Who is the manufacturer of COSMED K5 Wearable Metabolic Technology?

Cosmed Srl filed the 510(k) submission for COSMED K5 Wearable Metabolic Technology (K162515).

What is the FDA product code for COSMED K5 Wearable Metabolic Technology?

BZC. It is classified under 21 CFR 868.1880 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for COSMED K5 Wearable Metabolic Technology?

510(k) clearance (submission type: Traditional).

What are the predicate devices for COSMED K5 Wearable Metabolic Technology?

Jaeger Oxycon Mobile (K023120).

Who can help prepare an FDA 510(k) submission like COSMED K5 Wearable Metabolic Technology?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COSMED K5 Wearable Metabolic Technology

K162515 · Cosmed Srl · BZC · Jun 20, 2017 · Anesthesiology

Device Facts

Record ID	K162515
Device Name	COSMED K5 Wearable Metabolic Technology
Applicant	Cosmed Srl
Product Code	BZC · Anesthesiology
Decision Date	Jun 20, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1880
Device Class	Class 2

Intended Use

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 Story

Portable wearable metabolic system; measures resting and exercise metabolism. Inputs: breathing flow (turbine flowmeter), exhaled CO2 (infrared sensor), O2 (electrochemical sensor), heart rate (belt), ambient temperature/pressure/humidity. Transforms inputs via breath-by-breath or mixing chamber modes to calculate VO2, VCO2, VE, HR, RQ, and Energy Expenditure. Used in professional healthcare facilities by physicians or trained personnel. Data transmitted via Bluetooth telemetry to PC software for analysis, display, and storage. Assists clinicians in diagnosing cardio-pulmonary diseases by providing ergospirometric parameters during stress testing and rehabilitation.

Clinical Evidence

Bench testing only. Validated for electrical safety (IEC 60601-1:2005), EMC (IEC 60601-1-2:2007), and enclosure protection (IEC 60529:2013). Accuracy validation performed for Vt, RF, VO2, and VCO2. Coexistence testing per FCC Part 15. Biocompatibility of patient-contact components established via previous FDA clearances.

Technological Characteristics

Portable unit with bi-directional turbine flowmeter, electrochemical O2 sensor, infrared CO2 sensor, and piezo-resistive pressure sensor. Connectivity via Bluetooth telemetry. Powered by internal rechargeable Li-Ion battery or external AC/DC adapter. Form factor: 174 x 111 x 64 mm; weight 900g. Software-based analysis on Windows PC. Non-sterile. Type BF applied part.

Indications for Use

Indicated for adults and children >14 years for measurement of cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine, and related activities in professional healthcare facilities. Not for home use. Not a monitoring device; intended to assist clinicians in diagnosing cardio-pulmonary diseases.

Regulatory Classification

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.

Predicate Devices

Jaeger Oxycon Mobile (K023120)

Related Devices

K963373 — COSMED K4 · Cosmed Srl · Sep 10, 1997
K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors · Cosmed Srl · Feb 6, 2020
K200076 — Breezing Med · Tf Health Co. · Sep 25, 2020
K090722 — SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM · Shape Medical Systems, Inc. · Mar 31, 2009
K150888 — Shape-HF Cardiopulmonary Testing System · Shape Medical Systems, Inc. · Jan 21, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The profiles are stylized with flowing lines. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 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 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ 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 Srl Vi dei Piani di Monte Savello 37 Albano Laziale 00041 Rome Italy | | Phone: | +39 06 931 5492 | | Fax: | +39 06 931 4580 | | FDA Establishment Reg. Number: | 8021084 | | 510(k) Owner and Submitter: | Cosmed Srl Vi dei Piani di Monte Savello 37 Albano Laziale 00041 Rome Italy | | Owner/Operator Reg. Number: | 8021084 | | 510(k) Application Correspondent: | Mr Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Piazza Albania 10 00153 Rome Italy | | 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: 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. {4}------------------------------------------------ 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. 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 cardiopulmonary 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. #### 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 ● {5}------------------------------------------------ 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 Classification Name | Calculator, Pulmonary Function Data | Calculator, Pulmonary Function Data | Same | | | | FDA Regulation Number | 868.1880 | 868.1880 | Same | | | | Device description | A portable cardiopulmonary function testing system offering breath-by- breath and sample mixing options, with wireless telemetry | A portable cardiopulmonary function testing system offering breath-by- breath sampling and wireless telemetry | Similar | | | {6}------------------------------------------------ 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 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, 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. 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. | The Jaeger OXYCON MOBILE pulmonary function mobile test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The OXYCON MOBILE system allows the use of telemetry for the monitoring of metabolic parameters, The OXYCON MOBILE system is intended to use with adults and children over the age of 14 years. | Substantially equivalent | | Device description | A portable cardiopulmonary function testing system offering breath-by- breath and sample mixing options, with wireless telemetry | A portable cardiopulmonary function testing system offering breath-by- breath sampling and wireless telemetry | Similar | | User Population | Adults and children over the age of 14 years | Adults and children over the age of 14 years | Same | | Use environment | Professional healthcare facilities | Indoor and outdoor use | Different | | Device measurements | Cardiorespiratory functions during stress testing, rehabilitation, sport medicine and other related activities | Cardiorespiratory functions during stress testing, rehabilitation, sport medicine and other related activities | Same | | Measurement mode(s) | Breath by breath and mixing chamber | Breath by breath only | Different | | Output parameters | Ergospirometric key parameters such as ventilation, VO2, VCO2, anaerobic threshold, RQ, HR, VE/VO2, VE/VCO2. | Ergospirometric key parameters such as ventilation, VO2, VCO2, anaerobic threshold, RQ, HR, VE/VO2, VE/VCO2. | Same | | Major separate system components | K5 unit, flowmeter, masks, receiver USB 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 pressure sensor 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 keyboard and mouse | PC Keyboard and mouse | Different | | PC Software | Windows based application | Windows based application | Same | | Biocompatibility | All patient 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 | 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 / Internal Electric Power Source - type BF | IEC 60601-1: class II / Internal Electric 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/min VO2: 0.1-7 l/min VCO2: 0.1-7 l/min | Ventilation: 0-300 l/min VO2: 0-7 l/min VCO2: 0-7 l/min | Different | | Measurement Accuracy | Ventilation: <2% or 50 ml/min VO2: <3% VCO2: <3% | Ventilation: <2% or 50 ml/min VO2: <3% or 50 ml/min VCO2: <3% or 50 ml/min | Different | {7}------------------------------------------------ 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.