AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

K234134 · Resmed Pty Ltd (Registration Number: 3004604967) · BZD · Sep 24, 2024 · Anesthesiology

Device Facts

• Record ID: K234134
• Device Name: AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
• Applicant: Resmed Pty Ltd (Registration Number: 3004604967)
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 24, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The AirFit F30i mask has two product variants: AirFit F30i mask is intended for single-patent reuse in the home environment. AirFit F30i SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients. The AirFit F30i Non Magnetic mask has two product variants: The AirFit F30i Non Magnetic variant is intended for single-patient reuse in the home environment. The AirFit F30i Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. This mask is 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 Sleep Lab Mask is the only variant that is validated and intended for multipatient reprocessing and must be reprocessed if reused between patients. The Arcadia has two product variants: Arcadia mask is intended for single-patient reuse in the home environment. Arcadia SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. These masks are intended for patients weighing more than 66 lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

Device Story

Full-face conduit masks (AirFit F30i, AirFit F30i NM, Arcadia) serve as patient interface for CPAP/bi-level flow generators; treat OSA or provide non-life supporting ventilation. Input: pressurized air from flow generator. Transformation: mask provides seal around nose/mouth to deliver air to patient. Output: pressurized air delivery. Used in home or hospital/institutional settings; operated by patient or clinician. Healthcare provider uses mask to facilitate therapy delivery; improves patient compliance/treatment efficacy. Components: cushion, conduit frame, elbow, headgear. Arcadia and AirFit F30i use magnetic clips; AirFit F30i NM (Non-Magnetic) excludes magnets for patients with contraindications. Supplied non-sterile.

Clinical Evidence

Bench testing only. Performance verified per ISO 17510:2015 (CO2 rebreathing, exhaust flow, resistance to flow, AAV pressures, breathing resistance, vibration/noise). Mechanical integrity tested post-reprocessing and environmental stress. Biocompatibility evaluated per ISO 10993 and ISO 18562. Reprocessing validated per ISO 17664-2, ST98, and AAMI TIR12.

Technological Characteristics

Full-face conduit mask system. Components: cushion, conduit frame, elbow, headgear. 22mm conical connector (ISO 5356-1). Magnetic clips (except NM variant). High-level thermal disinfection for SLM variants. Non-sterile. Standards: ISO 17510, ISO 18562, ISO 10993, ISO 17664, ST98, AAMI TIR12.

Indications for Use

Indicated for patients >66lb (30kg) prescribed non-invasive CPAP or bi-level PAP therapy for OSA or non-life supporting ventilatory support. Variants include single-patient home use and multi-patient hospital/institutional use (requires reprocessing).

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

• Moore Park Mask (K183512)

Submission Summary (Full Text)

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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.

September 24, 2024

ResMed Pty Ltd % Sheila Bruschi Senior Director ReMed Corp 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K234134

Trade/Device Name: AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 29, 2023 Received: August 21, 2024

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 (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K234134

#### Device Name

AirFit F30i Mask System, AirFit F30i NM Mask System, Arcadia Mask System

Indications for Use (Describe)

AirFit F30i Mask System

The AirFit F30i mask has two product variants:

· AirFit F30i mask is intended for single-patent reuse in the home environment.

• AirFit F30i SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.

#### AirFit F30i NM Mask System

The AirFit F30i Non Magnetic mask has two product variants:

· The AirFit F30i Non Magnetic variant is intended for single-patient reuse in the home environment.

· The AirFit F30i Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

This mask is 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 Sleep Lab Mask is the only variant that is validated and intended for multipatient reprocessing and must be reprocessed if reused between patients.

Arcadia Mask System

The Arcadia has two product variants:

· Arcadia mask is intended for single-patient reuse in the home environment.

