AirFit F20 Mask System; AirFit F20 NM Mask System

K242547 · Resmed Pty , Ltd. · BZD · May 19, 2025 · Anesthesiology

Device Facts

• Record ID: K242547
• Device Name: AirFit F20 Mask System; AirFit F20 NM Mask System
• Applicant: Resmed Pty , Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: May 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

AirFit F20 Mask System: The AirFit F20 mask has two product variants: • AirFit F20 mask is intended for single-patent reuse in the home environment. • AirFit F20 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 reprocessed if reused between patients. AirFit F20 NM Mask System: The AirFit F20 Non Magnetic mask has two product variants: • The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment. • The AirFit F20 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.

Device Story

Full-face mask system serving as patient interface for CPAP/bi-level flow generators; delivers pressurized air to patient nose and mouth. Comprised of cushion, elbow, frame, and headgear. AirFit F20 NM variant utilizes non-magnetic clips; standard AirFit F20 uses magnetic clips. Used in home (single-patient) or hospital/institutional (multi-patient) settings. Multi-patient variants (SLM) require validated reprocessing. Provides seal for therapeutic air delivery; supports treatment of OSA and ventilatory support. Healthcare providers select mask size for patient fit; patients use device during sleep therapy. Benefits include effective delivery of prescribed airway pressure.

Clinical Evidence

Bench testing only. Performance verified against ISO 17510:2015 (CO2 rebreathing, exhaust flow, resistance to flow, anti-asphyxia valve pressure, breathing resistance, vibration/noise). Biocompatibility evaluated per ISO 10993 and ISO 18562 series. Multi-patient reprocessing validated per ISO 17664, ST98, and AAMI TIR12.

Technological Characteristics

Full-face mask system; polymeric materials, textile, and magnets (or non-magnetic clips). ISO 5356-1 (22mm) tubing connection. Multi-hole or diffuser vent. Operating pressure 3-40 cmH2O. Non-sterile. Biocompatibility per ISO 10993/18562. Reprocessing validated for SLM variants.

Indications for Use

Indicated for patients weighing >66lb (30kg) prescribed non-invasive CPAP or bi-level PAP therapy for OSA or ventilatory support.

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

• AirFit F20 (K170924)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 19, 2025

ResMed Pty Ltd
% Jason Gorman
Senior Director, Regulatory Affairs
ResMed Corp
9001 Spectrum Center Boulevard
San Diego, California 92123

Re: K242547
Trade/Device Name: AirFit F20 Mask System; AirFit F20 NM Mask System
Regulation Number: 21 CFR 868.5905
Regulation Name: Noncontinuous Ventilator (IPPB)
Regulatory Class: Class II
Product Code: BZD
Dated: April 17, 2025
Received: April 17, 2025

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K242547 - Sheila Bruschi
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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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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K242547 - Sheila Bruschi
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Sincerely,

Rachana Visaria -S

Rachana Visaria, PhD.
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K242547 | |
| Device Name AirFit F20 Mask System; AirFit F20 NM Mask System | |
| Indications for Use (Describe) AirFit F20 Mask System: The AirFit F20 mask has two product variants: • AirFit F20 mask is intended for single-patent reuse in the home environment. • AirFit F20 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 reprocessed if reused between patients. | |
| AirFit F20 NM Mask System: The AirFit F20 Non Magnetic mask has two product variants: • The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment. • The AirFit F20 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. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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ResMed

Traditional 510(k)

AirFit F20 and AirFit F20 Mask Systems

# 1 510(k) Summary

[As required by 21 CFR 807.92(c)]

Date of Submission: 26 August 2024

Company Name/Owner: ResMed Pty Ltd
1 Elizabeth Macarthur Drive
Bella Vista, NSW, 2153 Australia

Prepared and Submitted by: Mr. Lawrence Kwan
Regulatory Affairs Specialist
[e-mail]
Ms. Shu-Ying Huang
Regulatory Affairs Manager
[e-mail]

Official Contact: Mr. Jason Gorman
Senior Director, Regulatory Affairs
ResMed Corp.
9001 Spectrum Center Blvd San
Diego CA 92123 USA
Tel [phone]
[e-mail]

Device Trade Name: AirFit F20 Mask System, AirFit F20 NM Mask System

Device Common Name: Vented Full Face Mask

Classification and Classification Name: 21 CFR 868.5905, BZD (Class II)
Accessory to Noncontinuous Ventilator (IPPB)

Product Code: BZD

Predicate Device: AirFit F20 (K170924)

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ResMed

Traditional 510(k) AirFit F20 and AirFit F20 Mask Systems

# Device Description

The AirFit F20 and AirFit F20 NM Mask Systems are both full-face masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices. CPAP & Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or 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 F20 mask system has two product variants:

- AirFit F20 Mask: This is the home use variant that is intended for single patient re-use.
- AirFit F20 SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.

