Who is the manufacturer of Safey Peak Flow Meter?

Safey Medical Devices Pvt, Ltd. filed the 510(k) submission for Safey Peak Flow Meter (K200832).

What is the FDA product code for Safey Peak Flow Meter?

BZH. It is classified under 21 CFR 868.1860 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Safey Peak Flow Meter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Safey Peak Flow Meter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Safey Peak Flow Meter

K200832 · Safey Medical Devices Pvt, Ltd. · BZH · Jul 30, 2020 · Anesthesiology

Device Facts

Record ID	K200832
Device Name	Safey Peak Flow Meter
Applicant	Safey Medical Devices Pvt, Ltd.
Product Code	BZH · Anesthesiology
Decision Date	Jul 30, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1860
Device Class	Class 2
Attributes	Pediatric

Intended Use

Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.

Device Story

Pocket-sized peak flow meter for home use; measures PEF and FEV1. Input: patient exhalation through reusable mouthpiece; turbine vane rotation detected via infrared interrupt sensors. Device calculates flow/volume metrics; transmits data via Bluetooth Low Energy (BLE) to Safey App on smartphone. App displays real-time test results, stores data, and provides medication reminders. Used by patients (children >5, adolescents, adults) to track lung health; healthcare providers review stored data to inform clinical decisions. Benefits: enables longitudinal monitoring of respiratory status outside clinical settings.

Clinical Evidence

Bench testing only. Device performance validated using a Flow/Volume simulator per ATS Standardization of Spirometry (2005) guidelines. Biocompatibility testing conducted per ISO 10993-1. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2. Software verification and validation performed per IEC 62304.

Technological Characteristics

Infrared interrupt sensing principle; turbine-based flow measurement. Powered by 2x AAA alkaline batteries. Connectivity: BLE to mobile app. Dimensions: 95x58x18.12 mm. IP22 rating. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-1-11 (home use), ISO 10993-1 (biocompatibility), IEC 62304 (software lifecycle).

Indications for Use

Indicated for children >5 years, adolescents, and adults for home monitoring of Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1).

Regulatory Classification

Identification

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

Predicate Devices

Smart One (K181666)

