DreamWear Silicone Pillows Mask

K210844 · Respironics, Inc. · BZD · Aug 24, 2021 · Anesthesiology

Device Facts

• Record ID: K210844
• Device Name: DreamWear Silicone Pillows Mask
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Aug 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

The DreamWear Silicone Pillows Mask is a non-invasive interface for delivering CPAP or bi-level therapy. It consists of a nasal pillows cushion, silicone frame, elbow with swivel, and headgear. The device routes pressurized air from a therapy source through the frame to the nasal pillows, which seal at the nares. The design features a top-of-head air inlet to reduce movement restrictions during sleep; the frame is flexible, allowing one side to collapse if the patient lies on their side while maintaining therapy delivery. Exhalation ports are integrated into the cushion and elbow to flush CO2. It is used in home or hospital settings by patients prescribed respiratory therapy. Healthcare providers or patients assemble/disassemble the mask for cleaning or disinfection. The device benefits patients by improving comfort, reducing movement restrictions, and facilitating easier maintenance.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through non-clinical bench testing, including resistance, total/intentional mask leak, CO2 rebreathing, sound levels, deadspace, and validation of cleaning/disinfection processes.

Technological Characteristics

Materials: Silicone. Design: Nasal pillows interface with 22mm quick-disconnect swivel. Connectivity: Standalone. Sterilization: Non-sterile; validated for cleaning/disinfection. Standards: ISO 17510:2015, ISO 5356-1:2015, ISO 10993 series, ISO 18562 series, ISO 17664:2017, ISO 15223-1:2016.

Indications for Use

Indicated for patients (>66lbs/30kg) requiring CPAP or bi-level therapy for sleep disordered breathing or respiratory insufficiency.

Regulatory Classification

Identification

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

Predicate Devices

• TI Nasal Mask (K140980)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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### 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) | |
|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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| Date 510(k) Summary Prepared | August 24, 2021 |
|----------------------------------|---------------------------------------------------------------------|
| 510(k) Owner | Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
| Official Contact | Steve Lawrie<br>Senior 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) |

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## 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 .

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# 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.

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# Comparison Table of Predicate and Subject Device

