(573 days)
No
The device description explicitly states that the control unit is "pneumatically driven (i.e., no electronics)." The mechanism of action is based on gas flow control and partial rebreathing, not electronic processing or algorithmic decision-making. There is no mention of AI, ML, or any computational components in the summary.
Yes
Explanation: The device is intended for use as an "adjunctive treatment for patients suffering from carbon monoxide poisoning," which clearly indicates a therapeutic purpose.
No
The device is described as an "adjunctive treatment" for carbon monoxide poisoning that "enables accelerated elimination of carbon monoxide from the body." Its purpose is to induce isocapnic hyperventilation to speed up the elimination of CO, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "pneumatic device" consisting of a "Control unit ('briefcase')" with internal components that control gas flowrates and concentrations. It also includes breathing circuits, hoses, and a device stand. This clearly indicates the device is a hardware-based system, not software-only.
Based on the provided information, the ClearMate™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to be an "adjunctive treatment for patients suffering from carbon monoxide poisoning" by enabling "accelerated elimination of carbon monoxide from the body." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "pneumatic device" that "induce[s] isocapnic hyperventilation in patients." It controls gas flow and concentration delivered to the patient's airway. This is a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the device's mechanical and physiological performance (gas flow, concentration, biocompatibility, effect on CO elimination in animal and human subjects), not on the accuracy or reliability of a diagnostic test.
- Key Metrics: The document does not list diagnostic performance metrics like sensitivity, specificity, PPV, or NPV, which are standard for IVDs.
In summary, the ClearMate™ is a therapeutic medical device designed to treat carbon monoxide poisoning by facilitating the removal of CO from the body through controlled ventilation. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ClearMate™ is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate" enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.
Product codes (comma separated list FDA assigned to the subject device)
QFB
Device Description
This device is intended to induce isocapnic hyperventilation in patients to speed up elimination of carbon monoxide (CO). Isocapnic hyperventilation can be defined as large increases in patient minute volume with minimal changes in arterial partial pressure of carbon dioxide (CO2). This device replaces CO2 levels in the airway, thereby maintaining CO2 levels in the blood that ultimately causes hyperventilation. This pneumatic device initially provides 100% supplemental oxygen (O2) at minute volumes selected based on patient weight. If the patient minute volume demand is more than the preset supplement O2 volume, this device supplies a mixture of 94%/6% (O2/CO2), which maintains CO2 levels in the airway to enable isocapnic breathing by partial simulated rebreathing (of CO2). This device consists of:
-
- The subject of this De Novo, the Control unit ("briefcase"), connects to sources of O2 and CO2 (neither gas is supplied with this device). The unit includes pressure gauges to read the source gas pressures. Internal components control supplemental gas flowrates, gas concentrations, and CO2 diversion away from the gas delivery pathway should O2 pressures be insufficient. This unit weighs about 2 kg and is pneumatically driven (i.e., no electronics).
-
- Two breathing circuits, which are not the subject of this De Novo, can attach to the gas outlet ports of the control unit. These circuits are constructed of reservoir bags (21 CFR 868.5320, Class I), oxygen cannulas (21 CFR 868.5340, Class I), masks (21 CFR 868.5550, cleared under K953107), valves (21 CFR 868.5870, cleared under K142402), resuscitation bags (21 CFR 868.5915, cleared under K912203), and/or tubing (21 CFR 868.5925, cleared under K161420).
The circuits are described in greater detail below:
- a. The spontaneously breathing patient circuit has an O2 cannula (for supplemental O2 delivery) and corrugated cannula (for 02/CO2 delivery). The two cannulas deliver gases to the patient mask. An O2 reservoir is in the pathway to contain excess gases not consumed by the patient.
- b. The non-spontaneously breathing patient circuit has an O2 cannula (for supplemental O2 delivery), corrugated cannula (for O2/CO2 delivery), and pressure sample line. The two cannulas deliver gases past the O2 reservoir bag and self-inflating bag to the patient mask. Adjacent to the patient mask is the pressure sample line (monitored by the control unit).
