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.

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.

AI/ML Overview

The DELTAWAVE Nasal Pillows System is a medical device intended to noninvasively deliver pressurized airflow from a CPAP or Bi-Level device to adult patients (weighing 66 lbs or 30kg) who have been prescribed such therapy. It is designed for single-patient reuse in the home.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents a comparison of the DELTAWAVE Nasal Pillow System (subject device) to a predicate device, the Fisher & Paykel EVORA™ Nasal Mask (Model A), across various characteristics and performance metrics. The underlying acceptance criterion for substantial equivalence is that the differences do not raise new or different questions of safety or effectiveness.

Below is a table summarizing the reported device performance, with the implicit acceptance being "similar" or "does not raise new/different questions of safety and effectiveness" compared to the predicate.

Characteristic	DELTAWAVE™ Nasal Pillow System (K233415)	Predicate F&P EVORA™ A Model (K200089)	Acceptance Criteria & Comments (Implied)
Classification Characteristics
Intended Use/Indications For Use	Same as predicate. For adults ≥66lbs (30kg), prescribed CPAP/Bi-Level therapy, single-patient reuse in home.	Same as predicate.	Pass: SAME. No new or different questions of safety and effectiveness.
Product Code	BZD	BZD	Pass: SAME.
Regulation #	868.5905	868.5905	Pass: SAME.
Patient Population	Adults ≥66 lbs. (30kg). Home use only.	Adults ≥66 lbs. (30kg). Home use.	Pass: SAME.
Availability to Patient	By Prescription	By Prescription	Pass: SAME.
Sterile or Non-sterile	Non-Sterile	Non-Sterile	Pass: SAME.
Physical Characteristics
Operating Environment	Home	Home	Pass: SAME.
Mask Type	Nasal Pillow	Nasal	Pass: Both confined to patient's nose area. Design differences do not raise new/different questions of safety and effectiveness.
Exhalation Vent	Small vents in nasal cannula/mask serve as exhaust ports.	Small vents in the Frame which attaches to the Seal serve as the exhaust ports.	Pass: SAME function.
Tubing to connect to CPAP Device	22 mm	22 mm	Pass: 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.	Pass: 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. (Subject device dead space is lower than predicate).
Pressure Range	4 to 20 cmH2O	4 to 25 cmH2O	Pass: Subject device has a narrower pressure range. Design differences do not raise new/different questions of safety and effectiveness.
Exhaust Flow Rates	Provided for Small, Medium, Large at 4, 8, 12, 16, 20 cmH2O.	Unavailable	Pass: 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)	@50L/min: Small = 0.4, Medium = 0.2, Large = 0.2. @100L/min: Small = 1.5, Medium = 1.0, Large = 0.8.	@50L/min: Small, Medium, Large, Wide = 1.0 ± 0.1. @100L/min: Small = 1.4 ± 0.25, Medium = 1.2 ± 0.25, Large = 1.2 ± 0.25, Wide = 1.3 ± 0.25.	Pass: 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. (Subject device generally has lower resistance).
CO2 Rebreathing cm H2O	Small: Pre 2%, Post 4% (Diff 2%). Medium: Pre 0%, Post 3% (Diff 3%). Large: Pre 0%, Post 1% (Diff 1%).	Unavailable from predicate.	Pass: PRE values measured prior to aging, POST after aging. Relative Increase % is the difference between Baseline and Cannula/Mask measurement (ETCO2%). Implicitly, the rebreathing levels are considered acceptable, as no safety concerns are raised.
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).	A-weighted sound pressure level: 18.8 dBA, uncertainty of 2.5 dBA. A-weighted sound power level: 26.8 dBA, uncertainty of 2.5 dBA.	Pass: Adheres to Clause 5.3.1 of ISO 17510. Values disclosed to user per Clause 6 of ISO 17510. These differences do not raise different risk concerns. (Subject device has demonstrably higher sound levels than the predicate, but deemed acceptable by conforming to standards and disclosure).
Cleaning	Single patient, reusable. Hand wash.	Unavailable (from predicate).	Pass: Cleaning method supported through validation. Any differences do not raise different questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical performance testing. For specific performance metrics like Dead Space, Resistance, CO2 Rebreathing, and Sound Levels, it is likely that a sample size appropriate for engineering and laboratory testing (e.g., several units per size/type) was used, rather than a large clinical test set. The document does not specify the exact number of devices tested for each non-clinical performance test.

