Electronic Peak Flow Meter

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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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ ### 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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<br>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,<br>Liuxian Avenue, Xili Town, Nanshan District, Shenzhen,<br>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. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {5}------------------------------------------------ ### 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 {6}------------------------------------------------ | Item | Proposed Device | Predicate<br>Device:<br>(K170281) | Comments | | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------| | Device name and model | Electronic Peak Flow<br>Meter (DL-DF01) | MSA100BT Peak<br>Flow Meter | | | | Regulation number | 21 CFR 868.1860 | 21 CFR<br>868.1860 | Same | | | Classification | II | II | Same | | | Product code | BZH | BZH | Same | | | Intended use/Indications<br>for use | This device is intended<br>for monitoring PEF<br>(Peak Expiratory Flow)<br>for patient home use.<br>The device is designed<br>for children 5 years of<br>age or older,<br>adolescent and adult<br>subjects. | This device is<br>intended for<br>monitoring PEF<br>(Peak Expired<br>Flow Rate) and<br>FEV1 (Forced<br>Expiratory<br>Volume in one<br>second) for<br>patient home<br>use.<br>The device<br>is designed for<br>pediatric to adult<br>patients.<br>The device<br>is intended for<br>monitoring<br>respiratory<br>conditions such<br>as asthma. | Similar | | | Patient Population | The device is designed<br>for children greater<br>than five years of age,<br>adolescent and adult<br>subjects. | The device is<br>designed for<br>pediatric to adult<br>patients | Similar | | | OTC or Rx | OTC | OTC | Same | | | Materials | Polypropylene<br>(mouthpiece) | Polypropylene<br>(mouthpiece) | Same | | | | | | | | | Measuring range | PEF from 50 to 900 L/min | PEF from 50 to 900 L/min<br>FEV1 from 0.01 to 9.99 L | Same | | | | Measuring method | Flow: Turbine sensor | Flow: Turbine sensor<br>Volume: Flow Integration | Same | | Accuracy | | ±10 L/min or ±10%,<br>whichever is greater | PEF ± 20 L/min<br>or PEF ± 10% of the reading;<br>FEV1 ± 0.05 L or<br>FEV1 ± 3% of the reading | Similar | | | Repeatability | <5% or 10 L/min,<br>whichever is greater | not known | Similar | | | Measuring resolution | PEF 1 L/min | PEF 1 L/min;<br>FEV1 0.01 L | Same | | | Data transmission | BLE wireless<br>transmission | BLE wireless<br>transmission | Same | | Memory volume | 500 recordings | 250 recordings | Different | | | Power source | AAA 1.5×2 alkaline<br>batteries | AAA 1.5×2<br>alkaline batteries | Similar | | | Performance testing | Standardisation of<br>spirometry (2005<br>Revision) | Standardisation<br>of spirometry<br>(2005 Revision) | Same | | | | Electrical Safety and EMC | IEC 60601-1 and IEC<br>60601-1-2 | IEC 60601-1 and<br>IEC 60601-1-2 | Same | | Shelf-Life/Use-Life | | 3 years | not known | Similar | {7}------------------------------------------------ ### 7. Summary of Non-clinical Performance Testing ### 1) 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: {8}------------------------------------------------ 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 #### 2) 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) #### 3) 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 #### 4) 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 #### 5) 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 {9}------------------------------------------------ Contained in Medical Devices", and the software for this device was considered as a "moderate" level of concern. ### 6) 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 ### 7) Human Factors The device was evaluated for human factors and usability engineering. ### 8. Conclusion The subject device, Electronic Peak Flow Meter (model DL-DF01), manufactured by Taian Dalu Medical Instrument Co., Ltd. is substantially equivalent to the predicate device (MSA100BT Peak Flow Meter) manufactured by Beijing M&B Electronic Instruments Co., Ltd. (K170281). This conclusion is based upon comparison on intended use, technological characteristics, and performance testing.