DELTAWAVE Nasal Pillows System

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July 2, 2024 RemSleep Holdings % Judy Strzepek Regulatory Consultant Strzepek Consulting 18111 Littleton Place Lakewood Ranch, Florida 34202 Re: K233415 Trade/Device Name: DELTAWAVE Nasal Pillows System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: October 4, 2023 Received: October 10, 2023 Dear Judy Strzepek: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Binov J Binoy J. Mathews -S Mathews -S Date: 2024.07.02 14:35:07 -04'00' For Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices {2}------------------------------------------------ OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233415 Device Name DELTAWAVE Nasal Pillows System ### Indications for Use (Describe) The DELTAWAVE Nasal Pillows System is intended to noninvasively channel pressurized airflow to a patient from a Continuous Positive Airway Pressure (CPAP) or Bi-Level medical device. This medical device is intended for adult patients weighing 66 lbs (30kg), and for whom noninvasive Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy has been prescribed by a physician or other authorized healthcare professional. It is intended for single-patient reuse in the home. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The overall design is simple and modern. # K233415 510(k) SUMMARY July 2, 2024 #### 1 SUBMITTER REMSLEEP Holdings Inc., 14175 ICOT Blvd, Suite 300 Clearwater FL 33760 #### SUBMITTER CONTACT 2 Tom Wood Chief Executive Officer REMSLEEP Holdings Inc. # 3 SUBMISSION CORESPONDENT Judy Strzepek, Regulatory Consultant # 4 DEVICE | Subject Device | DELTAWAVE™ Nasal Pillows System | |----------------------|-----------------------------------------| | Common Name: | Nasal Mask, Mask, Cannula | | Classification Name | Ventilator, Non-Continuous (Respirator) | | Regulation Number | §21 CFR 868.5905 | | Medical Device Class | II | | Product Code | BZD | | Classification Panel | Anesthesiology | #### PREDICATE DEVICE L K200089, Fisher & Paykel EVORA™ Nasal Mask, Model A. This product is marketed in the US. No reference devices have been used for this submission. #### DEVICE DESCRIPTION ত The DELTAWAVE™ Nasal Pillow System is the subject device for this submission. It is a non-invasive medical device that directs pressurized air from a Continuous Positive Airway Pressure (CPAP) or Bi-level medical device to the patient. The {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for REMSleep. The logo is in blue and consists of the word "REM" in large, bold letters, followed by the word "Sleep" in a smaller, lighter font. Above the text is a curved line that resembles a sleeping person. subject device is a type of medical device prescribed by a physician or authorized professional for patients who have been diagnosed with Sleep Apnea. The subject device is designed to prevent pressure drop from the CPAP machine to the patient's nasal passages. That is accomplished by maintaining the same, or greater flow space from the machine output to the patient's nostrils. To further ensure the least amount of pressure drop the nasal pillows are designed to gently dilate the patient's nostrils to avoid restrictions to incoming air entering the nostrils. This allows air to enter the patient's nostrils at a lower driving pressure. Table 1 provides a list of the subject device components with the number of each provided to the patient in a system. | Part | Quantity | |----------------------|----------| | Retainer Bar | 2 | | Head Strap | 1 | | Cannula/Mask | 3 | | Tubing | 1 | | Swivel Adapter | 1 | | Swivel Angle Adapter | 1 | Table 1: Contents of DELTAWAVE™ Nasal Pillow System #### INTENDED USE 7 The DeltaWave Nasal Pillow System is intended to noninvasively channel pressurized airflow to a patient from a Continuous Positive Airway Pressure (CPAP) or Bi-Level medical device. This medical device is intended for adult patients weighing 66lbs (30kg), and for whom noninvasive Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy has been prescribed by a physician or other authorized healthcare professional. It is intended for single-patient reuse in the home. ## 7.1 TECHNOLOGY CHARACTERISTICS The subject device and predicate devices have similar appearance characteristics, both the subject and Predicate have the same mode of action, which is to function as the interface for CPAP pressurized air coming to the patient. - The Subject Device Cannula connects to the (CPAP) device . through standard conical connector, tubing, and a swivel adapter. