(70 days)
Not Found
No
The description focuses on standard spirometry technology (turbine sensor) and calculations based on established standards (ATS/ERS). There is no mention of AI, ML, or related concepts.
No.
The device is intended for diagnostic purposes (lung function and spirometry testing), not for treating a condition.
Yes
The device is intended to "conduct basic lung function and spirometry testing" and "performs full flow-volume loops including inspiratory and expiratory data," which are measurements used to assess and diagnose lung conditions.
No
The device description explicitly mentions hardware components such as a vertical turbine volume sensor, an electronic temperature sensor, an internal rechargeable Lithium battery, and a USB charging station. It also states compliance with hardware safety standards (ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11). While it uses software (the GoSpiro App), it is not solely software.
Based on the provided information, the GoSpiro® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- GoSpiro® Function: The GoSpiro® directly measures lung function by analyzing the air exhaled and inhaled by the patient. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "basic lung function and spirometry testing," which is a physiological measurement, not an analysis of a biological sample.
Therefore, the GoSpiro® falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The GoSpiro® is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing.
Product codes
BZG
Device Description
The GoSpiro® is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing.
The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.
It is used with the GoSpiro App display and communications software on a smartphone or tablet.
The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11.
The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
adults and children over 5 years old
Intended User / Care Setting
physician's offices, clinics and home settings
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)
- High level disinfection validation
- Post-disinfecting performance o
- Post-disinfecting biocompatibility о
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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December 4, 2020
Monitored Therapeutics, Inc. % Paul Dryden President - consultant Monitored Therapeutics, Inc. c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K202837
Trade/Device Name: GoSpiro® Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: November 3, 2020 Received: November 4, 2020
Dear Paul Dryden:
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/cfdocs/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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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,
for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K202837
Device Name
GoSpiro®
Indications for Use (Describe)
The GoSpiro® is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Sponsor: | Michael Taylor - CEO
Monitored Therapeutics, Inc.
5995 Shier Rings Road, Ste A
Dublin, OH 43016
Tel: +614-761-3555 |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | Paul Dryden
ProMedic, LLC |
| Proprietary or Trade Name: | GoSpiro® |
| Common/Usual Name: | Diagnostic Spirometer |
| Regulation Number:
Regulation Code:
Product Code:
Regulatory Class: | 21CFR 868.1840
Diagnostic Spirometer
BZG
II |
| Predicate Device: | Monitored Therapeutics, Inc. – K163249 – GoSpiro® |
Modification:
Changing the turbine from single patient, multi-patient, multi-patient, multi-use.
Device Description:
The GoSpiro® is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing.
The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.
It is used with the GoSpiro App display and communications software on a smartphone or tablet.
The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11.
The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.
4
Indications for Use:
The GoSpiro® is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing.
Device Comparison:
Table 1 compares the subject device to the predicate Monitored Therapeutics – GoSpiro®, K163249.
| Table 1 - Comparison Predicate to Proposed Device | |||||
|---|---|---|---|---|---|
| --------------------------------------------------- | -- | -- | -- | -- | -- |
| Technical feature/specification | Predicate
K163249 - GoSpiro® | Proposed
GoSpiro® |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The GoSpiro® is intended to be used by
adults and children over 5 years old in
physician's offices, clinics and home
settings to conduct basic lung function
and spirometry testing. It is single-
patient use device. | The GoSpiro® is intended to be used
by adults and children over 5 years old
in physician's offices, clinics and
home settings to conduct basic lung
function and spirometry testing. |
| Environment of use | Physician's offices, clinics and home
settings | Physician's offices, clinics and home