-
- Hoses for source gas connections and a device stand for steadying the device, which are a subject of this De Novo.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
greater than 16 years old and a minimum of 40 kg (80.8 lbs)
Intended User / Care Setting
emergency department medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Studies:
- Breathing Circuit Performance: Ten samples of spontaneously breathing and non-spontaneously breathing circuits (20 samples total) were tested for minimum pressures for reservoir bag inflation, one-way valve responses, worst case range of pressures experienced, leakage rate, and supplemental O2 flowrate accuracy. Circuits were tested to facilitate correct gas concentrations. Circuit dimensions were validated. Resuscitation bag was tested for ability to facilitate up to 80BPM. All predefined specifications were met.
- Control Unit Performance: Ten control units were tested for specified operation after exposure to normal and excessive source gas pressures. Operation of supplemental O2 concentration, blended gas concentrations, low O2 pressures that trigger the CO2-driven alarm, CO2 diversion to drive the alarm, blended gas pathway demand valve, blend gas pathway maximum flow rate, and supplemental 02 flowrate accuracy were evaluated. All predefined specifications were met.
- Use Life Performance: 5 device samples were challenged at double the typical maximum breaths per minute and 1.4 times the typical adult tidal volume (per breath) for 10 hours, simulating 30 minutes of use for approximately 8 patients per year. Validations of supplemental O2 accuracy and CO2 concentrations based on device settings were performed. The results confirm supplemental 02 output and 02/CO2 demand valve operating specifications.
Animal Studies:
- Fisher JA et al. (1999): Dog model, investigated isocapnic hyperpnea for CO poisoning. Concluded isocapnic hyperpnea more than doubles the rate of carboxyhemoglobin (COHb) elimination induced by normal ventilation with 100% oxygen.
- Krech T et al. (2001): Mechanically ventilated sheep model, evaluated effect of isocapnic hyperventilation on CO elimination and oxygen delivery. Concluded isocapnic hyperventilation increased the rate of carbon monoxide elimination without adversely affecting cardiac output or oxygen delivery.
Clinical Studies (Healthy Volunteers with CO Exposure):
- Anand et al. (2017): 13 chronic smokers, baseline COHb near 5%. Compared non-isocapnic hyperventilation (100% O2 with voluntary hyperventilation) with isocapnic hyperventilation using ClearMate for COHb reduction. Found elimination half-life of COHb significantly lowered with isocapnic hyperventilation. No serious adverse events reported.
- Rucker et al. (2002): Randomized single blind crossover study on 14 healthy volunteers with 10-12% COHb. Evaluated CO elimination times and cerebral blood flow after treatment with hyperoxia with or without normocapnia. Maintaining normocapnia during hyperoxic treatment resulted in significantly higher cerebral blood flow and a 21% decrease in the elimination half-life of CO.
- Takeuchi et al. (2000): Healthy human volunteers exposed to CO (10-12% COHb). Treated with either 100% oxygen at normal minute ventilation or isocapnic hyperventilation at 2-6 times resting minute ventilation. Elimination half-life of COHb fell from 78 to 31 minutes in the treatment group.
Clinical Studies (Anesthetic Agents):
- Katznelson et al. (2008): Randomized controlled trial comparing elimination of anesthetic agents with standard ventilation versus isocapnic hyperventilation. Isocapnic hyperventilation increased respiratory elimination of anesthetic agents.
- Kateznelson et al. (2011): 44 obese elective surgical patients randomized to conventional recovery vs. isocapnic hyperventilation. Minute ventilation preceding extubation was 22.6 L/min in the isocapnic hyperventilation group and 6.3 L/min in the conventional group. Anesthetic emergence was significantly accelerated in the isocapnic hyperventilation group.