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for REMSleep. The logo consists of the word "REM" in bold, dark blue letters, followed by the word "Sleep" in a lighter blue, thinner font. Above the text is a curved line that resembles a sleeping person. The predicate device has the same method of supplying pressurized air to the patient's nose. # 8 COMPARATIVE CHARACTERISTIC OF DELTAWAVE™ TO THE PREDICATE The following is a comparison of the DELTAWAVE™ Nasal Pillow System to the chosen predicate, F&P EVORA™ A Model. The content of this comparison is based upon several FDA guidance including "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" and "Format for Traditional and Abbreviated 510(k)s". тм | DEVICE<br>CHARACTERISTICS | DELTAWAVE™ Nasal Pillow<br>System<br>K233415 | Predicate F&P EVORA™<br>A Model<br>K200089 | COMMENTS | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | DELTAWAVE™ Nasal Pillow<br>System | F&P EVORA™ Nasal Mask<br>(A model) | None | | CLASSIFICATION CHARACTERISTICS | | | | | Intended<br>Use/Indications For<br>Use | DELTAWAVE™ Nasal Pillow<br>System is intended for adult<br>patients weighing ≥66lbs (30kg),<br>and for whom non-invasive<br>Continuous Positive Airway<br>Pressure (CPAP) or Bi-Level<br>therapy has been prescribed by a<br>physician or other authorized<br>healthcare professional.<br>DELTAWAVE™ Nasal Pillow<br>System is intended for single<br>patient reuse in the home. | The F&P EVORA Nasal Mask<br>is intended to be used by<br>adults weighing ≥66lbs<br>(30kgs) who have been<br>prescribed non- invasive<br>positive airway pressure<br>therapy such as CPAP or<br>bilevel by a physician. The<br>F&P Evora Nasal Mask (A<br>model) is intended for<br>single patients' use in the<br>home. | SAME | | Product Code | BZD | BZD | SAME | | Regulation # | 868.5905 | 868.5905 | SAME | | Patient Population | Adults weigh ≥66 lbs. (30kg).<br>Home use only | A Model - Adults weighing<br>≥66 lbs. (30kg). Home use. | SAME | | DEVICE<br>CHARACTERISTICS | DELTAWAVETM Nasal Pillow<br>System<br>K233415 | Predicate F&P EVORA™<br>A Model<br>K200089 | COMMENTS | | Availability to<br>Patient | By Prescription | By Prescription | SAME | | Sterile or Non-sterile | Non-Sterile | Non-Sterile | SAME | | PHYSICAL CHARACTERISTICS- | | | | | Operating<br>Environment | Home | Home | SAME | | Mask Type | Nasal Pillow | Nasal | Both device masks are<br>confined to the<br>patients nose area.<br>Design differences do<br>not raise new/different<br>questions of safety and<br>effectiveness | | Exhalation Vent | Small vents in the nasal<br>cannula/mask serve as exhaust<br>ports. | Small vents in the Frame<br>which attaches to the Seal<br>serve as the exhaust ports. | SAME | | Tubing to connect<br>Nasal Pillow to CPAP<br>Device | 22 mm | 22 mm | SAME | | OPERATING CHARACTERISTICS | | | | | Dead Space volume<br>for nasal pillows | Small = 19.50 cc<br>Medium = 19.50 cc<br>Large = 19.50 cc | Small = 28 cc<br>Medium = 26 cc<br>Large = 28 cc<br>Wide = 34 cc | All subject device<br>cannula/masks have<br>the same Dead Space<br>volume and Internal<br>Measurements<br>regardless of size.<br>Dead Space is<br>disclosed per ISO<br>17510.<br>Design differences do<br>not raise<br>new/different<br>questions of safety<br>and effectiveness. | | DEVICE<br>CHARACTERISTICS | DELTAWAVE™ Nasal Pillow<br>System<br>K233415 | Predicate F&P EVORA™<br>A Model<br>K200089 | COMMENTS | | Pressure Range | 4 to 20 cmH2O | 4 to 25 cmH2O | Subject device has a<br>narrower pressure<br>range.<br>Design differences do<br>not raise new/different<br>questions of safety and<br>effectiveness. | | Exhaust Flow Rates | SMALL<br>4 cm H2O – 18.4 LPM<br>8 cm H2O – 28.0 LPM<br>12 cm H2O – 36.2 LPM<br>16 cm H2O – 43.1 LPM<br>20 cm H2O – 49.6 LPM<br><br>MEDIUM<br>4 cm H2O – 22.0 LPM<br>8 cm H2O – 33.8 LPM<br>12 cm H2O – 43.5 LPM<br>16 cm H2O – 51.8 LPM<br>20 cm H2O – 59.6 LPM<br><br>LARGE<br>4 cm H2O – 26.2 LPM<br>8 cm H2O – 39.4 LPM<br>12 cm H2O - 50.4 LPM<br>16 cm H2O - 59.7 LPM<br>20 cm H2O - 68.6 LPM | Unavailable | Pressure – Flow curves<br>of Exhaust flow are<br>disclosed to the user<br>per Clause 4 of ISO<br>17510.