(266 days)
No reference devices have been used for this submission.
No
The device description and performance studies focus on the mechanical and airflow properties of a nasal pillow system for CPAP/Bi-Level therapy, with no mention of AI or ML technologies.
Yes
The device is intended to channel pressurized airflow for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy, which is a prescribed medical treatment. It is a component of a system designed to treat sleep apnea by preventing pressure drop and aiding in the delivery of air to the patient.
No
This device is a nasal pillow system intended to channel pressurized airflow for CPAP/Bi-Level therapy. It is used for treatment, not for diagnosing a medical condition.
No
The device description clearly indicates it is a physical system of nasal pillows designed to channel pressurized airflow, not a software application. The performance studies also focus on physical characteristics like pressure flow, resistance, and cleaning validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "noninvasively channel pressurized airflow to a patient from a Continuous Positive Airway Pressure (CPAP) or Bi-Level medical device." This describes a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on how the device facilitates the delivery of pressurized air for treating sleep apnea. It does not mention analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies listed are related to the physical and functional performance of the device (cleaning, shelf-life, CO2 rebreathing, pressure flow, resistance, vibration, noise). They do not involve evaluating the device's ability to diagnose a condition.
- Lack of Diagnostic Metrics: There are no mentions of diagnostic performance metrics like sensitivity, specificity, AUC, etc.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's nasal passages
patient's nostrils
patient's nose area
Indicated Patient Age Range
adult patients weighing 66 lbs (30kg)
Intended User / Care Setting
Home
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)
Non-Clinical Performance Testing: 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:
-
- Cleaning Validation Testing
-
- Shelf-life, Storage and Transportation
-
- CO2 Rebreathing
-
- Dead Space
-
- Pressure Flow Curve/Leakage
-
- Resistance to Flow/Pressure Drop
-
- Vibration and Noise
Key results: The differences between the subject device and predicate do not raise new/different questions of safety and effectiveness. nnn 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dead Space volume for nasal pillows:
Small = 19.50 cc
Medium = 19.50 cc
Large = 19.50 cc
Pressure Range:
4 to 20 cmH2O
Exhaust Flow Rates:
SMALL
4 cm H2O – 18.4 LPM
8 cm H2O – 28.0 LPM
12 cm H2O – 36.2 LPM
16 cm H2O – 43.1 LPM
20 cm H2O – 49.6 LPM
MEDIUM
4 cm H2O – 22.0 LPM
8 cm H2O – 33.8 LPM
12 cm H2O – 43.5 LPM
16 cm H2O – 51.8 LPM
20 cm H2O – 59.6 LPM
LARGE
4 cm H2O – 26.2 LPM
8 cm H2O – 39.4 LPM
12 cm H2O - 50.4 LPM
16 cm H2O - 59.7 LPM
20 cm H2O - 68.6 LPM
Resistance – Pressure Drop (cmH2O):
• Pressure drop through Small @50L/min = 0.4
• Pressure drop through Medium @50L/min = 0.2
• Pressure drop through Large @50L/min = 0.2
• Pressure drop through Small @ 100L/min = 1.5
• Pressure drop through Medium @100L/min = 1.0
• Pressure drop through Large @100L/min = 0.8
CO2 Rebreathing cm H2O:
SMALL
Pre 2%, Post 4%, Difference 2%
Pre 1%, Post 3%, Difference 2%
Pre 0%, Post 1%, Difference 1%
MEDIUM
Pre 0%, Post 3%, Difference 3%
Pre 1%, Post 2%, Difference 1%
Pre 0%, Post 0%, Difference 0%
LARGE
Pre 1%, Post -1%, Difference 0%
Pre 0%, Post -1%, Difference -1%
Pre 0%, Post -1%, Difference -1%
Sound Pressure & Power Level:
A-weighted Sound Pressure 29.7 dBA (at 10 cm H20)
A-weighted Sound Power Level 37.7 dBA (at 10 cm H20)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K200089, Fisher & Paykel EVORA™ Nasal Mask, Model A.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices have been used for this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Image /page/4/Picture/0 description: The image shows the logo for REMSleep. The logo is in blue and features the word "REMSleep" in a stylized font. Above the text is a curved line, resembling a wave or a sleeping person's silhouette. 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
CHARACTERISTICS | DELTAWAVE™ Nasal Pillow
System
K233415 | Predicate F&P EVORA™
A Model
K200089 | COMMENTS |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | DELTAWAVE™ Nasal Pillow
System | F&P EVORA™ Nasal Mask
(A model) | None |
| CLASSIFICATION CHARACTERISTICS | | | |
| Intended
Use/Indications For
Use | DELTAWAVE™ Nasal Pillow
System is intended for adult
patients weighing ≥66lbs (30kg),
and for whom non-invasive
Continuous Positive Airway
Pressure (CPAP) or Bi-Level
therapy has been prescribed by a
physician or other authorized
healthcare professional.
