Whitsundays Mask System
Device Facts
| Record ID | K223747 |
|---|---|
| Device Name | Whitsundays Mask System |
| Applicant | Resmed Pty Ltd (Registration Number: 3004604967) |
| Product Code | BZD · Anesthesiology |
| Decision Date | Jul 6, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The mask is intended to provide an interface for CPAP or bi-level devices.
Device Story
Whitsundays Mask System is a non-invasive interface for delivering CPAP or bi-level positive airway pressure to patients with Obstructive Sleep Apnea or requiring ventilatory support. Device consists of nasal cushion, conduit frame, elbow, and headgear. It connects to PAP flow generators via 22mm conical connector (ISO 5356-1). Used in home (single-patient) or hospital/institutional (multi-patient) settings. Airflow is delivered to the patient's upper airway via a seal under the nose. Healthcare providers select appropriate cushion/frame sizes for patient fit. Device facilitates therapy compliance by providing a stable, comfortable interface. SLM variant is validated for multi-patient reprocessing using high-level thermal disinfection.
Clinical Evidence
Bench testing only. No clinical data. Performance verified against ISO 17510:2015 (CO2 rebreathing, exhaust flow, resistance to flow). Mechanical integrity, pressure accuracy, and environmental testing (cleaning, storage, free fall) performed. Biocompatibility evaluated per ISO 10993-1 and ISO 18562-1. Reprocessing validation (cleaning/disinfection efficacy) performed per ISO 17664.
Technological Characteristics
Materials: silicone, nylon elastane, polycarbonate, polybutylene terephthalate, polyurethane, nylon elastane polyurethane laminate. Interface: nasal cushion with tubular conduit frame. Connection: 22mm conical connector (ISO 5356-1). Operating pressure: 4-25 cmH2O. Non-sterile. Reprocessing: High-level thermal disinfection for SLM variant. Complies with ISO 17510, ISO 18562, ISO 10993, and ISO 17664 standards.
Indications for Use
Indicated for patients weighing >66 lb (30 kg) prescribed non-invasive CPAP or bi-level PAP therapy. Whitsundays mask is for single-patient home use; Whitsundays SLM is for multi-patient hospital/institutional use and requires reprocessing between patients.
Regulatory Classification
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
Predicate Devices
- Scone mask (K180497)
Submission Summary (Full Text)
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July 6, 2023
ResMed Pty Ltd (Registration Number: 3004604967) % Sheila Bruschi Senior Director, Regulatory Affairs Resmed Corp (Registration Number: 3007573469) 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K223747
Trade/Device Name: Whitsundays Mask System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 14, 2022 Received: June 5, 2023
Dear Sheila Bruschi:
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
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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 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 (QS) 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 medical devices and radiation-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 -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K223747
Device Name Whitsundays Mask System
Indications for Use (Describe)
The Whitsundays Mask System has two product variants:
• Whitsundays mask
· Whitsundays SLM (Sleep Lab Mask)
Both masks are intended for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the ResMed logo. The logo consists of a curved line of dots that transitions from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font.
# 510(k) Summary
[As required by 21 CFR 807.92(c)]
| Date Prepared: | July 6, 2023 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name/Owner: | ResMed Pty Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista, NSW, 2153 Australia |
| Prepared and Submitted by: | Ms. Shu-Ying Huang<br>Regulatory Affairs Manager<br>Tel: +65 65727105<br>Shuying.huang@resmed.com.sg |
| Official Contact: | Ms. Sheila Bruschi<br>Senior Director, Regulatory Affairs<br>ResMed Corp.<br>9001 Spectrum Center Blvd<br>San Diego CA 92123 USA<br>Tel +1 858 922 1803<br>sheila.bruschi@resmed.com |
| Device Trade Name: | Whitsundays Mask System |
| Device Common Name: | Vented Nasal Mask |
| Classification and<br>Classification Name: | 21 CFR 868.5905, 73 BZD (Class II)<br>Accessory to Noncontinuous Ventilator (IPPB) |
| Product Code: | BZD |
| Predicate Device: | Scone mask (K180497) |
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Image /page/4/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font.
