Cloud9 System

K150365 · Insleep Technologies, LLC · BZD · Jul 21, 2015 · Anesthesiology

Device Facts

• Record ID: K150365
• Device Name: Cloud9 System
• Applicant: Insleep Technologies, LLC
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9® System maintains a continuous, positive low-pressure in the airway. The device is designed for prescription home use.

Device Story

Cloud9 System is a CPAP device for snoring reduction. It consists of an airflow unit (AFU) and a custom nasal mask (NiteCap). The device delivers continuous positive airway pressure at low levels (2-4 cmH2O). The blower is controlled by pressure measurements at the nasal interface to maintain constant pressure. It is intended for prescription home use by adults. The healthcare provider prescribes the device; the patient operates it at home. The output is a constant low-pressure airflow that stabilizes the airway to reduce snoring noise. This provides a non-invasive treatment option for simple snoring, potentially improving sleep quality for the user.

Clinical Evidence

Prospective, interventional study of 24 habitual simple snorers (subjects as own controls). Primary endpoint: reduction in snoring as % of sleep time. Results: 86% reduction in loud snoring and 67% reduction in all snoring (success criteria >50% reduction met). Secondary endpoint: reduction in nightly noise exposure below 45 dBA; loud snoring reduced from 34% to 5% of sleep time (success criteria >50% reduction met). No adverse events reported.

Technological Characteristics

CPAP blower system with custom nasal interface. Pressure range 2-4 cmH2O. Materials comply with ISO 10993-1. Connectivity: Standalone. Power: 100-240VAC. Standards: ISO 17510-1/2, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62366, IEC 62304, ISO 14971. Software: Firmware-based control of blower pressure via nasal interface feedback loop.

Indications for Use

Indicated for adults to reduce or eliminate simple snoring. Designed for prescription home use.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• AEIOMED Model 300157 CPAP System (now marketed by Somnetics as Transcend) (K100121)
• Resmed Swift Air (now marketed as AirFit P10) (K132013)

Reference Devices

• Invent (K120665)
• DeVilbiss Intellipap (K071689)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-002

July 21, 2015

inSleep Technologies, LLC (inSleep Health) C/O Ms. Adrienne Lenz Senior Consultant, Quality Assurance and Regulatory Affairs Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K150365

> Trade/Device Name: Cloud 9® System Regulation Number: 21 CFR 868.5905 Regulation Name: Non-Continuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 15, 2015 Received: June 22, 2015

Dear Ms. Lenz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150365

Device Name Cloud9® System

Indications for Use (Describe)

The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9® System maintains a continuous, positive low-pressure in the airway. The device is designed for prescription home use.

| Type of Use (Select one or both, as applicable): | |
|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| <div><span style="font-family: DejaVu Sans, sans-serif">✓</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(k) Summary

for

# Cloud9® System

### K150365

#### 1. Submission Sponsor

inSleep Health 12100 Singletree Lane Suite 183 Eden Prairie, MN 55344 USA Phone: [phone] Fax: [phone] Contact: Marty Kerber, SVP, Engineering and Manufacturing

#### 2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: PHONE Office Phone: [phone] Fax: [phone] Contact: Adrienne Lenz, Senior Consultant, Quality Assurance and Regulatory Affairs Email: [e-mail]

#### 3. Date Prepared

June 12, 2015

#### 4. Device Identification

| Trade/Proprietary Name: | Cloud9® System |
|----------------------------|----------------------------------------------|
| Common/Usual Name: | Continuous positive airway pressure (CPAP) |
| Classification Name: | Noncontinuous ventilator (IPPB) |
| Classification Regulation: | 868.5905 |
| Product Code: | BZD, ventilator, non-continuous (respirator) |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |

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### 5. Legally Marketed Predicate Device(s)

Main Predicate K100121 AEIOMED Model 300157 CPAP System (now marketed by Somnetics as Transcend)

K132013 Resmed Swift Air (now marketed as AirFit P10).

