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 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.

AI/ML Overview

The provided text describes the Safey Peak Flow Meter and its associated mobile application, which appears to be a Class II medical device intended for home use to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1). The document K200832 details the device's substantial equivalence to a predicate device, Smart One (K181666).

Here's an analysis of the acceptance criteria and the study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Safey Peak Flow Meter are primarily derived from international standards and guidance documents, particularly those related to accuracy for spirometry devices.

Acceptance Criteria (Standard / Guidance)	Reported Device Performance
Volume Accuracy (ATS/ERS): 3% or 0.1 L, whichever is greater	3% or 0.1 L, whichever is greater (Matches predicate)
Peak Flow Accuracy (ATS/ERS): 10% or 24 L/m (0.40 L/s), whichever is greater	10% or 24 L/m (0.40 L/s), whichever is greater (Matches predicate)
Electromagnetic Compatibility (IEC 60601-1-2:2014)	Passed (Tested as per standard)
General Requirements for Basic Safety & Essential Performance (IEC 60601-1:2005+AMD1:2012)	Passed (Tested as per standard)
Usability (IEC 60601-1-6:2010, AMD1:2013)	Passed (Tested as per standard)
Home Healthcare Environment Requirements (IEC 60601-1-11:2015)	Passed (Tested as per standard)
Biocompatibility (ISO 10993-1:2009)	Passed (Tested for cytotoxicity, irritation, sensitization)
Software Development Life Cycle / Verification & Validation (IEC 62304 & FDA Guidance)	Passed (Software considered "moderate" level of concern)
FCC Part 15 Subpart B and C (Intentional/Unintentional Radiators)	Passed (Device tested as per standard)

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not explicitly state the sample size used for the primary accuracy testing of the device. It mentions that the device was "tested on a Flow/Volume Simulator according to American Thoracic Society (ATS) Document 'Standardization of Spirometry -2005'".

Sample Size: Not specified in the provided document for the "Flow/Volume Simulator" test.
Data Provenance: The document implies that the testing was conducted in India by the manufacturer Safey Medical Devices Pvt Ltd as the company is based there. The nature of the testing with a simulator indicates it is a prospective test (performed specifically for this submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the accuracy testing against ATS/ERS standards using a Flow/Volume Simulator, the "ground truth" is established by the calibrated output of the simulator itself, which is designed to produce precise, known flow and volume profiles. Therefore, no human experts were used to establish ground truth for this specific performance test. The standard itself (ATS Standardization of Spirometry -2005) provides the expert consensus on what constitutes accurate spirometry measurements.

4. Adjudication Method for the Test Set

As the accuracy testing was conducted against a Flow/Volume Simulator, which provides a definitive and calibrated reference, no adjudication method involving human reviewers was necessary or applicable. The device's measurements were compared directly to the simulator's known outputs.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or reported in the provided document. The Safey Peak Flow Meter is a direct measurement device, not an AI-assisted diagnostic tool that interprets complex medical images or signals requiring human expert review. Its performance is evaluated based on its accuracy in measuring PEF and FEV1 against a calibrated standard.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the primary performance testing (accuracy of PEF and FEV1 measurements) was a standalone algorithm-only performance assessment. The device, through its embedded algorithm, calculated PEF and FEV1, and these measurements were compared against the outputs of a Flow/Volume Simulator. This evaluation did not involve a human in the loop for the actual measurement determination. The device's mobile app displays these results to the user, but the core measurement is standalone.

7. The Type of Ground Truth Used

The ground truth used for the accuracy of PEF and FEV1 measurements was calibrated output from a Flow/Volume Simulator, defined by the American Thoracic Society (ATS) Document "Standardization of Spirometry -2005" standards.

8. The Sample Size for the Training Set

The provided document does not detail any machine learning or AI model training for the core PEF and FEV1 measurement function, nor does it specify a training set size. The device operates on an "infrared interrupt concept" to measure the rotation of a vane within a turbine, which is a physical principle rather than a data-driven AI model in the traditional sense. While there is software in the device and app, it appears to be deterministic for calculations and data management, and the document focuses on software verification and validation rather than training data.

