The COSMED K5 Wearable Metabolic Technology is a device designed to measure cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine and other related activities, performed in professional healthcare facilities only. The system is not intended for Home Use.

The main measurements reported by the system are Oxygen Uptake production, Ventilation, Heart Rate and Energy Expenditure.

K5 is intended to use with adults and children over the age of 14 years.

It is to be used by physicians or by trained personnel on a physician responsibility.

The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It must not be intended as a monitoring device, nor as a sole means for determining a patient's diagnosis but for the purpose of assisting the clinician in the diagnosis of cardio-pulmonary diseases

Device Description

The COSMED K5 Wearable Metabolic Technology is a portable unit, designed for the measurement of resting and exercise metabolism in the laboratory, utilizing international measurement quidelines published by relevant scientific societies. The K5 consists of the following main parts:

Main portable unit
Optional Bluetooth receiver
PC software
Face mask with head cap
Turbine flowmeter with optoelectronic reader and wind cover
Harness
Heart rate monitor belt
02 sensor
Battery charger + batteries
AC/DC adapter
USB cable
Carrying case
Optional pressure regulator for calibration

The K5 system is intended to be used the laboratory, by either direct connection or by telemetry. The system offers both 'breath-by-breath' and 'mixing chamber' operational modes.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the COSMED K5 Wearable Metabolic Technology, based on the provided FDA 510(k) summary:

Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report. Therefore, some of the requested information, particularly regarding specific study details like training set provenance, expert qualifications, and detailed statistical methodologies for clinical trials, is not fully elaborated in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Accuracy validation (Vt, RF, VO2, VCO2)" as a non-clinical test. The table on page 7 provides specific measurement accuracies for ventilation, VO2, and VCO2, which serve as the acceptance criteria and reported performance.

Parameter	Acceptance Criteria (Subject Device)	Reported Device Performance (Subject Device)	Predicate Device Accuracy
Ventilation	<2% or 50 ml/min	<2% or 50 ml/min	<2% or 50 ml/min
Oxygen Uptake (VO2)	<3%	<3%	<3% or 50 ml/min
CO2 Production (VCO2)	<3%	<3%	<3% or 50 ml/min

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "non-clinical testing" for "Accuracy validation (Vt, RF, VO2, VCO2)." However, it does not specify the sample size used for these tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of data). These non-clinical tests are typically performed in a controlled laboratory environment using simulated physiological conditions or human volunteers, but the specifics are not detailed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. The accuracy validation tests for metabolic devices often rely on comparison to a gold standard measurement method or calibrated gas mixtures, rather than expert consensus on patient data. Therefore, the concept of "experts establishing ground truth for the test set" in the context of this device's performance validation as presented is not applicable in the way it might be for image-based diagnostic AI.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the type of non-clinical accuracy validation tests described for this device. Adjudication methods are typically used in clinical studies involving interpretation by multiple observers where there might be disagreement in assessing an outcome, which is not the case for direct physiological measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. This type of study is usually conducted for diagnostic imaging devices where human readers interpret images with and without AI assistance to determine the AI's impact on diagnostic accuracy. The COSMED K5 is a measurement device for physiological variables, not an interpretative diagnostic imaging tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance data presented in the table above (Ventilation, VO2, VCO2 accuracy) represents the standalone performance of the device's measurement algorithms. The device directly measures and calculates these physiological parameters. There isn't an "algorithm only" vs. "human-in-the-loop" distinction in the same way there would be for an AI-powered diagnostic tool. The device is designed to provide direct physiological measurements, and the accuracy validation confirms its ability to do so.

7. The Type of Ground Truth Used

For the accuracy validation tests (Vt, RF, VO2, VCO2), the ground truth would typically be established by:

Highly calibrated reference systems or gas analyzers: For VO2 and VCO2 measurements, this would involve comparing the device's readings against known gas concentrations or a highly accurate reference metabolic cart.
Volumetric calibration for ventilation (Vt, RF): Using precision syringes or flow calibrators to provide known volumes and rates of airflow.

The document does not explicitly state the specific "gold standard" methods used, but for this type of device, it would be based on physical standards and calibrated instruments.

