This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV 1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatic to adult patients. The device is intended for monitoring respiratory conditions such as asthma.

Device Description

The MSA100 Peak Flow Meter is a medical device that measures patient's maximum possible exhalation which is called "peak flow" (referred to in medical terms as PEF-Peak Expiratory Flow) and "forced expiratory volume" (commonly known as FEV1) in one second. Regular monitoring of the peak flow is useful for monitoring diseases of the airways such as asthma, C.O.P.D, or chronic bronchitis, is usually used for patient home use.

AI/ML Overview

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Predicate Device)	Reported Device Performance (Proposed MSA100 Peak Flow Meter)
PEF Measuring Range	50 to 900 l/min	50 to 900 l/min
FEV1 Measuring Range	0.01 to 9.99 liters	0.01 to 9.99 liters
PEF Accuracy	± 25 l/min or 12% of the reading	± 20 l/min or ± 10% of the reading
FEV1 Accuracy	± 0.1 l or ± 5% of the reading	± 0.05 l or ± 3% of the reading
PEF Measuring Resolution	1 l/min	1 l/min
FEV1 Measuring Resolution	0.01 l	0.01 l
Data Safety	Data rememorized by EEPROM	Data rememorized by Flash memory
Memory	240 measurements with date/time	300 measurements with date/time
Power Source	2 batteries of 1.5V, size AAA	AAA 1.5x2 alkaline batteries
Electrical Safety	IEC 60601-1 and IEC 60601-1-2	IEC 60601-1 and IEC 60601-1-2
Biocompatibility (In vitro cytotoxicity, irritation, sensitization)	Met acceptance criteria (implied by ISO standards)	Met acceptance criteria (ISO 10993-5: 2009; ISO 10993-10: 2010)
Performance Testing	ATS 2005 update	ATS 2005 update

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "The sponsor has performed bench tests to demonstrate the MSA100 Peak Flow Meter performs within specifications." This suggests the testing was laboratory-based rather than involving human subjects for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The testing appears to be based on engineering and laboratory standards, not clinical ground truth established by medical experts for individual cases.

4. Adjudication method for the test set:

Not applicable. The testing described involves bench tests against specified performance metrics and adherence to international standards, not subjective expert adjudication of results.

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. This device is a measurement instrument (Peak Flow Meter) and does not involve AI or human "readers" interpreting data in a typical MRMC study context.

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

The device is a standalone instrument for measuring PEF and FEV1. The "algorithm only" concept doesn't directly apply as it's a physical device with embedded measurement technology (turbine transducer, photoelectric conversion). The performance described is its standalone measurement accuracy.

7. The type of ground truth used:

The ground truth used for specific performance metrics (like accuracy for PEF and FEV1) would be established by reference standards or calibrated equipment used in the bench testing. For biocompatibility and electrical safety, the ground truth is adherence to the specified ISO and IEC standards.

8. The sample size for the training set:

Not applicable. This device is a hardware measurement instrument tested against established engineering and performance standards, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2014

Beijing M&B Electronic Instruments, Co., Ltd. C/O Mr. Mike Gu Regulatory Affairs Manager Osmunda Medical Device Consulting Co., Ltd 7th Floor, Jingui Business Building, No. 982 Congyun Rd Baiyun District Guangzhou, Guangdong China 510420

Re: K133975

Trade/Device Name: MSA100 Peak Flow Meter Regulation Number: 21 CFR 868.1860 Regulation Name: Meter, Peak Flow, Spirometry Regulatory Class: II Product Code: BZH Dated: August 20, 2014 Received: August 22, 2014

Dear Mr. Gu:

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. 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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Page 2 - Mr. Gu

