K Number
K172804
Device Name
Besmed Peak Flow Meter
Date Cleared
2018-01-11

(115 days)

Product Code
Regulation Number
868.1860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended device measures a patient's peak expiratory flow rate liters/minute.
Device Description
The Besmed Peak Flow Meter is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The proposed device can be used to measure PEF by tracking day-to-day changes in breathing patterns.
More Information

MINI WRIGHT LR AFS, K952713

No
The description focuses on a simple mechanical measurement of peak expiratory flow and does not mention any computational analysis or learning algorithms.

No
The device measures a patient's peak expiratory flow rate, serving as a monitoring tool for diagnostic purposes rather than providing direct therapy.

Yes

Explanation: The device measures the peak expiratory flow rate to track changes in breathing patterns, which helps in the diagnosis or monitoring of respiratory conditions.

No

The device description explicitly states it is a "hand-held monitoring device" and describes physical performance testing like "Mechanical - drop test," indicating it is 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. They are used to examine these samples outside of the body.
  • Device Function: The Besmed Peak Flow Meter measures a patient's peak expiratory flow rate directly from the patient's breath during a forced exhalation. 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 to measure PEF by tracking breathing patterns, which is a direct physiological measurement.

Therefore, since the device does not analyze samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The intended device measures a patient's peak expiratory flow rate liters/minute.

Product codes (comma separated list FDA assigned to the subject device)

BZH

Device Description

The Besmed Peak Flow Meter is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The proposed device can be used to measure PEF by tracking day-to-day changes in breathing patterns.

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

Patients 5 years and older

Intended User / Care Setting

Environment – Anywhere a patient may require the measurement of peak expiratory flow.

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)

We performed peak flow accuracy and the results demonstrated equivalent (or better) performance showing the Besmed Peak Flow Meter is equivalent to the predicate - Vitalograph Peak Flow Meter, K781922. The testing included:

  • Accuracy
  • Repeatability of accuracy
  • Ageing
  • Storage / Environmental conditions
  • Mechanical - drop test

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy +/- 10%
Intra device Precision +/- 5%
Inter device Precision +/- 5%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Vitalograph Peak Flow Meter, K781922

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

MINI WRIGHT LR AFS, K952713

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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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January 11, 2018

Besmed Health Business Corp. Paul Dryden Consultant No.5, Lane 116, Wu-Kong 2nd Rd Wu-Ku District, Tw

Re: K172804

Trade/Device Name: Besmed Peak Flow Meter Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter For Spirometry Regulatory Class: Class II Product Code: BZH Dated: December 14, 2017 Received: December 15, 2017

Dear Paul Dryden:

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.

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

1

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 (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Figure/6 description: The image shows the name "Tara A. Ryan -S" in a large font. To the right of the name is a digital signature from Tara A. Ryan -S. The signature includes the date 2018.01.11 and the time 08:20:45-05:00.

for Tina Kiang, Ph.D. Acting 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

K172804

Device Name

Besmed Peak Flow Meter

Indications for Use (Describe)

The intended device measures a patient's peak expiratory flow rate liters/minute.

Patient Population - Patients 5 years and older requiring the measurement of peak expiratory flow rate.

Environment – Anywhere a patient may require the measurement of peak expiratory flow.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary Page 1 of 4

Date Prepared:04-Jan-2018
Besmed Health Business Corp.
No. 5, Lane 116, Wu-Kong 2nd Rd,
Wu-Ku District, New Taipei City, TaiwanTel - 011-886-2-2290-3959
Fax - 011-886-2-2299-9076
Official Contact:Sarah Lu
Vice President / Sales Manager
Proprietary or Trade Name:Besmed Peak Flow Meter
Common/Usual Name:Peak Flow Meter
Classification Name:21CFR 868.1860
BZH - Meter, Peak Flow, Spirometry
Class II
Predicate Device:Vitalograph Peak Flow Meter, K781922
Reference Device:MINI WRIGHT LR AFS, K952713
Device Description:The Besmed Peak Flow Meter is a hand-held monitoring device that
measures Peak Expiratory Flow (PEF) generated by the patient during a
forced exhalation maneuver. The proposed device can be used to measure
PEF by tracking day-to-day changes in breathing patterns.

Indications for Use:

The intended device measures a patient's peak expiratory flow rate liters/minute.

Patient Population – Patients 5 years and older requiring the measurement of peak expiratory flow rate.

Environment – Anywhere a patient may require the measurement of peak expiratory flow.

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510(k) Summary

Comparison to Predicate

| Device Comparison | Besmed Peak Flow Meter | Predicate
Vitalograph Peak Flow Meter,
K781922 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | PF-29100 (Full Range for Adult)
PF-29200 (Low Range for Child) | 43800 AsmaPLAN
43800 AsmaPLAN+ |
| Indicated Use
Target Population
Environment of Use | The intended device measures a
patient's peak expiratory flow rate
liters/minute.

Patient Population – Patients 5 years
and older requiring the measurement of
peak expiratory flow rate.

Environment - Anywhere a patient
may require the measurement of peak
expiratory flow. | The intended device simply measures a
patient's peak expiratory flow rate in
liters/minute.

Patient population: Patients requiring
the measurement of peak expiratory
flow rate.

Environment of use: Anywhere a
patient may require the measurement of
peak expiratory flow. |
| OTC | Yes | Yes |
| Design | Single Patient. Multi Use | Single Patient Use |
| Components | Mouthpiece, disposable | |
| Measuring Principle | Tension Spring
Piston/Pointer | Tension Spring
Piston/Pointer |
| Biocompatibility | Surface Contact, Mucosa and
Externally Communicating
Tissue
Limited duration (