Who is the manufacturer of REEVUE INDIRECT CALORIMETER, MODEL#8100?

Korr Medical Technologies, Inc. filed the 510(k) submission for REEVUE INDIRECT CALORIMETER, MODEL#8100 (K021490).

What is the FDA product code for REEVUE INDIRECT CALORIMETER, MODEL#8100?

BZL. It is classified under 21 CFR 868.1730 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for REEVUE INDIRECT CALORIMETER, MODEL#8100?

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

What are the predicate devices for REEVUE INDIRECT CALORIMETER, MODEL#8100?

BodyGem (also marketed as MedGem) (K010577).

Who can help prepare an FDA 510(k) submission like REEVUE INDIRECT CALORIMETER, MODEL#8100?

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.

REEVUE INDIRECT CALORIMETER, MODEL#8100

K021490 · Korr Medical Technologies, Inc. · BZL · Jan 2, 2003 · Anesthesiology

Device Facts

Record ID	K021490
Device Name	REEVUE INDIRECT CALORIMETER, MODEL#8100
Applicant	Korr Medical Technologies, Inc.
Product Code	BZL · Anesthesiology
Decision Date	Jan 2, 2003
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1730
Device Class	Class 2
Attributes	Pediatric

Intended Use

The REEVUE is intended for use in clinical and research applications to measure oxygen uptake.

Device Story

The REEVUE is a desktop indirect calorimeter used in clinical settings by healthcare providers to assess metabolic needs. The device measures oxygen consumption (VO2) by analyzing expiratory gas. Patients breathe through a mouthpiece with unidirectional valves; expiratory gas is directed into a mixing chamber where oxygen concentration is measured via a galvanic fuel cell. The device also measures gas flow, barometric pressure, temperature, and humidity. Using an assumed respiratory quotient (RQ=0.83) and the Weir Equation, the device calculates Resting Metabolic Rate (RMR). Output is displayed to the clinician to guide nutritional counseling and caloric intake requirements. By providing an objective measure of energy expenditure, the device assists in managing nutritional status for patients with metabolic risks, such as those with obesity or sepsis.

Clinical Evidence

Clinical validation compared the REEVUE to the Douglas Bag method (gold standard) in 13 comparisons across 8 subjects. Measured VO2 ranged from 138 to 545 ml/min. Results showed a mean difference of -3.22% (-7.6 ml/min) with a standard deviation of 3.4% (6.7 ml/min). Linear regression analysis yielded R^2 = 0.99 and a slope of 1.0081, indicating high agreement between the device and the reference method.

Technological Characteristics

Desktop indirect calorimeter; fixed-orifice differential pressure pneumotach flow sensor; galvanic fuel cell oxygen sensor; mixing chamber design. Measures barometric pressure, temperature, and relative humidity. Electrical safety per EN60601-1, UL2601-1, CSA C22.2 NO 601.1-M90. Class 1, Type BF applied part. Single-patient use accessories (non-sterile).

Indications for Use

Indicated for clinical and research applications to measure oxygen uptake in patients weighing >33 kg (73 lbs), including pediatric to adult populations. Typical applications include nutritional assessment for obesity, burns, inflammatory states (sepsis), and patients receiving parenteral or enteral nutrition. Contraindicated for patients on mechanical ventilation or supplemental oxygen.

Regulatory Classification

Identification

An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.

Predicate Devices

BodyGem (also marketed as MedGem) (K010577)

Reference Devices

CO2SMO PLUS (K963380)
TEEN 1000 (K945213)
MMS-2400 (TRUEMAX 2400) (K941843)