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K133975

Device Name MSA100 Peak Flow Meter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	20 Dec 2013
Submitter:	Beijing M&B Electronic Instruments Co., Ltd,Room 6319, Building 1, No. 27, Yongwang Road, BeijingBioengineering and Medicine Industry Base, Huangcun Town,Daxing district, Beijing, People's Republic of China
Primary Contact Person:	Yang ShishengProject ManagerBeijing M&B Electronic Instruments Co., Ltd.Tel: +86-10-61253716-8037Fax: +86-10-61253794
Secondary Contact Person:	Mike GuRegulatory Affairs ManagerOSMUNDA Medical Device Service GroupTel: +86-20-62321333Fax: +86-20-86330253
Device:	Trade Name: MSA100 Peak Flow MeterCommon/Usual Name: Peak Flow MeterRegulation number 868.1860Classification Names: Meter, Peak Flow, SpirometryProduct Code: BZHPredicate Device(s): K040723, MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITHPEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITHSOFTWARE)Device Description: The MSA100 Peak Flow Meter is a medical device that measurespatient's maximum possible exhalation which is called "peakflow" (referred to in medical terms as PEF-Peak Expiratory Flow)and "forced expiratory volume" (commonly known as FEV1) inone second. Regular monitoring of the peak flow is useful formonitoring diseases of the airways such as asthma, C.O.P.D, orchronic bronchitis, is usually used for patient home use.Intended Use: This device is intended for monitoring PEF (Peak Expired FlowRate) and FEV1 (Forced Expiratory Volume in one second) forpatient home use. The device is designed for pediatric to adultpatients. The device is intended for monitoring respiratory

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Technology:

Technically, the turbine transducer is the key component for both predicate and proposed device, when air flow passes through, it makes the leaf of turbine rotate. Rotary speed of the leaf is linear relationship with air flow rate. By the technology of photoelectric conversion, turning of the leaf is converted to be pulse signal, which is processed by the main controller after sampling.

Specification	Predicate DeviceMicrolife ElectronicPeak Flow Monitor	ProposedMSA100 Peak FlowMeter
Device name	Microlife ElectronicPeak Flow Monitor, withPEF and FEV1, ModelsPF-100 and PF 100-1	MSA100 Peak FlowMeter
Manufacturer	Microlife IntellectualProperty GmbH	Beijing M&B ElectronicInstruments Co., Ltd
PatientPopulation	The device is designedfor pediatric to adultpatients	The device is designedfor pediatric to adultpatients
EnvironmentofUse	OTC	OTC
Measuring range	PEF from 50 to 900l/minFEV1 from 0.01 to 9.99liters	PEF from 50 to 900l/minFEV1 from 0.01 to 9.99liters
Measuringmethod	Flow: Turbine sensorVolume: Flow Integration	Flow: Turbine sensorVolume: FlowIntegration
Accuracy	PEF ± 25 l/min or 12% ofthe reading;FEV1 ± 0.1 l or ± 5% ofthe reading	PEF ± 20 l/min or± 10%of the reading;FEV1 ± 0.05 l or ± 3% ofthe reading
Measuringsolution	PEF 1 l/min; FEV1 0.01 l	PEF 1 l/min; FEV1 0.01 l
Data safety	Data rememorized byEEPROM	Data rememorized byFlash memory
Memory	240 measurements withdate/time	300measurementswith date/time
Power source	2 batteries of 1.5V, sizeAAA	AAA 1.5×2 alkalinebatteries

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MSA100 Peak Flow Meter 510k submission

Electrical Safety	IEC 60601-1 and IEC 60601-1-2	IEC 60601-1 and IEC 60601-1-2
-------------------	-------------------------------	-------------------------------

The following technological differences exist between the proposed device and the predicate device:

Use of flash memory
Different appearance

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The sponsor has performed bench tests to demonstrate the MSA100 Peak Flow Meter performs within specifications:

. Measuring range: PEF from 50 to 900 l/min; FEV1 from 0.01 to 9.99 liters
. Accuracy: PEF ± 20 l/min or± 10% of the reading; FEV1 ± 0.05L or ± 3% of the reading

Also the proposed device had met acceptance criteria of performance testing including biocompatibility (In vitro cytotoxicity, irritation and sensitization testing), electrical safety & EMC testing and ATS 2005:

1. IEC 60601-1: 2012;
1. IEC 60601-1-2: 2004;
1. AST 2005 update;
1. ISO 10993-5: 2009;
1. ISO 10993-10: 2010.

Summary of Clinical Tests:

The subject of this premarket submission, MSA100 Peak Flow Meter, did not require clinical studies to support substantial equivalence.

Beijing M&B Electronic Instruments Co., Ltd considers the Conclusion: MSA100 Peak Flow Meter to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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).