(126 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. It is a 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. It is a single-patient, use device.
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 avoids the need for individual calibration prior to performing a test.
The Monitored Therapeutics, Inc. GoSpiro® is a diagnostic spirometer intended for use by adults and children over 5 years old in physician's offices, clinics, and home settings for basic lung function and spirometry testing. It is a single-patient use device.
Here's an analysis of its acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests and compliance with established standards, but it does not explicitly list quantitative acceptance criteria for each spirometry parameter (e.g., FVC, FEV1) with specific numerical ranges. Instead, it states that "The GoSpiro passed the acceptance criteria for all the listed testing requirements and specifications." and "The performance and specifications demonstrate that the devices meet the ATS 2005 requirements for pulmonary function testing." This implies that the acceptance criteria are adherence to the ATS 2005 guidelines for spirometry, and the device met these.
However, the document does provide specific performance metrics in the comparison tables, which can be interpreted as demonstrating the device's capabilities relative to its predicates and standards.
| Acceptance Criteria (Implied by ATS 2005 and Predicate Comparison) | Reported Device Performance |
|---|---|
| Flow/Volume Accuracy | ±5% or 200 mL/s |
| Volume Accuracy | ±3% of reading, or 0.05 liters, whichever is greater |
| Flow Range | +14 l/s |
| Volume Range | 0-8 liters |
| Flow Resistance | 137 Pascals (Pa) per Liter per second, measured at 14 Liters per second (Lps) |
| Operating Conditions (Temperature) | 17 to 35°C |
| Operating Conditions (Humidity) | 30%RH to 75%RH |
| Compliance with ATS Spirometry Guidelines | Yes |
| Compliance with Safety Standards | AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 |
| Biocompatibility | Passed ISO 10993-1, including cytotoxicity, irritation, sensitization, VOC, CO, CO2, Ozone, and PM25 testing |
| Environmental Requirements | Passed |
| Modes of Operation (Functional) | Passed |
| ATS/ERS waveform simulator testing | Passed |
| High Altitude Performance | Passed |
| Possible Cough Detection (Functional) | Passed |
| Durability turbine life test | Passed |
| Mechanical Requirements | Passed |
| Electrical Requirements (Battery Safety, Wireless Coexistence, Bluetooth Module) | Passed (IEC 62133) and documented |
| PCB and Electrical Circuitry Requirements | Passed |
| Packaging and Shipping Requirements | Passed |
| Hardware Verification | Passed |
| Labeling Requirements | Passed |
| Manufacturing Requirements | Passed |
| Safety Requirements | Passed |
| Cleaning and Shelf-life | Passed |
| Software and System Verification and Validation | Passed (IEC 62304) |
| Human Factors study | Passed |
2. Sample size used for the test set and the data provenance
The document states that "ATS / ERS waveform simulator testing" was performed and passed. However, it does not specify the sample size (number of waveforms or individuals) used for this test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as this was likely a bench/simulator test rather than a clinical study with human subjects.
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 document because the testing appears to be primarily technical/bench validation against established spirometry standards (ATS/ERS waveform simulator testing) rather than a clinical study requiring expert ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
An adjudication method is not applicable or not described in the provided text, as the testing was focused on the device's technical performance against a simulator and compliance with standards, not on interpreting images or clinical outcomes that would require adjudicators.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. The GoSpiro is a diagnostic spirometer that measures lung function, not an AI-powered diagnostic system requiring human interpretation comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing described ("ATS / ERS waveform simulator testing") represents a standalone evaluation of the algorithm's accuracy at measuring flow, volume, and time against a known standard. Although not explicitly called an "algorithm-only" study, the nature of testing against a simulator implies measuring the device's output independently. The document states that the device performed all calculations to meet ATS/ERS requirements and included quality control measurements and indices of measurement quality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's performance appears to be established by ATS/ERS waveform simulator testing. This refers to a standardized set of flow-volume and volume-time curves designed to test spirometer accuracy against known, ideal physiological breathing patterns. These simulators provide a "gold standard" input against which the device's measurements are compared.