DELTAWAVE™ Nasal Pillow
System is intended for single
patient reuse in the home. | The F&P EVORA Nasal Mask
is intended to be used by
adults weighing ≥66lbs
(30kgs) who have been
prescribed non- invasive
positive airway pressure
therapy such as CPAP or
bilevel by a physician. The
F&P Evora Nasal Mask (A
model) is intended for
single patients' use in the
home. | SAME |
| Product Code | BZD | BZD | SAME |
| Regulation # | 868.5905 | 868.5905 | SAME |
| Patient Population | Adults weigh ≥66 lbs. (30kg).
Home use only | A Model - Adults weighing
≥66 lbs. (30kg). Home use. | SAME |
| DEVICE
CHARACTERISTICS | DELTAWAVETM Nasal Pillow
System
K233415 | Predicate F&P EVORA™
A Model
K200089 | COMMENTS |
| Availability to
Patient | By Prescription | By Prescription | SAME |
| Sterile or Non-sterile | Non-Sterile | Non-Sterile | SAME |
| PHYSICAL CHARACTERISTICS- | | | |
| Operating
Environment | Home | Home | SAME |
| Mask Type | Nasal Pillow | Nasal | Both device masks are
confined to the
patients nose area.
Design differences do
not raise new/different
questions of safety and
effectiveness |
| Exhalation Vent | Small vents in the nasal
cannula/mask serve as exhaust
ports. | Small vents in the Frame
which attaches to the Seal
serve as the exhaust ports. | SAME |
| Tubing to connect
Nasal Pillow to CPAP
Device | 22 mm | 22 mm | SAME |
| OPERATING CHARACTERISTICS | | | |
| Dead Space volume
for nasal pillows | Small = 19.50 cc
Medium = 19.50 cc
Large = 19.50 cc | Small = 28 cc
Medium = 26 cc
Large = 28 cc
Wide = 34 cc | All subject device
cannula/masks have
the same Dead Space
volume and Internal
Measurements
regardless of size.
Dead Space is
disclosed per ISO
17510.
Design differences do
not raise
new/different
questions of safety
and effectiveness. |
| DEVICE
CHARACTERISTICS | DELTAWAVE™ Nasal Pillow
System
K233415 | Predicate F&P EVORA™
A Model
K200089 | COMMENTS |
| Pressure Range | 4 to 20 cmH2O | 4 to 25 cmH2O | Subject device has a
narrower pressure
range.
Design differences do
not raise new/different
questions of safety and
effectiveness. |
| Exhaust Flow Rates | SMALL
4 cm H2O – 18.4 LPM
8 cm H2O – 28.0 LPM
12 cm H2O – 36.2 LPM
16 cm H2O – 43.1 LPM
20 cm H2O – 49.6 LPM
MEDIUM
4 cm H2O – 22.0 LPM
8 cm H2O – 33.8 LPM
12 cm H2O – 43.5 LPM
16 cm H2O – 51.8 LPM
20 cm H2O – 59.6 LPM
LARGE
4 cm H2O – 26.2 LPM
8 cm H2O – 39.4 LPM
12 cm H2O - 50.4 LPM
16 cm H2O - 59.7 LPM
20 cm H2O - 68.6 LPM | Unavailable | Pressure – Flow curves
of Exhaust flow are
disclosed to the user
per Clause 4 of ISO
17510.
Design differences do
not raise new/different
questions of safety and
effectiveness. |
| Resistance –
Pressure Drop**
(cmH2O) | • Pressure drop through
Small @50L/min = 0.4
• Pressure drop through
Medium @50L/min =
0.2
• Pressure drop through
Large @50L/min = 0.2
• Pressure drop through
Small @ 100L/min =
1.5
• Pressure drop through
Medium @100L/min =
1.0
• Pressure drop through Large
@100L/min = 0.8 | • Pressure drop
through small
50l/min: 1.0 ±
0.1cmH2O
• Pressure drop
through medium
50l/min: 1.0 ±
0.1cmH2O
• Pressure drop
through large
50l/min: 1.0 ±
0.1cmH2O
• Pressure drop
through wide
50l/min: 1.0 ±
0.1cmH2O | SIMILAR
Resistance at 50 L/min
and 100 L/min are
disclosed to user per
Clause 4 of ISO 17510.
