(155 days)
Not Found
No
The description focuses on the mechanical design and components of a CPAP mask, with no mention of AI or ML capabilities.
No.
The device is a mask that provides an interface for application of CPAP or bi-level therapy; it does not itself provide the therapy.
No.
The document describes a mask intended for delivering CPAP or bi-level therapy, which is a treatment modality, not a diagnostic one. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly outlines physical components such as a nasal pillows cushion, silicone mask frame, elbow, headgear, and optional fabric sleeves. It is a hardware device for delivering CPAP/bi-level therapy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a mask intended to provide an interface for applying CPAP or bi-level therapy. This therapy involves delivering pressurized air to the patient's airways.
- No Sample Analysis: There is no mention of the device collecting or analyzing any biological samples from the patient. Its function is purely mechanical, facilitating the delivery of air.
The device is a medical device, specifically a respiratory therapy accessory, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
BZD
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose
Indicated Patient Age Range
patients (>66lbs/30kg)
Intended User / Care Setting
single patient use in the home or multi-patient use in the hospital/institutional environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Deadspace Volume:
S Cushion – 72.8 ml
M Cushion – 74.0 ml
MW Cushion – 75.3 ml
L Cushion – 77.8 ml
Pressure Drop:
50 SPLM
S Cushion – 1.3 cm H2O
M Cushion – 1.19 cm H2O
MW Cushion – 1.02 cm H2O
L Cushion – 1.11 cm H2O
100 SPLM
S Cushion – 4.71 cm H2O
M Cushion – 4.29 cm H2O
MW Cushion - 3.7 cm H2O
L Cushion – 4.13 cm H2O
50 SPLM (one tube occluded)
S Cushion – 2.2 cm H2O
M Cushion – 2.1 cm H2O
MW Cushion – 1.94 cm H2O
L Cushion – 2.1 cm H2O
100 SPLM (one tube occluded)
S Cushion – 7.7 cm H2O
M Cushion – 7.41 cm H2O
MW Cushion – 6.66 cm H2O
L Cushion – 7.21 cm H2O
Sound Power and Pressure Level:
Measured Sound Pressure Level: 27dBA
Measured Sound Power Level: 19dBA
Intentional Mask Leak Specification:
13.5 SLPM @ 5 cm H2O
20 SLPM @ 10 cm H2O
25 SLPM @ 20 cm H2O
Results:
5 cm H2O:
S Cushion – 18.2 SPLM
M Cushion – 17.9 SPLM
MW Cushion – 17 SPLM
L Cushion – 17.3 SPLM
10 cm H2O:
S Cushion – 27.1 SPLM
M Cushion – 26.6 SPLM
MW Cushion - 25.6 SPLM
L Cushion – 26.3 SPLM
20 cm H2O:
S Cushion – 41 SPLM
M Cushion – 40.9 SPLM
MW Cushion – 39.3 SPLM
L Cushion – 40.6 SPLM
Total Mask Leak:
4 cm H2O
S Cushion – 18.4 SPLM
M Cushion – 18.9 SPLM
MW Cushion – 19.3 SPLM
L Cushion – 19.6 SPLM
5 cm H2O
S Cushion – 21 SPLM
M Cushion – 21.4 SPLM
MW Cushion - 21.9 SPLM
L Cushion – 22.3 SPLM
10 cm H2O
S Cushion – 31.7 SPLM
M Cushion – 32.3 SPLM
MW Cushion - 33.2 SPLM
L Cushion – 32.9 SPLM
20 cm H2O
S Cushion – 48.9 SPLM
M Cushion – 50.1 SPLM
MW Cushion - 51.2 SPLM
L Cushion - 51.6 SPLM
L Cushion – 49.5 SPLM
30 cm H2O
S Cushion – 64.8 SPLM
M Cushion – 66.5 SPLM
MW Cushion - 67.6 SPLM
L Cushion – 64.4 SPLM
CO2 Rebreathing (ETCO2%):
Results: MW Cushion with Large Frame
4 cm H2O – 5.0%
5 cm H2O – 5.0%
10 cm H2O – 5.0%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
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) |
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3
| Date 510(k) Summary Prepared | August 24, 2021 |
|---|---|
| 510(k) Owner | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| Official Contact | Steve Lawrie |
| 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) |
4
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 .
