(122 days)
Not Found
No
The device description details a mechanical measurement system based on infrared detection of a rotating vane. There is no mention of AI, ML, or any data processing beyond calculating PEF and FEV1 from the detected rotation. The performance studies and software documentation also do not indicate the use of AI/ML.
No.
The device is described as a diagnostic tool for measuring PEF and FEV1 to help patients track lung health, not to provide therapy or treatment.
Yes
The device is described as measuring Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) to help respiratory patients track their lung health, which are diagnostic indicators of lung function.
No
The device description explicitly states it is a "pocket device" that "operates on two AAA type standard alkaline batteries" and "works on infrared interrupt concept" with a "turbine" and "Infrared pairs". This indicates it is a physical hardware device, not solely software. While it connects to a mobile application, the core measurement functionality is performed by the hardware component.
Based on the provided information, the Safey Peak Flow Meter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Safey Peak Flow Meter Function: The Safey Peak Flow Meter measures lung function parameters (PEF and FEV1) directly from the patient's breath. It does not analyze a biological specimen.
Therefore, the Safey Peak Flow Meter falls under the category of a medical device used for direct physiological measurement, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZH
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.
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
children greater than five years of age, adolescent and adult subjects.
Intended User / Care Setting
respiratory patients, 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 Peak Flow Meter. 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 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.
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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
"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.