Clinical Study (Real-world use in China):
- Wu et al. (2015): Nonrandomized study of patients with acute CO poisoning. Control group (320 patients) received standard hyperbaric oxygen (HBO) treatment. Treatment group (319 patients) received ClearMate treatment immediately on-site or at emergency centers, followed by HBO and other treatment.
- Endpoints: Effective treatment defined as "Patient has clear consciousness, continence, major signs of CO poisoning disappearing, EEG shows minor abnormalities, and BI score is 40 - 60." Non-effective: "no improvement in consciousness and signs, exacerbation or death, moderate or serious abnormalities on EEG, and BI score
§ 868.5480 Isocapnic ventilation device.
(a)
Identification. An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (§ 868.5320), oxygen cannulas (§ 868.5340), masks (§ 868.5550), valves (§ 868.5870), resuscitation bags (§ 868.5915), and/or tubing (§ 868.5925).(b)
Classification. Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including the following performance characteristics:
(i) Gas concentration accuracy testing for the range of intended concentrations;
(ii) Airway pressure delivery accuracy testing;
(iii) Supplemental O
2 flowrate accuracy testing;(iv) Alarm testing; and
(v) Use life testing.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Labeling must include the following:
(i) Instructions for use;
(ii) A precaution that monitoring of capnography is necessary during treatment with non-spontaneously breathing patients; and
(iii) Use life specification.
0
DE NOVO CLASSIFICATION REQUEST FOR CLEARMATE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Isocapnic ventilation device. An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925).
NEW REGULATION NUMBER: 21 CFR 868.5480
CLASSIFICATION: Class II
PRODUCT CODE: QFB
BACKGROUND
DEVICE NAME: ClearMate™
SUBMISSION NUMBER: DEN170044
DATE OF DE NOVO: August 23, 2017
CONTACT: Thornhill Research, Inc. 5369 W. Wallace Ave Scottsdale, AZ 85254
INDICATIONS FOR USE
ClearMate™ is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate" enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.
LIMITATIONS
Intended Patient Population is adults aged greater than 16 years old and a minimum of 40 kg (80.8 lbs)
ClearMate™ is intended to be used by emergency department medical professionals. This device should always be used as adjunctive therapy; not intended to replace existing
1
protocol for treating carbon monoxide poisoning.
When providing treatment to a non-spontaneously breathing patient using the ClearMate™ non-spontaneous breathing patient circuit, CO2 monitoring equipment for the measurement of expiratory carbon dioxide concentration must be used.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS AND CAUTIONS.
DEVICE DESCRIPTION
This device is intended to induce isocapnic hyperventilation in patients to speed up elimination of carbon monoxide (CO). Isocapnic hyperventilation can be defined as large increases in patient minute volume with minimal changes in arterial partial pressure of carbon dioxide (CO2). This device replaces CO2 levels in the airway, thereby maintaining CO2 levels in the blood that ultimately causes hyperventilation. This pneumatic device initially provides 100% supplemental oxygen (O2) at minute volumes selected based on patient weight. If the patient minute volume demand is more than the preset supplement O2 volume, this device supplies a mixture of 94%/6% (O2/CO2), which maintains CO2 levels in the airway to enable isocapnic breathing by partial simulated rebreathing (of CO2). This device consists of:
-
- The subject of this De Novo, the Control unit ("briefcase"), connects to sources of O2 and CO2 (neither gas is supplied with this device). The unit includes pressure gauges to read the source gas pressures. Internal components control supplemental gas flowrates, gas concentrations, and CO2 diversion away from the gas delivery pathway should O2 pressures be insufficient. This unit weighs about 2 kg and is pneumatically driven (i.e., no electronics).
-
- Two breathing circuits, which are not the subject of this De Novo, can attach to the gas outlet ports of the control unit. These circuits are constructed of reservoir bags (21 CFR 868.5320, Class I), oxygen cannulas (21 CFR 868.5340, Class I), masks (21 CFR 868.5550, cleared under K953107), valves (21 CFR 868.5870, cleared under K142402), resuscitation bags (21 CFR 868.5915, cleared under K912203), and/or tubing (21 CFR 868.5925, cleared under K161420).