· Arcadia SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

These masks are intended for patients weighing more than 66 lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed 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/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 line of dots is the word "ResMed" in a bold, sans-serif font.

| 510(k) Summary | [As required by 21 CFR 807.92(c)] |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 24 September 2024 |
| 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>[e-mail] |
| 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 [phone]<br>[e-mail] |
| Device Trade Name: | AirFit F30i Mask System, AirFit F30i NM Mask System, Arcadia Mask System |
| Device Common Name: | Vented Full Face Mask |
| Classification and Classification Name: | 21 CFR 868.5905, 73 BZD (Class II)<br>Accessory to Noncontinuous Ventilator (IPPB) |
| Product Code: | BZD |
| Predicate Device: | Moore Park Mask (K183512) |
| Submission Reason: | Changes being effected<br>New device |

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Image /page/5/Picture/1 description: The image shows the logo for ResMed. The logo features the company name "ResMed" in a bold, sans-serif font, positioned below a stylized graphic. The graphic consists of a series of connected circles that form a curved line, transitioning in color from blue on the left to red on the right, with shades of purple in the middle.

#### Device description:

The AirFit F30i, AirFit F30i NM and Arcadia mask systems are full-face conduit masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or non-life supporting ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.

The AirFit F30i, AirFit F30i NM and Arcadia mask systems each have two product variants:

- . AirFit F30i Mask/ AirFit F30i NM Mask/ Arcadia Mask: This is the home use variant that is intended for single patient re-use.
- . AirFit F30i SLM/ AirFit F30i NM SLM/ Arcadia SLM (sleep lab mask): This is intended for multipatient re-use and must be reprocessed if reused between patients using the disinfection guide

The AirFit F30i, AirFit F30i NM and Arcadia mask systems are made up of the following four main component assemblies: Cushion, conduit frame, elbow and headgear. The cushion and conduit frame are available in various sizes to allow for adequate mask fit over the intended patient population.

The AirFit F30i, AirFit F30i NM and Arcadia mask systems are prescription devices supplied non-sterile.

Compared to the predicate:

- AirFit F30i mask system labeling was revised with magnet-related contraindications and warnings,
- . AirFit F30i NM mask system has no magnetic clips to enable usage of the device by patients who are now excluded from the intended users of the predicate due to new magnet-related contraindications and warnings,
- . Arcadia mask system is a new design with magnetic clips.

#### Indications for use:

#### AirFit F30i Mask System

The AirFit F30i mask has two product variants:

- AirFit F30i mask is intended for single-patent reuse in the home environment.
AirFit F30i SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. ● Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bilevel positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multipatient reprocessing and must be reprocessed if reused between patients.

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Image /page/6/Picture/1 description: The image contains the logo for ResMed. The logo features a curved line made up of a series of circles that transition in color from blue to red. Below the line of circles is the word "ResMed" in a bold, sans-serif font.

## AirFit F30i NM Mask System

The AirFit F30i Non Magnetic mask has two product variants:

- The AirFit F30i Non Magnetic variant is intended for single-patient reuse in the home environment. .
- . The AirFit F30i Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

This mask is 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 Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

### Arcadia Mask System

The Arcadia has two product variants:

- Arcadia mask is intended for single-patient reuse in the home environment.
- Arcadia SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

These masks are intended for patients weighing more than 66 lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask 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/7/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line of colored dots that transition from blue to red. Below the dots, the word "ResMed" is written in a bold, sans-serif font.