The data provenance is from non-clinical performance testing conducted by the manufacturer of the DELTAWAVE Nasal Pillows System (REMSLEEP Holdings Inc.). This type of data is typically collected prospectively in a laboratory setting. No country of origin for the non-clinical test data is specified, but it accompanies a US FDA submission, implying compliance with US regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is not an AI/CADe/CADx device that would typically rely on expert human interpretation to establish ground truth for a test set. The "ground truth" for the non-clinical performance tests (e.g., resistance, dead space, CO2 rebreathing) is established by using calibrated measurement equipment and adhering to recognized test standards (e.g., ISO, AAMI). Therefore, no human experts were used in this context to establish ground truth for a "test set" in the way it's understood for diagnostic imaging or AI devices. The product development and testing would involve engineers and quality control personnel with relevant expertise.

4. Adjudication method for the test set:

Not applicable, as this is primarily a non-clinical performance evaluation against predefined engineering specifications and international standards, not a diagnostic or AI performance study requiring human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is a physical medical device (nasal pillows system) and not an AI or imaging-based diagnostic tool. Therefore, an MRMC study is not relevant or applicable.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:

Not applicable, as this is not an algorithm or AI device. It is a physical accessory for CPAP/Bi-Level therapy.

7. The type of ground truth used:

The ground truth for the performance characteristics (e.g., Dead Space, Pressure Drop, CO2 Rebreathing, Sound Levels) is established through objective, standardized measurements and adherence to international consensus standards (e.g., ISO 17510, ISO 5356-1, various ISO 10993 and ISO 18562 standards for biocompatibility). For biocompatibility, the "ground truth" is defined by the absence of toxicity, irritation, etc., as assessed by validated biological test methods.

8. The sample size for the training set:

Not applicable, as this is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as this is not a machine learning device.

Summary

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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"

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(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

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OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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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.

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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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

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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.

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.

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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".

