The Dream Wear Silicone Pillows Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Device Description

The DreamWear Silicone Pillows Mask consists of a nasal pillows cushion, a silicone mask frame, an elbow with swivel and exhalation ports, headgear with arm extenders, and optional fabric sleeves. The nasal pillows cushion tips seal at the entrance to the nillows cushion base sits under the nares, and comes in four sizes (small, medium, medium wide, large).

Exhalation ports are incorporated into the mask. The built-in exhalation ports are molded into the front of the cushion as well as the top of the elbow. The mask exhalation ports for the DreamWear Silicone Pillows Mask were incorporated in both components, rather than only one of these components, to optimize diffusion, noise, comfort of breathing and CO2 inside the mask. The exhalation openings are used to flush exhaled CO2 out of the circuit. The fabric headgear is attached through the slots on the left and right headgear arms, which in turn are inserted into the slots on the sides of the frame to support the mask fit. The headgear can be adjusted with the hook and loop tabs. The elbow is inserted to the top of the frame. The fabric headgear goes over the mask frame and around the patient's head. The headgear comes in one size and includes adjustment sliders to allow for a large or small fitting on the patient's head. Fabric sleeves (optional) are also provided to provide additional comfort if desired.

The mask design is intended to remove movement restrictions during sleep with the air inlet on the top of the head and air movement through both sides of the frame and cushion for therapy delivery to the patient's nose. The tubing frame is intentionally designed such that one side can collapse when the patient is lying on their side, while therapy is delivered to the cushion through the open side of the frame. The frame is available in three sizes (small, medium, and large) The mask was tested and verified to ensure performance is maintained according to its specifications.

The mask elbow can rotate freely through 360 degrees and has a 22mm quick disconnect swivel that is used to connect the conventional air delivery hose between the mask and pressure source. The 22mm quick disconnect swivel can also rotate freely through 360 degrees and be easily removed from the elbow.

The mask is designed in such a way that they can be easily disassembled for cleaning or replacement purposes. The mask components may be cleaned by the patient in the home (single patient use) or disinfected by the professional in the hospital/institutional environment (multi-patient use).

The key benefits of this device to the patient are:

Ease of use ●
. Comfort
Fewer movement restrictions ●
Easy disassemblv .

AI/ML Overview

The provided text describes the regulatory clearance for a medical device, the DreamWear Silicone Pillows Mask, and compares it to a predicate device, the TI Nasal Mask. However, it does not describe an AI model or a study proving that an AI-driven device meets acceptance criteria.

The document details the device's design, intended use, and various performance characteristics through non-clinical laboratory testing, not a clinical study involving human readers or AI.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI device based on this input. The document explicitly states:

Clinical Tests: "Clinical tests were not required to demonstrate the safety and effectiveness of the DreamWear Silicone Pillows Mask. All risks have been sufficiently mitigated and product functionality has been adequately assessed by non-clinical tests." (page 13)

This product is a physical medical device (a CPAP mask), not an AI-powered diagnostic tool. The performance metrics discussed (e.g., pressure drop, sound levels, CO2 rebreathing, leaks) are physical or mechanical properties of the mask itself, verified through laboratory tests (non-clinical tests), not cognitive performance metrics of an AI.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 24, 2021

Respironics, Inc. Steve Lawrie Senior Regulatory Affairs Engineer 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

Re: K210844

Trade/Device Name: DreamWear Silicone Pillows Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: July 23, 2021 Received: July 23, 2021

Dear Steve Lawrie:

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. 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 located 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. 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.

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

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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,

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210844

Device Name DreamWear Silicone Pillows Mask

Indications for Use (Describe)

The Dream Wear Silicone Pillows Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>661bs/30kg) for whom CPAP or bi-level therapy has been prescribed.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Date 510(k) Summary Prepared	August 24, 2021
510(k) Owner	Respironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
Official Contact	Steve LawrieSenior Requlatory Affairs Engineer
Establishment Registration #	2518422
Proprietary Name	DreamWear Silicone Pillows Mask
Common/Usual Name	Nasal Mask
Classification	Class II device
Classification Panel	Anesthesiology
Classification Reference	21 CFR 868.5905
Classification Name/Product Code	Ventilator, non-continuous (respirator)/BZD
Predicate Device	TI Nasal Mask (K140980)

{4}------------------------------------------------

Device Description

The key benefits of this device to the patient are:

Ease of use ●
. Comfort
Fewer movement restrictions ●
Easy disassemblv .