# Comparison table

| | Predicate device | Subject device | | | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Design parameter or<br>feature | K183512 | K234134 | | | |
| | Moore Park Mask:<br>(Commercial name AirFit F30i) | Modified device:<br>AirFit F30i Mask<br>System | Modified device:<br>AirFit F30i NM Mask System | New device:<br>Arcadia Mask System | Comments |
| Indications for Use | The Moore Park mask is intended<br>to be used by patients weighing<br>more than 66 lb (30 kg) who<br>have been prescribed non-<br>invasive positive airway pressure<br>(PAP) therapy such as CPAP or bi-<br>level therapy. The mask is<br>intended for single patient re-use<br>in the home and multi-patient re-<br>use in the hospital/institutional<br>environment. | The AirFit F30i mask has<br>two product variants:<br>AirFit F30i mask is<br>intended for single-<br>patent reuse in the<br>home environment. AirFit F30i SLM<br>(Sleep Lab Mask)<br>variant is intended<br>for multi-patient<br>reuse in the<br>hospital/institutional<br>environment. Both masks are intended<br>for patients weighing<br>more than 66lb (30kg),<br>who have been<br>prescribed non-invasive<br>CPAP or bi-level positive<br>airway pressure (PAP)<br>therapy. The Sleep Lab<br>Mask is the only variant<br>that is validated and<br>intended for multi-<br>patient reprocessing and | The AirFit F30i Non Magnetic mask has<br>two product variants:<br>The AirFit F30i Non Magnetic<br>variant is intended for single-<br>patient reuse in the home<br>environment. The AirFit F30i Non Magnetic SLM<br>(Sleep Lab Mask) variant is<br>intended for multi-patient reuse in<br>the hospital/institutional<br>environment. This mask is for patients weighing more<br>than 66 lb (30 kg), who have been<br>prescribed non-invasive CPAP or bi-level<br>positive airway pressure (PAP) therapy.<br>The Sleep Lab Mask is the only variant<br>that is validated and intended for multi-<br>patient reprocessing and must be<br>reprocessed if reused between patients. | The Arcadia has two product<br>variants:<br>Arcadia mask is intended for<br>single-patient reuse in the<br>home environment. Arcadia SLM (Sleep Lab<br>Mask) variant is intended for<br>multi-patient reuse in the<br>hospital/institutional<br>environment. These masks are intended for<br>patients weighing more than 66 lb<br>(30kg), who have been prescribed<br>non-invasive CPAP or bi-level<br>positive airway pressure (PAP)<br>therapy. The Sleep Lab Mask 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 |

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Image /page/8/Picture/0 description: The image contains the ResMed logo. The logo features a curved line made of connected circles that transition in color from blue to red. Below the line is the word "ResMed" in a bold, sans-serif font.

| Design parameter or<br>feature | Predicate device<br>K183512 | Subject device<br>K234134 | | | Comments |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------|
| | Moore Park Mask:<br>(Commercial name AirFit F30i) | Modified device:<br>AirFit F30i Mask<br>System | Modified device:<br>AirFit F30i NM Mask System | New device:<br>Arcadia Mask System | |
| | | must be reprocesssed if<br>reused between patients. | | | |
| Intended Use | The mask is intended to<br>provide an interface for CPAP<br>or bi-level devices. | | The mask is intended to provide an interface for CPAP or bi-level devices. | | Identical |
| FDA Product Code | BZD | | BZD | | Identical |
| Patient population | Patients weighing more than<br>66lb (30kg) for whom positive<br>airway pressure therapy has<br>been prescribed. | | Patients weighing more than 66lb (30kg) for whom positive airway pressure therapy has been<br>prescribed. | | Identical |
| Environment of Use | Home or<br>hospital/institutional<br>environment. | | Home or hospital/institutional environment. | | Identical |
| Reprocessing claims | Single patient re-use or multi-<br>patient re-use. | | Single patient re-use or multi-patient re-use. | | Identical |
| Sterility state as provided | Non-sterile | | Non-sterile | | Identical |
| Validated reprocessing<br>methods | High-Level Thermal<br>disinfection | | High-Level Thermal disinfection | | Identical |
| Cushion type | Oral nasal cradle cushion that<br>seals under the nose and<br>around the mouth | | Oral nasal cradle cushion that seals under the nose and around<br>the mouth | Oral pillows cushions that seals<br>under the nose and around<br>the mouth | Equivalent |
| Frame type | Tubular conduit | | Tubular conduit | | Identical |

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Image /page/9/Picture/0 description: The image contains the ResMed logo. The logo features a curved line made of connected circles that transition in color from blue to red. Below the line is the word "ResMed" in a bold, sans-serif font.

