(159 days)
No
The device description explicitly states the blower is controlled continuously based on pressure measurements to maintain constant pressure, which is a standard feedback control loop, not AI/ML. There are no mentions of AI, ML, DNN, or training/test sets.
Yes
The device is indicated for use by adults to reduce or eliminate simple snoring, which is a medical condition. It delivers continuous positive airway pressure (CPAP), a known therapeutic intervention, and its performance is described as similar to currently used CPAP devices.
No
The device is described as a medical device for delivering continuous positive airway pressure (CPAP) to reduce or eliminate simple snoring, which is a therapeutic function, not a diagnostic one. Its purpose is to treat snoring, not to diagnose a condition.
No
The device description explicitly states that the system includes physical components: an airflow unit (AFU) and a custom nasal mask interface (NiteCap™). These are hardware components, not software.
Based on the provided information, the Cloud9® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "reduce or eliminate simple snoring" by maintaining positive airway pressure. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The device delivers continuous positive airway pressure (CPAP) via a nasal interface. This is a physical treatment method.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The Cloud9® System is a therapeutic device used to treat a condition (snoring) by applying physical pressure to the airway.
N/A
Intended Use / 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.
Product codes
BZD
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. Its 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Airway
Indicated Patient Age Range
Adults
Intended User / Care Setting
Prescription home use.
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)
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:
-
- Baseline assessment of snoring and sleep parameters by PSG
-
- 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.
-
- 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.
Study Endpoints, Results, and Conclusions:
Primary Endpoint: Reduction in the number of all snores or reduction in loud snores as percent of sleep time with the device (Visits #2 and #3). Success criteria: 50% reduction in all snores OR at least a 90% reduction in loud snores as a percent of sleep time.
Result: There was an average of 86% reduction in loud snoring and 67% reduction in all snoring.
Conclusion: The Cloud9 System is effective for its indication to reduce or eliminate simple snoring. The primary endpoint was met with a greater than 50% reduction in all snores.
Secondary Endpoint: Reduction in overall nightly noise exposure below the WHO limit of 45 dBA. Success criteria: 50% reduction in snoring time > 45 dBA.
Result: Loud snoring was reduced from 34% of sleep time to 5% of sleep time with the Cloud9™ and the total time spent in loud snoring was reduced from 148 minutes to 18 minutes, a greater than 50% reduction.
Conclusion: The Cloud9 System is effective for its indication to reduce or eliminate simple snoring. The secondary endpoint was met with a greater than 50% reduction in snoring time ≥ 45 dBA (loud snoring).
Safety Endpoint: No adverse events (nasal or skin irritation, epistaxis and sleep disruption) noted.
Result: No adverse events occurred during this study.
Conclusion: The safety endpoint was met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary Endpoint: 86% reduction in loud snoring, 67% reduction in all snoring.
Secondary Endpoint: Loud snoring reduced from 34% of sleep time to 5% of sleep time. Total loud snoring time reduced from 148 minutes to 18 minutes.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).
