(371 days)
Not Found
No
The summary describes a standard electronic peak flow meter with Bluetooth connectivity to a mobile app for data display and monitoring. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The performance studies focus on standard spirometry metrics (accuracy, repeatability) and reference a predicate device that is also a peak flow meter.
No.
The device is for monitoring PEF, not for treating a condition or disease.
Yes
The device monitors PEF (Peak Expiratory Flow) to assess respiratory health status, which is a diagnostic function to help understand a patient's condition.
No
The device description explicitly states it is made up of two elements: an Electronic Peak Flow Meter (hardware) and a Mobile Medical Application (software). The software is embedded in the hardware, and the combination of software and hardware realizes the device's functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: This device measures Peak Expiratory Flow (PEF), which is a physiological measurement of how fast a person can exhale. It does not involve the analysis of any biological specimens taken from the body.
- Intended Use: The intended use is for monitoring PEF for patient home use, which is a direct measurement of a physiological function, not an analysis of a specimen.
Therefore, while it is a medical device used for monitoring a health parameter, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for monitoring PEF (Peak Expiratory Flow) for patient home use. The device is designed for children 5 years of age or older, adolescent and adult subjects.
Product codes
BZH
Device Description
The device is made up of two elements – the Electronic Peak Flow Meter and a Mobile Medical Application for smartphones that communicate via Bluetooth. The device is a portable device that can measure the Peak Expiratory Flow (PEF). The Electronic Peak Flow Meter consists of the main unit, turbine, and blowing mouthpiece.
Electronic Peak Flow Meter software is embedded in the main control unit, which is used to control the whole system of operation. After compiling, the program is solidified into the hardware. The combination of software and hardware realizes the functions for electronic peak flow meter.
When Electronic Peak Flow Meter connected to APP of communication devices (such as a mobile) through Bluetooth. The changes of the patient's PEF data within one week can be monitored by APP, so that it is more convenient to monitor the respiratory health status.
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
children 5 years of age or older, adolescent and adult subjects
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)
Electrical Safety, Electromagnetic Compatibility
The subject device has passed safety testing in according to following standards:
- IEC 60601-1:2005, AMDI:2012 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
- IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
Performance testing
Performance testing was conducted on the Electronic Peak Flow Meter for the measurement of peak expiratory flow (PEF). Technical parameters of accuracy and repeatability were evaluated in the performance testing, according to ATS/ERS Task Force: Standardisation of lung function testing - Standardisation of spirometry 2005. Measurements of PEF meet the requirements in the standard.
Operational/Environmental Testing
IEC TR 60721-4-7:2001 Standardisation of spirometry (2005 Revision)
Transport testing
ISTA-3A:2018 Standardisation of spirometry (2005 Revision)
Biocompatibility test
Biocompatibility testing was conducted in accordance with the 2020 FDA guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Device Part 1: Evaluation and Testing."
The subject device has passed biocompatibility testing in according to following standards.
- ISO 10993-5:2019 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for . irritation and skin sensitization
Shelf/Use Life and Reprocessing
Shelf/Use life and reprocessing methods were validated in accordance with the following Standards:
- ASTM F1980-21 Standardisation of spirometry (2005 Revision) .
- AAMI TIR 12:2020 Designing, testing, and labeling medical devices intended for . processing by health care facilities: A guide for device manufacturers
- . ISO 17664-1:2021 Processing of Health Care products- Information to be provided by the medical device manufacturer for the processing of medical devices
Software Verification and Validation
The subject device contains an embedded software system and an APP software. Software verification and validation testing were conducted as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", and the software for this device was considered as a "moderate" level of concern.
