Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors

K190800 · Cosmed Srl · BTY · Feb 6, 2020 · Anesthesiology

Device Facts

• Record ID: K190800
• Device Name: Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
• Applicant: Cosmed Srl
• Product Code: BTY · Anesthesiology
• Decision Date: Feb 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are indicated for the measurement of Resting Energy Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following populations: - Spontaneously breathing subjects >15 kg (33 lb) when using a canopy; - Spontaneously breathing subjects age >6 and > 10 kg (22 lb) when using a face mask; - Ventilated subjects age >10 and >10 kg (22 1b). The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only (Iimited to ICUs for ventilated patients).

Device Story

Portable metabolic monitors measure Resting Energy Expenditure (REE), VO2, VCO2, and Respiratory Quotient (RQ); inputs include gas exchange data via canopy, face mask, or ventilator-integrated pneumotach; device uses internal mixing chamber technology and electrochemical O2/infrared CO2 sensors; operated by physicians or trained personnel in healthcare facilities; output displayed on integrated touch screen or PC software; assists clinicians in metabolic assessment; benefits include non-invasive monitoring of energy needs in clinical settings.

Clinical Evidence

Bench testing only. Includes electrical safety (ANSI/AAMI ES 60601-1), EMC, accuracy validation (mask, canopy, and ventilator modes), wireless coexistence, biocompatibility (ISO 10993, ISO 18562), reprocessing, and human factors testing.

Technological Characteristics

Portable metabolic monitor; 18mm turbine flowmeter (mask/canopy) or disposable variable orifice pneumotach (ventilator); electrochemical O2 sensor; infrared CO2 sensor; internal mixing chamber; internal Li-Ion battery or external power; touch screen interface; Windows-based PC software; non-sterile; biocompatible materials per ISO 10993/18562.

Indications for Use

Indicated for measurement of Resting Energy Expenditure (REE) in spontaneously breathing subjects >15 kg (canopy) or >6 years and >10 kg (face mask), and ventilated subjects >10 years and >10 kg. Intended for professional healthcare facilities (ICUs for ventilated patients).

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• Quark RMR Metabolic Cart (K120146)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 6, 2020

Cosmed Srl % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Piazza Albania 10 Rome, 00153 Italy

Re: K190800

Trade/Device Name: Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: BTY Dated: January 6, 2020 Received: January 9, 2020

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. 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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

James J. Lee, Ph.D. 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 Quality 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) K 190800

#### Device Name

Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors

Indications for Use (Describe)

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are indicated for the measurement of Resting Energy Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following populations:

- Spontaneously breathing subjects >15 kg (33 lb) when using a canopy;

- Spontaneously breathing subjects age >6 and > 10 kg (22 lb) when using a face mask;

- Ventilated subjects age >10 and >10 kg (22 1b).

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only (Iimited to ICUs for ventilated patients).

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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for COSMED, a metabolic company. The logo features a blue griffin inside of a blue circle on the left. To the right of the griffin is the company name, "COSMED" in large, blue letters. Below the company name is the tagline "The Metabolic Company" in smaller, gray letters.

| 510(k) Reference: | K190800 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Device Name: | Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors |
| Type of 510(k) submission: | Traditional |
| Date of submission: | 5 February 2020 |
| Manufacturer: | Cosmed Srl<br>Vi dei Piani di Monte Savello 37<br>Albano Laziale<br>00041 Rome, Italy |
| Phone:<br>Fax: | [phone]<br>[phone] |
| FDA Establishment Reg. Number: | 8021084 |
| 510(k) Owner and Submitter: | Cosmed Srl<br>Vi dei Piani di Monte Savello 37<br>Albano Laziale<br>00041 Rome, Italy |
| Owner/Operator Reg. Number: | 8021084 |
| 510(k) Application Correspondent: | Mr Roger Gray<br>VP Quality and Regulatory<br>Donawa Lifescience Consulting<br>Piazza Albania 10<br>00153 Rome, Italy |
| Phone:<br>Fax:<br>Email: | [phone]<br>[phone]<br>[e-mail] |
| FDA Product Code: | BTY |
| FDA Regulation Number: | 21 CFR 868.1890 |
| FDA Classification Name: | Calculator, Pulmonary Function Data |
| Classification Panel: | Anesthesiology |
| Common Name: | Calculator, predicted values, pulmonary function; Ventilator,<br>continuous, facility use |
| FDA Classification: | Class II |
| Submission Type: | 510(k) |

# 510(k) Summary

# Indications for Use:

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are indicated for the measurement of Resting Energy Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following populations:

- Spontaneously breathing subjects >15 kg (33 lb) when using a canopy;

- Spontaneously breathing subjects age >6 and >10 kg (22 lb) when using a face mask;

- Ventilated subjects age >10 and >10 kg (22 lb).

