(159 days)
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.
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.
The provided text describes the Cloud9® System, a medical device intended to reduce or eliminate simple snoring, and details a clinical study conducted to evaluate its safety and efficacy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Study Endpoint / Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|
| 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. | There was an average of 86% reduction in loud snoring and 67% reduction in all snoring. This meets the success criteria of "greater than 50% reduction in all snores." | 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. | Loud snoring was reduced from 34% of sleep time to 5% of sleep time with the Cloud9™. The total time spent in loud snoring was reduced from 148 minutes to 18 minutes, which is a greater than 50% reduction. | 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. | No adverse events occurred during this study. | The safety endpoint was met. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: A total of 24 subjects were evaluated.
- Data Provenance: The study was a prospective, interventional study. The country of origin of the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The text indicates that snoring and sleep parameters were assessed by PSG (Polysomnography). PSG is a medical test that records various physiological signals during sleep, often interpreted by trained sleep specialists or pulmonologists. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in this document.
4. Adjudication Method for the Test Set
The text describes that the study used PSG for baseline assessment and device evaluation. However, it does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set interpretation beyond stating that PSG was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This document describes a clinical study evaluating the Cloud9® System's effectiveness in reducing snoring, with subjects serving as their own controls (comparing baseline to device use). It does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. The device itself is a Continuous Positive Airway Pressure (CPAP) system, not an AI-powered diagnostic or assistive tool for human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The Cloud9® System is a hardware device (CPAP system) that delivers positive airway pressure. It's not an AI algorithm in the context of diagnostic image analysis or similar applications where standalone algorithm performance would be relevant. Therefore, a standalone algorithm performance study, as typically understood in AI/ML medical devices, was not performed or relevant in this context. The study evaluates the device's physiological effect on snoring.
7. The Type of Ground Truth Used
The ground truth for the test set endpoints (reduction in snores, reduction in loud snoring time) was established using Polysomnography (PSG) measurements for snoring and sleep parameters. This can be considered objective physiological measurement data, rather than expert consensus, pathology, or direct outcomes data (though snoring reduction is an outcome).
8. The Sample Size for the Training Set
The document describes a clinical study with 24 subjects for evaluating the device's efficacy. It does not mention a separate "training set" for an algorithm or AI model. The Cloud9® System is a mechanical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" or an AI/ML component requiring such a set, this question is not applicable based on the provided 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 (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
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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): | |
|---|---|
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (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 |
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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 (clearedby AEIOMED) | Resmed | SIGNIFICANTDIFFERENCES |
|---|---|---|---|---|
| Trade Name | Cloud9® System | Model 300157 CPAPSystem (nowmarketed asTranscend) | Swift Air (nowmarketed as AirFitP10) | |
| 510(k) Number | This submission | K100121 | K132013 | None |
| Product Code | BZD | BZD | BZD | None |
| RegulationNumber | 868.5905 | 868.5905 | 868.5905 | None |
| RegulationName | Noncontinuousventilator (IPPB) | Noncontinuousventilator (IPPB) | Noncontinuousventilator (IPPB) | None |
| Table 5A – Comparison of Characteristics | |
|---|---|
| ------------------------------------------ | -- |
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| Manufacturer | inSleep Health | Somnetics (clearedby AEIOMED) | Resmed | SIGNIFICANTDIFFERENCES |
|---|---|---|---|---|
| Trade Name | Cloud9® System | Model 300157 CPAPSystem (nowmarketed asTranscend) | Swift Air (nowmarketed as AirFitP10) | DIFFERENCES |
| Indications forUse | The Cloud9®System is indicatedfor use by adults toreduce oreliminate simplesnoring. TheCloud9® devicemaintains acontinuous,positive low-pressure in theairway. The deviceis designed forprescription homeuse. | The Model 300157CPAP System is asingle patientreusable device. TheModel 300157 CPAPSystem providescontinuous positiveairway pressure(CPAP) to supporttreatment of adults(over 30 kg) withObstructive SleepApnea. | The Swift Airchannels airflownoninvasively to apatient from apositive airwaypressure (PAP)device such as acontinuous positiveairway pressure(CPAP) or bileveldevice.The Swift Air is:* to be used bypatients (> 66 lb/30kg) for whompositive airwaypressure has beenprescribed* intended forsingle-patient re-usein the homeenvironment andmultipatient re-usein thehospital/institutional environment. | The Cloud9®System'sindication issimilar to theInvent (K120665)which providesexpiratorypositive airwaypressure toreduce oreliminatesnoring. |