The circuits are described in greater detail below:
- a. The spontaneously breathing patient circuit has an O2 cannula (for supplemental O2 delivery) and corrugated cannula (for 02/CO2 delivery). The two cannulas deliver gases to the patient mask. An O2 reservoir is in the pathway to contain excess gases not consumed by the patient.
2
Figure 1: Front Panel Layout
Image /page/2/Figure/1 description: The image shows a diagram of a device with several labeled components. The labels include A, B, C, D, and E, each pointing to a different part of the device. The device also has a label that says "Clear Mate".
| Front Panel Controls | |
|---|---|
| Label | Control / Gauge |
| A | Carbon Dioxide (CO2) Gas On/Off Switch |
| B | Carbon Dioxide (CO2) Gas Pressure Gauge |
| C | Oxygen (O2) Gas Pressure Gauge |
| D | O2 Flow Control (kg / LPM) Knob |
| E | Airway Pressure Gauge |
- b. The non-spontaneously breathing patient circuit has an O2 cannula (for supplemental O2 delivery), corrugated cannula (for O2/CO2 delivery), and pressure sample line. The two cannulas deliver gases past the O2 reservoir bag and self-inflating bag to the patient mask. Adjacent to the patient mask is the pressure sample line (monitored by the control unit).
Image /page/2/Figure/4 description: This image shows two diagrams of a medical device, likely a respiratory support system. The device includes components such as an oxygen reservoir, a self-inflating bag, and a patient mask. The diagrams also label various pressure gauges, flow controls, and tubing connections, including oxygen and blended carbon dioxide/oxygen gas supplies. Numerical values for pressure ranges are also included, such as O2 (47-52 psig / 3.2-3.6 bar) and CO2 (35-90 psig / 2.4-6.2 bar).
Figures 2 and 3: Spontaneously Breathing Patient Circuit (above, left) Non-Spontaneously Breathing Patient Circuit (above, right)
-
- Hoses for source gas connections and a device stand for steadying the device, which are a subject of this De Novo.
To use this device, O2 and CO2 source gases are connected to respective device input ports. A gauge identifies O2 source gas pressure (expected to be between 47-95psi). Then, the user sets supplemental O2 minute volume based on patient weight. After minute volume is set, CO2 can be switched on, at which point the CO2 gauge will show whether pressures are nominal (expected
- Hoses for source gas connections and a device stand for steadying the device, which are a subject of this De Novo.
3
between 35-95psi). Once the appropriate circuit is attached, the patient mask should be placed on the patient.
For the spontaneously breathing patient, when breathing exceeds supplemental 02 minute volume negative pressure – as low as 2cmHzO – this will cause the demand valve (corrugated tubing pathway) to deliver 94%/6% O2/CO2 mixture.
For the non-spontaneously breathing patient, the user manually compresses the self-inflating bag to facilitate the minute volume. Bagging at minute volumes greater than supplemental O2 settings will cause the demand valve to deliver 94%/6% O2/CO2 mixture. The pressure sampling line (only in this circuit) meters the airway pressure.
During use, the device offers the following features:
-
- If the O2 gas supply drops below 40 psig / 2.75 bar, CO2 gas is diverted from the blended gas pathway to drive an auditory pneumatic alarm.
-
- If the CO2 gas fails, or is exhausted, only O2 will continue to be delivered to the patient. The device does not alarm in this case.
-
- If the O2 supply fails while the CO2 source is attached, the system will shut off all gas to the demand valve and again, CO2 is diverted to drive an auditory pneumatic alarm. The alarm will sound until CO2 supply pressure is insufficient.
The device is designed such that the CO2 will neither be connected to the supplement O2 line nor the blended line in the event of O2 supply failure.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
A biological risk assessment was performed and found to be in accordance with FDA guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (issued June 16, 2016). Based on the risk assessment:
- . The face mask is a component with of the device with limited duration (