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only (limited to ICUs for ventilated patients).

{4}------------------------------------------------

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

# Device Description:

The Q-NRG and Q-NRG+ devices are Portable Metabolic Monitors, designed for the measurement of resting energy expenditure (REE) in both spontaneously breathing and mechanically ventilated patients.

The two versions of the product are detailed in Table 1.

| Table 1: Device versions | | | | |
|--------------------------|---------------|----------|--|--|
| Measurement Modes | Q-NRG | Q-NRG+ | | |
| Ventilator assisted | Not available | Standard | | |
| Canopy | Standard | Option | | |
| Face mask | Option | Option | | |

The Q-NRG and Q-NRG+ devices comprise the parts identified in Table 2.

| Table 2: Device components | | |
|----------------------------------------------|---------------|----------|
| Item | Q-NRG | Q-NRG+ |
| Main device | Standard | Standard |
| Canopy mode accessories | Standard | Option |
| Ventilation mode accessories | Not available | Option |
| Face mask mode accessories | Option | Option |
| PC Software (OMNIA) | Option | Option |
| Clamp for pole/rail with VESA mounting plate | Option | Option |
| Calibration syringe | Option | Option |
| Calibration Cylinder and Regulator | Option | Option |

#### Performance data:

The essential performance of the Q-NRG and Q-NRG+ devices is to measure or calculate:

- . REE (kcal/day) Resting Enerqy Expenditure
- VO2 (ml/min) Oxygen Uptake * ●
- . VCO2 (ml/min) Carbon Dioxide production
- RQ (---) Respiratory Quotient

* Average resting oxygen uptake for a healthy individual is 3.5 ml/Kg/min (1 MET - Metabolic Equivalent).

The Q-NRG and Q-NRG+ are to be used by physicians or by trained personnel under the responsibility of a physician.

The Q-NRG and Q-NRG+ are not intended for long term use or as continuous monitoring devices for surveillance of vital physiological processes.

#### Non-clinical testing:

Non-clinical testing of the Q-NRG and Q-NRG+ includes:

- Electrical safety
- Electromagnetic Compatibility (EMC)
- Accuracy validation ●
- Coexistence testing ●
- Biocompatibility
- Reprocessing validation ●
- Human factors ●

{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 griffin is the word "COSMED" in large blue letters. Below the word "COSMED" is the phrase "The Metabolic Company" in smaller letters.

More detail of the non-clinical testing is provided in Table 3.

| Table 3: Non-clinical testing | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test type | Reference |
| Electrical safety | ANSI/AAMI ES 60601-1:2005/®2012 + A1:2012 + C1:2009/®2012 + A2:2010/®2012, FDA<br>recognition #19-4<br>IEC 60601-1-2:2014, FDA recognition #19-8 |
| EMC | ETSI EN 301 489-17 v3.2.0 draft |
| | ETSI EN 301 489-1 v2.2.0 draft |
| | FCC Part 15 par. 107, 109 |
| | ICES-003 Issue 6: January 19, 2016, updated April 2017 |
| Accuracy validation | Mask Measurement Accuracy, according to internal validation protocol |
| | Canopy Measurement Accuracy, according to internal validation protocol |
| | Ventilator Measurement Accuracy, according to internal validation protocol |
| Coexistence<br>testing | Coexistence testing between Q-NRG/Q-NRG+ Bluetooth and other environmental<br>wireless disturbances (i.e. Network Wi-Fi), according to the indications reported in S.<br>Seidman, N. LaSorte, "An Experimental Method for Evaluating Wireless Coexistence of a<br>Bluetooth Medical Device," IEEE EMC Magazine, October 2014 |
| Biocompatibility | ISO 10993-1:2009, FDA recognition #2-220 |
| | ISO 10993-5:2009, FDA recognition #2-245 |
| | ISO 10993-10:2010, FDA recognition #2-174 |
| | ISO 18562-2:2017, FDA recognition #1-135 |
| | ISO 18562-3:2017, FDA recognition #1-136 |
| | ISO 18562-4:2017, FDA recognition #1-137 |
| | FDA Guidance Use of International Standard ISO 10993-1, June 16, 2016 |
| Reprocessing<br>validation | According to internal validation protocol |
| Human Factors | According to internal verification protocol |

The results of the above testing assist in demonstration of substantial equivalence of the subject device with the predicate device, as many of the same standards have been used.