8. The Sample Size for the Training Set

The 510(k) summary does not provide information on a "training set" in the context of machine learning. This device measures physiological variables directly and calculates parameters based on known physiological equations and sensor readings. It's not an AI/ML device that requires a large dataset for training a predictive model in the conventional sense. The "training" of such a device would involve calibration and optimization of its internal algorithms and sensor performance based on engineering principles and validation data, not a "training set" of patient data for an AI model.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI/ML model described for this device, the question of how its ground truth was established is not applicable in the AI sense. The development and calibration of the K5's measurement capabilities would rely on rigorous engineering, physical principles, and laboratory testing using established standards and known physiological conditions.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 20, 2017

Cosmed S.r.l. % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 IT

Re: K162515

Trade/Device Name: COSMED K5 Wearable Metabolic Technology Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-Function Data Calculator Regulatory Class: Class II Product Code: BZC Dated: May 17, 2017 Received: May 22, 2017

Dear Roger Gray:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162515

Device Name

COSMED K5 Wearable Metabolic Technology

Indications for Use (Describe)

The main measurements reported by the system are Oxygen Uptake production, Ventilation, Heart Rate and Energy Expenditure.

K5 is intended to use with adults and children over the age of 14 years.

It is to be used by physicians or by trained personnel on a physician responsibility.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for COSMED - The Metabolic Company. On the left side of the logo is a blue griffin inside of a blue circle. To the right of the griffin is the word "COSMED" in large blue font, with the words "The Metabolic Company" in a smaller font below it.

510(k) Summary

Device Name:	COSMED K5 Wearable Metabolic Technology
Type of 510(k) submission:	Traditional
Date of submission:	12 June 2017
Manufacturer:	Cosmed SrlVi dei Piani di Monte Savello 37Albano Laziale00041 RomeItaly
Phone:	+39 06 931 5492
Fax:	+39 06 931 4580
FDA Establishment Reg. Number:	8021084
510(k) Owner and Submitter:	Cosmed SrlVi dei Piani di Monte Savello 37Albano Laziale00041 RomeItaly
Owner/Operator Reg. Number:	8021084
510(k) Application Correspondent:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItaly
Phone:	+39 06 578 2665
Fax:	+39 06 574 3786
Email:	rgray@donawa.com
FDA Product Code:	BZC
FDA Regulation Number:	21 CFR 868.1880
FDA Classification Name:	Calculator, Pulmonary Function Data
Classification Panel:	Anesthesiology
Common Name:	Pulmonary Function Data Calculator
FDA Classification:	Class II
Submission Type:	510(k)

Indications for Use:

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Image /page/4/Picture/0 description: The image shows the logo for COSMED, The Metabolic Company. On the left is a blue circle containing a blue griffin. To the right of the circle is the word "COSMED" in large blue letters. Below the word "COSMED" are the words "The Metabolic Company" in smaller letters.

The main measurements reported by the system are Oxygen Uptake, Carbon Dioxide production, Ventilation, Heart Rate and Energy Expenditure.

K5 is intended to use with adults and children over the age of 14 years.

It is to be used by physicians or by trained personnel on a physician responsibility.

Device Description:

Main portable unit ●
Optional Bluetooth receiver
PC software ●
Face mask with head cap
Turbine flowmeter with optoelectronic reader and wind cover
Harness ●
Heart rate monitor belt
02 sensor
. Battery charger + batteries
AC/DC adapter ●
USB cable
Carrying case ●
Optional pressure regulator for calibration

The K5 system is intended to be used the laboratory, by either direct connection or by telemetry. The system offers both 'breath-by-breath' and 'mixing chamber' operational modes.

Performance data:

Measurement of exercise metabolism consists of collecting during physical activities (e.g. running, cycling, rowing, etc.) a number of physiological variables (including breathing flow, exhaled CO2 fraction, heart rate) and environmental signals (ambient temperature, pressure and humidity) in order to calculate the following main parameters:

VO2 (ml/min) Oxygen Uptake, known also as Oxygen Consumption ●
. VCO2 (ml/min) Carbon Dioxide production
VE (I/min) Minute Ventilation
HR (1/min) Heart Rate ●
. RQ (---) Respiratory Quotient

Measurement of resting metabolism consists of measuring at rest the following main parameters:

VO2 (ml/min) Oxygen Uptake, known also as Oxygen Consumption ●
VCO2 (ml/min) Carbon Dioxide production .
RQ (---) Respiratory Quotient ●
EE (Kcal/day) Energy Expenditure ●

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Image /page/5/Picture/0 description: The image shows the logo for COSMED, The Metabolic Company. On the left is a blue circle containing a blue griffin. To the right of the circle is the company name, COSMED, in large blue letters. Below the company name is the tagline, "The Metabolic Company", in smaller letters.