8. The sample size for the training set
This refers to a software or AI model's training data. The document does not mention a training set as the device is a hardware spirometer with embedded firmware/software for calculations, not a machine learning or AI model that undergoes a separate training phase with a distinct dataset.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI model, this information is not applicable in the provided text. The device's functionality relies on established physiological principles and engineering specifications, validated against standardized simulator inputs.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
Monitored Therapeutics, Inc. % Paul Dryden Promedic. LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134
Re: K163249
Trade/Device Name: GoSpiro® Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: February 22, 2017 Received: February 24, 2017
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. 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.
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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Tina Kiang -5
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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. It is a single-patient use device.
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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510(k) Summary
March 21, 2017 Page 1 of 8
| Official Contact: | William Zimlich, PresidentMonitored Therapeutics, Inc.5940 Venture Dr., Suite CDublin, OH 43017Tel: +614-761-3555 |
|---|---|
| Proprietary or Trade Name: | GoSpiro® |
| Common/Usual Name: | Diagnostic Spirometer |
| Classification Name: | Diagnostic SpirometerBZG, Class II, CFR 868.1840 |
| Predicate Device: | MIR Medical International Research - Spirobank G (K072979) |
| Reference Devices: | MIR - Spirotel (K130784)Micro Direct - Microlab (K031102) |
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. It is a single-patient, use device.
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 avoids the need for individual calibration prior to performing a test.
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 a single-patient use device.
Contraindications:
Do not use the GoSpiro if you have any of the following unless your physician has cleared you to perform forced exhaled lung function measurements. Failure to obtain approval from your physician if you have any of these could result in serious injury or death:
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510(k) Summary March 21, 2017
Page 2 of 8
- Hemoptysis (coughing up blood) of unknown origin
- Presence of a pneumothorax (collapsed lung)
- . Presence of unstable cardiovascular status:
- Recent (within one month) myocardial infarction (heart attack) o
- Uncontrolled hypertension (high blood pressure) o
- o Pulmonary embolism (blood clot in your lungs)
- History of a hemorrhagic cerebrovascular event (stroke) o
- 0 Unstable Angina (chest pain)
- Recent thoracic (chest), abdominal or eye surgery (2 weeks)
- . Nausea, vomiting or abdominal pain
- Thoracic or abdominal aneurysms (weak blood vessels in your chest or abdomen)
- History of syncope (fainting) associated with forced exhalation ●
- Active tuberculosis or Hepatitis B
- Unstable angina (chest pain)
Device Comparison
Table 1 compares the subject device to the predicate MIR Spirobank G (K072979) and the reference MIR Spirotel (K130784). The GoSpiro is similar to the Medical International Research predicate MIR Spirobank G (K072979) and the reference MIR Spirotel (K130784). The differences include: Oximetry measurements in the reference Spirotel, communication options including 3d party display device, coaching features, display of information, and power source.
| Technical | Predicate | Reference | Proposed |
|---|---|---|---|
| feature/specification | MIR Spirobank G (K072979) | MIR Spirotel (K130784) | GoSpiro® |
| Indications for Use | The Spirobank G spirometer isintended to be used by aphysician or by a patient underthe instruction of a physician orparamedic. The device isintended to test lung functionand can make spirometrytesting in people of all ages,excluding infants and neonates.It can be used in any setting. | The Spirotel spirometer andpulse oximeter is intended tobe used by a physician or by apatient under the instructionof a physician or paramedic totest lung function in people ofall ages. It is also intended tobe used as a single-patientdevice and can be used in anysetting - home, factory,pharmacy, hospital orphysician's office. | The GoSpiro® is intended tobe used by adults and childrenover 5 years old in physician'soffices, clinics and homesettings to conduct basic lungfunction and spirometrytesting. It is single-patient usedevice. |