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: | Similarities
and/or
Differences |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TI Nasal Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K140980 | DreamWear Silicone
Pillows Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K210844 | |
| Product Code | BZD | BZD | Unchanged from
K140980. |
| Intended Use | The TI Nasal 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 (>66
lbs/30kg) for whom CPAP
or bi-level therapy has
been prescribed. | 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 (>66
lbs/30 kg) for whom CPAP
or bi-level therapy has been
prescribed. | Unchanged from
K140980. |
| Patient Population | Patients (>66 lbs/30kg) | Patients (>66 lbs/30kg) | Unchanged from
K140980. |
| Functional
Indication | Interface for application of
CPAP or bi-level therapy to
patients | Interface for application of
CPAP or bi-level therapy to
patients | Unchanged from
K140980. |
| Environment of
Use | home or
hospital/institutional
environment | home or
hospital/institutional
environment | Unchanged from
K140980. |
| Patient Usage
Type | Single patient use or multi-
patient use | Single patient use or multi-
patient use | Unchanged from
K140980. |
| Anatomical Sites | Nose | Nose | Unchanged from
K140980. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities
and/or
Differences |
| | TI Nasal Mask
Manufacturer:
Respironics, Inc. | DreamWear Silicone
Pillows Mask
Manufacturer:
Respironics, Inc. | |
| | 510(k) Number: K140980 | 510(k) Number: K210844 | |
| Provided Sterile or
Non-Sterile | Non-sterile | Non-sterile | Unchanged from
K140980. |
| Pressure Range
Specification | 4 cm H2O to 30 cm H2O | 4 cm H2O to 30 cm H2O | Unchanged from
K140980. |
| Deadspace
Volume | Largest Cushion:
20 ml | S Frame
S Cushion – 72.8 ml
M Cushion – 74.0 ml
MW Cushion – 75.3 ml
L Cushion – 77.8 ml
Medium Frame
S Cushion – 75.8 ml
M Cushion – 77.0 ml
MW Cushion – 78.3 ml
L Cushion – 80.8 ml
Large Frame
S Cushion – 78.7 ml
M Cushion – 79.9 ml
MW Cushion – 81.2 ml
L Cushion – 83.7 ml | There are no
performance
requirements for
dead space
volume.
Measured dead
space is
disclosed in
labelling. |
| Pressure Drop | 50 SPLM
1.1 cm H2O
100 SPLM
3.6 cm H2O
50 SPLM (one tube
occluded)
2.1 cm H2O | 50 SPLM
S Cushion – 1.3 cm H2O
M Cushion – 1.19 cm H2O
MW Cushion – 1.02 cm H2O
L Cushion – 1.11 cm H2O
100 SPLM
S Cushion – 4.71 cm H2O
M Cushion – 4.29 cm H2O
MW Cushion - 3.7 cm H2O | There are no
performance
requirements for
pressure drop.
The pressure
drop for a device
is disclosed in
labeling
consistent with
the ISO |
| Feature/Function | Predicate Device: | Subject Device: | Similarities
and/or
Differences |
| | TI Nasal Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K140980 | DreamWear Silicone
Pillows Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K210844 | |
| | 100 SPLM (one tube
occluded)
$6.7 cm H_2O$ | L Cushion – $4.13 cm H_2O$
50 SPLM (one tube
occluded)
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 tube
occluded)
S Cushion – $7.7 cm H_2O$
M Cushion – $7.41 cm H_2O$
MW Cushion – $6.66 cm H_2O$
L Cushion – $7.21 cm H_2O$ | 17510:2015
requirements. |
| Sound Power and
Pressure Level | Measured Sound Pressure
Level:
25dBA
Measured Sound Power
Level:
18dBA | Measured Sound Pressure
Level:
27dBA
Measured Sound Power
Level:
19dBA | There is no
specification for
this parameter,
but values are
comparable to the
predicate. |
| Intentional Mask
Leak 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 SPLM
M Cushion – 17.9 SPLM
MW Cushion – 17 SPLM
L Cushion – 17.3 SPLM | Specification
unchanged from
K140980. Results
from the subject
device have been
provided. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities and/or Differences |
| | TI Nasal Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K140980 | DreamWear Silicone
Pillows Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K210844 | |
| | | 10 cm H2O
S Cushion – 27.1 SPLM
M Cushion – 26.6 SPLM
MW Cushion - 25.6 SPLM
L Cushion – 26.3 SPLM
20 cm H2O
S Cushion – 41 SPLM
M Cushion – 40.9 SPLM
MW Cushion – 39.3 SPLM
L Cushion – 40.6 SPLM | |
| Total Mask Leak | 5 cm H2O
18.7 SPLM
10 cm H2O
27.8 SPLM
20 cm H2O
41.3 SPLM | 4 cm H2O
S Cushion – 18.4 SPLM
M Cushion – 18.9 SPLM
MW Cushion – 19.3 SPLM
L Cushion – 19.6 SPLM
5 cm H2O
S Cushion – 21 SPLM
M Cushion – 21.4 SPLM
MW Cushion - 21.9 SPLM
L Cushion – 22.3 SPLM
10 cm H2O
S Cushion – 31.7 SPLM
M Cushion – 32.3 SPLM
MW Cushion - 33.2 SPLM
L Cushion – 32.9 SPLM
20 cm H2O
S Cushion – 48.9 SPLM
M Cushion – 50.1 SPLM
MW Cushion - 51.2 SPLM
L Cushion - 51.6 SPLM | There are no
performance
requirements for
total mask leak.