#### Device Description:
The Whitsundays Mask System is an accessory to deliver airflow and positive air pressure generated by positive airway pressure (PAP) devices such as CPAP or bi-level flow generator systems to the patient's airway, for the treatment of Obstructive Sleep Apnea (OSA) or ventilatory support (non-life support). It delivers the treatment pressure from the source to the patient's upper airway by providing an air seal between the PAP device and the bottom of the patient's nose.
The Whitsundays mask system has two product variants:
- Whitsundays mask This is the home use variant that is intended for single patient re-use.
- . Whitsundays SLM (Sleep Lab Mask) This is the SLM variant that is intended for multi-patient re-use and must be reprocessed if reused between patients.
The Whitsundays Mask System is made up of 4 main component assemblies: nasal cushion, conduit frame, elbow, and headgear. The nasal cushion and conduit frame are available in various sizes to allow for adequate mask fit in the intended patient population.
The Whitsundays Mask System is a prescription device supplied non- sterile.
#### Indications for Use:
The Whitsundays Mask System has two product variants:
- Whitsundays mask
- . Whitsundays SLM (Sleep Lab Mask)
Both masks are intended for patients weighing more than 66 lb (30 kg), who have been prescribed noninvasive CPAP or bi-level positive airway pressure (PAP) therapy. The Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.
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Image /page/5/Picture/0 description: The image contains the logo for ResMed. The logo features a curved line of dots that transition in color from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font.
## Comparison Table:
| Design parameter or<br>feature | Predicate device:<br>Error! Reference source not found.<br>Error! Reference source not found. | Subject device:<br>Error! Reference source not found. | Comments | |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Indications for Use | The Scone mask is intended to be<br>used by patients weighing more<br>than 66 lb (30 kg) who have been<br>prescribed non-invasive positive<br>airway pressure (PAP) therapy such<br>as CPAP or bi-level therapy. The<br>mask is intended for single patient<br>re-use in the home and multi-<br>patient re-use in the<br>hospital/institutional environment. | The Whitsundays mask system has<br>two product variants:<br>• Whitsundays mask<br>• Whitsundays SLM (Sleep Lab<br>Mask)<br>Both masks are intended for<br>patients weighing more than 66 lb<br>(30 kg), who have been prescribed<br>non-invasive CPAP or bi-level<br>positive airway pressure (PAP)<br>therapy. The Whitsundays mask is<br>intended for single-patient reuse in<br>the home environment and the<br>Whitsundays SLM is intended for<br>multi-patient reuse in the<br>hospital/institutional environment.<br>The Sleep Lab Mask (SLM) is the<br>only variant that is validated and<br>intended for multi-patient<br>reprocessing and must be<br>reprocessed if reused between<br>patients. | Equivalent | |
| Intended Use | The mask is intended to provide an<br>interface for CPAP or bi-level<br>devices. | The mask is intended to provide an<br>interface for CPAP or bi-level<br>devices. | Identical | |
| FDA Product Code | BZD | BZD | Identical | |
| Patient population | Patients weighing more than 66lb<br>(30kg) for whom positive airway<br>pressure therapy has been<br>prescribed. | Patients weighing more than 66lb<br>(30kg) for whom positive airway<br>pressure therapy has been<br>prescribed. | Identical | |
| Design parameter or<br>feature | Predicate device:<br>Error! Reference source not found.<br>Error! Reference source not found. | Subject device:<br>Error! Reference source not found. | Comments | |
| Environment of Use | Home or hospital/institutional<br>environment. | Home or hospital/institutional<br>environment. | Identical | |
| Reprocessing claims | Single patient re-use or multi-<br>patient re-use. | Single patient re-use or multi-<br>patient re-use. | Identical | |
| Sterility state as provided | Non-sterile | Non-sterile | Identical | |
| Validated reprocessing<br>methods | High-Level Thermal disinfection | High-Level Thermal disinfection | Identical | |