#### Substantial equivalence

The predicate device selected for comparison with the Q-NRG+ Portable Metabolic Monitors is:

| Predicate Device: | Quark RMR Metabolic Cart |
|----------------------|------------------------------------------------|
| Sponsor: | Cosmed Srl, Italy |
| 510(k) Number: | K120146 |
| Clearance Date: | 11 December 2012 |
| FDA Product Code: | BTY |
| Classification Name: | Predictive Pulmonary-Function Value Calculator |
| Regulation No: | 21 CFR 868.1890 |
| Class: | II |

#### Predicate device comparison table:

Table 4 provides evidence of substantial equivalence of the subject device with the selected predicate device.

| Table 4: Predicate device comparison table | | | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Subject device | Predicate device | Similarity |
| Device name | Q-NRG & Q-NRG+ Portable<br>Metabolic Monitors | Quark RMR Metabolic Cart | N/A |
| Table 4: Predicate device comparison table | | | |
| Feature | Subject device | Predicate device | Similarity |
| Device<br>Manufacturer | Cosmed Srl, Italy | Cosmed Srl, Italy | Same |
| 510(k) Reference | This submission | K120146 | N/A |
| FDA Product<br>Code | BTY | BTY | Same |
| FDA<br>Classification<br>Name | Calculator, Pulmonary<br>Function Data | Calculator, Pulmonary<br>Function Data | Same |
| FDA Regulation<br>Number | 21 CFR 868.1890 | 21 CFR 868.1890 | Same |
| Device<br>description | Portable metabolic monitors,<br>designed for the measurement<br>of resting energy expenditure<br>(REE) in both spontaneously<br>breathing and mechanically<br>ventilated patients | Metabolic cart for gas<br>exchange analysis (VO2,<br>VCO2) either during resting or<br>exercise. either with<br>spontaneously breathing<br>subjects (at rest and during<br>exercise) or mechanically<br>assisted patients | Similar, subject device is not<br>indicated for exercising patients |
| Indications for<br>use | The Q-NRG & Q-NRG+<br>Portable Metabolic Monitors<br>are indicated for the<br>measurement of Resting<br>Energy Expenditure (REE) for<br>spontaneously breathing and<br>(Q-NRG+ only) ventilated<br>patients, within the following<br>populations:<br>- Spontaneously breathing<br>subjects >15 kg (33 lb) when<br>using a canopy;<br>- Spontaneously breathing<br>subjects age >6 and >10 kg<br>(22 lb) when using a face<br>mask:<br>- Ventilated subjects age >10<br>and >10 kg (22 lb).<br>The Q-NRG & Q-NRG+<br>Portable Metabolic Monitors<br>are intended to be used in<br>professional healthcare<br>facilities only (limited to ICUs<br>for ventilated patients). | Measurement of resting<br>metabolism (face mask): age 6<br>to adults;<br>Measurement of resting<br>metabolism (canopy dilution):<br>15 kg/30 lb to adults;<br>Measurement of resting<br>metabolism (ventilated<br>patients): age 10 to adults. | Very similar. The subject device<br>adds a lower limit for the<br>patient's weight in order to avoid<br>use of the device on people<br>weighing less than 10 kg |
| Use environment | Indoor use (healthcare<br>facilities) | Indoor use (healthcare<br>facilities) | Same |
| Device<br>measurements<br>(output<br>parameters) | Resting Energy Expenditure<br>and related parameters (VO2,<br>VCO2, RQ) | Resting Energy Expenditure<br>and related parameters (VO2,<br>VCO2, RQ) (other<br>measurements available as<br>options) | Same |
| Measurement<br>mode(s) | Face mask, canopy,<br>mechanically ventilated<br>patients | Face mask, canopy,<br>mechanically ventilated<br>patients | Same |
| Measurement<br>Range | Ventilation: 1-25 l/min<br>VO2: 0.01-1 l/min<br>VCO2: 0.01-1 l/min | Ventilation: 0-50 l/min<br>VO2: not specified<br>VCO2: not specified | Substantially equivalent for the<br>maximum patient ventilation of<br>the intended patient population<br>and condition e.g. at rest. |
| Table 4: Predicate device comparison table | | | |
| Feature | Subject device | Predicate device | Similarity |
| Measurement<br>Accuracy | Ventilation: <2% or 100 ml/min<br>(whichever is greater)<br>VO2: ±3% or 5 ml/min<br>(whichever is greater)<br>VCO2: ±3% or 5 ml/min<br>(whichever is greater) | Ventilation: <3%<br>VO2: ±3%<br>VCO2: ±3% | Substantially equivalent |
