(210 days)
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.
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.
The provided document describes the Shanghai Sonmol Medical Equipment Co., Ltd. Peak Flow Meter (models SMPF-2S, SMPF-3A) and its substantial equivalence to a predicate device. Below is a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to performance tests conducted according to the American Thoracic Society Standard of Spirometry (2005 Revision). The acceptance criteria are implicit in the accuracy specifications, which are compared to the predicate device.
| Parameter | Acceptance Criteria (Targeted Device) | Reported Device Performance (Targeted Device) |
|---|---|---|
| Accuracy (PEF) | ±10% or ±18 L/min (whichever is greater) | Meets criteria (comparable to predicate K191239) |
| Accuracy (FEV1) | ±3% or ±0.05L (whichever is greater) | Meets criteria (comparable to predicate K191239) |
| Measuring Range (PEF) | 60 L/min ~ 840 L/min | Meets criteria (overlaps predicate K191239 and reference K053156) |
| Measuring Range (FEV1) | 0.5L ~ 8L | Meets criteria (similar to reference K053156) |
| Measuring Resolution (PEF) | 1 L/min | Meets criteria (identical to predicate K191239; better than reference K053156) |
| Measuring Resolution (FEV1) | 0.01L | Meets criteria (identical to predicate K191239; better than reference K053156) |
| Intra-instrument Repeatability | Meets requirements in standards (implicit in performance test claim) | Meets criteria |
| Inter-instrument Repeatability (PEF) | Meets requirements in standards (implicit in performance test claim) | Meets criteria |
| Electrical Safety | Conformance to IEC 60601-1 and IEC 60601-1-11 | Passed tests |
| EMC | Conformance to IEC 60601-1-2 | Passed tests |
| Biocompatibility | Conformance to ISO 10993-1 | Passed tests |
| Software Verification & Validation | Software functions as specified in requirements (for "moderate" level of concern) | Validated |
| Human Factors | Device and application are as safe and effective as predicate | Study results demonstrate conformance |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the performance test set. It mentions "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)."
The data provenance is not explicitly mentioned as country of origin, retrospective or prospective. However, based on the context of a 510(k) submission, these would typically be controlled laboratory or simulated environment tests, not involving human patient data collection in a clinical setting in the same way a clinical trial would.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance tests appear to be based on engineering and standardized testing rather than expert-established ground truth from clinical cases.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1, none) are not applicable or mentioned as the testing performed is based on direct measurement validation against established standards for spirometry devices, not interpretation by human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a measurement instrument, not an AI diagnostic tool that assists human readers in interpreting images or data.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While not an "algorithm" in the AI sense, the performance tests (accuracy, repeatability, range) are essentially standalone studies of the device's measurement capabilities. The device is intended for direct measurement by the patient/user, not for interpretation by a human-in-the-loop in a collaborative diagnostic setting.
7. The Type of Ground Truth Used
The ground truth for the performance tests appears to be based on:
- Established physical standards: The American Thoracic Society Standard of Spirometry (2005 Revision) provides the specifications for expected performance.
- Reference measurements: The accuracy and range are compared against predicate and reference devices, implying a standard of truth is upheld by these devices or by the testing methodologies described in the ATS standard.
- Engineering specifications: The device is tested against its own design specifications and regulatory standards (e.g., IEC 60601 series).
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a hardware measurement tool; it does not involve a "training set" in the context of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no machine learning training set for this device.
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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
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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
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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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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 |
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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: 0.01LFlow: 1L/min | Flow: 1L/min |
6. Technological characteristics and substantial equivalence
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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 apatient's Peak Expiratory Flow (PEF) andForced Expiratory Volume in one second(FEV1) at home. The device is intended formonitoring respiratory conditions such asasthma. The device is for Over-The-Counter Use. | This device is intended to monitor apatient's Peak Expiratory Flow (PEF) andForced Expiratory Volume in one second(FEV1) at home. The device is intended formonitoring respiratory conditions such asasthma. | The Mini-Wright Digital is a handheld,battery operated, electronic Peak FlowMeter and FEV1 monitoring device withan internal memory capable of storing240 sets of readings. This product will besold as an OTC device with appropriateinstructions. When used to monitorconditions such as asthma, this deviceshould be used under the direction of aphysician or licensed health careprofessional. The device is intended for usewith pediatric and adult patients in bothhome and clinical settings. | Identical tothe predicatedevice |
| Patient population | Pediatric to adult patients. | Pediatric to adult patients. | Pediatric to adult patients. | identical |
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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 | ||
| Measuringrange 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 tothe predicatedevice | ||
| Measuring | PEF: 1L/minFEV1: 0.01L | PEF: 1L/minFEV1: 0.01L | PEF: 5L/minFEV1: 0/05L | Identical tothe predicatedevice |
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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. | / | |
| Datatransmission | none | Bluetooth wireless transmission | / | |
| Workingconditions | Temperature: 10°C~+40°C,Humidity: 0% RH | Temperature: 10°C~+40°C,Humidity: 0% RH | Temperature: 15°C~35°C | identical |
| Storageconditions | Temperature:-10°C ~ +55°C;Humidity: ≤95%RHAtmospheric pressure:500hPa~1060hPa | Temperature:-20°C ~ +55°C,Humidity: 0%RH | Temperature: -10°C~+50°C, Humidity: 15to 95% | Note 8 |
| Biocompatibility | Passed the tests as per ISO 10993-1 | Passed the tests as per ISO 10993-1 | / | identical |
| Electricalsafety | Passed the tests as per IEC 60601-1 andIEC 60601-1-11 | Passed the tests as per IEC 60601-1 andIEC 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.
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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.
§ 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).