(255 days)
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.
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.
The acceptance criteria information can be found on page 4, under item 8, "Performance Data."
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (from predicate device) | Device Performance (Breezing Med™) |
|---|---|---|
| O2 volumes | +/-0.8% | Within specified accuracy of +/-0.8% |
| CO2 volumes | +/-0.8% | Within specified accuracy of +/-0.8% |
| Flow Rate | +/-0.3 Lpm < 10 Lpm and +/-3% >= 10 Lpm | Within specified accuracy of +/-0.3 Lpm < 10 Lpm and +/-3% >= 10 Lpm |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size, country of origin, or whether the data was retrospective or prospective for the performance study. It mentions a "verification test" and a "study to simulate clinical use."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The performance data seems to be based on direct measurements and comparison to performance specifications of the predicate device, rather than expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 was not conducted. This device measures metabolic functions and does not involve human readers interpreting data in a way that an MRMC study would be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done. The "verification test" and "study to simulate clinical use" assessed the device's ability to measure O2 volumes, CO2 volumes, and flow rates against established specifications. The device operates as a standalone measurement system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the performance study appears to be the specified accuracy ranges derived from the predicate device (Medical Graphics Express® Series). The device's measurements were compared against these predefined accuracy thresholds for O2 volumes, CO2 volumes, and flow rates. These specifications likely represent a gold standard for indirect calorimetry measurements.
8. The sample size for the training set
The document does not mention a training set, as it describes a medical device for direct measurement rather than an AI/ML algorithm that undergoes a training phase.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML algorithm is mentioned.
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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.
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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 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
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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)
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.
| 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)
-
- Predicate Device: Express Series (K070858)
4. 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.
-
- 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.
- Intended Use
6. Indications for 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
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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.
-
- 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.
- Technological Characteristics
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
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 and +/-3% >= 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
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TF Health
Corporation
Traditional Premarket Notification
Breezing Med™ Metabolism Analyzer
| Feature | Subject Device | Predicate Device |
|---|---|---|
| Device Name | Breezing MedTM | Express® Series (indirectcalorimeter) |
| 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 RegulationNumber | 868.1730 | 868.1730 |
| Device Description | Breezing MedTM is a restingmetabolic rate measurementsystem with an applicationinstalled on mobile devicesthat provides measurementsof exhalation rate, oxygenuptake and carbon dioxideproduction. | The Express® Series is acardiopulmonary exercise orresting metabolic ratemeasurement system with anintegrated touch screen computerthat provides breath by breathmeasurements of flow, oxygenuptake and carbon dioxideproduction. |
| Indications for use | Breezing MedTM MetabolismAnalyzer measures metabolicfunctions including restingenergy expenditure andrespiratory quotient duringresting conditions via directmeasurement of oxygenuptake and carbon dioxideproduction to providenutritional assessment, tooptimize nutritionalsupplements, and to quantifysubstrate utilization. Thenutritional assessmentenables the healthcareprofessional to further assessenergy expenditure andcaloric intake for weightmanagement, and to aid inthe diagnosis of diseasesrelated to abnormalmetabolic parameters.Breezing MedTM is intendedfor use with adults breathing | The Express® Series uses thedirect measurement of oxygenuptake to objectively andnoninvasively assess cardiac andpulmonary function duringexercise. The system can be usedto screen for early signs ofcardiac and pulmonarydysfunction; differentiate heartand lung disease; assess dyspneacomplaints; classify patientsaccording to disease as a guidefor patient management; establishan optimal exercise prescriptionand training program; evaluatethe efficiency of prescribedtherapy. The Express® Seriesuses the direct measurement ofoxygen uptake and carbondioxide production to providenutritional assessment, tooptimize nutritional supplementsand quantify substrate utilization.The Express® Series can also |
