Safey Pocket Spirometer

K201002 · Safey Medical Devices Pvt, Ltd. · BZG · Jul 30, 2020 · Anesthesiology

Device Facts

• Record ID: K201002
• Device Name: Safey Pocket Spirometer
• Applicant: Safey Medical Devices Pvt, Ltd.
• Product Code: BZG · Anesthesiology
• Decision Date: Jul 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Safey Pocket Spirometer is a spirometer intended to be used by a patient under the instruction of a physician to perform basic lung function and spirometry testing for users above 5 years of age in home healthcare environment.

Device Story

Portable spirometer for home use; measures lung function via infrared interrupt turbine; turbine vane rotation speed/direction detected by infrared pairs; data processed into spirometry values; connects via Bluetooth Low Energy (BLE) to Safey App on smartphone; app displays/stores test results; app includes medication reminder tool and social sharing functionality; powered by two AAA alkaline batteries; physician uses output to monitor respiratory patient lung health; patient benefits from remote tracking and adherence support.

Clinical Evidence

Bench testing only. Device performance validated against ATS 2005 spirometry standards using a Flow/Volume simulator. Biocompatibility testing performed per ISO 10993-1. Software verification and validation conducted per IEC 62304. Electrical safety and EMC testing performed per IEC 60601 series.

Technological Characteristics

Portable spirometer; infrared interrupt sensing principle; powered by 2x AAA alkaline batteries; BLE connectivity; IP22 rating; dimensions 95x58x18.12 mm; reusable mouthpiece. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, ATS 2005. Software development per IEC 62304.

Indications for Use

Indicated for patients above 5 years of age requiring basic lung function and spirometry testing in a home healthcare environment, under physician instruction.

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Predicate Devices

• Spirobank G (K072979)

Submission Summary (Full Text)

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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: K201002

Trade/Device Name: Safey Pocket Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: Class II Product Code: BZG

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, [phone] , Rachana. [e-mail].

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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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: K201002

Trade/Device Name: Safey Pocket Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: Class II Product Code: BZG 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 ([e-mail]) or phone [phone] 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

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#### Indications for Use

510(k) Number (if known) K201002

Device Name Safey Pocket Spirometer

Indications for Use (Describe)

Safey Pocket Spirometer is a spirometer intended to be used by a patient under the instruction of a physician to perform basic lung function and spirometry testing for users above 5 years of age in home healthcare environment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-family: DejaVu Sans, sans-serif;"> <span style="font-size: 12px;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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### 510(k) Summary

#### 1) Applicant Information

| Manufacturer | Safey Medical Devices Pvt Ltd<br>PAP-S-47&48, Chakan MIDC – II,<br>Pune 410501, Maharashtra<br>India |
|---------------------|------------------------------------------------------------------------------------------------------|
| Contact Information | Taher Ali Moiyed, CEO and Founder<br>[e-mail]<br>[phone] |

## Date of preparation

07/29/2020

#### 2) Device Information

| | Subject Device |
|------------------|----------------------------------------------------------------------------------------|
| Proprietary name | Safey Pocket Spirometer |
| Common Name | Spirometer |
| Classification | Diagnostic Spirometer<br>Regulatory Class II; per 21 CFR 868.1840<br>Product Code: BZG |
| Predicate Device | Spirobank G (K072979) |

#### 3) Device Description

Safey Pocket Spirometer is a prescription use medical device to help respiratory patients keep track of their lung health. This device is a portable spirometer intended for above 5 years of age. Safey Pocket Spirometer is a pocket device intended for home use and operates on two AAA type standard alkaline batteries.

Safey Pocket Spirometer 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 interpretable spirometry values. 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)

Safey Pocket Spirometer 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 Pocket Spirometer is a spirometer intended to be used by a patient under the instruction of a physician to perform basic lung function and spirometry testing for users above 5 years of age in home healthcare environment.

#### 5) Comparison of Technological Characteristics

The following is a comparison between the predicate and the subject device.