### 6. Device Description

The Cloud9® System is a device for delivery of low levels of continuous positive airway pressure (CPAP) that can be used by people who wish to reduce or eliminate their snoring. lts main components include the airflow unit (AFU) and custom nasal mask interface, called the NiteCap™. The Cloud9® System delivers CPAP at low pressures ranging from 2 to 4 cmH₂O, via a nasal interface. The blower generating the airstream is controlled continuously based on pressure measurements at the nasal interface to maintain the pressure at the nose of the user constant ("CPAP"). Its performance is similar to currently used CPAP devices.

### 7. Indication for Use Statement

The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9 System maintains a continuous, positive low-pressure in the airway. The device is designed for prescription home use.

### 8. Substantial Equivalence Discussion

The following table compares the Cloud9® System to the predicate devices with respect to indications for use, intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

| Manufacturer | inSleep Health | Somnetics (cleared<br>by AEIOMED) | Resmed | SIGNIFICANT<br>DIFFERENCES |
|----------------------|------------------------------------|---------------------------------------------------------------|----------------------------------------------|----------------------------|
| Trade Name | Cloud9® System | Model 300157 CPAP<br>System (now<br>marketed as<br>Transcend) | Swift Air (now<br>marketed as AirFit<br>P10) | |
| 510(k) Number | This submission | K100121 | K132013 | None |
| Product Code | BZD | BZD | BZD | None |
| Regulation<br>Number | 868.5905 | 868.5905 | 868.5905 | None |
| Regulation<br>Name | Noncontinuous<br>ventilator (IPPB) | Noncontinuous<br>ventilator (IPPB) | Noncontinuous<br>ventilator (IPPB) | None |

| Table 5A – Comparison of Characteristics | |
|------------------------------------------|--|
|------------------------------------------|--|