{5}------------------------------------------------

Indications for Use Statement

The DreamWear Silicone Pillows Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Similarities and Differences of the Indications for Use

Like the predicate device, the TI Nasal Mask (K140980), the subject device, the DreamWear Silicone Pillows Mask, is intended to provide an interface for application of CPAP or bi-level therapy. Both masks provide a connection between the noninvasive pressure ventilation device and the patient wearing the mask.

Both the predicate and the subject device are to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed. CPAP or bi-level therapy treats Sleep Disordered Breathing and Respiratory Insufficiency caused by central and/or mixed apneas, periodic breathing, and intermittent ventilatory support for individuals who require mechanical ventilation.

Additionally, both the predicate and the subject device are for single patient use in the home or multipatient use in the hospital/institutional environment.

Subject Device Compared to the Predicate Device

The subject device, the DreamWear Silicone Pillows Mask, has the following similarities to the previously cleared predicate device, Simple T Youth Nasal Mask (K140980):

Same operating principle
Same nasal mask design type ●
Same patient population
Same environment of use ●
Same patient usage type (single patient use/multi-patient use) ●
Similar performance specifications and materials

Respironics, Inc. has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the DreamWear Silicone Pillows Mask device in this submission is substantially equivalent to the predicate device.

{6}------------------------------------------------

Comparison Table of Predicate and Subject Device

Feature/Function	Predicate Device:	Subject Device:	Similaritiesand/orDifferences
	TI Nasal MaskManufacturer:Respironics, Inc.510(k) Number: K140980	DreamWear SiliconePillows MaskManufacturer:Respironics, Inc.510(k) Number: K210844
Product Code	BZD	BZD	Unchanged fromK140980.
Intended Use	The TI Nasal Mask isintended to provide aninterface for application ofCPAP or bi-level therapy topatients. The mask is forsingle patient use in thehome or multi-patient usein the hospital/institutionalenvironment. The mask isto be used on patients (>66lbs/30kg) for whom CPAPor bi-level therapy hasbeen prescribed.	The Dreamwear SiliconePillows Mask is intended toprovide an interface forapplication of CPAP or bi-level therapy to patients.The mask is for singlepatient use in the home ormulti-patient use in thehospital/institutionalenvironment. The mask isto be used on patients (>66lbs/30 kg) for whom CPAPor bi-level therapy has beenprescribed.	Unchanged fromK140980.
Patient Population	Patients (>66 lbs/30kg)	Patients (>66 lbs/30kg)	Unchanged fromK140980.
FunctionalIndication	Interface for application ofCPAP or bi-level therapy topatients	Interface for application ofCPAP or bi-level therapy topatients	Unchanged fromK140980.
Environment ofUse	home orhospital/institutionalenvironment	home orhospital/institutionalenvironment	Unchanged fromK140980.
Patient UsageType	Single patient use or multi-patient use	Single patient use or multi-patient use	Unchanged fromK140980.
Anatomical Sites	Nose	Nose	Unchanged fromK140980.
Feature/Function	Predicate Device:	Subject Device:	Similaritiesand/orDifferences
	TI Nasal MaskManufacturer:Respironics, Inc.	DreamWear SiliconePillows MaskManufacturer:Respironics, Inc.
	510(k) Number: K140980	510(k) Number: K210844
Provided Sterile orNon-Sterile	Non-sterile	Non-sterile	Unchanged fromK140980.
Pressure RangeSpecification	4 cm H2O to 30 cm H2O	4 cm H2O to 30 cm H2O	Unchanged fromK140980.
DeadspaceVolume	Largest Cushion:20 ml	S FrameS Cushion – 72.8 mlM Cushion – 74.0 mlMW Cushion – 75.3 mlL Cushion – 77.8 mlMedium FrameS Cushion – 75.8 mlM Cushion – 77.0 mlMW Cushion – 78.3 mlL Cushion – 80.8 mlLarge FrameS Cushion – 78.7 mlM Cushion – 79.9 mlMW Cushion – 81.2 mlL Cushion – 83.7 ml	There are noperformancerequirements fordead spacevolume.Measured deadspace isdisclosed inlabelling.
Pressure Drop	50 SPLM1.1 cm H2O100 SPLM3.6 cm H2O50 SPLM (one tubeoccluded)2.1 cm H2O	50 SPLMS Cushion – 1.3 cm H2OM Cushion – 1.19 cm H2OMW Cushion – 1.02 cm H2OL Cushion – 1.11 cm H2O100 SPLMS Cushion – 4.71 cm H2OM Cushion – 4.29 cm H2OMW Cushion - 3.7 cm H2O	There are noperformancerequirements forpressure drop.The pressuredrop for a deviceis disclosed inlabelingconsistent withthe ISO
Feature/Function	Predicate Device:	Subject Device:	Similaritiesand/orDifferences
	TI Nasal MaskManufacturer:Respironics, Inc.510(k) Number: K140980	DreamWear SiliconePillows MaskManufacturer:Respironics, Inc.510(k) Number: K210844
