(315 days)
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).
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 provided text describes the Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors, a medical device for measuring Resting Energy Expenditure (REE). The document highlights the device's technical specifications and comparisons to a predicate device (Quark RMR Metabolic Cart) to establish substantial equivalence.
However, the provided text does not contain the specific information required to answer your questions regarding acceptance criteria and the study proving the device meets those criteria in the context of an AI/human comparative effectiveness study. The document focuses on regulatory clearance and device performance and safety against general medical device standards.
Here's a breakdown of why the information you're looking for is not present:
- No mention of AI/machine learning: The device is described as a "Portable Metabolic Monitor," suggesting direct measurement or calculation based on sensor data, not an AI or machine learning algorithm requiring human-in-the-loop performance studies.
- No stated acceptance criteria for an AI algorithm: The "Accuracy Validation" section mentions internal validation protocols for mask, canopy, and ventilator measurement accuracy, with specific percentages for Ventilation, VO2, and VCO2 (e.g., Ventilation: <2% or 100 ml/min). These are likely the device's performance specifications, but not "acceptance criteria" in the context of an AI's performance against a specific clinical task.
- No details on a "test set" for an AI model: The accuracy validation refers to internal protocols, but not a defined test set for evaluating an AI model.
- No information on experts for ground truth, adjudication, or MRMC studies: These elements are specific to AI performance validation, which is not described for this device.
- No mention of training set size or ground truth for training set: Again, these are AI-specific details that are not in the document.
Based on the provided text, I can only provide the device's stated performance specifications, not acceptance criteria for an AI model or details of an AI performance study.
Here's the closest information I can extract regarding performance:
1. A table of acceptance criteria and the reported device performance:
| Metric | Q-NRG & Q-NRG+ Performance |
|---|---|
| Measurement Accuracy | |
| Ventilation | <2% or 100 ml/min |
| VO2 | ±3% or 5 ml/min |
| VCO2 | ±3% or 5 ml/min |
(Note: These are performance specifications, not explicitly "acceptance criteria" in the AI validation sense. The document states accuracy validation was done "according to internal validation protocol," implying these are the targets the device met.)
The following information cannot be found in the provided text:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
- If a standalone (algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI model.
- The sample size for the training set.
- How the ground truth for the training set was established.
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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
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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,
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
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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)
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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 SrlVi dei Piani di Monte Savello 37Albano Laziale00041 Rome, Italy |
| Phone:Fax: | +39 06 931 5492+39 06 931 4580 |
| FDA Establishment Reg. Number: | 8021084 |
| 510(k) Owner and Submitter: | Cosmed SrlVi dei Piani di Monte Savello 37Albano Laziale00041 Rome, Italy |
| Owner/Operator Reg. Number: | 8021084 |
| 510(k) Application Correspondent: | Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 Rome, Italy |
| Phone:Fax:Email: | +39 06 578 2665+39 06 574 3786rgray@donawa.com |
| 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,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).
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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 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 ●
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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 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, FDArecognition #19-4IEC 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 | |
| Coexistencetesting | Coexistence testing between Q-NRG/Q-NRG+ Bluetooth and other environmentalwireless disturbances (i.e. Network Wi-Fi), according to the indications reported in S.Seidman, N. LaSorte, "An Experimental Method for Evaluating Wireless Coexistence of aBluetooth 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 | |
| Reprocessingvalidation | 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+ PortableMetabolic Monitors | Quark RMR Metabolic Cart | N/A |
| Table 4: Predicate device comparison table | |||
| Feature | Subject device | Predicate device | Similarity |
| DeviceManufacturer | Cosmed Srl, Italy | Cosmed Srl, Italy | Same |
| 510(k) Reference | This submission | K120146 | N/A |
| FDA ProductCode | BTY | BTY | Same |