9. How the Ground Truth for the Training Set Was Established

Since no specific training set for a machine learning model is mentioned for the direct measurement function, the concept of "ground truth for the training set" as it relates to AI models is not applicable in this document. The ground truth for the device's operational accuracy relies on the physical principles and calibration against the ATS standards via the simulator.

Summary

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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

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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

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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) 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

Enclosure

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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)

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510(k) Summary

1) Applicant Information

Manufacturer	Safey Medical Devices Pvt LtdPAP-S-47&48, Chakan MIDC – II,Pune 410501, MaharashtraIndia
Contact Information	Taher Ali Moiyed, CEO and Foundertaher@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 spirometryRegulatory Class: Class II; per 21 CFR 868.1860Product Code: BZH
Predicate Device	Smart One (K181666)

3) Device Description

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.

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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 intendedfor home use by patientsto monitor PEF (PeakExpiratory Flow) andFEV1 (Forced ExpiratoryVolume in one second).The device is designedfor children greater thanfive years of age,adolescent and adultsubjects.	Safey Peak Flow Meter isintended for home use bypatients to monitor PEF(Peak Expiratory Flow)and FEV1 (ForcedExpiratory Volume in onesecond). The device isdesigned for childrengreater than five years ofage, adolescent and adultsubjects.	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 ofcommunication	Bluetooth Low Energy	Bluetooth Low Energy	Same
Measured Values	PEF and FEV1	PEF and FEV1	Same
Volume Accuracy	3% or 0.1 L whichever isgreater	3% or 0.1 L whichever isgreater	Same
Peak FlowAccuracy	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 VolumeAccuracyStandards	As per ATS/ERSStandards	As per ATS/ERS Standards	Same
IP Rating	IP22	IP22	Same
Maximum peakflow	16 L/s	16 L/s	Same
Maximum FEV1	10L	10L	Same
Test Feedback	Real time feedback andgraphical representationof flow	Real time feedback andgraphical representationof flow	Equivalent
Display screen	Mobile App	Mobile App	Same
Applicablestandards	Electrical Safety IEC60601-1	Electrical Safety IEC60601-1	Equivalent
ElectromagneticCompatibility IEC 60601–1–2ATS Standardization ofspirometry 1994 Update	ElectromagneticCompatibility IEC 60601–1–2IEC 60601-1-6IEC 60601-1-11ATS Standardization ofspirometry 2005

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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 essentialperformance
IEC 60601-1-2:2014(4th Edition)	Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - CollateralStandard: Electromagnetic disturbances - Requirements andtests
IEC 60601-1-6:2010, AMD1:2013	Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability
IEC 60601-1-11:2015	General requirements for basic safety and essentialperformance -Requirements for medical electrical equipmentand medical electrical systems used in the home healthcareenvironment
ATS Standardization ofSpirometry	The Pocket Spirometer device was tested on a Flow/VolumeSimulator according to American Thoracic Society (ATS)Document "Standardization of Spirometry -2005". The resultsobtained show that Safey Peak Flow Meter and Safey PocketSpirometer display results within ATS limits.
ISO 10993-1	Biocompatibility of the materials has been tested forcytotoxicity, irritation, and sensitization according to ISO10993-1: 2009, following FDA's guidance document "Use ofInternational Standard ISO 10993-1, "Biological evaluation ofmedical devices – Part 1: Evaluation and testing within a riskmanagement process".
IEC 62304	The evaluation of Software Development Life Cycle of theSoftware programmed into Safey Peak Flow Meter, SafeyPocket Spirometer and the Safey App was conducted as perIEC 62304. The software verification and validation wasconducted and documented as per "Guidance for the Contentof Premarket Submissions for Software Contained in MedicalDevices"
FCC Part 15 Subpart B and C	The device was tested as per 47 CFR Part 15 for intentionaland unintentional radiators.

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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.

Regulation Number and Section

§ 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).