K Number

Device Name

Breezing Med

Manufacturer

TF Health Co.

Date Cleared

2020-09-25

(255 days)

Product Code

BZL

Regulation Number

868.1730

Intended Use

Breezing Med™ Metabolism Analyzer measures metabolic functions including resting energy expenditure and respiratory quotient during resting conditions via direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements, and to quantify substrate utilization. The nutritional assessment enables the healthcare professional to further assess energy expenditure and caloric intake for weight management, and to aid in the diagnosis of diseases related to abnormal metabolic parameters. Breezing Med is intended for use with adults breathing normally on their own in a sitting position in a healthcare environment. Since the device is designed for the patient to breathe ambient air, it is not intended for patients where supplementary oxygen is being provided. Breezing Med is not intended to use as sole means for any diagnosis, and ultimately will provide data for evaluation by the professional.

Device Description

Breezing Med™ Metabolism Analyzer is a resting metabolic rate measurement system with an application installed on mobile devices that provides measurements of exhalation rate, oxygen uptake and carbon dioxide production. It is used to determine resting metabolic rates, teach energy balance, and pinpoint accurate caloric intake for weight management. Breezing Med™ is a stand-alone and fully integrated mask-like wearable metabolic analyzer based on the principle of indirect calorimetry, which is a gold standard for energy expenditure measurement. Breezing Med is designed for metabolic rate and respiratory quotient measurement and the main outputs include Resting Energy Expenditure (REE), Respiratory Quotient (RQ), Volume of Oxygen consumption (VO2), and Volume of Carbon Dioxide production (VCO2), where REE and RQ are calculated from measured parameters VO2 and VC02. Breezing Med measures the expiratory volume similar to the predicate device Medical Graphics Express® Series. Breezing Med consists of five components: 1) a device body; 2) a mask; 3) headgear; 4) a sensor cartridge; and 5) an application.

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

K070858

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that measures metabolic parameters using indirect calorimetry and calculates REE and RQ from these measurements. There is no mention of AI or ML in the device description, intended use, or performance studies. The calculations described are standard physiological formulas, not indicative of AI/ML.

Therapeutic

No
The device measures metabolic functions and parameters, and provides data for assessment and diagnosis by a healthcare professional. It is not intended to treat, mitigate, or prevent a disease, nor does it restore, modify, or correct body function.

Diagnostic

Yes

The device aids in the diagnosis of diseases related to abnormal metabolic parameters, which aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly lists five physical components: a device body, a mask, headgear, and a sensor cartridge, in addition to the application. This indicates it is a hardware device with accompanying software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Breezing Med™ Metabolism Analyzer is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Breezing Med's Function: The Breezing Med measures metabolic functions by analyzing the gases a patient breathes out (oxygen uptake and carbon dioxide production). This is a direct measurement of physiological processes within the body, not an analysis of a specimen taken from the body.
Intended Use: The intended use describes measuring metabolic functions during resting conditions via direct measurement of gases. It does not mention analyzing any bodily fluids or tissues.
Device Description: The device description reinforces that it's a "mask-like wearable metabolic analyzer" that measures "exhalation rate, oxygen uptake and carbon dioxide production."

Therefore, the Breezing Med falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

BZL

Device Description

Breezing Med™ is a stand-alone and fully integrated mask-like wearable metabolic analyzer based on the principle of indirect calorimetry, which is a gold standard for energy expenditure measurement. Breezing Med 104 is designed for metabolic rate and respiratory quotient measurement and the main outputs include Resting Energy Expenditure (REE), Respiratory Quotient (RQ), Volume of Oxygen consumption (VO2), and Volume of Carbon Dioxide production (VCO2), where REE and RQ are calculated from measured parameters VO2 and VC02.

Breezing Med™ consists of five components: 1) a device body; 2) a mask; 3) headgear; 4) a sensor cartridge; and 5) an application.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Patient's mouth and nose, through face mask

Indicated Patient Age Range

Adults

Intended User / Care Setting

Professional healthcare facilities

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)

A verification test of the Breezing Med™ to performance specifications derived from the predicate Medical Graphics Express series was conducted. The result of the test demonstrates substantial equivalence of the proposed to the predicate.

The summary of the Breezing Med™ test results are as follows:

Both devices measured O2 volumes within the specified accuracy of +/-0.8%.
Both devices measured CO2 volumes within the specified accuracy of +/-0.8%.
Both devices measured Flow Rate within +/- 0.3 Lpm = 10 Lpm.

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.

Express Series (K070858)

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.

Not Found

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

§ 868.1730 Oxygen uptake computer.