Non-clinical testing:

Subject device non-clinical testing confirms that the device meets its specification, including the requirements of relevant standards:

Electrical safety in accordance with IEC 60601-1:2005
EMC in accordance with IEC 60601-1-2:2007
Accuracy validation (Vt, RF, VO2, VCO2) .
. Coexistence testing (FCC Part 15)
Protection provided by enclosure (IEC 60529:2013) ●

In relation to biocompatibility, all of the K5 components that are either intended to contact the patient or may come into contact with the patient during use have been previously assessed for their biocompatibility, as appropriate for the nature of their body contact and contact duration, by FDA within already-cleared 510(k) submissions.

The results of the above testing, together with previous FDA clearances, assist in the demonstration of substantial equivalence of the subject device with the predicate device.

Substantial equivalence

The predicate device selected for comparison with the Cosmed K5 Wearable Metabolic Technology is:

Predicate Device:	Jaeger Oxycon Mobile
Sponsor:	SensorMedics, Inc.
510(k) Number:	K023120
Clearance Date:	12 November 2003
FDA Product Code:	BZC
Classification Name:	Calculator, Pulmonary Function Data
Regulation No:	21 CFR 868.1880
Class:	II

Predicate device comparison table:

Table 1 provides evidence of substantial equivalence of the subject device with the selected predicate device.

Table 1: Predicate device comparison table
Feature	Subject device	Predicate device	Similarity
Device name	K5 Wearable Metabolic Technology	Jaeger Oxycon Mobile	N/A
Device Manufacturer	Cosmed	SensorMedics	N/A
510(k) Reference	This submission	K023120	N/A
FDA Product Code	BZC	BZC	Same
FDA ClassificationName	Calculator, Pulmonary Function Data	Calculator, Pulmonary Function Data	Same
FDA RegulationNumber	868.1880	868.1880	Same
Device description	A portable cardiopulmonary functiontesting system offering breath-by-breath and sample mixing options,with wireless telemetry	A portable cardiopulmonary functiontesting system offering breath-by-breath sampling and wirelesstelemetry	Similar

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Image /page/6/Picture/0 description: The image shows the logo for COSMED, The Metabolic Company. On the left is a blue griffin inside of a blue circle. To the right of the griffin is the word "COSMED" in large blue letters, with the words "The Metabolic Company" in smaller letters underneath.