0
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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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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
2
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): | |
|---|---|
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
for
Cloud9® System
K150365
1. Submission Sponsor
inSleep Health 12100 Singletree Lane Suite 183 Eden Prairie, MN 55344 USA Phone: (952) 746-1324 Fax: (954) 888-9600 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: (512) 327.9997 Fax: (512) 327.9998 Contact: Adrienne Lenz, Senior Consultant, Quality Assurance and Regulatory Affairs Email: project.management@emergogroup.com
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 |
4
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
by AEIOMED) | Resmed | SIGNIFICANT
DIFFERENCES |
|----------------------|------------------------------------|---------------------------------------------------------------|----------------------------------------------|----------------------------|
| Trade Name | Cloud9® System | Model 300157 CPAP
System (now
marketed as
Transcend) | Swift Air (now
marketed as AirFit
P10) | |
| 510(k) Number | This submission | K100121 | K132013 | None |
| Product Code | BZD | BZD | BZD | None |
| Regulation
Number | 868.5905 | 868.5905 | 868.5905 | None |
| Regulation
Name | Noncontinuous
ventilator (IPPB) | Noncontinuous
ventilator (IPPB) | Noncontinuous
ventilator (IPPB) | None |
| Table 5A – Comparison of Characteristics | |
|---|---|
| ------------------------------------------ | -- |
5
| Manufacturer | inSleep Health | Somnetics (cleared
by AEIOMED) | Resmed | SIGNIFICANT
DIFFERENCES |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cloud9® System | Model 300157 CPAP
System (now
marketed as
Transcend) | Swift Air (now
marketed as AirFit
P10) | DIFFERENCES |
| Indications for
Use | The Cloud9®
System is indicated
for use by adults to
reduce or
eliminate simple
snoring. The
Cloud9® device
maintains a
continuous,
positive low-
pressure in the
airway. The device
is designed for
prescription home
use. | The Model 300157
CPAP System is a
single patient
reusable device. The
Model 300157 CPAP
System provides
continuous positive
airway pressure
(CPAP) to support
treatment of adults
(over 30 kg) with
Obstructive Sleep
Apnea. | The Swift Air
channels airflow
noninvasively to a
patient from a
positive airway
pressure (PAP)
device such as a
continuous positive
airway pressure
(CPAP) or bilevel
device.
The Swift Air is:
- to be used by
patients (> 66 lb/30
kg) for whom
positive airway
pressure has been
prescribed - intended for
single-patient re-use
in the home
environment and
multipatient re-use
in the
hospital/institutiona
l environment. | The Cloud9®
System's
indication is
similar to the
Invent (K120665)
which provides
expiratory
positive airway
pressure to
reduce or
eliminate
snoring. |
| Mechanism of
Action | Continuous
Positive Airway
Pressure (CPAP) | Continuous Positive
Airway Pressure
(CPAP) | Continuous Positive
Airway Pressure
(CPAP) or BiLevel
Positive Airway
Pressure (BiPAP) | None |
| Technology | Blower
Nasal mask held in
place with
adjustable
headgear that
straps the mask to
the face. | Blower
Nasal mask held in
place with
adjustable headgear
that straps the mask
to the face. | Nasal mask held in
place with
adjustable headgear
that straps the mask
to the face. | None |
| Manufacturer | inSleep Health | Somnetics (cleared
by AEIOMED) | Resmed | SIGNIFICANT
DIFFERENCES |
| Trade Name | Cloud9® System | Model 300157 CPAP
System (now
marketed as
Transcend) | Swift Air (now
marketed as AirFit
P10) | |
| CPAP Type | User adjustable
fixed CPAP
pressure | Auto CPAP | NA - channels
airflow
noninvasively to a
patient from a PAP
device such as a
CPAP or bilevel
device. | A prescribed
pressure is not
required for this
indication and
therefore users
can select the
pressure that
works best to
reduce or
eliminate their
snoring. |
| Patient Circuit
Connection | Custom connector
(15 mm ID) that
includes the
measurement
lumen in one single
connector | Air outlet connector
port: 19-mm
diameter
proprietary
connector
Universal Adapter
Port Dimensions 22-
mm diameter
connector | Conical connectors
(ref. ISO 5356-
1:2004). | The
Cloud9®System's
circuit includes a
second small
lumen to
measure
pressure at the
nose and a
custom
connector
prevents
patients from