| Design parameter or feature | Predicate device<br>K183512 | | Subject device<br>K234134 | | New device:<br>Arcadia Mask System | Comments | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--------------------------------------------|--|--|--|-----------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|------------------------|--|-----------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|------------------------|
| | Moore Park Mask:<br>(Commercial name AirFit F30i) | Modified device:<br>AirFit F30i Mask System | Modified device:<br>AirFit F30i NM Mask System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PAP tubing connection point | 22mm conical connector as per ISO 5356-1 over the head connection | | 22mm conical connector as per ISO 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 three sizes<br>Headgear available in one size | | Cushion available in four sizes<br>Frame available in three sizes<br>Headgear available in one size | | Pillows cushion available in three sizes<br>Frame available in three sizes<br>Headgear available in one size | Equivalent | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Mask exhaust flow<br>(Nominal) | Pressure (cm H2O) Flow (L/min) 'Full Face' curve 4 20 9 31 15 41 20 49 25 55 | | | | | | | | | | | | | | Pressure (cm H2O) Flow (L/min) 'Full Face' curve 4 22 11 38 17 48 24 59 30 67 | | | | | | | | | | | | | | Pressure (cm H2O) Flow (L/min) 'Full Face' curve 4 22 11 39 17 49 24 60 30 69 | | | | | | | | | | | | | ISO 17510:2015 Annex B |
| CO2 re-breathing performance – Normal Condition (<20%) | Pressure (cm H2O) Relative CO2 increase 4 8.1% 5 5.8% 10 1.9% | | | | | | | | | | Relative CO2 increase 7.7% 5.2% 1.5% | | | | | | Relative CO2 increase Arcadia Mask Arcadia SLM 9.9% 9.7% 8.5% 8.4% 6.3% 6.2% | | | | | | | | | | ISO 17510:2015 Annex F | | | | | | | | | | | | | | | |

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Image /page/10/Picture/0 description: The image shows the ResMed logo. The logo consists of a series of colored dots arranged in a curved line, transitioning from blue to red. Below the dots, the word "ResMed" is written in a bold, sans-serif font.

| Design parameter or feature | | Predicate device<br>K183512 | Subject device<br>K234134 | | | Comments |
|------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------|
| | | Moore Park Mask:<br>(Commercial name AirFit F30i) | Modified device:<br>AirFit F30i Mask System | Modified device:<br>AirFit F30i NM Mask System | New device:<br>Arcadia Mask System | |
| CO2 re-<br>breathing<br>performance<br>- Single Fault<br>Condition<br>(<60%) | Fault | Relative CO2 increase | Relative CO2 increase | | Relative CO2 increase | |
| | | | | | Arcadia Mask<br>Arcadia SLM | |
| | Fault 1 | 32.6% | 42.5% | | 42.8%<br>41.9% | ISO<br>17510:2015<br>Annex F |
| | Fault 2 | 45.3% | 55.1% | | 54.8%<br>54.3% | |
| Resistance to flow<br>(Pressure drop across<br>mask in cmH₂O) | | @50 L/min @100 L/min<br>0.2 1.0 | @50 L/min @100 L/min<br>0.2 1.0 | | @50 L/min @100 L/min<br>0.3 1.2 | ISO<br>17510:2015<br>Annex C |
| Breathing<br>Resistance<br>(cmH₂O) | Inspiratory | 0.2 | 0.2 | | 0.2 | ISO<br>17510:2015<br>Annex E |
| | Expiratory | 0.3 | 0.4 | | | |
| AAV<br>Operating<br>Pressures | Open-to-atmosphere<br>pressure | ≤ 4 cm H2O | | < 4 cm H2O | | Equivalent<br>ISO<br>17510:2015<br>Annex D |
| | Closed-to-atmosphere<br>pressure | ≤ 4 cm H2O | | < 4 cm H2O | | ISO<br>17510:2015<br>Annex D |
| Flow generator setting on<br>compatible ResMed CPAP | | "Full face" (Air 10 devices) | | "Full face" (Air 10 devices) | | Identical |
| Design parameter or<br>feature | | Predicate device<br>K183512 | Subject device<br>K234134 | | | Comments |
| | | Moore Park Mask:<br>(Commercial name AirFit F30i) | Modified device:<br>AirFit F30i Mask<br>System | Modified device:<br>AirFit F30i NM Mask System | New device:<br>Arcadia Mask System | |
| and Bi-level flow<br>generators. | | | | | | |
| Operating pressure range<br>(cmH2O) | | 4 - 25 | 4 - 30 | 4 - 30 | 4 - 30 | Equivalent |
| Sound | | Sound power level: 25 dBA<br>Sound pressure level: 18 dBA | Sound power level: 25 dBA<br>Sound pressure level: 18 dBA | Sound power level: 25 dBA<br>Sound pressure level: 18 dBA | Multi-hole vent<br>QuietAir vent<br>Sound power level: 22 dBA<br>Sound pressure level: 15 dBA | Equivalent |
| Magnetic<br>Clips | Number of<br>magnets | 4 | 4 | 0 | 4 | Equivalent |
| | Strength<br>(mT) on<br>the<br>surface | <400mT | <400mT | N/A | <400mT | |
| | Strength<br>(mT) at 50<br>mm<br>distance | <0.5 mT | <0.5 mT | N/A | <0.5 mT | |
| Operating and storage<br>temperature | | Operating temperature: 5°C<br>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 +60°C | | Identical |

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Image /page/11/Picture/0 description: The image contains the ResMed logo. The logo features a curved line of dots that transition in color from blue to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.