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| Manufacturer | inSleep Health | Somnetics (cleared<br>by AEIOMED) | Resmed | SIGNIFICANT<br>DIFFERENCES |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cloud9® System | Model 300157 CPAP<br>System (now<br>marketed as<br>Transcend) | Swift Air (now<br>marketed as AirFit<br>P10) | DIFFERENCES |
| Indications for<br>Use | The Cloud9®<br>System is indicated<br>for use by adults to<br>reduce or<br>eliminate simple<br>snoring. The<br>Cloud9® device<br>maintains a<br>continuous,<br>positive low-<br>pressure in the<br>airway. The device<br>is designed for<br>prescription home<br>use. | The Model 300157<br>CPAP System is a<br>single patient<br>reusable device. The<br>Model 300157 CPAP<br>System provides<br>continuous positive<br>airway pressure<br>(CPAP) to support<br>treatment of adults<br>(over 30 kg) with<br>Obstructive Sleep<br>Apnea. | The Swift Air<br>channels airflow<br>noninvasively to a<br>patient from a<br>positive airway<br>pressure (PAP)<br>device such as a<br>continuous positive<br>airway pressure<br>(CPAP) or bilevel<br>device.<br>The Swift Air is:<br>* to be used by<br>patients (> 66 lb/30<br>kg) for whom<br>positive airway<br>pressure has been<br>prescribed<br>* intended for<br>single-patient re-use<br>in the home<br>environment and<br>multipatient re-use<br>in the<br>hospital/institutiona<br>l environment. | The Cloud9®<br>System's<br>indication is<br>similar to the<br>Invent (K120665)<br>which provides<br>expiratory<br>positive airway<br>pressure to<br>reduce or<br>eliminate<br>snoring. |
| Mechanism of<br>Action | Continuous<br>Positive Airway<br>Pressure (CPAP) | Continuous Positive<br>Airway Pressure<br>(CPAP) | Continuous Positive<br>Airway Pressure<br>(CPAP) or BiLevel<br>Positive Airway<br>Pressure (BiPAP) | None |
| Technology | Blower<br>Nasal mask held in<br>place with<br>adjustable<br>headgear that<br>straps the mask to<br>the face. | Blower<br>Nasal mask held in<br>place with<br>adjustable headgear<br>that straps the mask<br>to the face. | Nasal mask held in<br>place with<br>adjustable headgear<br>that straps the mask<br>to the face. | None |
| Manufacturer | inSleep Health | Somnetics (cleared<br>by AEIOMED) | Resmed | SIGNIFICANT<br>DIFFERENCES |
| Trade Name | Cloud9® System | Model 300157 CPAP<br>System (now<br>marketed as<br>Transcend) | Swift Air (now<br>marketed as AirFit<br>P10) | |
| CPAP Type | User adjustable<br>fixed CPAP<br>pressure | Auto CPAP | NA - channels<br>airflow<br>noninvasively to a<br>patient from a PAP<br>device such as a<br>CPAP or bilevel<br>device. | A prescribed<br>pressure is not<br>required for this<br>indication and<br>therefore users<br>can select the<br>pressure that<br>works best to<br>reduce or<br>eliminate their<br>snoring. |
| Patient Circuit<br>Connection | Custom connector<br>(15 mm ID) that<br>includes the<br>measurement<br>lumen in one single<br>connector | Air outlet connector<br>port: 19-mm<br>diameter<br>proprietary<br>connector<br>Universal Adapter<br>Port Dimensions 22-<br>mm diameter<br>connector | Conical connectors<br>(ref. ISO 5356-<br>1:2004). | The<br>Cloud9®System's<br>circuit includes a<br>second small<br>lumen to<br>measure<br>pressure at the<br>nose and a<br>custom<br>connector<br>prevents<br>patients from<br>using another,<br>not approved<br>circuit with the<br>Air Flow Unit. |
| Pressure Range | 2 to 4 cm H2O | 4 to 20 cm H2O | 4 to 20 cm H2O | Lower maximum<br>pressure (4 cm<br>H2O) for the<br>treatment of<br>snoring. Other<br>CPAP devices,<br>such as DeVilbiss<br>Intellipap<br>(K071689) also<br>use lower<br>pressures, down<br>to 3 cmH2O. |
| Pressure Stability<br>(cmH2O) as<br>measured by ISO<br>17510-1 | Less than +/-1 cm<br>H2O at all pressure<br>levels | Not specified | Not applicable to<br>interface | Cloud9 meets<br>requirements of<br>ISO 17510-1 like<br>other CPAP<br>devices. |
| Manufacturer | inSleep Health | Somnetics (cleared<br>by AEIOMED) | Resmed | SIGNIFICANT<br>DIFFERENCES |
| Trade Name | Cloud9® System | Model 300157 CPAP<br>System (now<br>marketed as<br>Transcend) | Swift Air (now<br>marketed as AirFit<br>P10) | |
| Maximum Flow<br>(LPM) | 71 L/min for all<br>pressure settings | 71 L/min at<br>4cmH₂O, 75 L/min<br>at 8cmH₂O | Not applicable to<br>interface | Cloud9 meets<br>requirements of<br>ISO 17510-1 like<br>other CPAP<br>devices. |
| Maximum<br>System<br>Shutdown<br>Pressure | 30 cm H₂O | 30 cm H₂O | Not applicable to<br>interface | None |
| Mask Sizes | InSleep nasal<br>interface (the<br>Butterfly) is<br>available in Small,<br>Medium, Large and<br>Extra Large (S, M, L<br>& XL) | K100121 includes a<br>patient interface,<br>but details are not<br>publically available. | AirFit P10 XS, S,M, L<br>AirFit P10 for Her<br>XS, S, M,L | Both are<br>available in<br>various sizes to<br>fit different<br>users. |
| Mask Dead space | Less than 52 ml | Seal dead space<br>Less than 301 cc | Large pillows 123<br>mL. | The Cloud9®<br>System dead<br>space is lower<br>and thus better<br>than the<br>predicate device |
| Resistance/ Drop<br>in pressure as<br>measured<br>according to<br>17510-2 | at 50 L/min: 5.7 cm<br>H₂O<br>at 100 L/min: 21.1<br>cm H₂O | At 50 l/min 0.140<br>cm H₂O<br>At 100 l/min 0.278<br>cm H₂O | at 50 L/min: 0.4 cm<br>H₂O<br>at 100 L/min: 1.4 cm<br>H₂O | The Cloud9®<br>System is<br>working with<br>smaller hoses<br>which increases<br>the resistance.<br>The Cloud9®<br>mask and<br>interface can<br>therefore only<br>be used with the<br>Cloud9® AFU,<br>that is<br>specifically<br>designed to<br>work with the<br>higher resistance<br>mask. |