The measured
leak rates are
similar |
| Feature/Function | Predicate Device: | Subject Device: | Similarities and/or Differences |
| | TI Nasal Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K140980 | DreamWear Silicone
Pillows Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K210844 | |
| CO2 Rebreathing
(ETCO2%) | Results:
Largest Cushion
5 cm H2O - 4.8%
10 cm H2O – 4.7% | Results:
MW Cushion with Large
Frame
4 cm H2O – 5.0%
5 cm H2O – 5.0%
10 cm H2O – 5.0% | The CO2
Rebreathing is
consistent with
ISO 17510:2015
requirements. |
| | | L Cushion – 49.5 SPLM
30 cm H2O
S Cushion – 64.8 SPLM
M Cushion – 66.5 SPLM
MW Cushion - 67.6 SPLM
L Cushion – 64.4 SPLM | |
| Reprocessing
Methods | Air path and non-air path
components – Cleaning
with liquid dish detergent
Air path components –
High level chemical and
thermal disinfection | Air path and non-air path
components – Cleaning
with liquid dish detergent
Air path components - High
level chemical and thermal
disinfection
Non-air path components –
thermal disinfection | Additional
disinfection
options were
added for the
subject device.
These methods
were validated. |
| Cushion Design | A silicone nasal cradle
cushion that seals around
the bottom of the nose.
The cushion contains an
exhalation port. | A silicone nasal pillows
cushion with tips that seal at
the entrance to the nares.
The cushion contains
exhalation ports | The subject
device includes a
different nasal
cushion design
that seals at the
entrance to the
nares. |
| Frame Design | The tubing frame connects
to nasal cushion; Two slots | The tubing frame connects
to nasal cushion; Two slots | Identical to
K140980 |
| Feature/Function | Predicate Device: | Subject Device: | Similarities
and/or
Differences |
| | TI Nasal Mask
Manufacturer:
Respironics, Inc. | DreamWear Silicone
Pillows Mask
Manufacturer:
Respironics, Inc. | |
| | 510(k) Number: K140980 | 510(k) Number: K210844 | |
| | exist for insertion of
headgear straps | exist for insertion of
headgear straps, or
headgear stabilizer arms | |
| Exhalation/Exhaust | No separate exhalation
device is required.
Exhalation is built into the
elbow and nasal cushions | No separate exhalation
device is required.
Exhalation is built into the
elbow and nasal cushions | Identical to
K140980 |
| Headgear Design | Headgear with slots to
accept velcro pads on
frame. | Headgear includes
stabilizer arms that connect
to the headgear strap and
the slots on the mask
frame. | The subject
device includes
an additional
headgear option,
which includes
stabilizer arms
that connect the
headgear strap
and the slots on
the mask frame. |
| Patient Circuit
Connection | 22 mm swivel connector | 22 mm swivel connector | Identical to
K140980 |
| Sizes | One size headgear
3 nasal cradle cushion
sizes: Small, Medium,
Large
1 frame size | One size headgear
4 nasal pillows cushion
sizes: Small, Medium,
Medium Wide, Large
Three frame sizes (small,
medium, large) | The subject
device includes
an additional
cushion size and
frame sizes |
| Storage Conditions | Temperature: -4° to 140° F
(-20° to +60° C)
Relative Humidity: 15% to
95% | Temperature: -4° to 140° F
(-20° to +60° C)
Relative Humidity: 15% to
95% | Unchanged from
K140980. |
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510(k) Summary
8
510(k) Summary
9
10
11
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.