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Image /page/12/Picture/1 description: The image shows the ResMed logo. The logo consists of the word "ResMed" in a bold, sans-serif font, with the "R" slightly larger than the other letters. Above the word "ResMed" is a curved line made up of a series of colored dots that transition from blue to purple to red. The dots are arranged in a wave-like pattern, creating a visual representation of airflow or breathing.

## Non-clinical data submitted:

Non-clinical verification and validation assessment/testing demonstrated that AirFit F30i NM and Arcadia mask systems 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 (ISO 17510:2015 Annex F) ●
- . Exhaust flow (ISO 17510:2015 Annex B)
- Resistance to flow (ISO 17510:2015 Annex C)
- Anti-Asphyxia valve operating pressures (ISO 17510:2015 Annex D)
- Breathing resistance (ISO 17510:2015 Annex E) ●
- . Vibration and noise (ISO 17510:2015 Annex G)

#### Other bench tests:

- Pressure accuracy and pressure swing performance
- Mechanical Integrity of the mask system before and after the following environmental tests:
- Home cleaning
- l Transportation and Storage
- 트 Operation environment
- Free fall and sit test
- Reprocessing

Biocompatibility evaluation was assessed and/or conducted in accordance with ISO 18562-1, ISO 10993-1 and applicable regulatory guidance.

Validation of reprocessing claims (in accordance with ISO 17664-2, ST98 and AAMI TIR12) included a combination of cleaning efficacy, disinfection efficacy, residual toxicity and mechanical integrity assessment/testing.

Verification confirmed that the new device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate AirFit F30i mask system (K183512).

Risk assessment activities, including tests of magnetic field strength, were conducted to assess the risk of magnetic interference from static magnetic fields for ResMed masks containing magnets with medical implants/devices and metallic implanted objects.

The AirFit F30i, AirFit F30i NM and Arcadia mask systems were assessed and/or 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<br>and testing within a risk management process |
| ISO 18562-2:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for<br>emissions of particulate matter |

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Image /page/13/Picture/0 description: The image shows the logo for ResMed. The logo consists of the word "ResMed" in a bold, sans-serif font, with a stylized wave-like design above it. The wave is made up of a series of circles that transition in color from blue to red. The logo is simple, modern, and easily recognizable.

| ISO 18562-3:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for<br>emissions of volatile organic compounds (VOCs) |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for<br>leachables in condensate |
| ISO 10993-1:2018 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management<br>process |
| ISO 10993-3:2014 | Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive<br>toxicity |
| 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 10993-11:2017 | Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity |
| ISO10993-12:2021 | Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials |
| ISO 10993-17:2002 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable<br>substances |
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for<br>the processing of medical devices - Part 1: Critical and semi-critical medical devices |
| ISO17664-2:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for<br>the processing of medical devices - Part 2: Non-critical medical devices. |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1:<br>General requirements |
| ISO 20417:2021 | Medical devices — Information to be supplied by the manufacturer |
| ST98:2022 | Cleaning validation of health care products - Requirements for development and validation of a cleaning<br>process for medical devices |
| AAMI TIR12:2020 | Designing, Testing, And Labeling Medical Devices Intended For Processing By Health Care Facilities: A<br>Guide For Device Manufacturers |

#### Substantial Equivalence Conclusion:

The AirFit F30i, AirFit F30i NM and Arcadia mask systems are substantially equivalent to the predicate K183512:

- They have equivalent intended use ●
- . They have similar technological characteristics
- They have similar performance characteristics
- . The differences do not raise any new questions of safety or effectiveness
- They are as safe and as effective as the predicate device .