Related Devices

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K222982 — Virtus Metabolic Monitor · Virtus Technology Aps · Jun 23, 2023
K200076 — Breezing Med · Tf Health Co. · Sep 25, 2020
K190561 — NICU V'02 · Cosmed Nordic Aps · Sep 4, 2020
K021605 — MEDGEM · Healthetech, Inc. · Jun 14, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ #### K021490 510(k) Summary In accordance with the Safe Medical Devices Act of 1990 (SMDA), this is a summary of the safety and effectiveness information for this premarket notification upon which an equivalence determination could be based (510(k) summary) [21 CFR § 807.92(c)]. #### 1. Applicant Information | Applicant: | KORR Medical Technologies, Inc. | |------------|------------------------------------------------------------| | Contact: | Scott A. Kofoed | | Address: | 3090 East 3300 South Suite 100 Salt Lake City, UT 84109 | | Phone: | (801) 483-2080 | |------------------------|-----------------| | Fax: | (801) 483-2123 | | Date Summary Prepared: | October 1, 2002 | #### 2. Device Name and Classification | Trade name: | REEVUE Indirect Calorimeter Model: 8100 | |----------------------|--------------------------------------------| | Common Name: | Indirect Calorimeter | | Classification name: | Computer, Oxygen-Uptake | | Classification Code | CFR Section: 21 CFR ξ 868.1730 | | Product Code: | AN-BZL | | Panel: | Anesthesiology | | Class: | 2 | #### 3. Identification of Legally Marketed Predicate Device Device: ........................................BodyGem (also marketed as MedGem) Marketing Company: ......................Healthetech Inc. 510(k) Number:....................................K010577 {1}------------------------------------------------ #### Contents of Summary: | 1. Applicant Information | |----------------------------------------------------------------------------------| | 2. Device Name and Classification | | 3. Identification of Legally Marketed Predicate Device | | 4. Description of the Device | | 5. Intended Use / Indications for Use | | 5.1 Typical Applications Where the Device may be Used | | 6. Technological Characteristics Compared to Predicate Device | | 6.1 Comparison Table to Predicate Device | | 7. Non-clinical Performance Data to Establish Equivalence | | 8. Clinical Performance Data to Establish Equivalence | | 9. Substantial Equivalence Conclusion | | 9.1 Does the new device have same indication statements? | | | | materials? | | 9.3 Are the descriptive characteristics precise enough to ensure equivalence? 18 | | 9.4 Are performance data available to assess equivalence? | | 9.5 Does performance data demonstrate equivalence? | | 9.6 Substantially Equivalent Determination: | | | #### 4. Description of the Device The REEVUE is an indirect calorimeter. The REEVUE device measures oxygen consumption ($V_{O2}$) and estimates Resting Metabolic Rate (RMR) based on the measured $V_{O2}$ using an assumed respiratory quotient (RQ=0.83). Resting metabolic rate can also be referred to as Resting Energy Expenditure (REE). Measurement of energy requirements can be used for nutritional assessment. A typical application would be for counseling obese patients on their caloric intake requirements. During a test the patient breathes through a mouthpiece with unidirectional breathing valves. These valves allow the patient to breath in ambient air and then direct the expiratory gas down a hose to the device. The flow rate of the expiratory gas is measured and the patient's tidal volume and respiratory rate is calculated. The expiratory gas passes through a mixing chamber so that the mixed expiratory oxygen concentration can be found. The oxygen concentration of the mixed expiratory gas is measured. Oxygen consumption can be expressed as the volume of oxygen breathed in minus the volume of oxygen breathed out. This can be described as: $$\left[\left.V_{O2} - \left.V_{I}\right|_{IO2} - \left.V_{E}\right|_{E\ O2}\right] \tag{1}$$ where $V_{O2}$ is the oxygen consumption, $V_I$ is the inspiratory volume, $F_{IO2}$ is the inspiratory oxygen fraction, $V_E$ is the expiratory volume, and $F_{EO2}$ is the expiratory oxygen fraction. {2}------------------------------------------------ Since the REEVUE only measures the expiratory volume of gas breathed out, the