	100 SPLM (one tubeoccluded)$6.7 cm H_2O$	L Cushion – $4.13 cm H_2O$50 SPLM (one tubeoccluded)S Cushion – $2.2 cm H_2O$M Cushion – $2.1 cm H_2O$MW Cushion – $1.94 cm H_2O$L Cushion – $2.1 cm H_2O$100 SPLM (one tubeoccluded)S Cushion – $7.7 cm H_2O$M Cushion – $7.41 cm H_2O$MW Cushion – $6.66 cm H_2O$L Cushion – $7.21 cm H_2O$	17510:2015requirements.
Sound Power andPressure Level	Measured Sound PressureLevel:25dBAMeasured Sound PowerLevel:18dBA	Measured Sound PressureLevel:27dBAMeasured Sound PowerLevel:19dBA	There is nospecification forthis parameter,but values arecomparable to thepredicate.
Intentional MaskLeak Specification	Specification:> 13.5 SLPM @ $5 cm H_2O$> 20 SLPM @ $10 cm H_2O$> 25 SLPM @ $20 cm H_2O$Results:Not provided in K140980	Specification:> 13.5 SLPM @ $5 cm H_2O$> 20 SLPM @ $10 cm H_2O$> 25 SLPM @ $20 cm H_2O$Results:$5 cm H_2O$S Cushion – 18.2 SPLMM Cushion – 17.9 SPLMMW Cushion – 17 SPLML Cushion – 17.3 SPLM	Specificationunchanged fromK140980. Resultsfrom the subjectdevice have beenprovided.
Feature/Function	Predicate Device:	Subject Device:	Similarities and/or Differences
	TI Nasal MaskManufacturer:Respironics, Inc.510(k) Number: K140980	DreamWear SiliconePillows MaskManufacturer:Respironics, Inc.510(k) Number: K210844
		10 cm H2OS Cushion – 27.1 SPLMM Cushion – 26.6 SPLMMW Cushion - 25.6 SPLML Cushion – 26.3 SPLM20 cm H2OS Cushion – 41 SPLMM Cushion – 40.9 SPLMMW Cushion – 39.3 SPLML Cushion – 40.6 SPLM
Total Mask Leak	5 cm H2O18.7 SPLM10 cm H2O27.8 SPLM20 cm H2O41.3 SPLM	4 cm H2OS Cushion – 18.4 SPLMM Cushion – 18.9 SPLMMW Cushion – 19.3 SPLML Cushion – 19.6 SPLM5 cm H2OS Cushion – 21 SPLMM Cushion – 21.4 SPLMMW Cushion - 21.9 SPLML Cushion – 22.3 SPLM10 cm H2OS Cushion – 31.7 SPLMM Cushion – 32.3 SPLMMW Cushion - 33.2 SPLML Cushion – 32.9 SPLM20 cm H2OS Cushion – 48.9 SPLMM Cushion – 50.1 SPLMMW Cushion - 51.2 SPLML Cushion - 51.6 SPLM	There are noperformancerequirements fortotal mask leak.The measuredleak rates aresimilar
Feature/Function	Predicate Device:	Subject Device:	Similarities and/or Differences
	TI Nasal MaskManufacturer:Respironics, Inc.510(k) Number: K140980	DreamWear SiliconePillows MaskManufacturer:Respironics, Inc.510(k) Number: K210844
CO2 Rebreathing(ETCO2%)	Results:Largest Cushion5 cm H2O - 4.8%10 cm H2O – 4.7%	Results:MW Cushion with LargeFrame4 cm H2O – 5.0%5 cm H2O – 5.0%10 cm H2O – 5.0%	The CO2Rebreathing isconsistent withISO 17510:2015requirements.
		L Cushion – 49.5 SPLM30 cm H2OS Cushion – 64.8 SPLMM Cushion – 66.5 SPLMMW Cushion - 67.6 SPLML Cushion – 64.4 SPLM
ReprocessingMethods	Air path and non-air pathcomponents – Cleaningwith liquid dish detergentAir path components –High level chemical andthermal disinfection	Air path and non-air pathcomponents – Cleaningwith liquid dish detergentAir path components - Highlevel chemical and thermaldisinfectionNon-air path components –thermal disinfection	Additionaldisinfectionoptions wereadded for thesubject device.These methodswere validated.
Cushion Design	A silicone nasal cradlecushion that seals aroundthe bottom of the nose.The cushion contains anexhalation port.	A silicone nasal pillowscushion with tips that seal atthe entrance to the nares.The cushion containsexhalation ports	The subjectdevice includes adifferent nasalcushion designthat seals at theentrance to thenares.
Frame Design	The tubing frame connectsto nasal cushion; Two slots	The tubing frame connectsto nasal cushion; Two slots	Identical toK140980
Feature/Function	Predicate Device:	Subject Device:	Similaritiesand/orDifferences
	TI Nasal MaskManufacturer:Respironics, Inc.	DreamWear SiliconePillows MaskManufacturer:Respironics, Inc.
	510(k) Number: K140980	510(k) Number: K210844
	exist for insertion ofheadgear straps	exist for insertion ofheadgear straps, orheadgear stabilizer arms
Exhalation/Exhaust	No separate exhalationdevice is required.Exhalation is built into theelbow and nasal cushions	No separate exhalationdevice is required.Exhalation is built into theelbow and nasal cushions	Identical toK140980
Headgear Design	Headgear with slots toaccept velcro pads onframe.	Headgear includesstabilizer arms that connectto the headgear strap andthe slots on the maskframe.	The subjectdevice includesan additionalheadgear option,which includesstabilizer armsthat connect theheadgear strapand the slots onthe mask frame.
Patient CircuitConnection	22 mm swivel connector	22 mm swivel connector	Identical toK140980
Sizes	One size headgear3 nasal cradle cushionsizes: Small, Medium,Large1 frame size	One size headgear4 nasal pillows cushionsizes: Small, Medium,Medium Wide, LargeThree frame sizes (small,medium, large)	The subjectdevice includesan additionalcushion size andframe sizes
Storage Conditions	Temperature: -4° to 140° F(-20° to +60° C)Relative Humidity: 15% to95%	Temperature: -4° to 140° F(-20° to +60° C)Relative Humidity: 15% to95%	Unchanged fromK140980.