The subject device
does not have a
cannula/mask in a size
Wide.
Design differences do
not raise new/different
questions of safety and
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
CHARACTERISTICS | DELTAWAVE™ Nasal Pillow
System
K233415 | Predicate F&P EVORA™
A Model
K200089 | COMMENTS | | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------|------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | 100l/min: 1.4 ±
0.25cmH2O | | | | |
| | | • Pressure drop
through medium
100l/min: 1.2 ±
0.25cmH2O | | | | |
| | | • Pressure drop
through large
100l/min: 1.2 ±
0.25cmH2O | | | | |
| | | • Pressure drop
through wide
100l/min: 1.3 ±
0.25cmH2O | | | | |
| CO2 Rebreathing
cm H2O | SIZE | Pre | Post | Difference | Unavailable | PRE values were
measured with subject
device prior to aging
study. POST values
were measured with
subject devices after
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
the difference between
the Baseline
measurement
(ETCO2%) and the
Cannula/Mask
measurement
(ETCO2%). |
| | | 0% | -1% | -1% | | |
| | | 0% | -1% | -1% | | |
| Sound Pressure &
Power Level | A-weighted Sound Pressure 29.7
dBA (at 10 cm H20) | | | | A-weighted sound
pressure level of the mask
is 18.8 dBA, with
uncertainty of 2.5 dBA. | Adheres to Clause
5.3.1 of ISO 17510
Values disclosed to
user per Clause 6 of
ISO 17510 |
| | A-weighted Sound Power Level
37.7 dBA (at 10 cm H20) | | | | A-weighted sound power
level of the mask is 26.8
dBA, with uncertainty of
2.5 dBA. | These differences do
not raise different risk
concerns. |
| Cleaning | Single patient, reusable. Hand
wash in lukewarm water with
mild detergent. Rinse with clear
fresh water and allow to air dry
out of direct sunlight. Visually | | | | Unavailable | Cleaning method
supported through
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
CHARACTERISTICS | DELTAWAVE™ Nasal Pillow
System
K233415 | Predicate F&P EVORA™
A Model
K200089 | COMMENTS |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------|
| | inspect the device for residue
and rewash if necessary.
Inspect for damage and replace
with a new device if damage is
observed. | | Any differences do not
raise different
questions of safety or
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:
-
- Cleaning Validation Testing
-
- Shelf-life, Storage and Transportation
-
- CO2 Rebreathing
-
- Dead Space
-
- Pressure Flow Curve/Leakage
-
- Resistance to Flow/Pressure Drop
-
- Vibration and Noise
| Standards Conformance | DELTAWAVE™
Nasal Pillow System
K233415 | Predicate F&P
EVORA™ A Model
K200089 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------|
| ISO 17510:2015 Sleep Apnea Breathing Therapy-
Masks and Application Accessories | YES | YES |
| ISO 5356-1:2015 Anesthetic and respiratory
equipment- Conical connectors: Part 1: Cones and
sockets | YES | YES |
| | | |
| ISO 10993-1:2018, Biological evaluation of
medical devices - Part 1: Evaluation and testing
within a risk management process | YES | YES |
| ISO 10993-3:2014, Biological evaluation of
medical devices - Part 3: Tests for Genotoxicity
Carcinogenicity and reproductive toxicity | YES | YES |
| ISO 10993-5:2009, Biological evaluation of
medical devices - Part 5: Tests for in vitro
cytotoxicity | YES | YES |
| ISO 10993-10:2010, Biological evaluation of
medical devices - Part 10: Tests for irritation and
skin sensitization | YES | YES |
| ISO 10993-11:2017, Biological evaluation of
medical devices – Part 11: Tests for systemic
Toxicity | YES | YES |
| ISO 10993-17:2002, Biological evaluation of
medical devices - Part 17: Establishment of
allowable limits for leachable substances | YES | YES |
| ISO 10993-18:2005, Biological evaluation of
medical devices - Part 18: chemical
characterization of materials | YES | YES |
| ISO 18562-1:2017 Biocompatibility evaluation of
breathing gas pathways in healthcare
applications, Part 1: Evaluation and testing within
a risk management process | YES | YES |
| ISO 18562-2:2017 Biocompatibility evaluation of
breathing gas pathways in healthcare
applications, Part 2: Tests for emissions of
particulate matter | YES | YES |
| ISO 18562-3:2017 Biocompatibility evaluation of
breathing gas pathways in healthcare
applications, Part 3: Tests for emissions of volatile
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.