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| Manufacturer | inSleep Health | Somnetics (cleared<br>by AEIOMED) | Resmed | SIGNIFICANT<br>DIFFERENCES |
|--------------|----------------------------|---------------------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cloud9® System | Model 300157 CPAP<br>System (now<br>marketed as<br>Transcend) | Swift Air (now<br>marketed as AirFit<br>P10) | |
| AC Powered | 100 – 240VAC<br>50-60hz | Input<br>100-240 VAC, 50-<br>60Hz<br>Output<br>19VDC, 2.6 Amp | Not applicable to<br>interface | The Cloud9®<br>System meets<br>the same<br>standards for<br>electrical safety<br>and<br>electromagnetic<br>compatibility as<br>its predicate<br>devices. |
| Materials | Comply with ISO<br>10993-1 | Comply with ISO<br>10993-1 | Comply with ISO<br>10993-1 | None |

#### 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Cloud9® System and in showing substantial equivalence to the predicate devices, inSleep Health completed a risk analysis and a number of tests. The Cloud9® System meets all the requirements for overall design, cleaning, biocompatibility, electrical safety and software and test results confirm that the output meets the design inputs and specifications. The Cloud9® System passed all testing as shown by the acceptable results obtained.

The Cloud9® System complies with the applicable voluntary standards for biocompatibility, electrical safety, usability and CPAP performance. The device passed all the testing in accordance with the following international standards.

- ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part 1: Evaluation and . Testing
- IEC 60601-1: 2005, Medical Electrical Equipment - Part 1: General Requirements for Safety
- IEC 60601-1-2: 2007. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- ISO 17510-2: 2007: Sleep apnoea breathing therapy -Part 2: Masks and application accessories
- . ISO 17510-1: 2007: Sleep Apnoea Breathing Therapy. Part 1: Sleep Apnoea Breathing Therapy Equipment.
- IEC 62366: 2007 Medical devices - Application of usability engineering to medical devices

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- IEC 60601-1-6: 2010 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -- Collateral Standard: Usability
- . IEC 62304: 2006, Medical device software - Software life cycle processes
- . ISO 14971: 2007, Medical devices -- Application of risk management to medical devices

Table 5B summarizes the biocompatibility testing performed.

| Part Name | Contact Type/Duration | Tests Conducted |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Air Circuit | Skin - Permanent duration (>30<br>days) based on cumulative contact<br>every night.<br>AND<br>Airway gas - humidified due to<br>patient exhalation (considered<br>external communication with<br>tissue) permanent duration (>30<br>days) based on cumulative contact<br>every night | • Cytotoxicity<br>• Sensitization<br>• Irritation/intracutaneous<br>reactivity<br>• System toxicity (acute)<br>• Pyrogenicity (as part of<br>Systemic toxicity)<br>• Subchronic toxicity (subacute<br>toxicity)<br>• Genotoxicity<br>• Implantation<br>• Chemical Characterization<br>(identification of extractable<br>compounds) |
| Main Hose | Skin - Permanent duration (>30<br>days) based on cumulative contact<br>every night.<br>AND<br>Airway gas - dry. | • Cytotoxicity<br>• Sensitization<br>• Irritation/intracutaneous<br>reactivity<br>• Chemical Characterization<br>(identification of particulates<br>and VOCs) |
| Air flow unit<br>internal<br>components | Airway gas - dry. No direct patient<br>contact | • Chemical Characterization<br>(identification of particulates<br>and VOCs) |
| NiteCap™<br>Fit System -<br>Sport /<br>Athletic | Skin - Permanent duration (>30<br>days) based on cumulative contact<br>every night. | • Cytotoxicity<br>• Sensitization<br>• Irritation/intracutaneous<br>reactivity |

| | Table 5B - Biocompatibility Testing | |
|--|-------------------------------------|--|
|--|-------------------------------------|--|