{7}------------------------------------------------

510(k) Summary

{8}------------------------------------------------

510(k) Summary

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

510(k) Summary

{12}------------------------------------------------

Non-Clinical Tests

Performance testing was performed to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:

Resistance, derived from pressure drop (pre & post cleaning and disinfection) ●
Total Mask Leak (pre & post cleaning and disinfection)
Intentional Mask Leak ●
CO2 rebreathing ●
A-weighted sound power and pressure levels ●
Deadspace ●
Cleaning validation ●
Cleaning residuals
Disinfection validation ●
Disinfection residuals

Standards

The DreamWear Silicone Pillows Mask has been designed per the following standards:

ISO 17510: 2015 Medical Device Sleep Apnoea Breathing Therapy: Masks and Application . Accessories
ISO 5356-1: 2015 Anaesthetic and Respiratory Equipment Conical Connectors: Part 1: ● Cones and Sockets
. ISO 10993-1: 2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, . carcinogenicity and reproductive toxicity
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
. ISO 10993-10:2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 10993-17:2002 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
ISO 18562-1: 2017 Biocompatibility Evaluation of Breathing Gas Pathways In Healthcare ● Applications - Part 1: Evaluation and Testing Within A Risk Management Process
. ISO 18562-2:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications-Part 2: Tests for Emissions of Particulate Matter
ISO 18562-3:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare . Applications-Part 3: Tests for Emissions of Volatile Organic Compounds
. ISO 18562-4:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications-Part 4: Tests for leachables in Condensate

{13}------------------------------------------------

. ISO 17664: 2017 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 15223-1: 2016 Medical devices Symbols to be used with medical device labels, . labelling, and information to be supplied - Part 1: General requirements

Clinical Tests

Clinical tests were not required to demonstrate the safety and effectiveness of the DreamWear Silicone Pillows Mask. All risks have been sufficiently mitigated and product functionality has been adequately assessed by non-clinical tests.

Conclusion

The performance and technological characteristics of the DreamWear Silicone Pillows Mask are substantially equivalent to those of the TI Nasal Mask (K140980). The differences described above do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 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).