inspired volume must be estimated. This is similar to other legally marketed medical devices. When measuring both CO2 and O2 this is often referred as the Haldane method. To estimate the inspired volume, the components of the expiratory and inspiratory volumes need to be accounted for. In estimating the inspiratory volume the REEVUE requires an estimate of the Respiratory Quotient (Ro). The REEVUE uses an assumed $R_O$ of 0.83. The $R_O$ is defined as: $$R_Q = \frac{V_{CO_2}}{V_{O_2}}\tag{2}$$ where $V_{CO2}$ is the carbon dioxide eliminated by the patient's breathing. An estimate of Resting Energy Expenditure (REE) is calculated using the Weir Equation with the assumed $R_O$ value of 0.83. Substituting for the $V_{CO2}$ using the $R_O$ and the $V_{O2}$ the Weir Equation can be expressed as: $$\text{Calories} = \left\{ 3.941 \, V_{O2-STPD} + 1.106 R_Q \, V_{O2-STPD} \right\} \times \left\{ 1 - 0.082 \, P_F \right\} \tag{3}$$ Where Calories .......... is the calories burned per liter of oxygen consumed. $P_F$ ......................is the fraction of total energy production due to protein oxidation. Typical values for Pr range from 0.08 to 0.2, corresponding to 8 to 20% protein. We selected a default value of 0.125 for our calculations. In reporting (REE) in Kcal/day, this simplifies to: $$RMR_{\text{Kcal/day}} = \quad 6.925 \times V_{O2-ml/\text{min}-STPD} \tag{4}$$ {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a MetaCheck metabolic rate analyzer. The device is light gray with a darker gray control panel. A clear, corrugated tube is connected to the left side of the device and extends to a T-shaped connector. Figure 1 Picture of Prototype of Device. The product name on the prototype was "MetaCheck". Image /page/3/Picture/2 description: In the image, a woman is sitting in a chair with a tube in her mouth, while another woman stands next to a machine. The woman in the chair is wearing a dark shirt and has a white cloth draped over her lap. The tube in her mouth is connected to the machine, which is on a cart. The other woman is wearing a light-colored shirt and jeans and appears to be operating the machine. The image is labeled as "Figure 2 Example of a test with the Device." Figure 2 Example of a test with the Device {4}------------------------------------------------ #### 5. Intended Use / Indications for Use The device is intended for use in clinical and research applications to measure oxygen uptake. #### 5.1 Typical Applications Where the Device may be Used The device could be used in applications where oxygen consumption or measurements of indirect calorimetery would typically be used. This could include: - Diseases where patients may be at risk for malnutrition . - Burn Patients . - Weight Management . - Parenterally Fed Patients . - Enterally Fed Patients ● - Inflammatory States: Sepsis . Since the device does not measure carbon dioxide, and hence respiratory quotient, it could not be used in applications that require a measure of the respiratory quotient. Since the device assumes the patient is breathing ambient air, it is not intended for patients where supplementary oxygen is being given. #### 6. Technological Characteristics Compared to Predicate Device Both the device and the predicate device measure oxygen consumption and then estimate resting metabolic rate using the Weir Equation and an assumed respiratory quotient (Rg). Both devices measure gas flow, oxygen concentration, barometric pressure, temperature, and relative humidity. Both devices use a single-use mask or mouthpiece. The main difference between the current device (REEVUE) and the predicate device (BodyGem) is that the predicate device is a handheld device that measures oxygen concentration and gas flow near the patient's mouth. The current device (REEVUE) is a "bench top" unit that uses a traditional mixing chamber approach, which allows the expiratory gas to mix. Since the gas is mixed, the oxygen sensor does not need to have a high frequency response since it is continuously measuring the mixed expiratory oxygen concentration. {5}------------------------------------------------ # 6.1 Comparison Table to Predicate Device | Parameter | REEVUE (Current Device) | BodyGem (Predicate Device) | Comparison Notes | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | For use in clinical and research applications to measure oxygen uptake | For use in clinical and research applications to measure oxygen uptake | Intended use statements are similar. Both products are intended for oxygen consumption and indirect calorimetery measurements. | | Target Population | Weight > 33 kg (73 pounds) Pediatric to Adult Patients Device is not compatible with mechanical ventilation or patients on supplemental oxygen. Specified for breath rates of 5 to 40 breaths per minute and for tidal volumes ranging from 200 ml to 3000 ml. | Device is not compatible with mechanical ventilation or patients on supplemental oxygen. Specified for breath rates of 5 to 25 breaths per minute and for tidal volumes ranging from 500 ml to 1500 ml. | The minimum tidal volume of the predicate device is 500 ml. This is a typical tidal volume for an adult male. | | Sterility | All patient contact elements are single-patient use. These accessories are considered as clean, non-sterile. | The patient holds the reusable device in his/her hand. A filter is placed in the device to prevent cross-contamination of the gas breathed by the patient. | Neither device uses sterile components. Both devices use clean, non-sterile single patient use components. | | Biocompatibility | All patient contact components are legally marketed medical devices used as defined by their intended use statements. | No known issues. | Same. | | Mechanical Safety | No mechanical safety risks identified. | No mechanical safety risks identified. | Same. | | Chemical Safety | No chemical safety risks identified. | No Known Issues. | Same. | | Anatomical Sites | Measures the respiratory gases at the patient's mouth and nose. | Measures the respiratory gases at the patient's mouth and nose. | Same. | | Human Factors | Requires patient to keep mouthpiece/mask sealed about mouth/nose. | Requires patient to keep mouthpiece/mask sealed about mouth/nose. | Same. | | Energy Used | External 12-volt power supply from device. | External 12-volt power supply from device. | Same. | | Energy Delivered | No energy delivered to patient. | No energy delivered to patient. | Same. | | Compatibility with Environment | No known issues. | No known issues. | Same. | | Compatibility with Other Devices. | No known devices for compatibility issues. | No known devices for compatibility issues. | Same. | | Where used | Doctor's office. Hospital nutritional assessment. | Doctor's office. Hospital nutritional assessment. | Same. | | Parameter | REEVUE (Current Device) | BodyGem (Predicate Device) | Comparison Notes | | Standards: Electrical Safety | EN60601-1 (1996) UL2601-1 (2nd edition) CSA C22.2 NO 601.1-M90 Class 1, Type BF applied part Drip proof equipment (IPX1) | EN60601-1 (1996) UL2601-1 CSA601-1 Class II, Type B | Similar safety. The Class 2 on the predicate device is due to the plastic enclosure. The Class 1 on the current (REEVUE) device is due to the grounded metal enclosure. | | Standards: EMC Testing | EN60601-1-2 | EN60601-1-2 | Same. | | Standards: Voluntary | No applicable voluntary standards. | No applicable voluntary standards. | Same. | | Thermal Safety | No known thermal safety issues. | No known thermal safety issues. | Same. | | Radiation Safety | No known radiation safety issues. | No known radiation safety issues. | Same. | | Design - General | Device measures expiratory flow and oxygen concentration. Inspiratory volume is estimated. Ambient (inspired) oxygen concentration is assumed 20.93. Device is a desktop unit that connects to the patient via 1.5 meters of breathing circuit hose and a single-patient use mouthpiece. The display shows the Resting Metabolic Rate and VO2. | Ambient (inspired) oxygen concentration is assumed 20.93 for device calibration. Inspiratory and expiratory flow and oxygen measurements are integrated to obtain VO2. The device is handheld. The display shows the Resting Metabolic Rate and VO2. | The predicate device, the BodyGem, measures VO2 on a breath-by-breath basis whereas the current device uses a mixing chamber design. The mixing chamber is comparable to other legally marketed devices indicated in this 510(k) notification. | | Specification Comparison | | | | | Barometric Pressure Sensor | | | | | Accuracy | $\pm$ 5 mmHg | $\pm$ 4 mmHg | Not a significant Difference | | Resolution | 1 mmHg | 0.05 mmHg | Not a significant Difference | | Min/Max Range | 500 to 800 mmHg | 515 to 795 mmHg | Not a significant Difference | | Temperature Sensor | | | | | Accuracy | $\pm$ 1 °C | $\pm$ 1 °C | Not a significant Difference | | Resolution | 0.1 °C | 0.01 °C | Not a significant Difference | | Min/Max Range | 10 to 40 °C | 5 to 50 °C | Not a significant Difference | | Humidity Sensor | | | | | Accuracy | $\pm$ 10 %RH | $\pm$ 10 %RH | Not a significant Difference | | Resolution | 1 %RH | 1 %RH | Not a significant Difference | | Min/Max Range | 10 to 95 %RH | 10 to 98 %RH | Not a significant Difference | | Oxygen Sensor | | | | | Type | Galvanic Fuel Cell | Florescent Quenching | | | Accuracy | $\pm$ 0.2 %O2 | $\pm$ 0.4 to 0.8 %O2 | | | Resolution | 0.01 %O2 | 0.03 %O2 | Not a significant Difference | | Min/Max Range | 0 to 30 %O2 | 10 to 21 %O2 | Not a significant Difference | | Parameter | REEVUE (Current Device) | BodyGem (Predicate Device) | Comparison Notes | | Nominal Sensor Life | > 30 months | Not reported. However, the user manual does describe that an error message will be given when the sensor needs to be replaced. | The REEVUE notifies the user when the oxygen sensor is nearly depleted. When the senor is depleted device will lockout user operation. | | Flow Sensor | | | | | Type | Fixed-orifice Differential Pressure Pneumotach | Ultrasonic time-of-flight | Flow technology is different, but should not be significant if each works within the published specifications. The REEVUE flow sensor is also used in other legally marketed medical devices for measuring expiratory respiratory gas flow. | | Accuracy | ± 2% of reading | ±1% | Not a significant difference since the REEVUE estimates the inspired volume from the expired volume. (i.e. similar to traditional Haldane Equation) If both the expiratory and inspiratory volumes are measured, a higher flow sensor accuracy is required. | | Resolution | 10 ml / sec (0.01 LPM) | 1 ml / sec | Not a significant Difference | | Min/Max Range | - 40 to 150 LPM (-600 to 2500 ml / sec) | 0 to 2100 ml / sec | Not a significant Difference | | Respiratory Tidal Volume Measurements | | | | | Breathing Rate | 5 to 40 breaths/min | 5 to 25 breaths/min | Not a significant Difference | | Tidal Volume | 200 to 3000 ml | 500 to 1500 ml | Not a significant Difference | | VO2 Measurements | | | | | Range | < 70 to > 720 ml /min 02 | 72 to 721 ml /min 02 | Not a significant Difference | | Resolution | 1 ml/min 02 | 1 ml/min 02 | Same. | | RMR Measurements | | | | | Calculation Method | Weir Equation with assumed RQ = 0.83 | Weir Equation with assumed RQ = 0.85 | Not a significant Difference. | | Range | 500 to > 5,000 kcal/day | 500 to 5,000 kcal/day | Same. | | Resolution | 7 kcal/day | 10 kcal/day | Not a significant Difference. | | Measurement Time | 10 minutes | 10 min max | Not a significant Difference. | | Size & Weight | | | | | Size | 20 x 30 x 10 cm | 5.5 x 5.5 x 11.5 cm | REEVUE is a desktop unit. The predicate device is a handheld device. | | Weight | 5.75 lbs. (2.6 kg) | 4 oz. | REEVUE is a desktop unit. The predicate device is a handheld device. | | Disposables | | | | | Parameter | REEVUE (Current Device) | BodyGem (Predicate Device) | Comparison Notes | | Mask Sizes | N/A | Small, medium, large | REEVUE does not have a mask. | | Mouthpiece | One size | One size | Same. | | Filter Efficiency | Bacterial Filtration 99.999+% Viral Filtration 99.99+% | Better than 99% of particles at 2 microns at flow rates up to 30 liters per minute | Due to the uni-directional gas flow in the REEVUE, a filter is only recommended, but not required by the REEVUE. | | Operating Environment | | | | | Temperature Range | 15 to 30 °C (59 to 86 °F) | 15 to 30 °C (59 to 86 °F) | Same. | | Elevation Range | -30 to 3040 meters (-100 to 10,000 feet) | -30 to 3040 meters (-100 to 10,000 feet) | Same. | | Barometric Pressure Range | 525 to 780 mmHg | 525 to 780 mmHg | Same. | | Relative Humidity Range | 10 to 95% RH non-condensing | 10 to 88% RH non-condensing | Not a significant Difference | | Storage Environment | | | | | Temperature Range | -20 to 60 °C (-4 to 140 °F) | -20 to 60 °C (-4 to 140 °F)…