Additional verification and validation testing included:

- Validation of cleaning methods .
- . Validation to demonstrate that all features of the Cloud9 System were compliant with the system, software and firmware level requirements.
- Testing of the usability of the Cloud9 System to evaluate the ability of an adult to unpack, assemble, operate and disassemble the Cloud9® System safely and effectively.

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- Environmental testing to evaluate the use of Cloud9's Air Flow Unit in a variety of environmental conditions.
- . Testing to determine the 6-month recommended change interval for the Cloud9® System's Filter Assembly.
- Verification that the cleaning methods do not affect device performance over the ● claimed lifetime or replacement intervals
- Verification of the maximum pressure under single fault conditions
- . Verification of the maximum temperature at the patient connection port under normal and single fault conditions

# 10. Clinical Performance Data

A clinical study was conducted to evaluate safety and efficacy of the Cloud9® System to reduce or eliminate simple snoring. The study was a prospective, interventional study of habitual simple snorers with subjects serving as their own controls. The overall design involved four subject visits as follows:

- 1. Baseline assessment of snoring and sleep parameters by PSG
- 2. Titration study to determine the lowest effective level of CPAP within the range of 2 to 6 cm H₂O
- Full treatment night at the previously determined CPAP level (Visit 2) 3.
- 4. Second control night off CPAP to assess and change from baseline over the course of the trial.

Device safety was assessed by the occurrence of adverse events (nasal or skin irritation, epistaxis and sleep disruption) noted during device use (Visits 2 and 3).

A total of 24 subjects were evaluated at three centers. Table 5C presents the study endpoints, results and conclusions.

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| | . | |
|----------------------------|-------------------------------|------------------------------|
| Study Endpoint | Result | Conclusion |
| Primary - Reduction in | There was an average of 86% | The Cloud9 System is |
| the number of all snores | reduction in loud snoring and | effective for its indication |
| or reduction in loud | 67% reduction in all snoring | to reduce or eliminate |
| snores as percent of sleep | | simple snoring. The |
| time with the device | | primary endpoint was met |
| (Visits #2 and #3). | | with a greater than 50% |
| Success criteria: 50% | | reduction in all snores. |
| reduction in all snores OR | | |
| at least a 90% reduction | | |
| in loud snores as a | | |
| percent of sleep time | | |
| Secondary - Reduction in | Loud snoring was reduced | The Cloud9 System is |
| overall nightly noise | from 34% of sleep time to 5% | effective for its indication |
| exposure below the WHO | of sleep time with the | to reduce or eliminate |
| limit of 45 dBA. | Cloud9™ and the total time | simple snoring. The |
| Success criteria: 50% | spent in loud snoring was | secondary endpoint was |
| reduction in snoring time | reduced from 148 minutes to | met with a greater than |
| > 45 dBA | 18 minutes, a greater than | 50% reduction in snoring |
| | 50% reduction. | time ≥ 45 dBA (loud |
| | | snoring). |
| Safety — No adverse | No adverse events occurred | The safety endpoint was |
| events (nasal or skin | during this study. | met. |
| irritation, epistaxis and | | |
| sleep disruption) noted | | |

Table 5C – Study Results and Conclusions

### 11. Statement of Substantial Equivalence

It has been shown in this 510(k) submission that the difference between the Cloud9® System and the predicate devices do not raise any questions regarding its safety and effectiveness. The Cloud9® System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.