K Number

Device Name

GoSpiro

Manufacturer

MONITORED THERAPEUTICS, INC.

Date Cleared

2017-03-24

(126 days)

Product Code

BZG

Regulation Number

868.1840

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

MIR Medical International Research - Spirobank G (K072979)

Reference Devices

K130784, K031102

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard spirometry technology and calculations based on established standards (ATS/ERS). There is no mention of AI or ML in the device description, performance studies, or key metrics.

Therapeutic

No
The device is described as conducting basic lung function and spirometry testing, which are diagnostic or monitoring activities, not therapeutic interventions.

Diagnostic

Yes

Explanation: The device is intended for "basic lung function and spirometry testing" and performs "full flow-volume loops including inspiratory and expiratory data" to measure lung function. This type of testing is used to assess and evaluate health conditions, which falls under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly mentions hardware components like a turbine volume sensor, electronic temperature sensor, internal rechargeable Lithium battery, and a USB charging station. It also lists hardware verification and electrical requirements testing.

IVD (In Vitro Diagnostic)

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's Function: The GoSpiro measures lung function by analyzing the air a patient breathes in and out. It directly interacts with the patient's respiratory system, not with a specimen taken from the body.
Intended Use: The intended use clearly states it's for "conducting 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.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

BZG

Device Description

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.

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 (used by adults and children over 5 years old)

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)

Performance Testing: Nonclinical / Bench:

The GoSpiro Spirometer was tested against criteria for:

Environmental Requirements
Modes of Operation
Functional Requirements
ATS / ERS waveform simulator testing
High Altitude Performance
Flow Resistance
Possible Cough Detection
Performance Requirements
Durability turbine life test
Mechanical Requirements
Electrical Requirements
AAMI ANSI ES 60601-1
IEC 60601-1-11
IEC 60601-1-2
Battery Safety Testing IEC 62133
Wireless Coexistence Testing
Bluetooth Module Data Sheet
PCB and Electrical Circuitry Requirements Packaging and Shipping Requirements
Hardware Verification
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

MIR Medical International Research - Spirobank G (K072979)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outline of the face visible. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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.

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

Indications for Use

510(k) Number (if known)

K163249

Device Name

GoSpiro®

Indications for Use (Describe)

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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FORM FDA 3881 (8/14

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

510(k) Summary

March 21, 2017 Page 1 of 8

| Official Contact: | William Zimlich, President
Monitored Therapeutics, Inc.
5940 Venture Dr., Suite C
Dublin, OH 43017
Tel: +614-761-3555 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | GoSpiro® |
| Common/Usual Name: | Diagnostic Spirometer |
| Classification Name: | Diagnostic Spirometer
BZG, 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:

It is used with the GoSpiro App display and communications software on a smartphone or tablet.

Indications for Use:

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:

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
intended to be used by a
physician or by a patient under
the instruction of a physician or
paramedic. The device is
intended to test lung function
and can make spirometry
testing in people of all ages,
excluding infants and neonates.
It can be used in any setting.	The Spirotel spirometer and
pulse oximeter is intended to
be used by a physician or by a
patient under the instruction
of a physician or paramedic to
test lung function in people of
all ages. It is also intended to
be used as a single-patient
device and can be used in any
setting - home, factory,
pharmacy, hospital or
physician's office.	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.
Environment of use	All settings	home, factory, pharmacy,
hospital or physician's office.	physician's offices, clinics and
home settings
Patient Population	People of all ages, excluding
infants and neonates.	People of all ages	Adults and pediatric patients
over 5 years old
Technology for
measure flow and
volume	Bidirectional Turbine	Bidirectional Turbine	Bidirectional Turbine
Energy Type	9V Alkaline battery	Rechargeable 3.7V, 1100
mAh Lithium battery	Rechargeable 3.7V, 500 mAh
Lithium battery
Physical
configuration	Touchscreen / LCD and
membrane keys	Touchscreen / LCD	Touchscreen on smartphone or
tablet and hard buttons
Technical
feature/specification	Predicate
MIR Spirobank G (K072979)	Reference
MIR Spirotel (K130784)	Proposed
GoSpiroⓇ
Operating Conditions	Temperature - 10 – 40°C
Humidity - 30% to 90% RH	Temperature: 10 – 40 °C
Humidity: 30% to 90% RH	Temperature - 17 to 35°C
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