(70 days)
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® 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.
The provided text describes a 510(k) premarket notification for the GoSpiro® device, which is a diagnostic spirometer. The primary change introduced in this submission (K202837) is the ability to clean, disinfect, and reuse the turbine for multi-patient, multi-use, as opposed to the predicate device (K163249) where the turbine had to be replaced if no filter was used.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results for all device functionalities. However, it implicitly uses the predicate device's specifications as the standard for equivalence. The key performance parameters related to spirometry and their stated values are:
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (GoSpiro®) |
|---|---|
| Flow Range: ±14 l/s | Flow Range: ±14 l/s |
| Flow Accuracy: ±5% or 200 mL/s | Flow Accuracy: ±5% or 200 mL/s |
| Flow Resistance: 137 Pascals (Pa) per Liter per second, measured at 14 Liters per second (Lps) | Flow Resistance: 137 Pascals (Pa) per Liter per second, measured at 14 Liters per second (Lps) |
| Volume Range: 0-8 liters | Volume Range: 0-8 liters |
| Volume Accuracy: ±3% of reading, or 0.05 liters, whichever is greater | Volume Accuracy: ±3% of reading, or 0.05 liters, whichever is greater |
| Compliance with ATS Spirometry guidelines | Complies with ATS Spirometry guidelines |
| Compliance with AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Complies with AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 |
| Water Ingress Protection: IP22 | Water Ingress Protection: IP22 |
| Biocompatibility: Externally communicating (Indirect), Tissue and Surface Contact, Mucosa, limited exposure | Similar patient contact and identical materials (Biocompatibility evaluated per ISO 10993-1) |
| Cleaning of mouthport (predicate) | Cleaning of mouthport (Same mouthport); Cleaning and disinfection of Turbine (Proposed) |
The primary acceptance criterion that needed separate validation for the proposed device was the effectiveness of turbine cleaning and disinfection. The document states: "The validation testing has been performed demonstrating that the turbine may be cleaned, disinfected and reused." This implies that the acceptance criteria for cleaning and disinfection (e.g., reduction of microbial load, retention of device functionality, no adverse material degradation) were met, though the specific quantitative criteria are not detailed in this excerpt.
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "High level disinfection validation", "Post-disinfecting performance", and "Post-disinfecting biocompatibility" as types of performance testing.
- Sample Size: The document does not specify the sample size used for these validation tests (e.g., number of turbines subjected to disinfection, number of cycles tested, or number of biological or performance tests).
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the excerpt. The studies mentioned (disinfection, performance, biocompatibility) are laboratory/engineering tests, not clinical studies that typically involve expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The studies described are validation tests (e.g., disinfection efficacy, material properties, device function) rather than clinical evaluations requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable as the GoSpiro® is a diagnostic spirometer for measuring lung function, not an AI-assisted diagnostic tool that relies on human readers interpreting images or data with and without AI. It directly measures physiological parameters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable in the context of the GoSpiro® device. It is a physical medical device that measures spirometry parameters. Its "performance" is determined by the accuracy and precision of its physical measurements, not by an algorithm's standalone diagnostic capability in the absence of human interaction (beyond the user performing the spirometry maneuver). The device and its internal program perform calculations to meet ATS/ERS requirements, and its accuracy targets are detailed above.
7. The Type of Ground Truth Used
For the core spirometry measurements (Flow, Volume, Accuracy, Resistance), the ground truth is implicitly based on established physical and physiological standards and measurement principles (e.g., traceable reference spirometers or calibrated flow/volume sources). For the specific validation related to the new submission:
- Cleaning and Disinfection Validation: The ground truth would likely be established through standard microbiological testing methods (e.g., reduction of specified microorganisms to acceptable levels) and material compatibility assessments according to recognized standards (e.g., AAMI TIR12, ISO 17664, or specific FDA guidance).
- Post-disinfecting performance: The ground truth would be that the device, after disinfection, continues to meet its specified flow/volume accuracy and resistance criteria.
- Post-disinfecting biocompatibility: The ground truth would be that the materials, after disinfection, remain biocompatible as per ISO 10993-1.
8. The Sample Size for the Training Set
This information is not applicable as the GoSpiro® is a physical measurement device and its underlying technology (bidirectional turbine) and internal program for calculations are not described as based on machine learning or AI models requiring a "training set" in the conventional sense. The "internal program" would be developed based on physics and engineering principles, not statistical learning from data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
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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
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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
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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 - CEOMonitored Therapeutics, Inc.5995 Shier Rings Road, Ste ADublin, OH 43016Tel: +614-761-3555 |
|---|---|
| Submission Correspondent: | Paul DrydenProMedic, LLC |
| Proprietary or Trade Name: | GoSpiro® |
| Common/Usual Name: | Diagnostic Spirometer |
| Regulation Number:Regulation Code:Product Code:Regulatory Class: | 21CFR 868.1840Diagnostic SpirometerBZGII |
| 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.
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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 | PredicateK163249 - GoSpiro® | ProposedGoSpiro® |
|---|---|---|
| Indications for Use | The GoSpiro® is intended to be used byadults and children over 5 years old inphysician's offices, clinics and homesettings to conduct basic lung functionand spirometry testing. It is single-patient use device. | The GoSpiro® is intended to be usedby adults and children over 5 years oldin physician's offices, clinics andhome settings to conduct basic lungfunction and spirometry testing. |
| Environment of use | Physician's offices, clinics and homesettings | Physician's offices, clinics and homesettings |
| Patient Population | Adults and pediatric patients over 5years old | Adults and pediatric patients over 5years old |
| Use with PFT filter after each use | Yes | Yes |
| Turbine may be cleaned / disinfected | No, had to be replaced if no filter wasused | Cleaned and Disinfected |
| Technology for measure flow andvolume | Bidirectional Turbine | Bidirectional Turbine |
| Energy Type | Rechargeable 3.7V, 500 mAh Lithiumbattery | Rechargeable 3.7V, 500 mAh Lithiumbattery |
| Physical configuration | Touchscreen on smartphone or tablet andhard buttons | Touchscreen on smartphone or tabletand hard buttons |
| Operating Conditions | Temperature - 17 to 35°CHumidity - 30%RH to 75%RH | Temperature - 17 to 35°CHumidity - 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, whicheveris greater. | ±3% of reading, or 0.05 liters,whichever is greater. |
| Used with PFT filter and / ormouthpiece | Yes | Yes |
| Communication | Bluetooth to Wi-Fi or Cellular | Bluetooth to Wi-Fi or Cellular |
| Coaching | Display of flow-time curves, 6 secondcount-down timer, tone at 6 seconds. | Display of flow-time curves, 6 secondcount-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 forcedexhalation | 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 60601-1IEC 60601-1-2IEC 60601-1-11 | AAMI ANSI ES 60601-1IEC 60601-1-2IEC 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 identicalmaterials |
| Cleaning and Disinfection validation | Cleaning of mouthport | Same mouthportCleaning and disinfection of Turbine |
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510(k) Summary
December 4, 2020
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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.
§ 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).