(a)
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2020

TF Health Co. % Roberta (Bobbi) Druyor-Sanchez Regulatory Consultant NDA Partners 1761 W. University Dr., Suite 140 Tempe, Arizona 85281

Re: K200076

Trade/Device Name: Breezing Med Regulation Number: 21 CFR 868.1730 Regulation Name: Oxygen Uptake Computer Regulatory Class: Class II Product Code: BZL Dated: August 28, 2020 Received: September 3, 2020

Dear Roberta (Bobbi) Druyor-Sanchez:

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 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.

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200076

Device Name

Breezing MedTM Metabolism Analyzer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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TF Healt

Corporation

Traditional Premarket Notification

Breezing Med™ Metabolism Analyzer

510(K) SUMMARY (21 CFR 807.92(C))

Applicant

TF Health Co. 1761 W University Dr. Suite 140 Tempe, AZ 85281

Primary Contact Erik Herrmann VP Operations, TF Health 480-629-5360 Email: erik.herrmann@breezing.co

2. Device

Trade Name: Breezing MedTM Metabolism Analyzer ●
Common Name: Indirect calorimeter ●
Classification Name: Computer, Oxygen Update (21 CFR 868.1730, product code ● BZL)
1. Predicate Device: Express Series (K070858)

4. Device Description

1. Intended Use
  Breezing Med™ Metabolism Analyzer is intended for professional use, to determine resting metabolic rates, teach energy balance, and pinpoint accurate caloric intake for weight management.

6. Indications for Use

Traditional Premarket Notification

Breezing Med™ Metabolism Analyzer

management, and to aid in the diagnosis of diseases related to abnormal metabolic parameters. Breezing Med 100 is intended for use with adults breathing normally on their own in a sitting position in a healthcare environment. Since the device is designed for the patient to breathe ambient air. it is not intended for patients where supplementary oxygen is being provided. Breezing Med™ is not intended to use as sole means for any diagnosis, and ultimately will provide data for evaluation by the professional.

1. Technological Characteristics
  Breezing Med™ is a stand-alone and fully integrated mask-like wearable metabolic analyzer based on the principle of indirect calorimetry, which is a gold standard for energy expenditure measurement. Breezing Med 104 is designed for metabolic rate and respiratory quotient measurement and the main outputs include Resting Energy Expenditure (REE), Respiratory Quotient (RQ), Volume of Oxygen consumption (VO2), and Volume of Carbon Dioxide production (VCO2), where REE and RQ are calculated from measured parameters VO2 and VC02.

Breezing Med M measures the expiratory volume similar to the predicate device Medical Graphics Express® Series.

Breezing Med "" consists of five components: 1) a device body; 2) a mask; 3) headgear; 4) a sensor cartridge; and 5) an application.

8. Performance Data

The summary of the Breezing Med™ test results are as follows:

Both devices measured O2 volumes within the specified accuracy of +/-0.8%. ●
Both devices measured CO2 volumes within the specified accuracy of +/-0.8%. .
Both devices measured Flow Rate within +/- 0.3 Lpm = 10 Lpm.

We have also performed testing to ISO10993, IEC 60601-1 General requirements for basic safety and essential performance and IEC 60601-1-2 Electromagnetic disturbances.

9. Predicate Device Comparison

The Breezing Med Metabolism Analyzer is substantially equivalent to the Express Series (K070858). Both Breezing Med Me Metabolism Analyzer and its predicate device have a similar intended use. A summary comparison of technological characteristics is provided in Table 5.1.

Table 5.1 - Breezing Med 111 Metabolism Analyzer and Predicate Comparative Analysis

