meter (SMPF-2S, SMPF-3A) is substantially equivalent to the predicate device.