AirFit F20 (K170924) had a "For Her" variant which was cleared with aesthetic colour pops, the AirFit F20 Mask and AirFit F20 SLM also have the same "For Her" variant.

The AirFit F20 NM mask system has two product variants:

- AirFit F20 NM Mask: This is the home use variant that is intended for single patient re-use.
- AirFit F20 NM SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.

The AirFit F20 and AirFit F20 NM Mask Systems share a common design architecture as the predicate AirFit F20 (K170924), except that the AirFit F20 NM Mask System has non-magnetic clips.

The AirFit F20 and AirFit F20 NM mask systems are made up of the following four main component assemblies: cushion, elbow, frame, and headgear. The cushion and headgear are available in various sizes to allow for adequate mask fit over the intended patient population.

The AirFit F20 and AirFit F20 NM mask systems are prescription devices supplied non-sterile.

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ResMed

Traditional 510(k)

AirFit F20 and AirFit F20 Mask Systems

# Indications for Use:

## AirFit F20 Mask System:

The AirFit F20 mask has two product variants:

- AirFit F20 mask is intended for single-patent reuse in the home environment.
- AirFit F20 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 reprocessed if reused between patients.

## AirFit F20 NM Mask System:

The AirFit F20 Non Magnetic mask has two product variants:

- The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment.
- The AirFit F20 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.

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ResMed

Traditional 510(k)

AirFit F20 and AirFit F20 Mask Systems

Comparison Table

| Design parameter or feature | Predicate device: AirFit F20, K170924 | Modified device: AirFit F20 Mask System | Modified device: AirFit F20 NM Mask System | Comments |
| --- | --- | --- | --- | --- |
| Indications for Use | The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The AirFit F20 is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment. | The AirFit F20 masks have two product variants:
• The AirFit F20 variants are intended for single-patient reuse in the home environment
• The AirFit F20 SLM (Sleep Lab Masks) variants are intended for multi-patient reuse in the hospital/institutional environment.
These 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 Masks are the only variants that are validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients. | The AirFit F20 Non Magnetic mask has two product variants:
• The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment
• The AirFit F20 Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
This mask is 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 Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients. | Equivalent |
| Intended Use | The mask is intended to provide an interface for CPAP 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 | Weighing more than 66 lb (30 kg) | Patients weighing more than 66lb (30kg) | | Identical |
| Environment of Use | Home or health institution | Home or health institution. | | Identical |

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ResMed

Traditional 510(k)

AirFit F20 and AirFit F20 Mask Systems

| Design parameter or feature | Predicate device: AirFit F20, K170924 | | Modified device: AirFit F20 Mask System | | Modified device: AirFit F20 NM Mask System | | Comments |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Reprocessing claims | Single patient re-use or multi-patient re-use. | | Single patient re-use or multi-patient re-use. | | | | Identical |
| Sterility state as provided | Non-sterile | | Non-sterile | | | | Identical |
| Validated reprocessing methods | High-Level Thermal disinfection, Sterilization | | High-Level Thermal disinfection, Sterilization | | | | Identical |
| Vent type | Multi-hole vent | | Multi-hole vent and diffuser vent | | | | Equivalent |
| PAP tubing connection point | ISO 5356-1 (22mm) | | ISO 5356-1 (22mm) | | | | Identical |
| Construction material | Polymeric materials, Textile and magnets | | Polymeric materials, Textile and magnets | | Polymeric materials, Textile | | Equivalent |
| Operating pressure range (cmH₂O) | 3 - 40 | | 3 – 40 | | | | Identical |
| Sizes | Cushion available in three sizes
Headgear available in three sizes
Frame available in one size | | Cushion available in three sizes
Headgear available in three sizes
Frame available in one size | | | | Identical |
| Mask exhaust flow (Nominal)
ISO 17510:2015
Annex B | Pressure (cm H₂O) | Flow (L/min)
‘Full Face’ curve | Pressure (cm H₂O) | Flow (L/min)
‘Full Face’ curve | Pressure (cm H₂O) | Flow (L/min)
‘Full Face’ curve | Equivalent |
| | 3 | 20.1 | 3 | 19 | 3 | 19 | |
| | 20 | 55.5 | 20 | 54 | 20 | 54 | |
| | 40 | 82.4 | 40 | 82 | 40 | 82 | |

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ResMed

Traditional 510(k)