| FDAClassificationName | Calculator, PulmonaryFunction Data | Calculator, PulmonaryFunction Data | Same |
| FDA RegulationNumber | 21 CFR 868.1890 | 21 CFR 868.1890 | Same |
| Devicedescription | Portable metabolic monitors,designed for the measurementof resting energy expenditure(REE) in both spontaneouslybreathing and mechanicallyventilated patients | Metabolic cart for gasexchange analysis (VO2,VCO2) either during resting orexercise. either withspontaneously breathingsubjects (at rest and duringexercise) or mechanicallyassisted patients | Similar, subject device is notindicated for exercising patients |
| Indications foruse | The Q-NRG & Q-NRG+Portable Metabolic Monitorsare indicated for themeasurement of RestingEnergy Expenditure (REE) forspontaneously breathing and(Q-NRG+ only) ventilatedpatients, within the followingpopulations:- Spontaneously breathingsubjects >15 kg (33 lb) whenusing a canopy;- Spontaneously breathingsubjects age >6 and >10 kg(22 lb) when using a facemask:- Ventilated subjects age >10and >10 kg (22 lb).The Q-NRG & Q-NRG+Portable Metabolic Monitorsare intended to be used inprofessional healthcarefacilities only (limited to ICUsfor ventilated patients). | Measurement of restingmetabolism (face mask): age 6to adults;Measurement of restingmetabolism (canopy dilution):15 kg/30 lb to adults;Measurement of restingmetabolism (ventilatedpatients): age 10 to adults. | Very similar. The subject deviceadds a lower limit for thepatient's weight in order to avoiduse of the device on peopleweighing less than 10 kg |
| Use environment | Indoor use (healthcarefacilities) | Indoor use (healthcarefacilities) | Same |
| Devicemeasurements(outputparameters) | Resting Energy Expenditureand related parameters (VO2,VCO2, RQ) | Resting Energy Expenditureand related parameters (VO2,VCO2, RQ) (othermeasurements available asoptions) | Same |
| Measurementmode(s) | Face mask, canopy,mechanically ventilatedpatients | Face mask, canopy,mechanically ventilatedpatients | Same |
| MeasurementRange | Ventilation: 1-25 l/minVO2: 0.01-1 l/minVCO2: 0.01-1 l/min | Ventilation: 0-50 l/minVO2: not specifiedVCO2: not specified | Substantially equivalent for themaximum patient ventilation ofthe intended patient populationand condition e.g. at rest. |
| Table 4: Predicate device comparison table | |||
| Feature | Subject device | Predicate device | Similarity |
| MeasurementAccuracy | Ventilation: <2% or 100 ml/min(whichever is greater)VO2: ±3% or 5 ml/min(whichever is greater)VCO2: ±3% or 5 ml/min(whichever is greater) | Ventilation: <3%VO2: ±3%VCO2: ±3% | Substantially equivalent |
| Major separatesystemcomponents | · Q-NRG unit· Canopy hood & accessories· Optional PC software· Optional "Face Mask Mode"accessories· Optional ventilation modeaccessories· Optional calibrationaccessories· Optional cart | · Quark RMR unit· Canopy hood & accessories· PC software· Optional "Face Mask Mode"accessories· Optional calibrationaccessories· Optional cart | Same |
| Flowmetertechnology | Face mask: 18mm turbineflowmeterCanopy: 18mm turbineflowmeterVentilator mode: disposablevariable orifice pneumotach | Face mask: 18mm turbineflowmeterCanopy: 18mm turbineflowmeterVentilator mode: disposablevariable orifice pneumotach | Same |
| O2 sensortechnology | Electrochemical | Paramagnetic | Substantially equivalenttechnology, the O2electrochemical sensor isalready used in K162515 andK071533 |
| CO2 sensortechnology | Infrared | Infrared | Same |
| Samplingtechnology | Internal mixing chamber | Breath by breath | Substantially equivalenttechnology, internal mixingchamber technology is alreadyused in K162515 and K071533 |
| User interface | Touch screen (unit) orkeyboard and mouse (PC) | Keyboard and mouse (PC) | Similar. Subject device isdesigned to be mainly operatedas a stand-alone unit |
| PC Software | Windows based application | Windows based application | Same |
| Biocompatibility | All direct patient contact andgas pathway components arebiocompatible or used inalready legally marketeddevices with the sameintended use | All direct and indirect patientcontact components arebiocompatible | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Anatomical sites | Indirect contact with patient'sairways | Indirect contact with patient'sairways | Same |
| Energy used | External or internal powersupply | External power supply | Similar. Subject device can alsobe powered by an internal Li-Ionbattery |
| Energy delivered | No energy delivered to patient | No energy delivered to patient | Same |
| Safety Standard: | ANSI/AAMI ES 60601-1:2005/(R)2012 + A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012:class I / Internal power source,type BF applied part | IEC 60601-1: class I, type BFapplied part | Similar. Subject device can bealso powered by an internal Li-Ion battery |
| Dimensions | 31 x 21 x 27 cm | 17 x 30 x 45 cm | Differences have no effect onsafety or effectiveness |
| Weight | 4.65 kg | 8 kg | Differences have no effect onsafety or effectiveness |
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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.
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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.
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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.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).