(265 days)
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 reprocesssed 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.
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.
The provided FDA 510(k) clearance letter and associated summary pertain to the AirFit F20 Mask Systems, which are non-continuous ventilators (CPAP/Bi-Level masks). This type of device does not typically involve complex diagnostic algorithms or AI components that would necessitate the study structure outlined in your request (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance for AI).
Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (AirFit F20, K170924) through non-clinical performance and safety testing, adherence to recognized standards, and biocompatibility evaluations.
Therefore, many of the specific questions you've asked cannot be directly answered from this document as they are not relevant to the type of device and clearance process involved.
Here's an attempt to extract the relevant information and address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a format typically used for diagnostic algorithm validation. Instead, it compares specific design parameters and performance characteristics of the new devices (AirFit F20 Mask System and AirFit F20 NM Mask System) against the predicate device (AirFit F20, K170924). The "Comments" column often indicates that the performance is "Equivalent" or "Identical," implying that the new devices meet or perform similarly to the established safety and performance profile of the predicate, which serves as the de facto acceptance benchmark.
Here's a summary derived from the comparison table (Pages 9-12 of the provided document):
| Design parameter or feature | Predicate device: AirFit F20, K170924 (Performance/Criteria based on predicate) | Modified device: AirFit F20 Mask System (Reported Performance) | Modified device: AirFit F20 NM Mask System (Reported Performance) | Acceptance Criteria (Implied) |
|---|---|---|---|---|
| Indications for Use | Specified for CPAP/bi-level, >66lb (30kg), single-patient home, multi-patient hospital use. | Equivalent to predicate, with variants for home/sleep lab use. | Equivalent to predicate, with variants for home/sleep lab use. | Equivalent to predicate |
| Intended Use | Interface for CPAP/bi-level devices. | Identical | Identical | Identical to predicate |
| FDA Product Code | BZD | BZD | BZD | Identical to predicate |
| Patient population | Weighing more than 66 lb (30 kg) | Patients weighing more than 66lb (30kg) | Patients weighing more than 66lb (30kg) | Identical to predicate |
| Environment of Use | Home or health institution | Home or health institution | Home or health institution | Identical to predicate |
| Reprocessing claims | Single patient re-use or multi-patient re-use. | Identical | Identical | Identical to predicate |
| Sterility state as provided | Non-sterile | Non-sterile | Non-sterile | Identical to predicate |
| Validated reprocessing methods | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | Identical to predicate |
| Vent type | Multi-hole vent | Multi-hole vent and diffuser vent | Multi-hole vent and diffuser vent | Equivalent to predicate's safety/efficacy profile |
| PAP tubing connection point | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | Identical to predicate |
| Construction material | Polymeric, Textile, magnets | Polymeric, Textile, magnets | Polymeric, Textile | Equivalent to predicate's safety/efficacy profile (NM variant removes magnets) |
| Operating pressure range (cmH2O) | 3 - 40 | 3 – 40 | 3 – 40 | Identical to predicate |
| Sizes | Cushion (3), Headgear (3), Frame (1) | Identical | Identical | Identical to predicate |
| Mask exhaust flow (Nominal) ISO 17510:2015 Annex B | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 20.1, 55.5, 82.4 | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 19, 54, 82 | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 19, 54, 82 | Equivalent to predicate (minor differences within acceptable range for substantial equivalence) |
| CO2 rebreathing performance (normal condition) ISO 17510:2015 Annex F | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: 14.8%, 7.5%, 6.8% SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Equivalent (<20%) (as per ISO standard for substantial equivalence) |
| CO2 rebreathing performance (single fault condition) ISO 17510:2015 Annex F | Fault (ISO 17510:2015) -> Relative CO2 increase Non-SLM: 32.3%, 39.5% SLM: 40.5%, 52.7% | Fault (ISO 17510:2015) -> Relative CO2 increase Non-SLM: ≤ 53.1%, ≤ 53.1% SLM: 40.5%, 52.7% | Fault (ISO 17510:2015) -> Relative CO2 increase Non-SLM: ≤ 53.1%, ≤ 53.1% SLM: 40.5%, 52.7% | Equivalent (<60%) (as per ISO standard for substantial equivalence) |