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DEVICECHARACTERISTICS	DELTAWAVE™ Nasal PillowSystemK233415	Predicate F&P EVORA™A ModelK200089	COMMENTS
Trade Name	DELTAWAVE™ Nasal PillowSystem	F&P EVORA™ Nasal Mask(A model)	None
CLASSIFICATION CHARACTERISTICS
IntendedUse/Indications ForUse	DELTAWAVE™ Nasal PillowSystem is intended for adultpatients weighing ≥66lbs (30kg),and for whom non-invasiveContinuous Positive AirwayPressure (CPAP) or Bi-Leveltherapy has been prescribed by aphysician or other authorizedhealthcare professional.DELTAWAVE™ Nasal PillowSystem is intended for singlepatient reuse in the home.	The F&P EVORA Nasal Maskis intended to be used byadults weighing ≥66lbs(30kgs) who have beenprescribed non- invasivepositive airway pressuretherapy such as CPAP orbilevel by a physician. TheF&P Evora Nasal Mask (Amodel) is intended forsingle patients' use in thehome.	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
DEVICECHARACTERISTICS	DELTAWAVETM Nasal PillowSystemK233415	Predicate F&P EVORA™A ModelK200089	COMMENTS
Availability toPatient	By Prescription	By Prescription	SAME
Sterile or Non-sterile	Non-Sterile	Non-Sterile	SAME
PHYSICAL CHARACTERISTICS-
OperatingEnvironment	Home	Home	SAME
Mask Type	Nasal Pillow	Nasal	Both device masks areconfined to thepatients nose area.Design differences donot raise new/differentquestions of safety andeffectiveness
Exhalation Vent	Small vents in the nasalcannula/mask serve as exhaustports.	Small vents in the Framewhich attaches to the Sealserve as the exhaust ports.	SAME
Tubing to connectNasal Pillow to CPAPDevice	22 mm	22 mm	SAME
OPERATING CHARACTERISTICS
Dead Space volumefor nasal pillows	Small = 19.50 ccMedium = 19.50 ccLarge = 19.50 cc	Small = 28 ccMedium = 26 ccLarge = 28 ccWide = 34 cc	All subject devicecannula/masks havethe same Dead Spacevolume and InternalMeasurementsregardless of size.Dead Space isdisclosed per ISO17510.Design differences donot raisenew/differentquestions of safetyand effectiveness.
DEVICECHARACTERISTICS	DELTAWAVE™ Nasal PillowSystemK233415	Predicate F&P EVORA™A ModelK200089	COMMENTS
Pressure Range	4 to 20 cmH2O	4 to 25 cmH2O	Subject device has anarrower pressurerange.Design differences donot raise new/differentquestions of safety andeffectiveness.
Exhaust Flow Rates	SMALL4 cm H2O – 18.4 LPM8 cm H2O – 28.0 LPM12 cm H2O – 36.2 LPM16 cm H2O – 43.1 LPM20 cm H2O – 49.6 LPMMEDIUM4 cm H2O – 22.0 LPM8 cm H2O – 33.8 LPM12 cm H2O – 43.5 LPM16 cm H2O – 51.8 LPM20 cm H2O – 59.6 LPMLARGE4 cm H2O – 26.2 LPM8 cm H2O – 39.4 LPM12 cm H2O - 50.4 LPM16 cm H2O - 59.7 LPM20 cm H2O - 68.6 LPM	Unavailable	Pressure – Flow curvesof Exhaust flow aredisclosed to the userper Clause 4 of ISO17510.Design differences donot raise new/differentquestions of safety andeffectiveness.
Resistance –Pressure Drop**(cmH2O)	• Pressure drop throughSmall @50L/min = 0.4• Pressure drop throughMedium @50L/min =0.2• Pressure drop throughLarge @50L/min = 0.2• Pressure drop throughSmall @ 100L/min =1.5• Pressure drop throughMedium @100L/min =1.0• Pressure drop through Large@100L/min = 0.8	• Pressure dropthrough small50l/min: 1.0 ±0.1cmH2O• Pressure dropthrough medium50l/min: 1.0 ±0.1cmH2O• Pressure dropthrough large50l/min: 1.0 ±0.1cmH2O• Pressure dropthrough wide50l/min: 1.0 ±0.1cmH2O	SIMILARResistance at 50 L/minand 100 L/min aredisclosed to user perClause 4 of ISO 17510.The subject devicedoes not have acannula/mask in a sizeWide.Design differences donot raise new/differentquestions of safety andeffectiveness.

able 2: Characteristic comparison of subject device to the predicate

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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.

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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.

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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.

DEVICECHARACTERISTICS	DELTAWAVE™ Nasal PillowSystemK233415	Predicate F&P EVORA™A ModelK200089	COMMENTS
		100l/min: 1.4 ±0.25cmH2O
		• Pressure dropthrough medium100l/min: 1.2 ±0.25cmH2O
		• Pressure dropthrough large100l/min: 1.2 ±0.25cmH2O
		• Pressure dropthrough wide100l/min: 1.3 ±0.25cmH2O
CO2 Rebreathingcm H2O	SIZE	Pre	Post	Difference	Unavailable	PRE values weremeasured with subjectdevice prior to agingstudy. POST valueswere measured withsubject devices afteraging 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 % isthe difference betweenthe Baselinemeasurement(ETCO2%) and theCannula/Maskmeasurement(ETCO2%).
		0%	-1%	-1%
		0%	-1%	-1%
Sound Pressure &Power Level	A-weighted Sound Pressure 29.7dBA (at 10 cm H20)				A-weighted soundpressure level of the maskis 18.8 dBA, withuncertainty of 2.5 dBA.	Adheres to Clause5.3.1 of ISO 17510Values disclosed touser per Clause 6 ofISO 17510
	A-weighted Sound Power Level37.7 dBA (at 10 cm H20)				A-weighted sound powerlevel of the mask is 26.8dBA, with uncertainty of2.5 dBA.	These differences donot raise different riskconcerns.
Cleaning	Single patient, reusable. Handwash in lukewarm water withmild detergent. Rinse with clearfresh water and allow to air dryout of direct sunlight. Visually				Unavailable	Cleaning methodsupported throughvalidation.

