GoSpiro

K163249 · Monitored Therapeutics, Inc. · BZG · Mar 24, 2017 · Anesthesiology

Device Facts

• Record ID: K163249
• Device Name: GoSpiro
• Applicant: Monitored Therapeutics, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Mar 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

GoSpiro is a handheld, portable diagnostic spirometer for lung function testing in clinical and home settings. It uses a vertical turbine volume sensor to measure airflow and volume directly at BTPS (body temperature and pressure, saturated). An internal electronic temperature sensor on the PCB enables correction of inspired volumes and flows. The device transmits real-time flow-volume loop data via Bluetooth to a smartphone or tablet running the GoSpiro App. It performs calculations meeting ATS/ERS requirements, including quality control indices like time to peak flow and back-extrapolated volume. The device is powered by a rechargeable Lithium battery. Healthcare providers use the transmitted data and quality indices to assess lung function and make clinical decisions. The device benefits patients by enabling remote monitoring and tele-healthcare applications for respiratory conditions.

Clinical Evidence

Bench testing only. Testing included ATS/ERS waveform simulator performance, flow resistance, high altitude performance, battery safety (IEC 62133), wireless coexistence, and biocompatibility (ISO 10993-1, -5, -10). Human factors study performed. No clinical trial data presented.

Technological Characteristics

Handheld turbine-based spirometer. Materials: Biocompatible per ISO 10993. Sensing: Vertical turbine transducer; electronic temperature sensor for BTPS correction. Energy: 3.7V 500mAh rechargeable Lithium battery. Connectivity: Bluetooth to mobile app. Standards: AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11. Ingress Protection: IP22. Software: IEC 62304 compliant.

Indications for Use

Indicated for adults and children over 5 years old for basic lung function and spirometry testing in physician offices, clinics, and home settings. Contraindicated for patients with hemoptysis of unknown origin, pneumothorax, unstable cardiovascular status (recent MI, uncontrolled hypertension, pulmonary embolism, stroke, unstable angina), recent thoracic/abdominal/eye surgery, nausea/vomiting/abdominal pain, thoracic/abdominal aneurysms, history of syncope associated with forced exhalation, active tuberculosis, or Hepatitis B, unless cleared by a physician.

Regulatory Classification

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.

Predicate Devices

• MIR Medical International Research - Spirobank G (K072979)

Reference Devices

• MIR - Spirotel (K130784)
• Micro Direct - Microlab (K031102)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