| Resistance to flow (Pressure drop across mask in cmH2O) ISO 17510:2015 Annex C | @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 | Equivalent (Identical performance) |
| Breathing Resistance (cmH2O) ISO 17510:2015 Annex E | Inspiratory: 0.44 @ 50L/min Expiratory: 0.60 @ 50L/min | Inspiratory: 0.6 @ 50L/min Expiratory: 0.80 @ 50L/min | Inspiratory: 0.6 @ 50L/min Expiratory: 0.80 @ 50L/min | Equivalent (within acceptable limits for substantial equivalence) |
| AAV Operating Pressures ISO 17510:2015 Annex D | De-activation: 1.5 cm H2O Activation: 1.0 cm H2O | De-activation: 2.0 cm H2O Activation: 1.5 cm H2O | De-activation: 2.0 cm H2O Activation: 1.5 cm H2O | Equivalent (within acceptable limits for substantial equivalence) |
| Flow generator setting on compatible ResMed CPAP and Bi-level flow generators | "Full face" | "Full face" | "Full face" | Identical to predicate |
| Sound | Sound power level: 30 dBA Sound pressure level: 23 dBA | Multi-hole vent: 30 dBA power, 22 dBA pressure. Diffuser vent: 21 dBA power, 13 dBA pressure. | Multi-hole vent: 30 dBA power, 22 dBA pressure. Diffuser vent: 21 dBA power, 13 dBA pressure. | Equivalent to predicate (Diffuser vent improves sound) |
| Operating and storage temperature | Operating: 5°C to 40°C Storage: -20°C to +60°C | Identical | Identical | Identical to predicate |
| Magnetic Clips | Number: 4, Surface Strength: <400 mT, 50mm distance: <0.5 mT | Number: 4, Surface Strength: <400 mT, 50mm distance: <0.5 mT | Number: 0, Surface Strength: N/A, 50mm distance: N/A | Equivalent (NM variant removes magnets for specific patient needs) |
2. Sample size used for the test set and the data provenance
The document states that "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." This primarily refers to bench testing and in-vitro studies.
- Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of diagnostic performance. For physical device performance, testing involves multiple units of the product to ensure consistency and reliability, but specific sample sizes for tests (e.g., number of masks tested for exhaust flow, CO2 rebreathing, resistance) are not detailed in this summary.
- Data Provenance: This is not a clinical study in the typical sense. The data comes from non-clinical bench testing conducted by the manufacturer (ResMed Pty Ltd, Australia, with a US office). It is not retrospective or prospective patient data from a particular country, but rather laboratory test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a medical mask system, not a diagnostic algorithm that requires expert interpretation for a "ground truth." The "ground truth" for performance is established by recognized international standards (e.g., ISO 17510:2015 for mask performance, ISO 10993 for biocompatibility) and engineering specifications. Compliance is measured against these standards, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
This question is not applicable for the same reasons as #3. Performance is determined by objective measurements against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This clearance is for a physical medical device (CPAP/Bi-Level mask), not an AI-powered diagnostic tool. There are no "human readers" or "AI assistance" in the context described for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on:
- Compliance with international standards: For physical performance (e.g., CO2 rebreathing, exhaust flow, resistance, AAV pressures, sound) as defined by ISO 17510:2015 and other relevant ISO standards.
- Biocompatibility testing: According to ISO 10993 series and ISO 18562 series.
- Mechanical integrity testing: To ensure durability after various environmental stressors (home cleaning, transport, storage, operation, free fall, reprocessing).
- Cleaning and reprocessing validation: Against standards like ISO 17664-1, ISO 17664-2, ST98, and AAMI TIR12.
Essentially, the ground truth is objective measurement against established engineering and safety standards.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not a machine learning or AI algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
FDA 510(k) Clearance Letter - AirFit F20 Mask Systems
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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"
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K242547 - Sheila Bruschi Page 2
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K242547 - Sheila Bruschi Page 3
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
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 reprocesssed 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:
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
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
lawrence.kwan@resmed.com.au
Ms. Shu-Ying Huang
Regulatory Affairs Manager
Shuying.huang@resmed.com.sg
Official Contact:
Mr. Jason Gorman
Senior Director, Regulatory Affairs
ResMed Corp.