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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.

DEVICECHARACTERISTICS	DELTAWAVE™ Nasal PillowSystemK233415	Predicate F&P EVORA™A ModelK200089	COMMENTS
	inspect the device for residueand rewash if necessary.Inspect for damage and replacewith a new device if damage isobserved.		Any differences do notraise differentquestions of safety oreffectiveness.

NON-CLINICAL PERFORMANCE TESTING 9

Testing for DELTAWAVE™ was conducted to demonstrate the Subject Device's compliance with its pre-determined specifications and regulatory requirements. Performance and Biocompatibility testing and Validation of reprocessing claims were conducted to verify compliance with FDA Consensus Standards and Guidance documents to ensure the Subject Device is safe and substantially equivalent for its Intended Use. The DELTAWAVE Nasal Pillow System is compared to the Fisher & Paykel EVORA Model A, demonstrating Substantial Equivalence™ the predicate device.

Summary of Non-Clinical Testing Performed:

1. Cleaning Validation Testing
1. Shelf-life, Storage and Transportation
1. CO2 Rebreathing
1. Dead Space
1. Pressure Flow Curve/Leakage
1. Resistance to Flow/Pressure Drop
1. Vibration and Noise

Standards Conformance	DELTAWAVE™Nasal Pillow SystemK233415	Predicate F&PEVORA™ A ModelK200089
ISO 17510:2015 Sleep Apnea Breathing Therapy-Masks and Application Accessories	YES	YES
ISO 5356-1:2015 Anesthetic and respiratoryequipment- Conical connectors: Part 1: Cones andsockets	YES	YES

ISO 10993-1:2018, Biological evaluation ofmedical devices - Part 1: Evaluation and testingwithin a risk management process	YES	YES
ISO 10993-3:2014, Biological evaluation ofmedical devices - Part 3: Tests for GenotoxicityCarcinogenicity and reproductive toxicity	YES	YES
ISO 10993-5:2009, Biological evaluation ofmedical devices - Part 5: Tests for in vitrocytotoxicity	YES	YES
ISO 10993-10:2010, Biological evaluation ofmedical devices - Part 10: Tests for irritation andskin sensitization	YES	YES
ISO 10993-11:2017, Biological evaluation ofmedical devices – Part 11: Tests for systemicToxicity	YES	YES
ISO 10993-17:2002, Biological evaluation ofmedical devices - Part 17: Establishment ofallowable limits for leachable substances	YES	YES
ISO 10993-18:2005, Biological evaluation ofmedical devices - Part 18: chemicalcharacterization of materials	YES	YES
ISO 18562-1:2017 Biocompatibility evaluation ofbreathing gas pathways in healthcareapplications, Part 1: Evaluation and testing withina risk management process	YES	YES
ISO 18562-2:2017 Biocompatibility evaluation ofbreathing gas pathways in healthcareapplications, Part 2: Tests for emissions ofparticulate matter	YES	YES
ISO 18562-3:2017 Biocompatibility evaluation ofbreathing gas pathways in healthcareapplications, Part 3: Tests for emissions of volatileorganic compounds (VOCs)	YES	YES

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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.

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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.

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).