(281 days)
Not Found
No
The summary describes a standard peak flow meter that measures PEF and FEV1 based on physical exhalation. There is no mention of AI, ML, image processing, or any data analysis beyond basic measurement and accuracy specifications. The performance studies are bench tests and standard safety/performance testing, not AI/ML model validation.
No.
The device is solely for monitoring and does not provide therapy or treatment.
No
The device is intended for "monitoring" rather than establishing a diagnosis. It measures specific physiological parameters (PEF and FEV1) to track respiratory conditions.
No
The device description explicitly states "The MSA100 Peak Flow Meter is a medical device that measures patient's maximum possible exhalation..." and the performance studies include bench tests, biocompatibility, electrical safety & EMC testing, and compliance with standards like IEC 60601-1, which are all indicative of a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The MSA100 Peak Flow Meter measures PEF and FEV1 by having the patient exhale directly into the device. This is a direct measurement of a physiological function, not an analysis of a sample taken from the body.
- Intended Use: The intended use is for monitoring respiratory conditions by measuring lung function, not by analyzing biological samples.
Therefore, the MSA100 Peak Flow Meter falls under the category of a medical device that measures a physiological parameter, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
BZH
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.
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
pediatic to adult patients
Intended User / Care Setting
patient home 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)
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:
-
- IEC 60601-1: 2012;
-
- IEC 60601-1-2: 2004;
-
- AST 2005 update;
-
- ISO 10993-5: 2009;
-
- ISO 10993-10: 2010.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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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
2
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)
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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Image /page/3/Picture/0 description: The image shows a logo with a stylized blue flower or plant-like shape on the left side. To the right of the flower, there is a circled "R" symbol, indicating a registered trademark. The background is plain white, which makes the blue logo stand out.
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, Beijing | |
| Bioengineering and Medicine Industry Base, Huangcun Town, | |
| Daxing district, Beijing, People's Republic of China | |
| Primary Contact Person: | Yang Shisheng |
| Project Manager | |
| Beijing M&B Electronic Instruments Co., Ltd. | |
| Tel: +86-10-61253716-8037 | |
| Fax: +86-10-61253794 | |
| Secondary Contact Person: | Mike Gu |
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Service Group | |
| Tel: +86-20-62321333 | |
| Fax: +86-20-86330253 | |
| Device: | Trade Name: MSA100 Peak Flow Meter |
| Common/Usual Name: Peak Flow Meter | |
| Regulation number 868.1860 | |
| Classification Names: Meter, Peak Flow, Spirometry | |
| Product Code: BZH | |
| Predicate Device(s): K040723, MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH | |
| PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH | |
| SOFTWARE) | |
| 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. | |
| 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 |
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Image /page/4/Picture/1 description: The image shows a blue logo. The logo is a stylized flower with three petals. There is a registered trademark symbol to the right of the flower.
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
Microlife Electronic
Peak Flow Monitor | Proposed
MSA100 Peak Flow
Meter |
|--------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Device name | Microlife Electronic
Peak Flow Monitor, with
PEF and FEV1, Models
PF-100 and PF 100-1 | MSA100 Peak Flow
Meter |
| Manufacturer | Microlife Intellectual
Property GmbH | Beijing M&B Electronic
Instruments Co., Ltd |
| Patient
Population | The device is designed
for pediatric to adult
patients | The device is designed
for pediatric to adult
patients |
| Environment
of
Use | OTC | OTC |
| Measuring range | PEF from 50 to 900
l/min
FEV1 from 0.01 to 9.99
liters | PEF from 50 to 900
l/min
FEV1 from 0.01 to 9.99
liters |
| Measuring
method | Flow: Turbine sensor
Volume: Flow Integration | Flow: Turbine sensor
Volume: Flow
Integration |
| Accuracy | PEF ± 25 l/min or 12% of
the reading;
FEV1 ± 0.1 l or ± 5% of
the reading | PEF ± 20 l/min or± 10%
of the reading;
FEV1 ± 0.05 l or ± 3% of
the reading |
| Measuring
solution | PEF 1 l/min; FEV1 0.01 l | PEF 1 l/min; FEV1 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 1.5×2 alkaline
batteries |
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Image /page/5/Picture/0 description: The image shows a blue logo. The logo is a stylized flower with three petals. There is a registered trademark symbol to the right of the flower.
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:
-
- IEC 60601-1: 2012;
-
- IEC 60601-1-2: 2004;
-
- AST 2005 update;
-
- ISO 10993-5: 2009;
-
- 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).