| Materials | Materials include silicone, polycarbonate, polybutylene<br>terephthalate and nylon elastane polyurethane laminate. | Whitsundays mask system has new materials for the nasal cushion and<br>for the sleeve on the the conduit frame.<br>Device materials include silicone, nylon elastane, polycarbonate, polybutylene terephthalate, polyurethane and nylon elastane polyurethane laminate | Equivalent. All of the materials used<br>in the subject device have been<br>included in previously cleared<br>submissions or have undergone<br>biological evaluation as per ISO<br>10993-1 and ISO 18562-1. | |
| Cushion type | Cradles patient's nose and seals<br>under the nose | Cradles patient's nose and seals<br>under the nose | Identical. The cushion is designed to<br>seal in the same way. | |
| Frame type | Tubular conduit | Tubular conduit | Identical. | |
| PAP tubing connection<br>point | 22mm conical connector as per ISO<br>5356-1 over the head connection | 22mm conical connector as per ISO<br>5356-1 over the head connection | Identical. | |
| Exhaust port location | Elbow and cushion | Elbow and cushion | Identical. | |
| Sizes | Cushion available in four sizes<br>Frame available in two sizes<br>Headgear available in one size | Cushion available three sizes<br>Frame available in two sizes<br>Headgear available in one size | Equivalent | |
| Mask exhaust<br>flow (Nominal)<br>ISO 17510:2015<br>Annex B | Pressure<br>(cm<br>H2O) | Flow<br>(L/min)<br>'Pillows' curve | Flow<br>(L/min)<br>'Pillows' curve | |
| | 4 | 20 | 20 | Identical |
| | 9 | 31 | 31 | |
| | 15 | 41 | 41 | |
| | 20 | 49 | 49 | |
| | 25 | 55 | 55 | |
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Image /page/6/Picture/0 description: The image shows the logo for ResMed. The logo features a curved line made of dots that transition in color from blue to red. Below the line of dots, the text "ResMed" is written in a bold, sans-serif font.
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Image /page/7/Picture/0 description: The image shows the logo for ResMed. The logo consists of the word "ResMed" in a bold, sans-serif font, with the "R" slightly larger than the other letters. Above the wordmark is a curved line made up of a series of dots that transition in color from blue on the left to red on the right. The dots are arranged to create a wave-like pattern.
| Design parameter or<br>feature | Predicate device:<br>Error! Reference source not found.<br>Error! Reference source not found. | Subject device:<br>Error! Reference source not found. | Comments | | | | | | | | | | |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------|-----------------|------------|------------|-----|-----|-------------------------------------------------|--|-----|------------------------------------------------------------------------------------------------------------|
| CO2 re-breathing<br>performance (<20%), ISO<br>17510:2015<br>Annex F | Complies with ISO 17510:2015 CO2<br>requirements (<20%) | Complies with ISO 17510:2015 CO2<br>requirements (<20%) | Identical | | | | | | | | | | |
| Physical Dead space<br>(mL) | Frame size | | SML | STD | Cushion<br>Size | Frame size | | SML | STD | Equivalent. This is a record-only<br>parameter. | | | |
| | Cushion<br>Size | S | 109 | 116 | | SW | 116 | 124 | | | | | |
| | | SW | 105 | 112 | | M | 119 | 127 | | | | | |
| | | M | 113 | 120 | | L | 123 | 130 | | | | | |
| W | | 112 | 119 | | | | | | | | | | |
| Resistance to flow (Pressure<br>drop across mask in cmH2O)<br>ISO 17510:2015<br>Annex C | @50 L/min | | 0.5 | @100 L/min | | 2.3 | @50 L/min | | 0.4 | @100 L/min | | 1.6 | Resistance to flow values is reported<br>in the instructions for use in<br>accordance with ISO 17510:2015. |
| Flow generator setting on<br>compatible ResMed CPAP<br>and Bi-level flow<br>generators. | "Pillows" | | | "Pillows" | | | Identical | | | | | | |
| Operating pressure range<br>(cmH2O) | 4 - 25 | | | 4 - 25 | | | Identical | | | | | | |
| Sound | Sound power level: 21 dBA<br>Sound pressure level: 14 dBA | | | Sound power level: 24 dBA<br>Sound pressure level: 17 dBA | | | Equivalent | | | | | | |