| Environment of use | All settings | home, factory, pharmacy,hospital or physician's office. | physician's offices, clinics andhome settings |
| Patient Population | People of all ages, excludinginfants and neonates. | People of all ages | Adults and pediatric patientsover 5 years old |
| Technology formeasure flow andvolume | Bidirectional Turbine | Bidirectional Turbine | Bidirectional Turbine |
| Energy Type | 9V Alkaline battery | Rechargeable 3.7V, 1100mAh Lithium battery | Rechargeable 3.7V, 500 mAhLithium battery |
| Physicalconfiguration | Touchscreen / LCD andmembrane keys | Touchscreen / LCD | Touchscreen on smartphone ortablet and hard buttons |
| Technicalfeature/specification | PredicateMIR Spirobank G (K072979) | ReferenceMIR Spirotel (K130784) | ProposedGoSpiroⓇ |
| Operating Conditions | Temperature - 10 – 40°CHumidity - 30% to 90% RH | Temperature: 10 – 40 °CHumidity: 30% to 90% RH | Temperature - 17 to 35°CHumidity - 30%RH to 75%RH |
| Weight | 6.3 oz. | 5.3 oz. | 10.5 oz. |
| Size | 1.3" x 1.9" x 6.4" | 1.5" x 2.9" x 3.5" | 3.5 x 4.5" |
| Flow Range | +16 1/s | +16 1/s | +14 1/s |
| Flow Accuracy | ±5% or 200 mL/s | ±5% or 200 mL/s | ±5% or 200 mL/s |
| Flow Resistance | <0.5 cmH2O/L/s | <0.5 cmH2O/L/s | 137 Pascals (Pa) per Liter persecond, measured at 14 Litersper second (Lps) |
| Volume Range | 0-10 liters | 0-10 liters | 0-8 liters |
| Volume accuracy | ±3% or 50 mL,whichever is greater | ±3% of reading, or 0.05 liters,whichever is greater. | ±3% of reading, or 0.05 liters,whichever is greater. |
| Used with PFT filterand / or mouthpiece | Mouthpiece | Mouthpiece | Filter and mouthport |
| Communication | Bluetooth or USB | Bluetooth, USB orGSM/GPRS/EDGE | Bluetooth to Wi-Fi or Cellular |
| Coaching | Display of volume-time andflow-volume curves | Some instructions on screen,tone at 6 seconds, flowdependent tone frequency | Display of flow-time curves, 6second count-down timer, toneat 6 seconds. |
| Feedback of testquality | Yes – Traffic lights forinterpretation | Yes – Trend data and trafficlights for interpretation | Yes– Trend data |
| Test stored | Yes | Yes | Yes |
| Typical battery lifeper charge | -- | -- | Approximately 140measurements |
| Auditory / visualalarms | Yes | Yes | Yes |
| Allows inspirationbefore forcedexhalation | Yes | Yes | Yes |
| Technicalfeature/specification | Predicate | Reference | ProposedGoSpiro® |
| MIR Spirobank G (K072979) | MIR Spirotel (K130784) | ||
| Measurements Calculated and Displayed | |||
| Tests Performed | *FVCFEV *FEV1, *FEV6 | FVCFEV1 | *FVCFEV0.75, *FEV1, FEV3,FEV6 |
| FEV/FVC (FER) for *1, 6 | FEV/FVC (FER) for 0.75 /1 /3/ 6 | ||
| *PEF | PEF | *PEF | |
| MMEF | MMEF | ||
| FEF 25/50/75 | FEF 25/50/75 | ||
| *FEF 25-75% | FEF25-75 (MEF) | FEF25-75 (MEF) | |
| FIV1 | FIV1 | ||
| *FIVC | FIVC | ||
| PIF | PIF | ||
| FIF25-75 (MIF25-75) | |||
| FIF 25/50/75 | |||
| MET25-75 | |||
| FEV0.75/FEV6 | |||
| FEV1/FEV6 | FEV1/FEV6 | ||
| FEF50/FVC | |||
| MMEF/FVC (FEF25-75/FVC) | |||
| FIV1/FIVC (FIR) | |||
| R50 (FEF50/FIF50) | |||
| *FET | Error Message | FET | |
| MVV | MVV (ind) | ||
| Extrap Vol | Error Message | Vext | |
| Time to PEF | Error Message | Time to PEF | |
| Possible Cough | |||
| Error Message | LAST500V | ||
| Flow / Volume Curve | Flow / Volume Curve (onserver) | ||
| Volume / Time Curve | Volume / Time Curve (onserver) | ||
| Flow / Time Curve | |||
| ATS Spirometryguidelines | Yes | Yes | Yes |
| StandardsCompliance | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | AAMI ANSI ES 60601-1IEC 60601-1-2IEC 60601-1-11 |
| Water IngressProtection | IPX1 | IPX1 | IP22 |
| Biocompatibility andPatient Contact | Externally communicating(Indirect), Tissue and SurfaceContact, Mucosa, limitedexposure | Externally communicating(Indirect), Tissue and SurfaceContact, Mucosa, limitedexposure | Externally communicating(Indirect), Tissue and SurfaceContact, Mucosa, limitedexposure |
Table 1 - Comparison Predicate to Proposed Device
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510(k) Summary
March 21, 2017
March 21, 201
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510(k) Summary
March 21, 2017
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Page 4 of 8
- Indicates parameters displayed for patients only.