9001 Spectrum Center Blvd San Diego CA 92123 USA
Tel +1 608 622 4038
jason.gorman@resmed.com
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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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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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 reprocesssed 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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Comparison Table
| Design parameter or feature | Predicate device: AirFit F20, K170924 | Modified device: AirFit F20 Mask System | Modified device: AirFit F20 NM Mask System |
|---|---|---|---|
| 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 multipatient 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 multipatient 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 multipatient reprocessing and must be reprocessed if reused between patients. |
| 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. | The mask is intended to provide an interface for CPAP or bi-level devices. |
| FDA Product Code | BZD | BZD | BZD |
| Patient population | Weighing more than 66 lb (30 kg) | Patients weighing more than 66lb (30kg) | Patients weighing more than 66lb (30kg) |
| Environment of Use | Home or health institution | Home or health institution. | Home or health institution. |
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| 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. | The mask is intended to provide an interface for CPAP or bi-level devices. | Identical |
| FDA Product Code | BZD | BZD | BZD | Identical |
| Patient population | Weighing more than 66 lb (30 kg) | Patients weighing more than 66lb (30kg) | Patients weighing more than 66lb (30kg) | Identical |
| Environment of Use | Home or health institution | Home or health institution. | Home or health institution. | Identical |
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| 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. | Single patient re-use or multi-patient re-use. | Identical |
| Sterility state as provided | Non-sterile | Non-sterile | Non-sterile | Identical |
| Validated reprocessing methods | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | Identical |
| Vent type | Multi-hole vent | Multi-hole vent and diffuser vent | Multi-hole vent and diffuser vent | Equivalent |
| PAP tubing connection point | ISO 5356-1 (22mm) | 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 | 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 | 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): 3, 20, 40 Flow (L/min) 'Full Face' curve: 20.1, 55.5, 82.4 | Pressure (cm H2O): 3, 20, 40 Flow (L/min) 'Full Face' curve: 19, 54, 82 | Pressure (cm H2O): 3, 20, 40 Flow (L/min) 'Full Face' curve: 19, 54, 82 | Equivalent |
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| Design parameter or feature | Predicate device: AirFit F20, K170924 | Modified device: AirFit F20 Mask System | Modified device: AirFit F20 NM Mask System | Comments |
|---|---|---|---|---|
| CO2 rebreathing performance (normal condition) | Pressure (cm H2O): 3, 5, 10 Relative CO2 increase Non-SLM: 14.8%, 7.5%, 6.8% SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Equivalent (<20%) ISO 17510:2015 Annex F |
| CO2 rebreathing performance (single fault condition) | Fault (ISO 17510:2015) Relative CO2 increase Non-SLM: 32.3%, 39.5% SLM: 40.5%, 52.7% | Fault (ISO 17510:2015) Relative CO2 increase Non-SLM: ≤ 53.1%, ≤ 53.1% SLM: 40.5%, 52.7% | Fault (ISO 17510:2015) Relative CO2 increase Non-SLM: ≤ 53.1%, ≤ 53.1% SLM: 40.5%, 52.7% | Equivalent (<60%) ISO 17510:2015 Annex F |
| Resistance to flow (Pressure drop across mask in cmH2O) ISO 17510:2015 Annex C | @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 | Equivalent |
| Breathing Resistance (cmH2O) ISO 17510:2015 Annex E | Inspiratory: 0.44 cm H20 @ 50L/min Expiratory: 0.60 cm H20 @ 50L/min | Inspiratory: 0.6 cm H20 @ 50L/min Expiratory: 0.80 cm H20 @ 50L/min | Inspiratory: 0.6 cm H20 @ 50L/min Expiratory: 0.80 cm H20 @ 50L/min | Equivalent |
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| Design parameter or feature | Predicate device: AirFit F20, K170924 | Modified device: AirFit F20 Mask System | Modified device: AirFit F20 NM Mask System | Comments |
|---|---|---|---|---|
| AAV Operating Pressures ISO 17510:2015 Annex D | De-activation: 1.5 cm H2O Activation: 1.0 cm H2O | De-activation: 2.0 cm H2O Activation: 1.5 cm H2O | De-activation: 2.0 cm H2O Activation: 1.5 cm H2O | Equivalent |
| Flow generator setting on compatible ResMed CPAP and Bi-level flow generators | "Full face" | "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 | 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 | Operating temperature: 5°C to 40°C Storage temperature: -20°C to +60°C | Identical |
| Magnetic Clips | Number of magnets: 4 Strength on the surface (mT): < 400 Strength at 50mm distance (mT): < 0.5 | Number of magnets: 4 Strength on the surface (mT): < 400 Strength at 50mm distance (mT): < 0.5 | Number of magnets: 0 Strength on the surface (mT): N/A Strength at 50mm distance (mT): N/A | Equivalent |
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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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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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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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§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).