<br>Design differences do<br>not raise new/different<br>questions of safety and<br>effectiveness. | | Resistance –<br>Pressure Drop**<br>(cmH2O) | • Pressure drop through<br>Small @50L/min = 0.4<br><br>• Pressure drop through<br>Medium @50L/min =<br>0.2<br><br>• Pressure drop through<br>Large @50L/min = 0.2<br><br>• Pressure drop through<br>Small @ 100L/min =<br>1.5<br><br>• Pressure drop through<br>Medium @100L/min =<br>1.0<br><br>• Pressure drop through Large<br>@100L/min = 0.8 | • Pressure drop<br>through small<br>50l/min: 1.0 ±<br>0.1cmH2O<br><br>• Pressure drop<br>through medium<br>50l/min: 1.0 ±<br>0.1cmH2O<br><br>• Pressure drop<br>through large<br>50l/min: 1.0 ±<br>0.1cmH2O<br><br>• Pressure drop<br>through wide<br>50l/min: 1.0 ±<br>0.1cmH2O | SIMILAR<br><br>Resistance at 50 L/min<br>and 100 L/min are<br>disclosed to user per<br>Clause 4 of ISO 17510.<br><br>The subject device<br>does not have a<br>cannula/mask in a size<br>Wide.<br><br>Design differences do<br>not raise new/different<br>questions of safety and<br>effectiveness. | ### able 2: Characteristic comparison of subject device to the predicate {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for REMSleep. The logo is in blue and features the word "REM" in a larger, bolder font than the word "Sleep." Above the text is a curved line that resembles a wave or a sleeping person's head and shoulders. The logo is simple and modern. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for REMSleep. The logo is in blue and features the word "REMSleep" in a sans-serif font. Above the word "REM" is a curved line that resembles a sleeping person. The logo is simple and clean, and it is likely used to promote a sleep-related product or service. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for REMSleep. The logo is in blue and features the word "REMSleep" in a bold, sans-serif font. Above the word is a curved line that resembles a wave or a sleeping person's head on a pillow. The logo is simple and modern, and the blue color gives it a calming feel. | DEVICE<br>CHARACTERISTICS | DELTAWAVE™ Nasal Pillow<br>System<br>K233415 | Predicate F&P EVORA™<br>A Model<br>K200089 | COMMENTS | | | | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------|------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | | | 100l/min: 1.4 ±<br>0.25cmH2O | | | | | | | | • Pressure drop<br>through medium<br>100l/min: 1.2 ±<br>0.25cmH2O | | | | | | | | • Pressure drop<br>through large<br>100l/min: 1.2 ±<br>0.25cmH2O | | | | | | | | • Pressure drop<br>through wide<br>100l/min: 1.3 ±<br>0.25cmH2O | | | | | | CO2 Rebreathing<br>cm H2O | SIZE | Pre | Post | Difference | Unavailable | PRE values were<br>measured with subject<br>device prior to aging<br>study. POST values<br>were measured with<br>subject devices after<br>aging study. | | | SMALL | 2% | 4% | 2% | | | | | | 1% | 3% | 2% | | | | | | 0% | 1% | 1% | | | | | MEDIUM | 0% | 3% | 3% | | | | | | 1% | 2% | 1% | | | | | | 0% | 0% | 0% | | | | | LARGE | 1% | -1% | 0% | | Relative Increase % is<br>the difference between<br>the Baseline<br>measurement<br>(ETCO2%) and the<br>Cannula/Mask<br>measurement<br>(ETCO2%). | | | | 0% | -1% | -1% | | | | | | 0% | -1% | -1% | | | | Sound Pressure &<br>Power Level | A-weighted Sound Pressure 29.7<br>dBA (at 10 cm H20) | | | | A-weighted sound<br>pressure level of the mask<br>is 18.8 dBA, with<br>uncertainty of 2.5 dBA. | Adheres to Clause<br>5.3.1 of ISO 17510<br>Values disclosed to<br>user per Clause 6 of<br>ISO 17510 | | | A-weighted Sound Power Level<br>37.7 dBA (at 10 cm H20) | | | | A-weighted sound power<br>level of the mask is 26.8<br>dBA, with uncertainty of<br>2.5 dBA. | These differences do<br>not raise different risk<br>concerns. | | Cleaning | Single patient, reusable. Hand<br>wash in lukewarm water with<br>mild detergent. Rinse with clear<br>fresh water and allow to air dry<br>out of direct sunlight. Visually | | | | Unavailable | Cleaning method<br>supported through<br>validation. | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for REMSleep. The logo is blue and features the word "REM" in bold, followed by the word "Sleep" in a thinner font. Above the text is a curved line that resembles a wave or a sleeping person's head. | DEVICE<br>CHARACTERISTICS | DELTAWAVE™ Nasal Pillow<br>System<br>K233415 | Predicate F&P EVORA™<br>A Model<br>K200089 | COMMENTS | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------| | | inspect the device for residue<br>and rewash if necessary.