settings |
| Patient Population | Adults and pediatric patients over 5
years old | Adults and pediatric patients over 5
years old |
| Use with PFT filter after each use | Yes | Yes |
| Turbine may be cleaned / disinfected | No, had to be replaced if no filter was
used | Cleaned and Disinfected |
| Technology for measure flow and
volume | Bidirectional Turbine | Bidirectional Turbine |
| Energy Type | Rechargeable 3.7V, 500 mAh Lithium
battery | Rechargeable 3.7V, 500 mAh Lithium
battery |
| Physical configuration | Touchscreen on smartphone or tablet and
hard buttons | Touchscreen on smartphone or tablet
and hard buttons |
| Operating Conditions | Temperature - 17 to 35°C
Humidity - 30%RH to 75%RH | Temperature - 17 to 35°C
Humidity - 30%RH to 75%RH |
| Weight | 10.5 oz. | 10.5 oz. |
| Size | 3.5 x 4.5" | 3.5 x 4.5" |
| Flow Range | ±14 l/s | ±14 l/s |
| Flow Accuracy | ±5% or 200 mL/s | ±5% or 200 mL/s |
| Flow Resistance | 137 Pascals (Pa) per Liter per second,
measured at 14 Liters per second (Lps) | 137 Pascals (Pa) per Liter per second,
measured at 14 Liters per second (Lps) |
| Volume Range | 0-8 liters | 0-8 liters |
| Technical feature/specification | Predicate | Proposed |
| | K163249 - GoSpiro® | GoSpiro® |
| Volume accuracy | ±3% of reading, or 0.05 liters, whichever
is greater. | ±3% of reading, or 0.05 liters,
whichever is greater. |
| Used with PFT filter and / or
mouthpiece | Yes | Yes |
| Communication | Bluetooth to Wi-Fi or Cellular | Bluetooth to Wi-Fi or Cellular |
| Coaching | Display of flow-time curves, 6 second
count-down timer, tone at 6 seconds. | Display of flow-time curves, 6 second
count-down timer, tone at 6 seconds. |
| Feedback of test quality | Yes- Trend data | Yes- Trend data |
| Test stored | Yes | Yes |
| Typical battery life per charge | Approximately 140 measurements | Approximately 140 measurements |
| Auditory / visual alarms | Yes | Yes |
| Allows inspiration before forced
exhalation | Yes | Yes |
| Tests Performed | *FVC | *FVC |
| | FEV0.75, *FEV1, FEV3, FEV6 | FEV0.75, *FEV1, FEV3, FEV6 |
| | FEV/FVC (FER) for 0.75 /1 /3 / 6 | FEV/FVC (FER) for 0.75 /1 /3 / 6 |
| | *PEF | *PEF |
| | MMEF | MMEF |
| | FEF 25/50/75 | FEF 25/50/75 |
| | FEF25-75 (MEF) | FEF25-75 (MEF) |
| | FIV1 | FIV1 |
| | FIVC | FIVC |
| | PIF | PIF |
| | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) |
| | FIF 25/50/75 | FIF 25/50/75 |
| | MET25-75 | MET25-75 |
| | FEV0.75/FEV6 | FEV0.75/FEV6 |
| | FEV1/FEV6 | FEV1/FEV6 |
| | FEF50/FVC | FEF50/FVC |
| | MMEF/FVC (FEF25-75/FVC) | MMEF/FVC (FEF25-75/FVC) |
| | FIV1/FIVC (FIR) | FIV1/FIVC (FIR) |
| | R50 (FEF50/FIF50) | R50 (FEF50/FIF50) |
| | FET | FET |
| | MVV (ind) | MVV (ind) |
| | Vext | Vext |
| | Time to PEF | Time to PEF |
| | Possible Cough | Possible Cough |
| | LAST500V | LAST500V |
| | Flow / Volume Curve (on server) | Flow / Volume Curve (on server) |
| | Volume / Time Curve (on server) | Volume / Time Curve (on server) |
| | Flow / Time Curve | Volume / Time Curve (on server) |
| Page 4 of 4 | | |
| Technical feature/specification | Predicate | Proposed |
| | K163249 - GoSpiro® | GoSpiro® |
| ATS Spirometry guidelines | Yes | Yes |
| Standards Compliance | AAMI ANSI ES 60601-1
IEC 60601-1-2
IEC 60601-1-11 | AAMI ANSI ES 60601-1
IEC 60601-1-2
IEC 60601-1-11 |
| Water Ingress Protection | IP22 | IP22 |
| Biocompatibility and Patient Contact | Externally communicating (Indirect),
Tissue and Surface Contact, Mucosa,
limited exposure | Similar patient contact and identical
materials |
| Cleaning and Disinfection validation | Cleaning of mouthport | Same mouthport
Cleaning and disinfection of Turbine |
5
510(k) Summary
December 4, 2020
6
510(k) Summary December 4, 2020
- Indicates parameters displayed for patients only.
Differences vs. Predicate:
The only difference between the predicate and the subject device is the labeling to allow for cleaning, disinfection and reuse of the turbine. The validation testing has been performed demonstrating that the turbine may be cleaned, disinfected and reused.
All other features and specifications are identical to the cleared K163249 device.
Substantial Equivalence Discussion:
As the devices are identical the only discussion relates to the change in the ability to clean, disinfect and reuse the turbine for multi-patient, multi-use. Disinfection is only required when a filter is not used with each patient.
All other comparative features are identical.
- Indications for Use / Patient Population / Environment of Use ●
- Prescriptive
- Design and Technology ●
- Performance and Specifications ●
- Compliance with Standards
- Performance Testing ●
- High level disinfection validation
- Post-disinfecting performance o
- Post-disinfecting biocompatibility о
- . Biocompatibility
- The materials have been evaluated per ISO 10993-1 o
Substantial Equivalence Conclusion:
The GoSpiro® is substantially equivalent to the cleared GoSpiro® predicate, K163249.