Table 1: Predicate device comparison table
Feature	Subject device	Predicate device	Similarity
Indications for use	The COSMED K5 WearableMetabolic Technology is a devicedesigned to measure cardio-respiratory and metabolic functionsduring stress testing, rehabilitation,sports medicine and other relatedactivities, performed in professionalhealthcare facilities only. The systemis not intended for Home Use.The main measurements reported bythe system are Oxygen Uptake,Carbon Dioxide production,Ventilation, Heart Rate and EnergyExpenditure.K5 is intended to use with adults andchildren over the age of 14 years.It is to be used by physicians or bytrained personnel on a physicianresponsibility.The system and its accessories areindicated for the acquisition, analysis,formatting, display, printing andstorage of certain physiologic signals.It must not be intended as amonitoring device, nor as a solemeans for determining a patient'sdiagnosis but for the purpose ofassisting the clinician in the diagnosisof cardio-pulmonary diseases.	The Jaeger OXYCON MOBILEpulmonary function mobile testsystem is a device which monitors thecardio-respiratory functions duringstress testing, rehabilitation, sportsmedicine and other related activities.The OXYCON MOBILE system allowsthe use of telemetry for the monitoringof metabolic parameters, TheOXYCON MOBILE system isintended to use with adults andchildren over the age of 14 years.	Substantiallyequivalent
Device description	A portable cardiopulmonary functiontesting system offering breath-by-breath and sample mixing options,with wireless telemetry	A portable cardiopulmonary functiontesting system offering breath-by-breath sampling and wirelesstelemetry	Similar
User Population	Adults and children over the age of 14years	Adults and children over the age of 14years	Same
Use environment	Professional healthcare facilities	Indoor and outdoor use	Different
Device measurements	Cardiorespiratory functions duringstress testing, rehabilitation, sportmedicine and other related activities	Cardiorespiratory functions duringstress testing, rehabilitation, sportmedicine and other related activities	Same
Measurement mode(s)	Breath by breath and mixing chamber	Breath by breath only	Different
Output parameters	Ergospirometric key parameters suchas ventilation, VO2, VCO2, anaerobicthreshold, RQ, HR, VE/VO2,VE/VCO2.	Ergospirometric key parameters suchas ventilation, VO2, VCO2, anaerobicthreshold, RQ, HR, VE/VO2,VE/VCO2.	Same
Major separate systemcomponents	K5 unit, flowmeter, masks, receiverUSB stick (to PC)	Oxycon unit (2 pieces), flowmeter,masks, receiver unit (to PC)	Different
Flowmeter technology	Bi-directional turbine	Bi-directional turbine	Same
O2 sensor technology	Electrochemical	Electrochemical	Same
CO2 sensor technology	Infrared	Thermal conductivity	Different
Barometric pressuresensor technology	Piezo-resistive	Piezo-resistive	Same
Telemetry	Bluetooth, bi-directional	2401-2495 MHz, bi-directional	Different
Table 1: Predicate device comparison table
Feature	Subject device	Predicate device	Similarity
User interface	LCD touchscreen plus PC keyboardand mouse	PC Keyboard and mouse	Different
PC Software	Windows based application	Windows based application	Same
Biocompatibility	All patient contact components arebiocompatible and used in alreadylegally marketed devices with thesame intended use	All patient contact components arebiocompatible and used in alreadylegally marketed devices with thesame intended use	Same
Sterility	Non-sterile	Non-sterile	Same
Anatomical sites	Patient's mouth, through face mask	Patient's mouth, through face mask	Same
Energy used	External or internal power supply	External or internal power supply	Same
Energy delivered	No energy delivered to patient	No energy delivered to patient	Same
Standards: Safety	IEC 60601-1: class II / InternalElectric Power Source - type BF	IEC 60601-1: class II / InternalElectric Power Source - type BF	Same
Battery	Lithium-Ion, rechargeable	Lithium-Ion, rechargeable	Same
Dimensions	1 unit 174 x 111 x 64 mm	2 units 126 x 96 x 41mm	Different
Weight	900g (31.7 oz)	950g (33.4 oz)	Similar
Measurement Range	Ventilation: 0-300 l/minVO2: 0.1-7 l/minVCO2: 0.1-7 l/min	Ventilation: 0-300 l/minVO2: 0-7 l/minVCO2: 0-7 l/min	Different
Measurement Accuracy	Ventilation: <2% or 50 ml/minVO2: <3%VCO2: <3%	Ventilation: <2% or 50 ml/minVO2: <3% or 50 ml/minVCO2: <3% or 50 ml/min	Different

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Image /page/7/Picture/0 description: The image shows the logo for COSMED, The Metabolic Company. On the left is a blue circle with a white griffin inside. To the right of the circle is the company name, COSMED, in large blue letters, with the tagline "The Metabolic Company" in smaller letters below.

The subject device and the predicate device have many identical or similar properties or features. The differences that exist and are identified in the above table include:

Measurement mode(s)
Major separate system components
CO2 sensor technology ●
Use environment
. Telemetry
User interface ●
Dimensions
Measurement range
. Measurement accuracy

None of the identified differences introduce new aspects of safety or effectiveness.

12.4 Conclusion

Based on the information contained within this submission, it is concluded that the COSMED K5 Wearable Metabolic Technology is substantially equivalent to the identified predicate device already in interstate commerce within the USA.

Regulation Number and Section

§ 868.1880 Pulmonary-function data calculator.

(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).