AirFit F20 and AirFit F20 Mask Systems

| Design parameter or feature | | Predicate device: AirFit F20, K170924 | | Modified device: AirFit F20 Mask System | | Modified device: AirFit F20 NM Mask System | | Comments |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CO2 re-breathing performance (normal condition) | Pressure (cm H2O) | Relative CO2 increase | | Relative CO2 increase | | | | Equivalent (<20%) ISO 17510:2015 Annex F |
| | | Non-SLM | SLM | Non-SLM | SLM | Non-SLM | SLM | |
| | 3 | 14.8% | | 11.7% | ≤ 11.4% | 11.7% | ≤ 11.4% | |
| | 5 | 7.5% | | 7.3% | | 7.3% | | |
| | 10 | 6.8% | | 2.9% | | 2.9% | | |
| CO2 re-breathing performance (single fault condition) | Fault (ISO 17510:2015) | Relative CO2 increase | | Relative CO2 increase | | | | Equivalent (<60%) ISO 17510:2015 Annex F |
| | | Non-SLM | SLM | Non-SLM | SLM | Non-SLM | SLM | |
| | Fault 1 | 32.3% | | 40.5 % | ≤ 53.1% | 40.5 % | ≤ 53.1% | |
| | Fault 2 | 39.5% | | 52.7% | | 52.7% | | |
| Resistance to flow (Pressure drop across mask in cmH2O) ISO 17510:2015 Annex C | | | | | | | Equivalent | |
| | | @50 L/min <0.8 cmH2O | @100 L/min <1.6 cmH2O | @50 L/min <0.8 cmH2O | @100 L/min <1.6 cmH2O | @50 L/min <0.8 cmH2O | | @100 L/min <1.6 cmH2O |
| | | 0.2 cm H2O | 0.9 cm H2O | 0.2 cm H2O | 0.6 cm H2O | 0.2 cm H2O | | 0.6 cm H2O |
| Breathing Resistance (cmH2O) ISO 17510:2015 Annex E | Inspiratory | 0.44 cm H2O @ 50L/min | | 0.6 cm H2O @ 50L/min | | | | Equivalent |
| | Expiratory | 0.60 cm H2O @ 50L/min | | 0.80 cm H2O @ 50L/min | | | | Equivalent |

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ResMed

Traditional 510(k)

AirFit F20 and AirFit F20 Mask Systems

| AAV Operating Pressures ISO 17510:2015 Annex D | De-activation | 1.5 cm H2O | 2.0 cm H2O | | Equivalent |
| --- | --- | --- | --- | --- | --- |
| | Activation | 1.0 cm H2O | 1.5 cm H2O | | Equivalent |
| Design parameter or feature | | Predicate device: AirFit F20, K170924 | Modified device: AirFit F20 Mask System | Modified device: AirFit F20 NM Mask System | Comments |
| Flow generator setting on compatible ResMed CPAP and Bi-level flow generators. | | “Full face” | “Full face” | | Identical |
| Sound | | Sound power level: 30 dBA Sound pressure level: 23 dBA | Multi-hole vent
Sound power level: 30 dBA
Sound pressure level: 22 dBA
Diffuser vent
Sound power level: 21 dBA Sound pressure level: 13 dBA | | Equivalent |
| Operating and storage temperature | | Operating temperature: 5°C to 40°C
Storage temperature: -20°C to +60°C | Operating temperature: 5°C to 40°C
Storage temperature: -20°C to +60°C | | Identical |
| Magnetic Clips | Number of magnets | 4 | 4 | 0 | Equivalent |
| | Strength on the surface (mT) | < 400 | < 400 | N/A | |
| | Strength at 50mm distance (mT) | < 0.5 | < 0.5 | N/A | |

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ResMed

Traditional 510(k) AirFit F20 and AirFit F20 Mask Systems

# Non-clinical data submitted:

Non-clinical verification and validation testing completed for the AirFit F20 and AirFit F20 NM Mask Systems demonstrated that the 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 performance testing
- 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
- Reprocessing

Biocompatibility evaluation was assessed and/or conducted in accordance with ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process, ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process and applicable regulatory guidance.

Validation of multi-patient re-use reprocessing claims (in accordance with ISO 17664-1 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices, ISO 17664-2 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices, ST98 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices and AAMI TIR12 Designing, Testing, And Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide For Device Manufacturers) included a combination of cleaning efficacy, disinfection efficacy, residual toxicity and mechanical integrity assessment/testing.

Verification confirmed that AirFit F20 and AirFit F20 NM Mask Systems met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate AirFit F20 Mask (K170924).

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ResMed

Traditional 510(k)

AirFit F20 and AirFit F20 Mask Systems

The AirFit F20 and AirFit F20 NM 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 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 10993-11:2017 | 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 substances |
| ISO 10993-18:2021 | Biological evaluation of medical devices – Part 18: Chemical characterization of materials |
| ISO 10993-23:2021 | Biological evaluation of medical devices – Part 23: Tests for irritation |
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for 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 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: 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 process for medical devices |
| AAMI TIR12:2020 | Designing, Testing, And Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide For Device Manufacturers |

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ResMed

Traditional 510(k)

AirFit F20 and AirFit F20 Mask Systems

## Substantial Equivalence Conclusion:

The AirFit F20 mask systems and AirFit F20 NM mask systems are substantially equivalent to the predicate AirFit F20 (K170924):

- 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

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