| Feature/Function | Predicate Device: | Subject Device: | Similarities<br>and/or<br>Differences |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TI Nasal Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K140980 | DreamWear Silicone<br>Pillows Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K210844 | |
| Product Code | BZD | BZD | Unchanged from<br>K140980. |
| Intended Use | The TI Nasal Mask is<br>intended to provide an<br>interface for application of<br>CPAP or bi-level therapy to<br>patients. The mask is for<br>single patient use in the<br>home or multi-patient use<br>in the hospital/institutional<br>environment. The mask is<br>to be used on patients (>66<br>lbs/30kg) for whom CPAP<br>or bi-level therapy has<br>been prescribed. | The Dreamwear Silicone<br>Pillows Mask is intended to<br>provide an interface for<br>application of CPAP or bi-<br>level therapy to patients.<br>The mask is for single<br>patient use in the home or<br>multi-patient use in the<br>hospital/institutional<br>environment. The mask is<br>to be used on patients (>66<br>lbs/30 kg) for whom CPAP<br>or bi-level therapy has been<br>prescribed. | Unchanged from<br>K140980. |
| Patient Population | Patients (>66 lbs/30kg) | Patients (>66 lbs/30kg) | Unchanged from<br>K140980. |
| Functional<br>Indication | Interface for application of<br>CPAP or bi-level therapy to<br>patients | Interface for application of<br>CPAP or bi-level therapy to<br>patients | Unchanged from<br>K140980. |
| Environment of<br>Use | home or<br>hospital/institutional<br>environment | home or<br>hospital/institutional<br>environment | Unchanged from<br>K140980. |
| Patient Usage<br>Type | Single patient use or multi-<br>patient use | Single patient use or multi-<br>patient use | Unchanged from<br>K140980. |
| Anatomical Sites | Nose | Nose | Unchanged from<br>K140980. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities<br>and/or<br>Differences |
| | TI Nasal Mask<br>Manufacturer:<br>Respironics, Inc. | DreamWear Silicone<br>Pillows Mask<br>Manufacturer:<br>Respironics, Inc. | |
| | 510(k) Number: K140980 | 510(k) Number: K210844 | |
| Provided Sterile or<br>Non-Sterile | Non-sterile | Non-sterile | Unchanged from<br>K140980. |
| Pressure Range<br>Specification | 4 cm H2O to 30 cm H2O | 4 cm H2O to 30 cm H2O | Unchanged from<br>K140980. |
| Deadspace<br>Volume | Largest Cushion:<br>20 ml | S Frame<br>S Cushion – 72.8 ml<br>M Cushion – 74.0 ml<br>MW Cushion – 75.3 ml<br>L Cushion – 77.8 ml<br><br>Medium Frame<br>S Cushion – 75.8 ml<br>M Cushion – 77.0 ml<br>MW Cushion – 78.3 ml<br>L Cushion – 80.8 ml<br><br>Large Frame<br>S Cushion – 78.7 ml<br>M Cushion – 79.9 ml<br>MW Cushion – 81.2 ml<br>L Cushion – 83.7 ml | There are no<br>performance<br>requirements for<br>dead space<br>volume.<br>Measured dead<br>space is<br>disclosed in<br>labelling. |
| Pressure Drop | 50 SPLM<br>1.1 cm H2O<br>100 SPLM<br>3.6 cm H2O<br>50 SPLM (one tube<br>occluded)<br>2.1 cm H2O | 50 SPLM<br>S Cushion – 1.3 cm H2O<br>M Cushion – 1.19 cm H2O<br>MW Cushion – 1.02 cm H2O<br>L Cushion – 1.11 cm H2O<br><br>100 SPLM<br>S Cushion – 4.71 cm H2O<br>M Cushion – 4.29 cm H2O<br>MW Cushion - 3.7 cm H2O | There are no<br>performance<br>requirements for<br>pressure drop.<br>The pressure<br>drop for a device<br>is disclosed in<br>labeling<br>consistent with<br>the ISO |
| Feature/Function | Predicate Device: | Subject Device: | Similarities<br>and/or<br>Differences |
| | TI Nasal Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K140980 | DreamWear Silicone<br>Pillows Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K210844 | |
| | 100 SPLM (one tube<br>occluded)<br>$6.7 cm H_2O$ | L Cushion – $4.13 cm H_2O$<br>50 SPLM (one tube<br>occluded)<br>S Cushion – $2.2 cm H_2O$<br>M Cushion – $2.1 cm H_2O$<br>MW Cushion – $1.94 cm H_2O$<br>L Cushion – $2.1 cm H_2O$<br>100 SPLM (one tube<br>occluded)<br>S Cushion – $7.7 cm H_2O$<br>M Cushion – $7.41 cm H_2O$<br>MW Cushion – $6.66 cm H_2O$<br>L Cushion – $7.21 cm H_2O$ | 17510:2015<br>requirements. |
| Sound Power and<br>Pressure Level | Measured Sound Pressure<br>Level:<br>25dBA<br>Measured Sound Power<br>Level:<br>18dBA | Measured Sound Pressure<br>Level:<br>27dBA<br>Measured Sound Power<br>Level:<br>19dBA | There is no<br>specification for<br>this parameter,<br>but values are<br>comparable to the<br>predicate. |
| Intentional Mask<br>Leak Specification | Specification:<br>> 13.5 SLPM @ $5 cm H_2O$<br>> 20 SLPM @ $10 cm H_2O$<br>> 25 SLPM @ $20 cm H_2O$<br>Results:<br>Not provided in K140980 | Specification:<br>> 13.5 SLPM @ $5 cm H_2O$<br>> 20 SLPM @ $10 cm H_2O$<br>> 25 SLPM @ $20 cm H_2O$<br>Results:<br>$5 cm H_2O$<br>S Cushion – 18.2 SPLM<br>M Cushion – 17.9 SPLM<br>MW Cushion – 17 SPLM<br>L Cushion – 17.3 SPLM | Specification<br>unchanged from<br>K140980. Results<br>from the subject<br>device have been<br>provided. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities and/or Differences |
