Besmed Peak Flow Meter

K172804 · Besmed Health Business Corp · BZH · Jan 11, 2018 · Anesthesiology

Device Facts

• Record ID: K172804
• Device Name: Besmed Peak Flow Meter
• Applicant: Besmed Health Business Corp
• Product Code: BZH · Anesthesiology
• Decision Date: Jan 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Hand-held peak flow meter; measures peak expiratory flow (PEF) during forced exhalation. Principle of operation: tension spring and piston/pointer mechanism; user exhales into mouthpiece; airflow moves piston against spring tension; calibrated scale displays flow rate in L/min. Includes one-way valve mouthpiece to prevent inhalation through device and reduce cleaning requirements. Used by patients in any environment (home, clinic) for self-monitoring. Healthcare providers use output to track respiratory status and adjust clinical management. Benefits include portable, accessible monitoring of breathing patterns.

Clinical Evidence

Bench testing only. Performance testing included peak flow accuracy, repeatability, aging, storage/environmental conditions, and mechanical drop tests. Results demonstrated equivalent or better performance compared to the predicate device, meeting ISO 23747 requirements with accuracy of +/- 10% and precision of +/- 5%. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Mechanical peak flow meter; tension spring and piston/pointer sensing principle. Materials: surface contact/mucosa-communicating components tested per ISO 10993-1. Dimensions/form factor: hand-held. Models: PF-29100 (50-800 L/min) and PF-29200 (50-300 L/min). No software or electronic components.

Indications for Use

Indicated for patients 5 years and older requiring measurement of peak expiratory flow rate (PEF) to track day-to-day changes in breathing patterns.

Regulatory Classification

Identification

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

Predicate Devices

• Vitalograph Peak Flow Meter (K781922)

Reference Devices

• MINI WRIGHT LR AFS (K952713)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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.<br>No. 5, Lane 116, Wu-Kong 2nd Rd,<br>Wu-Ku District, New Taipei City, Taiwan | Tel - 011-886-2-2290-3959<br>Fax - 011-886-2-2299-9076 | |
| Official Contact: | Sarah Lu<br>Vice President / Sales Manager | |
| Proprietary or Trade Name: | Besmed Peak Flow Meter | |
| Common/Usual Name: | Peak Flow Meter | |
| Classification Name: | 21CFR 868.1860<br>BZH - Meter, Peak Flow, Spirometry<br>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<br>measures Peak Expiratory Flow (PEF) generated by the patient during a<br>forced exhalation maneuver. The proposed device can be used to measure<br>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<br>Vitalograph Peak Flow Meter,<br>K781922 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | PF-29100 (Full Range for Adult)<br>PF-29200 (Low Range for Child) | 43800 AsmaPLAN<br>43800 AsmaPLAN+ |
| Indicated Use<br>Target Population<br>Environment of Use | The intended device measures a<br>patient's peak expiratory flow rate<br>liters/minute.<br><br>Patient Population – Patients 5 years<br>and older requiring the measurement of<br>peak expiratory flow rate.<br><br>Environment - Anywhere a patient<br>may require the measurement of peak<br>expiratory flow. | The intended device simply measures a<br>patient's peak expiratory flow rate in<br>liters/minute.<br><br>Patient population: Patients requiring<br>the measurement of peak expiratory<br>flow rate.<br><br>Environment of use: Anywhere a<br>patient may require the measurement of<br>peak expiratory flow. |
| OTC | Yes | Yes |
| Design | Single Patient. Multi Use | Single Patient Use |
| Components | Mouthpiece, disposable | |
| Measuring Principle | Tension Spring<br>Piston/Pointer | Tension Spring<br>Piston/Pointer |
| Biocompatibility | Surface Contact, Mucosa and<br>Externally Communicating<br>Tissue<br>Limited duration (<24 hr.)<br>Cytotoxicity<br>Sensitization<br>Intracutaneous reactivity | Surface Contact, Mucosa and<br>Externally Communicating<br>Tissue<br>Limited duration (<24 hr.)<br>Cytotoxicity<br>Sensitization<br>Intracutaneous reactivity |
| Range | 50~800 L/min (PF-29100, adult)<br>50~300 L/min (PF-29200, child) | 50~800 L/min |
| ISO 23747 requirements | | |
| Accuracy | +/- 10% | +/- 10% |
| Intra device Precision | +/- 5% | +/- 5% |
| Inter device Precision | +/- 5% | +/- 5% |
| Performance | | |
| Effects of Aging | No change in performance | Unknown |
| Drop test | No change in performance | Unknown |
| Environmental conditions | 10-40°C | 10-40°C |
| Storage conditions | 10-40°C | 10-40°C |
| Cleaning | Proper cleaning with mild detergent in | unknown |

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#### 510(k) Summary Page 3 of 4 04-Jan-2018

The Besmed Peak Flow Meter is viewed as substantially equivalent to the predicate device because:

#### Indications for Use / Patient Population / Environment of Use-

The indications for use are similar between both devices.

#### Discussion -

The indications for use are similar for the proposed device and the predicate - Vitalograph Peak Flow Meter, K781922

#### Technology -

The technology is simple spring tension, that when the user exhales the indicator moves and the spring has been calibrated to represent the flow rate of the user. The proposed device includes a mouthpiece with oneway valve to prevent the user from inhaling through the measurement portion and thus prevent the necessity of cleaning that portion of the device. Only the mouthpiece with one-way valve needs to be cleaned between uses.

#### Discussion -

The technology is similar for the proposed device as compared to the predicate - Vitalograph Peak Flow Meter, K781922

#### Non-Clinical Testing Summary -

#### Biocompatibility of Materials -

The components in patient contact are characterized similar for the proposed device and the predicate, which is:

- External Communicating ●
- Tissue / Bone / Dentin
- . And
- Surface Contact
- Mucosa
- Duration of Use limited (< 24 hours) ●

#### Discussion -

The type and duration of patient contact is similar for the proposed and predicate device. We have performed ISO 10993-1 testing for the materials in patient contact.

#### Performance Testing including Comparative:

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

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## 510(k) Summary Page 4 of 4 04-Jan-2018

# Substantial Equivalence Conclusion:

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent