MSA100 PEAK FLOW METER

K133975 · Beijing M&B Electronic Instruments Co., Ltd. · BZH · Oct 3, 2014 · Anesthesiology

Device Facts

• Record ID: K133975
• Device Name: MSA100 PEAK FLOW METER
• Applicant: Beijing M&B Electronic Instruments Co., Ltd.
• Product Code: BZH · Anesthesiology
• Decision Date: Oct 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatric to adult patients. The device is intended for monitoring respiratory conditions such as asthma.

Device Story

MSA100 Peak Flow Meter measures patient's maximum exhalation (PEF) and forced expiratory volume in one second (FEV1); intended for home use by pediatric to adult patients. Device utilizes turbine transducer; air flow rotates turbine leaf; photoelectric conversion transforms rotation into pulse signals; main controller processes signals to calculate flow and volume. Output displayed for patient/clinician to monitor respiratory conditions like asthma, COPD, or chronic bronchitis. Device stores up to 300 measurements with date/time in flash memory. Powered by two AAA alkaline batteries.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including measurement range and accuracy verification, biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and ATS 2005 performance standards.

Technological Characteristics

Turbine transducer sensing; photoelectric conversion; main controller processing. Flash memory storage. Powered by 2x AAA 1.5V alkaline batteries. Biocompatibility per ISO 10993-5 and ISO 10993-10. Electrical safety per IEC 60601-1:2012 and IEC 60601-1-2:2004. Performance per ATS 2005.

Indications for Use

Indicated for pediatric to adult patients for monitoring respiratory conditions such as asthma, COPD, or chronic bronchitis by measuring PEF and FEV1.

Regulatory Classification

Identification

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

Predicate Devices

• MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (K040723)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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)

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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,<br>Room 6319, Building 1, No. 27, Yongwang Road, Beijing<br>Bioengineering and Medicine Industry Base, Huangcun Town,<br>Daxing district, Beijing, People's Republic of China |
| Primary Contact Person: | Yang Shisheng<br>Project Manager<br>Beijing M&B Electronic Instruments Co., Ltd.<br>Tel: [phone]-8037<br>Fax: [phone] |
| Secondary Contact Person: | Mike Gu<br>Regulatory Affairs Manager<br>OSMUNDA Medical Device Service Group<br>Tel: [phone]<br>Fax: [phone] |
| Device: | <b>Trade Name:</b> MSA100 Peak Flow Meter<br><b>Common/Usual Name:</b> Peak Flow Meter<br><b>Regulation number</b> 868.1860<br><b>Classification Names:</b> Meter, Peak Flow, Spirometry<br><b>Product Code:</b> BZH<br><b>Predicate Device(s):</b> K040723, MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH<br>PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH<br>SOFTWARE)<br><b>Device Description:</b> The MSA100 Peak Flow Meter is a medical device that measures<br>patient's maximum possible exhalation which is called "peak<br>flow" (referred to in medical terms as PEF-Peak Expiratory Flow)<br>and "forced expiratory volume" (commonly known as FEV1) in<br>one second. Regular monitoring of the peak flow is useful for<br>monitoring diseases of the airways such as asthma, C.O.P.D, or<br>chronic bronchitis, is usually used for patient home use.<br><b>Intended Use:</b> This device is intended for monitoring PEF (Peak Expired Flow<br>Rate) and FEV1 (Forced Expiratory Volume in one second) for<br>patient home use. The device is designed for pediatric to adult<br>patients. 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 Device<br>Microlife Electronic<br>Peak Flow Monitor | Proposed<br>MSA100 Peak Flow<br>Meter |
|--------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Device name | Microlife Electronic<br>Peak Flow Monitor, with<br>PEF and FEV1, Models<br>PF-100 and PF 100-1 | MSA100 Peak Flow<br>Meter |
| Manufacturer | Microlife Intellectual<br>Property GmbH | Beijing M&B Electronic<br>Instruments Co., Ltd |
| Patient<br>Population | The device is designed<br>for pediatric to adult<br>patients | The device is designed<br>for pediatric to adult<br>patients |
| Environment<br>of<br>Use | OTC | OTC |
| Measuring range | PEF from 50 to 900<br>l/min<br>FEV1 from 0.01 to 9.99<br>liters | PEF from 50 to 900<br>l/min<br>FEV1 from 0.01 to 9.99<br>liters |
| Measuring<br>method | Flow: Turbine sensor<br>Volume: Flow Integration | Flow: Turbine sensor<br>Volume: Flow<br>Integration |
| Accuracy | PEF ± 25 l/min or 12% of<br>the reading;<br>FEV1 ± 0.1 l or ± 5% of<br>the reading | PEF ± 20 l/min or± 10%<br>of the reading;<br>FEV1 ± 0.05 l or ± 3% of<br>the reading |
| Measuring<br>solution | PEF 1 l/min; FEV1 0.01 l | PEF 1 l/min; FEV1 0.01 l |
| Data safety | Data rememorized by<br>EEPROM | Data rememorized by<br>Flash memory |
| Memory | 240 measurements with<br>date/time | 300<br>measurements<br>with date/time |
| Power source | 2 batteries of 1.5V, size<br>AAA | AAA 1.5×2 alkaline<br>batteries |

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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;
- 2. IEC 60601-1-2: 2004;
- 3. AST 2005 update;
- 4. ISO 10993-5: 2009;
- 5. 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).