using another,
not approved
circuit with the
Air Flow Unit. |
| Pressure Range | 2 to 4 cm H2O | 4 to 20 cm H2O | 4 to 20 cm H2O | Lower maximum
pressure (4 cm
H2O) for the
treatment of
snoring. Other
CPAP devices,
such as DeVilbiss
Intellipap
(K071689) also
use lower
pressures, down
to 3 cmH2O. |
| Pressure Stability
(cmH2O) as
measured by ISO
17510-1 | Less than +/-1 cm
H2O at all pressure
levels | Not specified | Not applicable to
interface | Cloud9 meets
requirements of
ISO 17510-1 like
other CPAP
devices. |
| Manufacturer | inSleep Health | Somnetics (cleared
by AEIOMED) | Resmed | SIGNIFICANT
DIFFERENCES |
| Trade Name | Cloud9® System | Model 300157 CPAP
System (now
marketed as
Transcend) | Swift Air (now
marketed as AirFit
P10) | |
| Maximum Flow
(LPM) | 71 L/min for all
pressure settings | 71 L/min at
4cmH₂O, 75 L/min
at 8cmH₂O | Not applicable to
interface | Cloud9 meets
requirements of
ISO 17510-1 like
other CPAP
devices. |
| Maximum
System
Shutdown
Pressure | 30 cm H₂O | 30 cm H₂O | Not applicable to
interface | None |
| Mask Sizes | InSleep nasal
interface (the
Butterfly) is
available in Small,
Medium, Large and
Extra Large (S, M, L
& XL) | K100121 includes a
patient interface,
but details are not
publically available. | AirFit P10 XS, S,M, L
AirFit P10 for Her
XS, S, M,L | Both are
available in
various sizes to
fit different
users. |
| Mask Dead space | Less than 52 ml | Seal dead space
Less than 301 cc | Large pillows 123
mL. | The Cloud9®
System dead
space is lower
and thus better
than the
predicate device |
| Resistance/ Drop
in pressure as
measured
according to
17510-2 | at 50 L/min: 5.7 cm
H₂O
at 100 L/min: 21.1
cm H₂O | At 50 l/min 0.140
cm H₂O
At 100 l/min 0.278
cm H₂O | at 50 L/min: 0.4 cm
H₂O
at 100 L/min: 1.4 cm
H₂O | The Cloud9®
System is
working with
smaller hoses
which increases
the resistance.
The Cloud9®
mask and
interface can
therefore only
be used with the
Cloud9® AFU,
that is
specifically
designed to
work with the
higher resistance
mask. |
6
7
8
| Manufacturer | inSleep Health | Somnetics (cleared
by AEIOMED) | Resmed | SIGNIFICANT
DIFFERENCES |
|--------------|----------------------------|---------------------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cloud9® System | Model 300157 CPAP
System (now
marketed as
Transcend) | Swift Air (now
marketed as AirFit
P10) | |
| AC Powered | 100 – 240VAC
50-60hz | Input
100-240 VAC, 50-
60Hz
Output
19VDC, 2.6 Amp | Not applicable to
interface | The Cloud9®
System meets
the same
standards for
electrical safety
and
electromagnetic
compatibility as
its predicate
devices. |
| Materials | Comply with ISO
10993-1 | Comply with ISO
10993-1 | Comply with ISO
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
9
- 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 | |
| days) based on cumulative contact | ||
| every night. | ||
| AND | ||
| Airway gas - humidified due to | ||
| patient exhalation (considered | ||
| external communication with | ||
| tissue) permanent duration (>30 | ||
| days) based on cumulative contact | ||
| every night | • Cytotoxicity | |
| • Sensitization | ||
| • Irritation/intracutaneous | ||
| reactivity | ||
| • System toxicity (acute) | ||
| • Pyrogenicity (as part of | ||
| Systemic toxicity) | ||
| • Subchronic toxicity (subacute | ||
| toxicity) | ||
| • Genotoxicity | ||
| • Implantation | ||
| • Chemical Characterization | ||
| (identification of extractable | ||
| compounds) | ||
| Main Hose | Skin - Permanent duration (>30 | |
| days) based on cumulative contact | ||
| every night. | ||
| AND | ||
| Airway gas - dry. | • Cytotoxicity | |
| • Sensitization | ||
| • Irritation/intracutaneous | ||
| reactivity | ||
| • Chemical Characterization | ||
| (identification of particulates | ||
| and VOCs) | ||
| Air flow unit | ||
| internal | ||
| components | Airway gas - dry. No direct patient | |
| contact | • Chemical Characterization | |
| (identification of particulates | ||
| and VOCs) | ||
| NiteCap™ | ||
| Fit System - | ||
| Sport / | ||
| Athletic | Skin - Permanent duration (>30 | |
| days) based on cumulative contact | ||
| every night. | • Cytotoxicity | |
| • Sensitization | ||
| • Irritation/intracutaneous | ||
| 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:
-
- Baseline assessment of snoring and sleep parameters by PSG
-
- 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.
-
- 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.