K163249

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, President<br>Monitored Therapeutics, Inc.<br>5940 Venture Dr., Suite C<br>Dublin, OH 43017<br>Tel: [phone] |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | GoSpiro® |
| Common/Usual Name: | Diagnostic Spirometer |
| Classification Name: | Diagnostic Spirometer<br>BZG, Class II, CFR 868.1840 |
| Predicate Device: | MIR Medical International Research - Spirobank G (K072979) |
| Reference Devices: | MIR - Spirotel (K130784)<br>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 is<br>intended to be used by a<br>physician or by a patient under<br>the instruction of a physician or<br>paramedic. The device is<br>intended to test lung function<br>and can make spirometry<br>testing in people of all ages,<br>excluding infants and neonates.<br>It can be used in any setting. | The Spirotel spirometer and<br>pulse oximeter is intended to<br>be used by a physician or by a<br>patient under the instruction<br>of a physician or paramedic to<br>test lung function in people of<br>all ages. It is also intended to<br>be used as a single-patient<br>device and can be used in any<br>setting - home, factory,<br>pharmacy, hospital or<br>physician's office. | The GoSpiro® is intended to<br>be used by adults and children<br>over 5 years old in physician's<br>offices, clinics and home<br>settings to conduct basic lung<br>function and spirometry<br>testing. It is single-patient use<br>device. |
| Environment of use | All settings | home, factory, pharmacy,<br>hospital or physician's office. | physician's offices, clinics and<br>home settings |
| Patient Population | People of all ages, excluding<br>infants and neonates. | People of all ages | Adults and pediatric patients<br>over 5 years old |
| Technology for<br>measure flow and<br>volume | Bidirectional Turbine | Bidirectional Turbine | Bidirectional Turbine |
| Energy Type | 9V Alkaline battery | Rechargeable 3.7V, 1100<br>mAh Lithium battery | Rechargeable 3.7V, 500 mAh<br>Lithium battery |
| Physical<br>configuration | Touchscreen / LCD and<br>membrane keys | Touchscreen / LCD | Touchscreen on smartphone or<br>tablet and hard buttons |
| Technical<br>feature/specification | Predicate<br>MIR Spirobank G (K072979) | Reference<br>MIR Spirotel (K130784) | Proposed<br>GoSpiroⓇ |
| Operating Conditions | Temperature - 10 – 40°C<br>Humidity - 30% to 90% RH | Temperature: 10 – 40 °C<br>Humidity: 30% to 90% RH | Temperature - 17 to 35°C<br>Humidity - 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 per<br>second, measured at 14 Liters<br>per second (Lps) |
| Volume Range | 0-10 liters | 0-10 liters | 0-8 liters |
| Volume accuracy | ±3% or 50 mL,<br>whichever is greater | ±3% of reading, or 0.05 liters,<br>whichever is greater. | ±3% of reading, or 0.05 liters,<br>whichever is greater. |
| Used with PFT filter<br>and / or mouthpiece | Mouthpiece | Mouthpiece | Filter and mouthport |
| Communication | Bluetooth or USB | Bluetooth, USB or<br>GSM/GPRS/EDGE | Bluetooth to Wi-Fi or Cellular |
| Coaching | Display of volume-time and<br>flow-volume curves | Some instructions on screen,<br>tone at 6 seconds, flow<br>dependent tone frequency | Display of flow-time curves, 6<br>second count-down timer, tone<br>at 6 seconds. |
| Feedback of test<br>quality | Yes – Traffic lights for<br>interpretation | Yes – Trend data and traffic<br>lights for interpretation | Yes– Trend data |
| Test stored | Yes | Yes | Yes |
| Typical battery life<br>per charge | -- | -- | Approximately 140<br>measurements |
| Auditory / visual<br>alarms | Yes | Yes | Yes |
| Allows inspiration<br>before forced<br>exhalation | Yes | Yes | Yes |
| Technical<br>feature/specification | Predicate | Reference | Proposed<br>GoSpiro® |
| | MIR Spirobank G (K072979) | MIR Spirotel (K130784) | |
| Measurements Calculated and Displayed | | | |
| Tests Performed | *FVC<br>FEV *FEV1, *FEV6 | FVC<br>FEV1 | *FVC<br>FEV0.75, *FEV1, FEV3,<br>FEV6 |
| | FEV/FVC (FER) for *1, 6 | | FEV/FVC (FER) for 0.75 /1 /3<br>/ 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 (on<br>server) |
| | Volume / Time Curve | | Volume / Time Curve (on<br>server) |
| | | | Flow / Time Curve |
| ATS Spirometry<br>guidelines | Yes | Yes | Yes |
| Standards<br>Compliance | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | AAMI ANSI ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 |
| Water Ingress<br>Protection | IPX1 | IPX1 | IP22 |
| Biocompatibility and<br>Patient Contact | Externally communicating<br>(Indirect), Tissue and Surface<br>Contact, Mucosa, limited<br>exposure | Externally communicating<br>(Indirect), Tissue and Surface<br>Contact, Mucosa, limited<br>exposure | Externally communicating<br>(Indirect), Tissue and Surface<br>Contact, Mucosa, limited<br>exposure |

### 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

March 21, 2017

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 | | |
|------------------------------------------------|--|--|
| | | |

| Technical<br>feature/specification | Reference<br>Microlab / SpiroUSB – K031102 | Proposed<br>GoSpiro® |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Microlab spirometer is intended, for<br>prescription use only, to measure the<br>maximal volume and flow of air that can be<br>moved in and out of a patient's lungs. The<br>system is intended for use with pediatric (4<br>to 17 years) and adult (18 to 99 years)<br>patients in hospitals, physician offices,<br>laboratories and occupational health testing<br>environments. | The GoSpiro® is intended to be used by<br>adults and children over 5 years old in<br>physician's offices, clinics and home<br>settings to conduct basic lung function<br>and spirometry testing. It<br>is single-patient use device. |
| Environment of use | hospitals, physician offices, laboratories and<br>occupational health testing | physician's offices, clinics and home<br>settings |
| Patient Population | 4 – 17 – pediatric<br>18 – 99 – adults | Adults<br>Pediatric patients over 5 years old |
| Technology for<br>measure flow and<br>volume | Turbine | Turbine |
| Energy Type | USB power | 3.7V, 500 mAh Lithium battery |
| Physical<br>configuration | Attached to PC | Data transmitted to tablet,<br>computer or smartphone for |
| Operating Conditions | Temperature: 32 - 104F<br>Humidity: 30% to 90% RH | Temperature - 17 to<br>35°C Humidity -<br>30%RH to 75%RH<br>Atmospheric 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…