| | Spirobank G | Safey Pocket<br>Spirometer | Comparison |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| 510(k) number | K072979 (Predicate) | K201002 | |
| Intended Use | The Spirobank G<br>spirometer is intended to<br>be used by a physician or<br>by a patient under the<br>instruction of a physician<br>or paramedic. The device<br>is intended to test lung<br>function and can make<br>spirometry testing in<br>people of all ages,<br>excluding infants and<br>neonates. | Safey Pocket Spirometer<br>is a spirometer intended<br>to be used by a patient<br>under the instruction of a<br>physician to perform<br>basic lung function and<br>spirometry testing for<br>users above 5 years of<br>age in home healthcare<br>environment. | Substantially<br>Equivalent |
| Type of Use | Rx | Rx | Same |
| Classification | BZG | BZG | Same |
| Use environment | All settings | Home use | Different use<br>environments |
| Size | 109x49x21 mm | 95x58x18.12 mm | Different<br>dimensions |
| Operating<br>Principal | Infrared Interrupts | Infrared Interrupts | Same |
| Method of<br>communication | Bluetooth Low Energy | Bluetooth Low Energy | Same |
| Mouthpiece type | Reusable | Reusable | Same |
| Volume Accuracy | 3% or 0.1 L whichever is<br>greater | 3% or 0.1 L whichever is<br>greater | Same |
| Peak Flow<br>Accuracy | 10% or 24 L/m (0.40 L/s)<br>whichever is greater | 10% or 24 L/m (0.40 L/s)<br>whichever is greater | Same |
| Power source | 2x Alkaline AAA Batteries | 2x Alkaline AAA<br>Batteries | Same |
| Flow and Volume<br>Accuracy<br>Standards | As per ATS/ERS Standards | As per ATS/ERS<br>Standards | Same |
| IP Rating | IP22 | IP22 | Same |
| Maximum peak<br>flow | 16 L/s | 16 L/s | Same |
| Test Feedback | Real time feedback and<br>graphical representation<br>of flow | Real time feedback and<br>graphical representation<br>of flow | Same |
| Applicable<br>standards | Electrical Safety IEC<br>60601-1<br>Electromagnetic<br>Compatibility IEC 60601-<br>1-2<br>ATS Standardization of<br>spirometry 1994 Update | Electrical Safety IEC<br>60601-1<br>Electromagnetic<br>Compatibility IEC<br>60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-11<br>ATS Standardization of<br>spirometry 2005 | Same |
| Measured Values | | | |
| Forced vital<br>capacity | FVC | FVC | Same |
| Volume expired in<br>the first | FEV0.75, FEV1, FEV3,<br>FEV6 | FEV0.75, FEV1, FEV3,<br>FEV6 | Same |
| Ratio between<br>volume expired in<br>a certain time<br>period and FVC | FEV/FVC (FER) for<br>0.75/1/3/6 | FEV/FVC (FER) for<br>0.75/1/3/6 | Same |
| Peak expiratory<br>flow | PEF | PEF | Same |
| Forced expiratory<br>flow between the<br>first 25% and 75%<br>of the FVC | FEF25-75 (MEF) | FEF25-75 (MEF) | Same |
| Volume inspired in<br>the first second of<br>the test | FIV1 | FIV1 | Same |
| Forced inspiratory<br>volume | FIVC | FIVC | Same |
| Peak inspiratory<br>flow | PIF | PIF | Same |
| Forced inspiratory<br>flow in the first<br>25% and 75% of<br>the FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same |
| Ratio between<br>FEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same |
| Forced expiratory<br>flow at 50% of FVC<br>divided by FVC | FEF50/FVC | FEF50/FVC | Same |
| Forced inspiratory<br>flow in the first<br>25% and 75% of<br>the FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same |
| Ratio between<br>FEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same |
| Forced expiratory<br>flow at 50% of FVC<br>divided by FVC | FEF50/FVC | FEF50/FVC | Same |
| Force inspiratory<br>flow at first | FIV1/FIVC (FIR) | FIV1/FIVC (FIR) | Same |
| second device<br>forced inspiratory<br>volume | | | |
| Forced expiratory<br>time | FET | FET | Same |
| Maximum<br>voluntary<br>ventilation | MVV | - | Different |

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# safey

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Apart from structural differences which do not affect the substantial equivalence of the product, the following are the differences between the subject and predicate device: -

Use Environment

The predicate device is rated for all settings whereas the subject device is rated for home use only. Since the subject device is rated for a more restricted environment compared to the predicate device, it is deemed to be at least as safe and as effective as the predicate device.

#### 6) Performance Data

A series of non-clinical tests are conducted on Safey Pocket Spirometer. 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<br>for basic safety and essential performance - Collateral<br>Standard: Electromagnetic disturbances - Requirements and<br>tests |
| IEC 60601-1-6:2010, AMD1:2013 | Medical electrical equipment - Part 1-6: General requirements<br>for basic safety and essential performance - Collateral<br>standard: Usability |
| IEC 60601-1-11:2015 | General requirements for basic safety and essential<br>performance -Requirements for medical electrical equipment<br>and medical electrical systems used in the home healthcare<br>environment |
| ATS Standardization of<br>Spirometry | The Safey Pocket Spirometer device was tested on a<br>Flow/Volume Simulator according to American Thoracic<br>Society (ATS) Document "Standardization of Spirometry -<br>2005". The results obtained show that Safey Pocket<br>Spirometer display results within ATS limits. |
| ISO 10993-1 | Biocompatibility of the materials has been tested for<br>cytotoxicity, irritation, and sensitization according to ISO<br>10993-1: 2009, following FDA's guidance document "Use of<br>International Standard ISO 10993-1, "Biological evaluation of<br>medical devices – Part 1: Evaluation and testing within a risk<br>management process". |
| IEC 62304 | The evaluation of Software Development Life Cycle of the<br>Software programmed into Safey Pocket Spirometer and the<br>Safey App was conducted as per IEC 62304. The software<br>verification and validation was conducted and documented as |

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| | per "Guidance for the Content of Premarket Submissions for<br>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<br>unintentional radiators. |

All performance tests conducted on Safey Pocket Spirometer were passed.

Software verification and validation testing was 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:

• 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 its predicate device.