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510(k) Summary March 21, 2017 Page 5 of 8
Many of the parameters calculated and displayed for the subject device are variations of the same parameter, e.g., FEV, in which time is the only variable. We recognize that the predicate has fewer measured and reportable parameters; therefore we have selected a reference device, Microlab – K031102 from MicroDirect that has similar indications for use and with more measured and reportable parameters.
| Table 2 Comparison Reference to Subject Device | ||
|---|---|---|
| Technicalfeature/specification | ReferenceMicrolab / SpiroUSB – K031102 | ProposedGoSpiro® |
|---|---|---|
| Indications for Use | The Microlab spirometer is intended, forprescription use only, to measure themaximal volume and flow of air that can bemoved in and out of a patient's lungs. Thesystem is intended for use with pediatric (4to 17 years) and adult (18 to 99 years)patients in hospitals, physician offices,laboratories and occupational health testingenvironments. | 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. Itis single-patient use device. |
| Environment of use | hospitals, physician offices, laboratories andoccupational health testing | physician's offices, clinics and homesettings |
| Patient Population | 4 – 17 – pediatric18 – 99 – adults | AdultsPediatric patients over 5 years old |
| Technology formeasure flow andvolume | Turbine | Turbine |
| Energy Type | USB power | 3.7V, 500 mAh Lithium battery |
| Physicalconfiguration | Attached to PC | Data transmitted to tablet,computer or smartphone for |
| Operating Conditions | Temperature: 32 - 104FHumidity: 30% to 90% RH | Temperature - 17 to35°C Humidity -30%RH to 75%RHAtmospheric pressure – |
| Weight | 4.6 oz. | 10.5 oz. |
| Size | 2" x 2.4" x 3.5" | 3.5" x 4.5" |
| Flow Range | Not specified | +14 l/s |
| Flow Accuracy | +3% | ±5% or 200 mL/s |
| Flow Resistance | Not provided | 137 Pascals (Pa) per Liter persecond, measured at 14 Liters |
| Volume Range | Not specified | 0-8 liters |
| Volume accuracy | +3% | ±3% of reading, or 0.05 liters,whichever is greater. |
| Used with PFT filterand / or mouthpiece | Filter and mouthpiece | Filter and mouthport |
| Technicalfeature/specification | ReferenceMicrolab / SpiroUSB – K031102 | ProposedGoSpiro® |
| Communication | Direct USB connection | Bluetooth to mobile app |
| Test duration | Minimum of 15 seconds | 15 to 20 seconds |
| Feedback of testquality | No | Not to user. Quality indicatorstransmitted to clinician. |
| Test stored | Yes on PC | Yes until transmitted and stored remotely |
| Typical battery lifeper charge | No battery | Approximately 140 measurements |
| Auditory / visualalarms | No | Blinking LED if no Bluetoothconnection, graph displayed onsmartphone or tablet, count-down |
| Allows inspirationbefore 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 | |
| FEF25-75 (MEF) | FEF25-75 (MEF) | |
| FIV1 | FIV1 | |
| FIVC | FIVC | |
| PIF | PIF | |
| FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | |
| MET25-75 | MET25-75 | |
| FEV0.75/FEV6 | FEV0.75/FEV6 | |
| FEV1/FEV6 | FEV1/FEV6 | |
| FEF50/FVC | FEF50/FVC | |
| MMEF/FVC (FEF50/FVC) | MMEF/FVC (FEF25-75/FVC) | |
| FIV1/FIVC (FIR) | FIV1/FIVC (FIR) | |
| R50 (FEF50/FIF50) | R50 (FEF50/FIF50) | |
| FET | ||
| MVV (ind) | MVV (ind) | |
| Vext | ||
| PEAKTIME | ||
| POSSIBLE_COUGH | ||
| LAST500V | ||
| Flow / Volume Curve | Flow / Volume Curve | |
| Volume / Time Curve | Volume / Time Curve | |
| Flow / Time Curve | ||
| No | N/A | |
| Page 7 of 8 | ||
| Technicalfeature/specification | ReferenceMicrolab / SpiroUSB – K031102 | ProposedGoSpiro® |
| Calculated | N/A | N/A |
| N/A | N/A | |
| N/A | N/A | |
| N/A | N/A | |
| N/A | N/A | |
| N/A | N/A | |
| N/A | N/A | |
| N/A | N/A | |