| Operating and storage<br>temperature | Operating temperature: 5°C to 40°C<br>Storage temperature: -20°C to<br>+60°C | | | Operating temperature: 5°C to 40°C<br>Storage temperature: -20°C to<br>+60°C | | | Identical | | | | | | |
| Use life | Scone mask: Visual inspection per<br>instructions for use<br>Scone SLM: 30 validated<br>reprocessing cycles | | | Whitsundays mask: Visual<br>inspection per instructions for use<br>Whitsundays SLM: 30 validated<br>reprocessing cycles | | | Identical | | | | | | |
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Image /page/8/Picture/0 description: The image shows the ResMed logo. The logo features a curved line of dots that transition in color from blue to red. Below the dots, the word "ResMed" is written in a bold, italicized font. The logo is simple and modern, with a focus on the company name and a visual element that suggests movement or flow.
#### Non-Clinical Data Submitted:
Non-clinical verification and validation testing completed for the new device demonstrated that Whitsundays Mask System met all intended performance requirements. These included:
Applicable performance and safety tests in accordance with ISO 17510:2015 Medical devices – Sleep apnoea breathing therapy - Masks and application accessories:
- CO2 rebreathing
- Mask exhaust flow .
- Resistance to flow
Other bench tests:
- Physical dead space
- . Pressure accuracy and pressure swing performance
- . Mechanical Integrity of the mask system before and after the following environmental tests:
- Home cleaning
- Transportation and Storage
- . Operation environment
- Free fall and sit test
- Cleaning and Reprocessing
Biocompatibility evaluation was conducted in accordance with ISO 18562-1 and ISO 10993-1. This evaluation was conducted on components that had patient exposure classifications of long-term external communicating device (tissue) and /or long-term skin contact.
Validation of reprocessing claims (in accordance with ISO 17664-1 and ISO 17664-2) included a combination of cleaning efficacy, disinfection efficacy, residual toxicity, and mechanical integrity testing.
Whitsundays mask system was designed and tested in accordance with the applicable requirements in relevant FDA consensus standards including:
| Standards | Title |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 17510:2015 | Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories |
| 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 (VOCs) |
| ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate |
| ISO 10993-1:2018 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process |
| ISO 10993-5:2009 | Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity |
| ISO 10993-10:2021 | Biological evaluation of medical devices – Part 10: Tests for skin sensitization |
| ISO 10993-17:2002 | Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-18:2021 | Biological evaluation of medical devices – Part 18: Chemical characterization of materials |
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Image /page/9/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line made up of a series of dots that transition in color from blue to purple to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device<br>manufacturer for the processing of medical devices - Part 1: Critical and semi-critical<br>medical devices |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO17664-2:2021 | Processing of health care products - Information to be provided by the medical device<br>manufacturer for the processing of medical devices - Part 2: Non-critical medical<br>devices. |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and<br>sockets |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied by the<br>manufacturer - Part 1: General requirements |
| ISO 20417:2021 | Medical devices — Information to be supplied by the manufacturer |
### Substantial Equivalence Conclusion:
The Whitsundays mask system is substantially equivalent to the predicate Scone mask (K180497):
- It has equivalent intended use .
- It has similar technological characteristics
- It has similar performance characteristics ●
- . The differences do not raise any new questions of safety or effectiveness
- It is as safe and as effective as the predicate device
