(105 days)
No
The device description details a mechanical and infrared-based measurement system and mentions standard software verification and validation, with no indication of AI/ML algorithms for data processing or interpretation.
No
The device is a spirometer used to perform basic lung function and spirometry testing, which is a diagnostic and monitoring tool, not a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to be used by a patient under the instruction of a physician to perform basic lung function and spirometry testing". Performing spirometry testing for lung function is a diagnostic activity.
No
The device description explicitly details hardware components like a turbine, infrared pairs, and batteries, and mentions testing according to hardware standards (IEC 60601 series, FCC Part 15). While it connects to a mobile application, the core spirometry measurement is performed by the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Safey Pocket Spirometer Function: The Safey Pocket Spirometer measures lung function by analyzing the flow and volume of air exhaled by the patient. It does this by detecting the rotation of a vane within the device based on the patient's breath.
- No Specimen Examination: The device does not examine any specimens derived from the human body (like blood, urine, or tissue). It directly measures a physiological parameter (airflow and volume).
Therefore, based on the provided information, the Safey Pocket Spirometer falls under the category of a medical device that measures a physiological function, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
BZG
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.
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
above 5 years of age
Intended User / Care Setting
Used by a patient under the instruction of a physician in home healthcare environment.
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)
A series of non-clinical tests are conducted on Safey Pocket Spirometer. They include:
- 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 Safey 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 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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volume Accuracy: 3% or 0.1 L whichever is greater
Peak Flow Accuracy: 10% or 24 L/m (0.40 L/s) whichever is greater
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows 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 features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in bold blue letters and "ADMINISTRATION" in smaller blue letters below.
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, (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: 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
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) 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) | |
|---|---|
| ☑ 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
"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
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 Pocket Spirometer |
| Common Name | Spirometer |
| Classification | Diagnostic Spirometer |
| Regulatory Class II; per 21 CFR 868.1840 | |
| 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.
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.
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
Spirometer | Comparison |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| 510(k) number | K072979 (Predicate) | K201002 | |
| Intended Use | The Spirobank G
spirometer is intended to
be used by a physician or
by a patient under the
instruction of a physician
or paramedic. The device
is intended to test lung
function and can make
spirometry testing in
people of all ages,
excluding infants and
neonates. | 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. | Substantially
Equivalent |
| Type of Use | Rx | Rx | Same |
| Classification | BZG | BZG | Same |
| Use environment | All settings | Home use | Different use
environments |
| 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 |
| Mouthpiece type | Reusable | Reusable | 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 |
| 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 |
| Test Feedback | Real time feedback and
graphical representation
of flow | Real time feedback and
graphical representation
of flow | Same |
| Applicable
standards | Electrical Safety IEC
60601-1
Electromagnetic
Compatibility IEC 60601-
1-2
ATS Standardization of
spirometry 1994 Update | Electrical Safety IEC
60601-1
Electromagnetic
Compatibility IEC
60601-1-2
IEC 60601-1-6
IEC 60601-1-11
ATS Standardization of
spirometry 2005 | Same |
| Measured Values | | | |
| Forced vital
capacity | FVC | FVC | Same |
| Volume expired in
the first | FEV0.75, FEV1, FEV3,
FEV6 | FEV0.75, FEV1, FEV3,
FEV6 | Same |
| Ratio between
volume expired in
a certain time
period and FVC | FEV/FVC (FER) for
0.75/1/3/6 | FEV/FVC (FER) for
0.75/1/3/6 | Same |
| Peak expiratory
flow | PEF | PEF | Same |
| Forced expiratory
flow between the
first 25% and 75%
of the FVC | FEF25-75 (MEF) | FEF25-75 (MEF) | Same |
| Volume inspired in
the first second of
the test | FIV1 | FIV1 | Same |
| Forced inspiratory
volume | FIVC | FIVC | Same |
| Peak inspiratory
flow | PIF | PIF | Same |
| Forced inspiratory
flow in the first
25% and 75% of
the FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same |
| Ratio between
FEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same |
| Forced expiratory
flow at 50% of FVC
divided by FVC | FEF50/FVC | FEF50/FVC | Same |
| Forced inspiratory
flow in the first
25% and 75% of
the FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same |
| Ratio between
FEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same |
| Forced expiratory
flow at 50% of FVC
divided by FVC | FEF50/FVC | FEF50/FVC | Same |
| Force inspiratory
flow at first | FIV1/FIVC (FIR) | FIV1/FIVC (FIR) | Same |
| second device
forced inspiratory
volume | | | |
| Forced expiratory
time | FET | FET | Same |
| Maximum
voluntary
ventilation | MVV | - | Different |
6
safey
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 letters are closely spaced together, creating a compact and unified appearance. The background is plain white, which makes the text stand out.
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 |
| 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 Safey 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 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 Pocket Spirometer and the | |
| Safey App was conducted as per IEC 62304. The software | |
| verification and validation was conducted and documented as |
8
Image /page/8/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 in lowercase letters and appears to be a logo or brand name.
| | 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. |
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.