| Feature | Subject Device | Predicate Device |
| sitting position in ahealthcare environment.Since the device is designedfor the patient to breatheambient air, it is not intendedfor patients wheresupplementary oxygen isbeing provided. BreezingMedTM is not intended to useas sole means for anydiagnosis, and ultimately willprovide data for evaluationby the professional. | of cardiac output using real timeoxygen uptake measurements. | |
| Target population | Adults | Unspecified |
| Use Environment | Professional healthcarefacilities | Professional healthcare facilities |
| DeviceMeasurements | Metabolic functions duringresting conditions | Non-invasive assessment of thecardiopulmonary response toexercise or measurement ofenergy expenditure using indirectcalorimetry. |
| MeasurementMode(s) | Mixing chamber | Breath by breath |
| Output Parameters | Main outputs include restingenergy expenditure (REE),respiratory quotient (RQ),oxygen consumption (VO2),carbon dioxide production(VCO2), and respiratoryparameters. | Main outputs include restingenergy expenditure (REE),respiratory quotient (RQ), oxygenconsumption (VO2), carbondioxide production (VCO2), andrespiratory parameters. |
| Major SeparateSystem Components | Device body, disposablemask, headgear, sensorcartridge, app in a mobiledevice | Express® Series indirectcalorimeter, face tent/face mask,printer, mobile cart |
| FlowmeterTechnology | Fixed-orifice differentialpressure pneumotach | Bi-directional Pitot Tube FlowSensor |
| O2 SensorTechnology | Colorimetry | Galvanic |
| CO2 SensorTechnology | 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 componentsare biocompatible and usedin already legally marketeddevices with the sameintended use | All patient contact componentsare biocompatible and used inalready legally marketed deviceswith the same intended use |
| Mechanical Safety | No mechanical safety riskidentified. | No mechanical safety riskidentified. |
| Chemical Safety | No chemical safety risksidentified. | No chemical safety risksidentified. |
| Anatomical Sites | Patient's mouth and nose,through face mask | Patient's mouth and nose, throughface tent/face mask |
| Human factors | Requires patient to keepmask sealed. | Requires patient to keep facetent/face mask sealed. |
| Energy used | External or internal powersupply | External power supply |
| Energy delivered | No energy delivered to thepatient. | No energy delivered to thepatient. |
| Battery | Lithium-Ion, rechargeable | NA |
| Compatibility withenvironment | No known issues. | No known issues. |
| Compatibility withother devices | No known devices forcompatibility issues. | No known devices forcompatibility issues. |
| Standards Electricalsafety | IEC 60601-1: class II /Internal Electric PowerSource - type BF | Unspecified |
| Standards: EMCTesting | EN60601-1-2 | Unspecified |
| Thermal Safety | No known thermal safetyissues | No known thermal safety issues |
| Radiation Safety | No known radiation safetyissues. | No known radiation safety issues. |
| Sensor cartridge | One-time use sensorcartridge for simultaneouslyO2 and CO2 sensing | O2 and CO2 sensors are for longtime use (e.g. 1 year), and changeduring 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/minO2: 10-21%CO2: 0-10% | Flow: 0-40 l/min*O2: 5-85%*CO2: 0-10% * |
| Feature | Subject Device | Predicate Device |
| MeasurementAccuracyError/Resolution | Flow Accuracy: <3% or 10ml/min | Flow Accuracy: <3% or 10ml/min* |
| O2 Accuracy: <1% | O2 Accuracy: <1%* | |
| O2 Resolution: ±0.1% | O2 Resolution: ±0.1%* | |
| CO2 Accuracy: <1% | CO2 Accuracy: N/A | |
| CO2 Resolution: ±0.1% | CO2 Resolution: ±0.1%* |
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TF Health
Corporation
Traditional Premarket Notification
Breezing Med™ Metabolism Analyzer
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TF Health
Corporation
Traditional Premarket Notification
Breezing Med™ Metabolism Analyzer
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TF Healt
Corporation
Traditional Premarket Notification
Breezing Med™ Metabolism Analyzer
*Note: Data from CCM Express Indirect Calorimeter's specification sheet provided on the product web page:
https://mgcdiagnostics.com/images/uploads/CCMexpress_sellsheet_060065rF_web.pdf
- Substantial Equivalence Conclusion
Breezing Med™ Metabolism Analyzer is substantially equivalent to the predicate Express Series in terms of intended use and technical characteristics. Breezing Med 110 Metabolism Analyzer successfully underwent bench testing, which includes safety testing (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1) compliance. A study was performed to simulate clinical use showing that the device works according to its intended use, in addition to its indications for use. There were no new issues of safety and effectiveness, and performance data. Verification and validation results demonstrate that the Breezing Med1114 Metabolism Analyzer is safe and effective. Based on the information provided in this 510(k), TF Health concludes that the Breezing Med™ Metabolism Analyzer is substantially equivalent to the predicate device identified in this submission and is safe and effective.
§ 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).