| Mechanism ofAction | ContinuousPositive AirwayPressure (CPAP) | Continuous PositiveAirway Pressure(CPAP) | Continuous PositiveAirway Pressure(CPAP) or BiLevelPositive AirwayPressure (BiPAP) | None |
| Technology | BlowerNasal mask held inplace withadjustableheadgear thatstraps the mask tothe face. | BlowerNasal mask held inplace withadjustable headgearthat straps the maskto the face. | Nasal mask held inplace withadjustable headgearthat straps the maskto the face. | None |
| Manufacturer | inSleep Health | Somnetics (clearedby AEIOMED) | Resmed | SIGNIFICANTDIFFERENCES |
| Trade Name | Cloud9® System | Model 300157 CPAPSystem (nowmarketed asTranscend) | Swift Air (nowmarketed as AirFitP10) | |
| CPAP Type | User adjustablefixed CPAPpressure | Auto CPAP | NA - channelsairflownoninvasively to apatient from a PAPdevice such as aCPAP or bileveldevice. | A prescribedpressure is notrequired for thisindication andtherefore userscan select thepressure thatworks best toreduce oreliminate theirsnoring. |
| Patient CircuitConnection | Custom connector(15 mm ID) thatincludes themeasurementlumen in one singleconnector | Air outlet connectorport: 19-mmdiameterproprietaryconnectorUniversal AdapterPort Dimensions 22-mm diameterconnector | Conical connectors(ref. ISO 5356-1:2004). | TheCloud9®System'scircuit includes asecond smalllumen tomeasurepressure at thenose and acustomconnectorpreventspatients fromusing another,not approvedcircuit with theAir Flow Unit. |
| Pressure Range | 2 to 4 cm H2O | 4 to 20 cm H2O | 4 to 20 cm H2O | Lower maximumpressure (4 cmH2O) for thetreatment ofsnoring. OtherCPAP devices,such as DeVilbissIntellipap(K071689) alsouse lowerpressures, downto 3 cmH2O. |
| Pressure Stability(cmH2O) asmeasured by ISO17510-1 | Less than +/-1 cmH2O at all pressurelevels | Not specified | Not applicable tointerface | Cloud9 meetsrequirements ofISO 17510-1 likeother CPAPdevices. |
| Manufacturer | inSleep Health | Somnetics (clearedby AEIOMED) | Resmed | SIGNIFICANTDIFFERENCES |
| Trade Name | Cloud9® System | Model 300157 CPAPSystem (nowmarketed asTranscend) | Swift Air (nowmarketed as AirFitP10) | |
| Maximum Flow(LPM) | 71 L/min for allpressure settings | 71 L/min at4cmH₂O, 75 L/minat 8cmH₂O | Not applicable tointerface | Cloud9 meetsrequirements ofISO 17510-1 likeother CPAPdevices. |
| MaximumSystemShutdownPressure | 30 cm H₂O | 30 cm H₂O | Not applicable tointerface | None |
| Mask Sizes | InSleep nasalinterface (theButterfly) isavailable in Small,Medium, Large andExtra Large (S, M, L& XL) | K100121 includes apatient interface,but details are notpublically available. | AirFit P10 XS, S,M, LAirFit P10 for HerXS, S, M,L | Both areavailable invarious sizes tofit differentusers. |
| Mask Dead space | Less than 52 ml | Seal dead spaceLess than 301 cc | Large pillows 123mL. | The Cloud9®System deadspace is lowerand thus betterthan thepredicate device |
| Resistance/ Dropin pressure asmeasuredaccording to17510-2 | at 50 L/min: 5.7 cmH₂Oat 100 L/min: 21.1cm H₂O | At 50 l/min 0.140cm H₂OAt 100 l/min 0.278cm H₂O | at 50 L/min: 0.4 cmH₂Oat 100 L/min: 1.4 cmH₂O | The Cloud9®System isworking withsmaller hoseswhich increasesthe resistance.The Cloud9®mask andinterface cantherefore onlybe used with theCloud9® AFU,that isspecificallydesigned towork with thehigher resistancemask. |
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| Manufacturer | inSleep Health | Somnetics (clearedby AEIOMED) | Resmed | SIGNIFICANTDIFFERENCES |
|---|---|---|---|---|
| Trade Name | Cloud9® System | Model 300157 CPAPSystem (nowmarketed asTranscend) | Swift Air (nowmarketed as AirFitP10) | |
| AC Powered | 100 – 240VAC50-60hz | Input100-240 VAC, 50-60HzOutput19VDC, 2.6 Amp | Not applicable tointerface | The Cloud9®System meetsthe samestandards forelectrical safetyandelectromagneticcompatibility asits predicatedevices. |
| Materials | Comply with ISO10993-1 | Comply with ISO10993-1 | Comply with ISO10993-1 | 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 (>30days) based on cumulative contactevery night.ANDAirway gas - humidified due topatient exhalation (consideredexternal communication withtissue) permanent duration (>30days) based on cumulative contactevery night | • Cytotoxicity• Sensitization• Irritation/intracutaneousreactivity• System toxicity (acute)• Pyrogenicity (as part ofSystemic toxicity)• Subchronic toxicity (subacutetoxicity)• Genotoxicity• Implantation• Chemical Characterization(identification of extractablecompounds) |
| Main Hose | Skin - Permanent duration (>30days) based on cumulative contactevery night.ANDAirway gas - dry. | • Cytotoxicity• Sensitization• Irritation/intracutaneousreactivity• Chemical Characterization(identification of particulatesand VOCs) |
| Air flow unitinternalcomponents | Airway gas - dry. No direct patientcontact | • Chemical Characterization(identification of particulatesand VOCs) |
| NiteCap™Fit System -Sport /Athletic | Skin - Permanent duration (>30days) based on cumulative contactevery night. | • Cytotoxicity• Sensitization• Irritation/intracutaneousreactivity |
| 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.
§ 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).