Related Devices

K181666 — Smart One · Mir Medical International Research · Aug 1, 2018
K230423 — Electronic Peak Flow Meter · Taian Dalu Medical Instrument Co., Ltd. · Feb 23, 2024
K170281 — MSA100BT Peak Flow Meter · Beijing M&B Electronic Instruments Co., Ltd. · Oct 6, 2017
K191239 — Smart Peak Flow Meter · Guangzhou Homesun Medical Technology Co., Ltd. · Dec 6, 2019
K201002 — Safey Pocket Spirometer · Safey Medical Devices Pvt, Ltd. · Jul 30, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and it features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 31, 2020 Safey Medical Devices Pvt Ltd Taher Moiyed CEO and Founder PAP-S-47&48, Chakan MIDC - II, Pune 410501, Maharashtra India Re: K200832 Trade/Device Name: Safey Peak Flow Meter Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-flow meter for spirometry Regulatory Class: Class II Product Code: BZH Dear Taher Moiyed: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 30, 2020. Specifically, FDA is updating this SE Letter as an administrative correction (incorrect contact information). Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Rachana Visaria, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, (240) 402-5628, Rachana. Visaria@fda.hhs.gov. Sincerely, ## Rachana Visaria -S for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. July 30, 2020 Safey Medical Devices Pvt Ltd Taher Moiyed CEO and Founder 3rd Floor, Office 303, Nvati Emporius, S no 105 H no 4A, Baner, Pune, Maharashtra 411045 India Re: K200832 Trade/Device Name: Safey Peak Flow Meter Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-flow meter for spirometry Regulatory Class: Class II Product Code: BZH Dated: June 30, 2020 Received: June 30, 2020 Dear Taher Moiyed: 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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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. 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 {2}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and 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) K200832 Device Name Safey Peak Flow Meter Indications for Use (Describe) Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects. | 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) | 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." Form Approved: OMB No. 0910-0120 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "safey" in a bold, sans-serif font. The color of the text is a dark blue. The word is written in lowercase letters. The background is white. ### 510(k) Summary #### 1) Applicant Information | Manufacturer | Safey Medical Devices Pvt Ltd PAP-S-47&48, Chakan MIDC – II, Pune 410501, Maharashtra India | |---------------------|------------------------------------------------------------------------------------------------------| | Contact Information | Taher Ali Moiyed, CEO and Founder taher@safeymedicaldevices.com +44 7855 535353 | | Date of preparation | 07/29/2020 | #### 2) Device Information | | Subject Device | |------------------|--------------------------------------------------------------------------------------------------------| | Proprietary name | Safey Peak Flow Meter | | Common Name | Peak Flow meter | | Classification | Peak-flow meter for spirometry Regulatory Class: Class II; per 21 CFR 868.1860 Product Code: BZH | | Predicate Device | Smart One (K181666) | #### 3) Device Description Safey Peak Flow Meter is an over-the-counter medical device to help respiratory patients keep track of their lung health. This device measures Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1). Safey Peak Flow Meter is a pocket device intended for home use and operates on two AAA type standard alkaline batteries. Safey Peak Flow Meter works on infrared interrupt concept. The turbine consists of a vane which rotates clockwise or anti-clockwise depending on the direction of flow into the turbine. The device consists of Infrared pairs which detects the direction and speed of rotation of the vane, which is further calculated to PEF and FEV1. The device connects with a Medical Mobile Application (Safey App) using BLE (Bluetooth Low Energy) to display the test results to the User. #### Mobile Medical Device (Safey App) 3.1 Safey Peak Flow Meter connects to the smartphone with Safey App installed using Bluetooth (low energy). Upon conducting the tests as per instruction, the test result information is synched to the Safey App in real time. The App displays and stores this information for future use. The Safey App is also a medication reminder tool. It helps users by reminding to take their medications on time. The Safey App also has the functionality which helps users to connect with friends and family members to share medication reminder related information. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "safey" in a sans-serif font. The word is written in a dark blue color. The letters are all lowercase and connected to each other. The background is white. #### 4) Indications for Use Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects. #### 5) Comparison of Technological Characteristics The following is a comparison between the predicate and the subject device. | | Smart One | Safey Peak Flow Meter | Comparison | |--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | 510(k) number | K181666 (Predicate) | K200832 | | | Intended Use | Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects. | Safey Peak Flow Meter is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects. | Same | | Type of Use | OTC | OTC | Same | | Classification | BZH | BZH | Same | | Size | 109x49x21 mm | 95x58x18.12 mm | Different dimensions | | Operating Principal | Infrared Interrupts | Infrared Interrupts | Same | | Method of communication | Bluetooth Low Energy | Bluetooth Low Energy | Same | | Measured Values | PEF and FEV1 | PEF and FEV1 | Same | | Volume Accuracy | 3% or 0.1 L whichever is greater | 3% or 0.1 L whichever is greater | Same | | Peak Flow Accuracy | 10% or 24 L/m (0.40 L/s) whichever is greater | 10% or 24 L/m (0.40 L/s) whichever is greater | Same | | Mouthpiece type | Reusable | Reusable | Same | | Power source | 2x Alkaline AAA Batteries | 2x Alkaline AAA Batteries | Same | | Flow and Volume Accuracy Standards | As per ATS/ERS Standards | As per ATS/ERS Standards | Same | | IP Rating | IP22 | IP22 | Same | | Maximum peak flow | 16 L/s | 16 L/s | Same | | Maximum FEV1 | 10L | 10L | Same | | Test Feedback | Real time feedback and graphical representation of flow | Real time feedback and graphical representation of flow | Equivalent | | Display screen | Mobile App | Mobile App | Same | | Applicable standards | Electrical Safety IEC 60601-1 | Electrical Safety IEC 60601-1 | Equivalent | | Electromagnetic Compatibility IEC 60601– 1–2 ATS Standardization of spirometry 1994 Update | Electromagnetic Compatibility IEC 60601– 1–2 IEC 60601-1-6 IEC 60601-1-11 ATS Standardization of spirometry 2005 | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "safey" in a bold, sans-serif font. The color of the text is a dark blue. The word is presented on a white background. The letters are closely spaced, giving the word a compact appearance. In comparison to the predicate device, Safey Peak Flow Meter has some differences mainly in the shape, size and color of the devices. There are no differences in features, accuracy or any other factor which effects the safety and efficacy of the device. ### 6) Performance Data A series of non-clinical tests are conducted on Safey Peak Flow Meter. They include: - | Standard | Description | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1:2005+AMD1:2012 | General requirements for basic safety and essential performance | | IEC 60601-1-2:2014(4th Edition) | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | | IEC 60601-1-6:2010, AMD1:2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | IEC 60601-1-11:2015 | General requirements for basic safety and essential performance -Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | | ATS Standardization of Spirometry | The Pocket Spirometer device was tested on a Flow/Volume Simulator according to American Thoracic Society (ATS) Document "Standardization of Spirometry -2005". The results obtained show that Safey Peak Flow Meter and Safey Pocket Spirometer display results within ATS limits. | | ISO 10993-1 | Biocompatibility of the materials has been tested for cytotoxicity, irritation, and sensitization according to ISO 10993-1: 2009, following FDA's guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". | | IEC 62304 | The evaluation of Software Development Life Cycle of the Software programmed into Safey Peak Flow Meter, Safey Pocket Spirometer and the Safey App was conducted as per IEC 62304. The software verification and validation was conducted and documented as per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | | FCC Part 15 Subpart B and C | The device was tested as per 47 CFR Part 15 for intentional and unintentional radiators. | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "safey" in a bold, sans-serif font. The color of the text is a dark blue. The background is white, providing a clean contrast that makes the text stand out. All performance tests conducted on Safey Peak Flow Meter passed. Software verification and validation testing were conducted, and documentation was provided 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. In addition, the following FDA guidance documents were also followed in this submission: - Guidance For Labeling Peak Flow Meters For Over The Counter Sale, Version 1.0, 1993 - Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, August 4, 2013 - Design Considerations for Devices intended for home Use, Nov 24, 2014 - · Postmarket management of Cybersecurity in Medical Devices, Dec 28, 2016 #### 7) Conclusion Based on these results, it is our determination that the device is substantially equivalent to predicate device.