| | TI Nasal Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K140980 | DreamWear Silicone<br>Pillows Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K210844 | |
| | | 10 cm H2O<br>S Cushion – 27.1 SPLM<br>M Cushion – 26.6 SPLM<br>MW Cushion - 25.6 SPLM<br>L Cushion – 26.3 SPLM<br><br>20 cm H2O<br>S Cushion – 41 SPLM<br>M Cushion – 40.9 SPLM<br>MW Cushion – 39.3 SPLM<br>L Cushion – 40.6 SPLM | |
| Total Mask Leak | 5 cm H2O<br>18.7 SPLM<br><br>10 cm H2O<br>27.8 SPLM<br><br>20 cm H2O<br>41.3 SPLM | 4 cm H2O<br>S Cushion – 18.4 SPLM<br>M Cushion – 18.9 SPLM<br>MW Cushion – 19.3 SPLM<br>L Cushion – 19.6 SPLM<br><br>5 cm H2O<br>S Cushion – 21 SPLM<br>M Cushion – 21.4 SPLM<br>MW Cushion - 21.9 SPLM<br>L Cushion – 22.3 SPLM<br><br>10 cm H2O<br>S Cushion – 31.7 SPLM<br>M Cushion – 32.3 SPLM<br>MW Cushion - 33.2 SPLM<br>L Cushion – 32.9 SPLM<br><br>20 cm H2O<br>S Cushion – 48.9 SPLM<br>M Cushion – 50.1 SPLM<br>MW Cushion - 51.2 SPLM<br>L Cushion - 51.6 SPLM | There are no<br>performance<br>requirements for<br>total mask leak.<br>The measured<br>leak rates are<br>similar |
| Feature/Function | Predicate Device: | Subject Device: | Similarities and/or Differences |
| | TI Nasal Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K140980 | DreamWear Silicone<br>Pillows Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K210844 | |
| CO2 Rebreathing<br>(ETCO2%) | Results:<br>Largest Cushion<br>5 cm H2O - 4.8%<br>10 cm H2O – 4.7% | Results:<br>MW Cushion with Large<br>Frame<br>4 cm H2O – 5.0%<br>5 cm H2O – 5.0%<br>10 cm H2O – 5.0% | The CO2<br>Rebreathing is<br>consistent with<br>ISO 17510:2015<br>requirements. |
| | | L Cushion – 49.5 SPLM<br>30 cm H2O<br>S Cushion – 64.8 SPLM<br>M Cushion – 66.5 SPLM<br>MW Cushion - 67.6 SPLM<br>L Cushion – 64.4 SPLM | |
| Reprocessing<br>Methods | Air path and non-air path<br>components – Cleaning<br>with liquid dish detergent<br>Air path components –<br>High level chemical and<br>thermal disinfection | Air path and non-air path<br>components – Cleaning<br>with liquid dish detergent<br>Air path components - High<br>level chemical and thermal<br>disinfection<br>Non-air path components –<br>thermal disinfection | Additional<br>disinfection<br>options were<br>added for the<br>subject device.<br>These methods<br>were validated. |
| Cushion Design | A silicone nasal cradle<br>cushion that seals around<br>the bottom of the nose.<br>The cushion contains an<br>exhalation port. | A silicone nasal pillows<br>cushion with tips that seal at<br>the entrance to the nares.<br>The cushion contains<br>exhalation ports | The subject<br>device includes a<br>different nasal<br>cushion design<br>that seals at the<br>entrance to the<br>nares. |
| Frame Design | The tubing frame connects<br>to nasal cushion; Two slots | The tubing frame connects<br>to nasal cushion; Two slots | Identical to<br>K140980 |
| Feature/Function | Predicate Device: | Subject Device: | Similarities<br>and/or<br>Differences |
| | TI Nasal Mask<br>Manufacturer:<br>Respironics, Inc. | DreamWear Silicone<br>Pillows Mask<br>Manufacturer:<br>Respironics, Inc. | |
| | 510(k) Number: K140980 | 510(k) Number: K210844 | |
| | exist for insertion of<br>headgear straps | exist for insertion of<br>headgear straps, or<br>headgear stabilizer arms | |
| Exhalation/Exhaust | No separate exhalation<br>device is required.<br>Exhalation is built into the<br>elbow and nasal cushions | No separate exhalation<br>device is required.<br>Exhalation is built into the<br>elbow and nasal cushions | Identical to<br>K140980 |
| Headgear Design | Headgear with slots to<br>accept velcro pads on<br>frame. | Headgear includes<br>stabilizer arms that connect<br>to the headgear strap and<br>the slots on the mask<br>frame. | The subject<br>device includes<br>an additional<br>headgear option,<br>which includes<br>stabilizer arms<br>that connect the<br>headgear strap<br>and the slots on<br>the mask frame. |
| Patient Circuit<br>Connection | 22 mm swivel connector | 22 mm swivel connector | Identical to<br>K140980 |
| Sizes | One size headgear<br>3 nasal cradle cushion<br>sizes: Small, Medium,<br>Large<br>1 frame size | One size headgear<br>4 nasal pillows cushion<br>sizes: Small, Medium,<br>Medium Wide, Large<br>Three frame sizes (small,<br>medium, large) | The subject<br>device includes<br>an additional<br>cushion size and<br>frame sizes |
| Storage Conditions | Temperature: -4° to 140° F<br>(-20° to +60° C)<br>Relative Humidity: 15% to<br>95% | Temperature: -4° to 140° F<br>(-20° to +60° C)<br>Relative Humidity: 15% to<br>95% | Unchanged from<br>K140980. |

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### 510(k) Summary

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#### 510(k) Summary

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### 510(k) Summary

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# 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

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- . 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.