TF Health

Corporation

Traditional Premarket Notification

Breezing Med™ Metabolism Analyzer

Feature	Subject Device	Predicate Device
Device Name	Breezing MedTM	Express® Series (indirect
calorimeter)
Device Manufacturer	TF Health Co.	MGC Diagnostics Corporation
510(k) Reference	This submission	K070858
FDA Product Code	BZL	BZL
FDA Classification	Computer, Oxygen Uptake	Computer, Oxygen Uptake
FDA Regulation
Number	868.1730	868.1730
Device Description	Breezing MedTM is a resting
metabolic rate measurement
system with an application
installed on mobile devices
that provides measurements
of exhalation rate, oxygen
uptake and carbon dioxide
production.	The Express® Series is a
cardiopulmonary exercise or
resting metabolic rate
measurement system with an
integrated touch screen computer
that provides breath by breath
measurements of flow, oxygen
uptake and carbon dioxide
production.
Indications for use	Breezing MedTM Metabolism
Analyzer measures metabolic
functions including resting
energy expenditure and
respiratory quotient during
resting conditions via direct
measurement of oxygen
uptake and carbon dioxide
production to provide
nutritional assessment, to
optimize nutritional
supplements, and to quantify
substrate utilization. The
nutritional assessment
enables the healthcare
professional to further assess
energy expenditure and
caloric intake for weight
management, and to aid in
the diagnosis of diseases
related to abnormal
metabolic parameters.
Breezing MedTM is intended
for use with adults breathing	The Express® Series uses the
direct measurement of oxygen
uptake to objectively and
noninvasively assess cardiac and
pulmonary function during
exercise. The system can be used
to screen for early signs of
cardiac and pulmonary
dysfunction; differentiate heart
and lung disease; assess dyspnea
complaints; classify patients
according to disease as a guide
for patient management; establish
an optimal exercise prescription
and training program; evaluate
the efficiency of prescribed
therapy. The Express® Series
uses the direct measurement of
oxygen uptake and carbon
dioxide production to provide
nutritional assessment, to
optimize nutritional supplements
and quantify substrate utilization.
The Express® Series can also
Feature	Subject Device	Predicate Device
	sitting position in a
healthcare environment.
Since the device is designed
for the patient to breathe
ambient air, it is not intended
for patients where
supplementary oxygen is
being provided. Breezing
MedTM is not intended to use
as sole means for any
diagnosis, and ultimately will
provide data for evaluation
by the professional.	of cardiac output using real time
oxygen uptake measurements.
Target population	Adults	Unspecified
Use Environment	Professional healthcare
facilities	Professional healthcare facilities
Device
Measurements	Metabolic functions during
resting conditions	Non-invasive assessment of the
cardiopulmonary response to
exercise or measurement of
energy expenditure using indirect
calorimetry.
Measurement
Mode(s)	Mixing chamber	Breath by breath
Output Parameters	Main outputs include resting
energy expenditure (REE),
respiratory quotient (RQ),
oxygen consumption (VO2),
carbon dioxide production
(VCO2), and respiratory
parameters.	Main outputs include resting
energy expenditure (REE),
respiratory quotient (RQ), oxygen
consumption (VO2), carbon
dioxide production (VCO2), and
respiratory parameters.
Major Separate
System Components	Device body, disposable
mask, headgear, sensor
cartridge, app in a mobile
device	Express® Series indirect
calorimeter, face tent/face mask,
printer, mobile cart
Flowmeter
Technology	Fixed-orifice differential
pressure pneumotach	Bi-directional Pitot Tube Flow
Sensor
O2 Sensor
Technology	Colorimetry	Galvanic
CO2 Sensor
Technology	Colorimetry	Non-dispersive infrared (NDIR)
User Interface	App on Mobile device	Touchscreen display
Software	Application	Intuitive icon-based software
Sterility	Non-sterile	Non-sterile
Feature	Subject Device	Predicate Device
Biocompatibility	All user contact components
are biocompatible and used
in already legally marketed
devices with the same
intended use	All patient contact components
are biocompatible and used in
already legally marketed devices
with the same intended use
Mechanical Safety	No mechanical safety risk
identified.	No mechanical safety risk
identified.
Chemical Safety	No chemical safety risks
identified.	No chemical safety risks
identified.
Anatomical Sites	Patient's mouth and nose,
through face mask	Patient's mouth and nose, through
face tent/face mask
Human factors	Requires patient to keep
mask sealed.	Requires patient to keep face
tent/face mask sealed.
Energy used	External or internal power
supply	External power supply
Energy delivered	No energy delivered to the
patient.	No energy delivered to the
patient.
Battery	Lithium-Ion, rechargeable	NA
Compatibility with
environment	No known issues.	No known issues.
Compatibility with
other devices	No known devices for
compatibility issues.	No known devices for
compatibility issues.
Standards Electrical
safety	IEC 60601-1: class II /
Internal Electric Power
Source - type BF	Unspecified
Standards: EMC
Testing	EN60601-1-2	Unspecified
Thermal Safety	No known thermal safety
issues	No known thermal safety issues
Radiation Safety	No known radiation safety
issues.	No known radiation safety issues.
Sensor cartridge	One-time use sensor
cartridge for simultaneously
O2 and CO2 sensing	O2 and CO2 sensors are for long
time use (e.g. 1 year), and change
during maintenance periods
Dimensions	80 x 110 x 160 mm	240 x 190 x 267 mm*
Weight	170 gm	9.2 lbs. *
Measurement Range	Flow: 0-150 l/min
O2: 10-21%
CO2: 0-10%	Flow: 0-40 l/min*
O2: 5-85%*
CO2: 0-10% *
Feature	Subject Device	Predicate Device
Measurement
Accuracy
Error/Resolution	Flow Accuracy: