(105 days)
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.
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.
The provided document, a 510(k) Summary for the Safey Pocket Spirometer, outlines the device's technical characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device (Spirobank G, K072979). While it details various non-clinical tests and adherence to standards, it does not provide acceptance criteria tables or the specific results of the ATS/ERS flow/volume simulator test in a format that directly addresses the prompt's request for "acceptance criteria and reported device performance" with specific numerical values for metrics like accuracy, precision, sensitivity, or specificity.
The document states: "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." This implies that the device met the ATS standards for spirometry accuracy, but the numerical acceptance criteria and the actual performance results are not explicitly tabulated.
Therefore, the following response will infer some acceptance criteria based on the comparison table and general industry standards (ATS/ERS) and report the device's performance as "meets ATS limits" where specific numbers are not provided. Much of the requested information (e.g., sample size for test/training sets, number and qualifications of experts, adjudication methods) is absent from this 510(k) summary, as these details are typically required for studies involving qualitative or diagnostic AI/ML models with human performance components, rather than a quantitative measurement device like a spirometer.
Acceptance Criteria and Device Performance for Safey Pocket Spirometer
The Safey Pocket Spirometer is a diagnostic spirometer. The primary performance evaluation for such devices revolves around the accuracy of flow and volume measurements against established standards, such as those from the American Thoracic Society (ATS) and European Respiratory Society (ERS).
1. Table of Acceptance Criteria and Reported Device Performance
Given the information provided in the 510(k) summary, the acceptance criteria are implicitly based on the ATS/ERS standards, and the reported performance is that the device meets these standards. The comparison table with the predicate device also indicates shared performance characteristics.
| Performance Metric | Acceptance Criteria (Based on ATS/ERS and Predicate) | Reported Device Performance (Safey Pocket Spirometer) |
|---|---|---|
| Volume Accuracy (FVC) | 3% or 0.1 L, whichever is greater (ATS/ERS standard) | Meets 3% or 0.1 L, whichever is greater |
| Peak Flow Accuracy (PEF) | 10% or 24 L/m (0.40 L/s), whichever is greater (ATS/ERS standard) | Meets 10% or 24 L/m (0.40 L/s), whichever is greater |
| Flow and Volume Accuracy Standards | As per ATS/ERS Standards (Standardization of Spirometry - 2005) | Meets ATS/ERS Standards |
| Maximum Peak Flow | 16 L/s | 16 L/s |
Note: The document only states that "The results obtained show that Safey Pocket Spirometer display results within ATS limits." It does not provide the exact numerical results for accuracy beyond stating that it meets the accepted limits.
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify a separate "test set" sample size in terms of human subjects or distinct spirometry measurements. The performance testing was conducted on a "Flow/Volume Simulator." The number of samples/measurements performed on this simulator is not specified.
- Data Provenance: The testing was non-clinical, done on a simulator, and focused on device accuracy rather than patient data. The device manufacturer, Safey Medical Devices Pvt Ltd, is based in Pune, Maharashtra, India.
3. Number and Qualifications of Experts for Ground Truth
This type of device (a diagnostic spirometer) does not typically require human experts to establish "ground truth" in the same way an AI/ML diagnostic imaging device would. The ground truth for spirometry measurements is established by physical standards and calibrated simulators, often traceable to national or international metrology standards. Therefore, the concept of "experts establishing ground truth" in the context of human interpretation is not directly applicable here.
4. Adjudication Method for the Test Set
Not applicable. As the testing was conducted on a flow/volume simulator, no human adjudication was involved in generating the "ground truth" measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a standalone measurement device, not an AI-assisted diagnostic tool designed to improve human reader performance. Its performance is validated against physical standards, not human interpretations.
6. Standalone Performance (Algorithm Only)
The provided data describes the standalone performance of the device (Safey Pocket Spirometer) and its integrated software. The device's ability to accurately measure and report spirometry values (volume, flow, etc.) is the core of its standalone performance. The testing against ATS/ERS standards on a flow/volume simulator represents this standalone (algorithm/device only) validation.
7. Type of Ground Truth Used
The ground truth used was based on physical standards and calibrated spirometry flow/volume simulators. These simulators are designed to generate precise and known flow and volume patterns, serving as the "true" values against which the device's measurements are compared. The reference for these ground truth values is the American Thoracic Society (ATS) Document "Standardization of Spirometry - 2005."
8. Sample Size for the Training Set
Not applicable/Not specified. This device operates on an "infrared interrupt" concept to measure flow and volume, which relies on physical principles and calibration rather than machine learning models that require large training data sets. Therefore, there's no "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning algorithm. The device's method of operation is based on established physics and engineering principles, not learned patterns from data.
{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 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 Pocket Spirometer |
| Common Name | Spirometer |
| Classification | Diagnostic SpirometerRegulatory Class II; per 21 CFR 868.1840Product 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 PocketSpirometer | Comparison | |
|---|---|---|---|
| 510(k) number | K072979 (Predicate) | K201002 | |
| Intended Use | The Spirobank Gspirometer is intended tobe used by a physician orby a patient under theinstruction of a physicianor paramedic. The deviceis intended to test lungfunction and can makespirometry testing inpeople of all ages,excluding infants andneonates. | Safey Pocket Spirometeris a spirometer intendedto be used by a patientunder the instruction of aphysician to performbasic lung function andspirometry testing forusers above 5 years ofage in home healthcareenvironment. | SubstantiallyEquivalent |
| Type of Use | Rx | Rx | Same |
| Classification | BZG | BZG | Same |
| Use environment | All settings | Home use | Different useenvironments |
| Size | 109x49x21 mm | 95x58x18.12 mm | Differentdimensions |
| OperatingPrincipal | Infrared Interrupts | Infrared Interrupts | Same |
| Method ofcommunication | Bluetooth Low Energy | Bluetooth Low Energy | Same |
| Mouthpiece type | Reusable | Reusable | 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 |
| Power source | 2x Alkaline AAA Batteries | 2x Alkaline AAABatteries | Same |
| Flow and VolumeAccuracyStandards | As per ATS/ERS Standards | As per ATS/ERSStandards | Same |
| IP Rating | IP22 | IP22 | Same |
| Maximum peakflow | 16 L/s | 16 L/s | Same |
| Test Feedback | Real time feedback andgraphical representationof flow | Real time feedback andgraphical representationof flow | Same |
| Applicablestandards | Electrical Safety IEC60601-1ElectromagneticCompatibility IEC 60601-1-2ATS Standardization ofspirometry 1994 Update | Electrical Safety IEC60601-1ElectromagneticCompatibility IEC60601-1-2IEC 60601-1-6IEC 60601-1-11ATS Standardization ofspirometry 2005 | Same |
| Measured Values | |||
| Forced vitalcapacity | FVC | FVC | Same |
| Volume expired inthe first | FEV0.75, FEV1, FEV3,FEV6 | FEV0.75, FEV1, FEV3,FEV6 | Same |
| Ratio betweenvolume expired ina certain timeperiod and FVC | FEV/FVC (FER) for0.75/1/3/6 | FEV/FVC (FER) for0.75/1/3/6 | Same |
| Peak expiratoryflow | PEF | PEF | Same |
| Forced expiratoryflow between thefirst 25% and 75%of the FVC | FEF25-75 (MEF) | FEF25-75 (MEF) | Same |
| Volume inspired inthe first second ofthe test | FIV1 | FIV1 | Same |
| Forced inspiratoryvolume | FIVC | FIVC | Same |
| Peak inspiratoryflow | PIF | PIF | Same |
| Forced inspiratoryflow in the first25% and 75% ofthe FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same |
| Ratio betweenFEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same |
| Forced expiratoryflow at 50% of FVCdivided by FVC | FEF50/FVC | FEF50/FVC | Same |
| Forced inspiratoryflow in the first25% and 75% ofthe FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same |
| Ratio betweenFEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same |
| Forced expiratoryflow at 50% of FVCdivided by FVC | FEF50/FVC | FEF50/FVC | Same |
| Force inspiratoryflow at first | FIV1/FIVC (FIR) | FIV1/FIVC (FIR) | Same |
| second deviceforced inspiratoryvolume | |||
| Forced expiratorytime | FET | FET | Same |
| Maximumvoluntaryventilation | 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 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 Safey Pocket Spirometer device was tested on aFlow/Volume Simulator according to American ThoracicSociety (ATS) Document "Standardization of Spirometry -2005". The results obtained show that 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 Pocket Spirometer and theSafey App was conducted as per IEC 62304. The softwareverification 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 forSoftware Contained in Medical Devices" | |
|---|---|
| FCC Part 15 Subpart B and C | The device was tested as per 47 CFR Part 15 for intentional andunintentional 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.
§ 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).