| N/A | N/A | |
| ATS Spirometryguidelines | Yes | Yes |
| StandardsCompliance | IEC 60601-1IEC 60601-1-2 | AAMI ANSI ES 60601-1IEC 60601-1-2IEC 60601-1-11 |
| Biocompatibility andPatient Contact | Externally communicating (Indirect), Tissueand Surface Contact, Mucosa, limitedexposure | Externally communicating (Indirect),Tissueand Surface Contact, Mucosa, |
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510(k) Summary
Page 6 of 8
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510(k) Summary March 21, 2017
Substantial Equivalence Discussion
Indications for Use / Patient Population / Environment of Use:
As in comparison of Indications For Use above, we can conclude that the indications for use for the GoSpiro and the predicates are substantially equivalent.
The GoSpiro is for use in physician's offices, clinics and home settings whereas the predicate also included the hospital. The GoSpiro, predicate and references are prescription devices.
Design and Technology:
As discussed above, both devices have the same basic design for a handheld, portable turbine based spirometer which calculates volume, flow and time and then presents the data in typical pulmonary function parameters.
Discussion:
It is noted that the subject and predicate devices present almost all the same measured pulmonary function parameters to a patient self-testing at home and more parameters for the physician when displayed on a tablet. There are many different calculations that a clinician might wish to have, however they are all based upon flow, volume and time. The GoSpiro presents the total measured parameters similar to the reference device.
Performance and Specifications:
The performance and specifications demonstrate that the devices meet the ATS 2005 requirements for pulmonary function testing.
Compliance with Standards:
The GoSpiro complies with the currently recognized safety and EMC standards (AAMI/ANSI/ES 60601-1:2005+A1, IEC 60601-1-2:2007and IEC 60601-1-11:2015).
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510(k) Summary March 21, 2017 Page 8 of 8
Performance Testing: Nonclinical / Bench:
The GoSpiro Spirometer was tested against criteria for:
- Environmental Requirements
- . Modes of Operation
.
- Functional Requirements
- O ATS / ERS waveform simulator testing
- o High Altitude Performance
- o Flow Resistance
- Possible Cough Detection o
- . Performance Requirements
- Durability turbine life test o
- . Mechanical Requirements
- Electrical Requirements
- AAMI ANSI ES 60601-1 O
- IEC 60601-1-11 O
- IEC 60601-1-2 O
- O Battery Safety Testing IEC 62133
- Wireless Coexistence Testing O
- Bluetooth Module Data Sheet o
- . PCB and Electrical Circuitry Requirements Packaging and Shipping Requirements
- Hardware Verification ●
- o Hardware verification
- . Labeling Requirements
- . Manufacturing Requirements
- . Safety Requirements
- . Cleaning and Shelf-life
- Software and System Verification and Validation (IEC 62304) .
- Human Factors study
The GoSpiro passed the acceptance criteria for all the listed testing requirements and specifications.
Biocompatibility:
Biocompatibility has been tested and passed for all materials that come in contact with the patient directly or indirectly according to ISO 10993-1. The required tests performed were cytotoxicity (ISO 10993-5), irritation and sensitization (ISO 10993-10), Volatile Organic Compounds (VOC), CO, CO2, Ozone, and PM25 testing.
Substantial Equivalence Conclusion
Based upon the foregoing performance testing and comparison to the legally marketed predicate devices for indications for use, technology, and performance we believe we have demonstrated that the GoSpiro is substantially equivalent and as safe and as effective as the predicate.
§ 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).