Cybersecurity Management
The device was evaluated for cybersecurity according to the following guidelines and standards
- Content of Premarket Submissions for Management of Cybersecurity in Medical . Devices
- IEEE/ANSI C63.27:2017
Human Factors
The device was evaluated for human factors and usability engineering.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±10 L/min or ±10%, whichever is greater
Repeatability:
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 23, 2024
Taian Dalu Medical Instrument Co., Ltd. % Liz Li Counselor Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518000 China
Re: K230423
Trade/Device Name: Electronic Peak Flow Meter Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter For Spirometry Regulatory Class: Class II Product Code: BZH Dated: January 11, 2024 Received: January 19, 2024
Dear Liz Li:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and
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Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230423
Device Name Electronic Peak Flow Meter
Indications for Use (Describe)
This device is intended for monitoring PEF (Peak Expiratory Flow) for patient home use. The device is designed for children 5 years of age or older, adolescent and adult subjects.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Taian Dalu Medical Instrument Co., Ltd. | |
|---|---|---|
| Address | West Part of Yitianmen Street, Hi-tech Zone, Taian | |
| 271000, Shandong, P.R. China | ||
| Phone No. | +86-538-8931961-8006 | |
| Contact person | Wang Yuqin | |
| Contact person's e-mail | mobilepef@163.com | |
| Date Prepared | Feb.15. 2023 | |
| 1.2 Submission Correspondent | ||
| Correspondent Name | Shenzhen Joyantech Consulting Co., Ltd. | |
| Address | 1713A, 17th Floor, Block A, Zhongguan Times Square, | |
| Liuxian Avenue, Xili Town, Nanshan District, Shenzhen, | ||
| Guangdong Province, China | ||
| Phone No. | +86 755-86069197 | |
| Contact person | Liz Li | |
| Contact person's e-mail | liz@cefda.com; grace@cefda.com | |
| Website | http://www.cefda.com |
2. Device information
| Trade name | Electronic Peak Flow Meter |
|---|---|
| Device Class | II |
| Classification name | Peak-flow meter for spirometry |
| Product code | BZH |
| Regulation No. | 21 CFR 868.1860 |
3. Legally Marketed Predicate Device
| Trade Name | MSA100BT Peak Flow Meter |
|---|---|
| 510(k) Number | K170281 |
| Product Code | BZH |
| Manufacturer | Beijing M&B Electronic Instruments Co., Ltd. |
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4. Device Description
The device is made up of two elements – the Electronic Peak Flow Meter and a Mobile Medical Application for smartphones that communicate via Bluetooth. The device is a portable device that can measure the Peak Expiratory Flow (PEF). The Electronic Peak Flow Meter consists of the main unit, turbine, and blowing mouthpiece.
Electronic Peak Flow Meter software is embedded in the main control unit, which is used to control the whole system of operation. After compiling, the program is solidified into the hardware. The combination of software and hardware realizes the functions for electronic peak flow meter.
When Electronic Peak Flow Meter connected to APP of communication devices (such as a mobile) through Bluetooth. The changes of the patient's PEF data within one week can be monitored by APP, so that it is more convenient to monitor the respiratory health status.
5. Intended use
This device is intended for monitoring PEF (Peak Expiratory Flow) for patient home use. The device is designed for children 5 years of age or older, adolescent and adult subjects.
6. Substantial Equivalence Comparison
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| Item | Proposed Device | Predicate
Device:
(K170281) | Comments | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------|
| Device name and model | Electronic Peak Flow
Meter (DL-DF01) | MSA100BT Peak
Flow Meter | | |
| Regulation number | 21 CFR 868.1860 | 21 CFR
868.1860 | Same | |
| Classification | II | II | Same | |
| Product code | BZH | BZH | Same | |
| Intended use/Indications
for use | This device is intended
for monitoring PEF
(Peak Expiratory Flow)
for patient home use.
The device is designed
for children 5 years of
age or older,
adolescent and adult
subjects. | 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. | Similar | |
| Patient Population | The device is designed
for children greater
than five years of age,
adolescent and adult
subjects. | The device is
designed for
pediatric to adult
patients | Similar | |
| OTC or Rx | OTC | OTC | Same | |
| Materials | Polypropylene
(mouthpiece) | Polypropylene
(mouthpiece) | Same | |
| | | | | |
| Measuring range | PEF from 50 to 900 L/min | PEF from 50 to 900 L/min
FEV1 from 0.01 to 9.99 L | Same | |
| | Measuring method | Flow: Turbine sensor | Flow: Turbine sensor
Volume: Flow Integration | Same |
| Accuracy | | ±10 L/min or ±10%,
whichever is greater | PEF ± 20 L/min
or PEF ± 10% of the reading;
FEV1 ± 0.05 L or
FEV1 ± 3% of the reading | Similar |
| | Repeatability |