<br>Inspect for damage and replace<br>with a new device if damage is<br>observed. | | Any differences do not<br>raise different<br>questions of safety or<br>effectiveness. | #### NON-CLINICAL PERFORMANCE TESTING 9 Testing for DELTAWAVE™ was conducted to demonstrate the Subject Device's compliance with its pre-determined specifications and regulatory requirements. Performance and Biocompatibility testing and Validation of reprocessing claims were conducted to verify compliance with FDA Consensus Standards and Guidance documents to ensure the Subject Device is safe and substantially equivalent for its Intended Use. The DELTAWAVE Nasal Pillow System is compared to the Fisher & Paykel EVORA Model A, demonstrating Substantial Equivalence™ the predicate device. ## Summary of Non-Clinical Testing Performed: - 1. Cleaning Validation Testing - 2. Shelf-life, Storage and Transportation - 3. CO2 Rebreathing - 4. Dead Space - 5. Pressure Flow Curve/Leakage - 6. Resistance to Flow/Pressure Drop - 7. Vibration and Noise | Standards Conformance | DELTAWAVE™<br>Nasal Pillow System<br>K233415 | Predicate F&P<br>EVORA™ A Model<br>K200089 | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------| | ISO 17510:2015 Sleep Apnea Breathing Therapy-<br>Masks and Application Accessories | YES | YES | | ISO 5356-1:2015 Anesthetic and respiratory<br>equipment- Conical connectors: Part 1: Cones and<br>sockets | YES | YES | | | | | | ISO 10993-1:2018, Biological evaluation of<br>medical devices - Part 1: Evaluation and testing<br>within a risk management process | YES | YES | | ISO 10993-3:2014, Biological evaluation of<br>medical devices - Part 3: Tests for Genotoxicity<br>Carcinogenicity and reproductive toxicity | YES | YES | | ISO 10993-5:2009, Biological evaluation of<br>medical devices - Part 5: Tests for in vitro<br>cytotoxicity | YES | YES | | ISO 10993-10:2010, Biological evaluation of<br>medical devices - Part 10: Tests for irritation and<br>skin sensitization | YES | YES | | ISO 10993-11:2017, Biological evaluation of<br>medical devices – Part 11: Tests for systemic<br>Toxicity | YES | YES | | ISO 10993-17:2002, Biological evaluation of<br>medical devices - Part 17: Establishment of<br>allowable limits for leachable substances | YES | YES | | ISO 10993-18:2005, Biological evaluation of<br>medical devices - Part 18: chemical<br>characterization of materials | YES | YES | | ISO 18562-1:2017 Biocompatibility evaluation of<br>breathing gas pathways in healthcare<br>applications, Part 1: Evaluation and testing within<br>a risk management process | YES | YES | | ISO 18562-2:2017 Biocompatibility evaluation of<br>breathing gas pathways in healthcare<br>applications, Part 2: Tests for emissions of<br>particulate matter | YES | YES | | ISO 18562-3:2017 Biocompatibility evaluation of<br>breathing gas pathways in healthcare<br>applications, Part 3: Tests for emissions of volatile<br>organic compounds (VOCs) | YES | YES | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for REMSleep. The logo is in blue and features the word "REM" in a bold, sans-serif font, followed by "Sleep" in a lighter, more slender font. Above the text is a curved line that resembles a wave or a sleeping person's head and shoulders. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for REMSleep. The logo is in blue and consists of the word "REMSleep" with a curved line above it. The word "REM" is in a bold, sans-serif font, while the word "Sleep" is in a lighter, sans-serif font. # 10. CONCLUSION The differences between the subject device and predicate do not raise new/different questions of safety and effectiveness. ন্নীন conclusions drawn from the nonclinical tests (discussed above) demonstrate that the device is as safe and as effective as the predicate device. The Deltawave Nasal Pillow System is substantially equivalent to the F&P EVORA Nasal Mask Model A.