| Major separate<br>system<br>components | · Q-NRG unit<br>· Canopy hood & accessories<br>· Optional PC software<br>· Optional "Face Mask Mode"<br>accessories<br>· Optional ventilation mode<br>accessories<br>· Optional calibration<br>accessories<br>· Optional cart | · Quark RMR unit<br>· Canopy hood & accessories<br>· PC software<br>· Optional "Face Mask Mode"<br>accessories<br>· Optional calibration<br>accessories<br>· Optional cart | Same |
| Flowmeter<br>technology | Face mask: 18mm turbine<br>flowmeter<br>Canopy: 18mm turbine<br>flowmeter<br>Ventilator mode: disposable<br>variable orifice pneumotach | Face mask: 18mm turbine<br>flowmeter<br>Canopy: 18mm turbine<br>flowmeter<br>Ventilator mode: disposable<br>variable orifice pneumotach | Same |
| O2 sensor<br>technology | Electrochemical | Paramagnetic | Substantially equivalent<br>technology, the O2<br>electrochemical sensor is<br>already used in K162515 and<br>K071533 |
| CO2 sensor<br>technology | Infrared | Infrared | Same |
| Sampling<br>technology | Internal mixing chamber | Breath by breath | Substantially equivalent<br>technology, internal mixing<br>chamber technology is already<br>used in K162515 and K071533 |
| User interface | Touch screen (unit) or<br>keyboard and mouse (PC) | Keyboard and mouse (PC) | Similar. Subject device is<br>designed to be mainly operated<br>as a stand-alone unit |
| PC Software | Windows based application | Windows based application | Same |
| Biocompatibility | All direct patient contact and<br>gas pathway components are<br>biocompatible or used in<br>already legally marketed<br>devices with the same<br>intended use | All direct and indirect patient<br>contact components are<br>biocompatible | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Anatomical sites | Indirect contact with patient's<br>airways | Indirect contact with patient's<br>airways | Same |
| Energy used | External or internal power<br>supply | External power supply | Similar. Subject device can also<br>be powered by an internal Li-Ion<br>battery |
| Energy delivered | No energy delivered to patient | No energy delivered to patient | Same |
| Safety Standard: | ANSI/AAMI ES 60601-1:2005/<br>(R)2012 + A1:2012 + C1:2009/<br>(R)2012 + A2:2010/(R)2012:<br>class I / Internal power source,<br>type BF applied part | IEC 60601-1: class I, type BF<br>applied part | Similar. Subject device can be<br>also powered by an internal Li-<br>Ion battery |
| Dimensions | 31 x 21 x 27 cm | 17 x 30 x 45 cm | Differences have no effect on<br>safety or effectiveness |
| Weight | 4.65 kg | 8 kg | Differences have no effect on<br>safety or effectiveness |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for COSMED - The Metabolic Company. The logo features a blue griffin inside of a blue circle on the left. To the right of the griffin is the company name, COSMED, in large blue letters. Below the company name is the tagline "The Metabolic Company" in smaller blue letters.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for COSMED, a 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, bold letters. Underneath the word "COSMED" is the phrase "The Metabolic Company" in smaller, non-bold, blue letters.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for COSMED, a metabolic company. The logo features a blue griffin inside of a blue circle on the left. To the right of the griffin is the company name, "COSMED" in large, blue letters. Below the company name is the tagline "The Metabolic Company" in smaller, gray letters.

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:

- Device description ●
- . Indications for use
- 02 sensor technology
- . Sampling technology
- User interface
- . Dimensions and weight
- . Power supply

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

## Conclusion

The subject and predicate devices have very similar intended uses and fundamental technological characteristics. Any differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.